OBG Management

Cooley JJ, Maguire FB, Morris CR, et al. Cervical cancer stage at diagnosis and survival among women ≥65 years in California. Cancer Epidemiol Biomarkers Prev. 2023;32:91-97. doi:10.1158/1055-9965.EPI-22-0793.

EXPERT COMMENTARY

Cervical cancer screening guidelines recommend screening cessation at age 65 once specific exit criteria are met. (According to the American Cancer Society, individuals aged >65 years who have no history of cervical intraepithelial neoplasia [CIN] grade 2 or more severe disease within the past 25 years, and who have documented adequate negative prior screening in the prior 10 years, discontinue all cervical cancer screening.)¹ We know, however, that about one-fifth of all cervical cancer cases are diagnosed among individuals aged 65 or older, and for Black women that proportion is even higher when data are appropriately adjusted to account for the increased rate of hysterectomy among Black versus White women.^2-4

Early-stage cervical cancer is largely a curable disease with very high 5-year overall survival rates. Unfortunately, more than half of all cervical cancer is diagnosed at a more advanced stage, and survival rates are much lower for this population.⁵

Cervical cancer incidence rates plummeted in the United States after the introduction of the Pap test for cervical cancer screening. However, the percentage of women who are not up to date with cervical cancer screening may now be increasing, from 14% in 2005 to 23% in 2019 according to one study from the US Preventive Services Task Force.⁶ When looking at cervical cancer screening rates by age, researchers from the Centers for Disease Control and Prevention estimate that the proportion of patients who have not been recently screened goes up as patients get older, with approximately 845,000 American women aged 61 to 65 not adequately screened in 2015 alone.⁷

Details of the study

Cooley and colleagues sought to better characterize the cohort of women diagnosed with cervical cancer at a later age, specifically the stage at diagnosis and survival.⁸ They used data from the California Cancer Registry (CCR), a large state-mandated, population-based data repository that is affiliated with the Surveillance, Epidemiology, and End Results (SEER) program.

The researchers identified 12,442 womenin the CCR who were newly diagnosed with cervical cancer from 2009 to 2018, 17.4% of whom were age 65 or older. They looked at cancer stage at diagnosis as it relates to relative survival rate (“the ratio of the observed survival rate among those who have cancer divided by the expected survival rate for people of the same sex, race/ethnicity, and age who do not have cancer”), Charlson comorbidity score, socioeconomic status, health insurance status, urbanicity, and race/ethnicity.

Results. In this study, 71% of women aged 65 or older presented with advanced-stage disease (FIGO [International Federation of Gynecology and Obstetrics] stage II–IV) as compared with only 48% in those aged 21 to 64. Five-year relative survival rates also were lower in the older cohort—23% to 37%, compared with 42% to 52% in the younger patients. In a sensitivity analysis, late-stage disease was associated with older age, increasing medical comorbidities, and nonadenocarcinoma histology.

Interestingly, older women of Hispanic ethnicity were less likely to be diagnosed with late-stage disease when compared with non-Hispanic White women.

Study strengths and limitations

Although this study’s conclusions—that patients with advanced-stage cancer are more likely to do poorly than those with early-stage cancer—may seem obvious to some even without the proven data, it is still important to highlight what a clinician may intuit with data to support that intuition. It is particularly important to emphasize this risk in older women in light of the aging population in the United States, with adults older than age 65 expected to account for more than 20% of the nation’s population by 2030.⁹

The study by Cooley and colleagues adds value to the existing literature due to its large study population, which included more than 12,000 patients diagnosed with cervical cancer.⁸ And although its results may not be completely generalizable as the data were gathered from only a California-specific population, the sample was diverse with significant portions of Hispanic and Black patients. This study supports previous data that showed high rates of advanced cervical cancer in women older than age 65, with resultant worse 5-year relative survival in this population of older women specifically.⁴ ●

Cooley JJ, Maguire FB, Morris CR, et al. Cervical cancer stage at diagnosis and survival among women ≥65 years in California. Cancer Epidemiol Biomarkers Prev. 2023;32:91-97. doi:10.1158/1055-9965.EPI-22-0793.

EXPERT COMMENTARY

Cervical cancer screening guidelines recommend screening cessation at age 65 once specific exit criteria are met. (According to the American Cancer Society, individuals aged >65 years who have no history of cervical intraepithelial neoplasia [CIN] grade 2 or more severe disease within the past 25 years, and who have documented adequate negative prior screening in the prior 10 years, discontinue all cervical cancer screening.)¹ We know, however, that about one-fifth of all cervical cancer cases are diagnosed among individuals aged 65 or older, and for Black women that proportion is even higher when data are appropriately adjusted to account for the increased rate of hysterectomy among Black versus White women.^2-4

Early-stage cervical cancer is largely a curable disease with very high 5-year overall survival rates. Unfortunately, more than half of all cervical cancer is diagnosed at a more advanced stage, and survival rates are much lower for this population.⁵

Cervical cancer incidence rates plummeted in the United States after the introduction of the Pap test for cervical cancer screening. However, the percentage of women who are not up to date with cervical cancer screening may now be increasing, from 14% in 2005 to 23% in 2019 according to one study from the US Preventive Services Task Force.⁶ When looking at cervical cancer screening rates by age, researchers from the Centers for Disease Control and Prevention estimate that the proportion of patients who have not been recently screened goes up as patients get older, with approximately 845,000 American women aged 61 to 65 not adequately screened in 2015 alone.⁷

Details of the study

Cooley and colleagues sought to better characterize the cohort of women diagnosed with cervical cancer at a later age, specifically the stage at diagnosis and survival.⁸ They used data from the California Cancer Registry (CCR), a large state-mandated, population-based data repository that is affiliated with the Surveillance, Epidemiology, and End Results (SEER) program.

The researchers identified 12,442 womenin the CCR who were newly diagnosed with cervical cancer from 2009 to 2018, 17.4% of whom were age 65 or older. They looked at cancer stage at diagnosis as it relates to relative survival rate (“the ratio of the observed survival rate among those who have cancer divided by the expected survival rate for people of the same sex, race/ethnicity, and age who do not have cancer”), Charlson comorbidity score, socioeconomic status, health insurance status, urbanicity, and race/ethnicity.

Results. In this study, 71% of women aged 65 or older presented with advanced-stage disease (FIGO [International Federation of Gynecology and Obstetrics] stage II–IV) as compared with only 48% in those aged 21 to 64. Five-year relative survival rates also were lower in the older cohort—23% to 37%, compared with 42% to 52% in the younger patients. In a sensitivity analysis, late-stage disease was associated with older age, increasing medical comorbidities, and nonadenocarcinoma histology.

Interestingly, older women of Hispanic ethnicity were less likely to be diagnosed with late-stage disease when compared with non-Hispanic White women.

Study strengths and limitations

Although this study’s conclusions—that patients with advanced-stage cancer are more likely to do poorly than those with early-stage cancer—may seem obvious to some even without the proven data, it is still important to highlight what a clinician may intuit with data to support that intuition. It is particularly important to emphasize this risk in older women in light of the aging population in the United States, with adults older than age 65 expected to account for more than 20% of the nation’s population by 2030.⁹

The study by Cooley and colleagues adds value to the existing literature due to its large study population, which included more than 12,000 patients diagnosed with cervical cancer.⁸ And although its results may not be completely generalizable as the data were gathered from only a California-specific population, the sample was diverse with significant portions of Hispanic and Black patients. This study supports previous data that showed high rates of advanced cervical cancer in women older than age 65, with resultant worse 5-year relative survival in this population of older women specifically.⁴ ●

Cooley JJ, Maguire FB, Morris CR, et al. Cervical cancer stage at diagnosis and survival among women ≥65 years in California. Cancer Epidemiol Biomarkers Prev. 2023;32:91-97. doi:10.1158/1055-9965.EPI-22-0793.

EXPERT COMMENTARY

Cervical cancer screening guidelines recommend screening cessation at age 65 once specific exit criteria are met. (According to the American Cancer Society, individuals aged >65 years who have no history of cervical intraepithelial neoplasia [CIN] grade 2 or more severe disease within the past 25 years, and who have documented adequate negative prior screening in the prior 10 years, discontinue all cervical cancer screening.)¹ We know, however, that about one-fifth of all cervical cancer cases are diagnosed among individuals aged 65 or older, and for Black women that proportion is even higher when data are appropriately adjusted to account for the increased rate of hysterectomy among Black versus White women.^2-4

Early-stage cervical cancer is largely a curable disease with very high 5-year overall survival rates. Unfortunately, more than half of all cervical cancer is diagnosed at a more advanced stage, and survival rates are much lower for this population.⁵

Cervical cancer incidence rates plummeted in the United States after the introduction of the Pap test for cervical cancer screening. However, the percentage of women who are not up to date with cervical cancer screening may now be increasing, from 14% in 2005 to 23% in 2019 according to one study from the US Preventive Services Task Force.⁶ When looking at cervical cancer screening rates by age, researchers from the Centers for Disease Control and Prevention estimate that the proportion of patients who have not been recently screened goes up as patients get older, with approximately 845,000 American women aged 61 to 65 not adequately screened in 2015 alone.⁷

Details of the study

Cooley and colleagues sought to better characterize the cohort of women diagnosed with cervical cancer at a later age, specifically the stage at diagnosis and survival.⁸ They used data from the California Cancer Registry (CCR), a large state-mandated, population-based data repository that is affiliated with the Surveillance, Epidemiology, and End Results (SEER) program.

The researchers identified 12,442 womenin the CCR who were newly diagnosed with cervical cancer from 2009 to 2018, 17.4% of whom were age 65 or older. They looked at cancer stage at diagnosis as it relates to relative survival rate (“the ratio of the observed survival rate among those who have cancer divided by the expected survival rate for people of the same sex, race/ethnicity, and age who do not have cancer”), Charlson comorbidity score, socioeconomic status, health insurance status, urbanicity, and race/ethnicity.

Results. In this study, 71% of women aged 65 or older presented with advanced-stage disease (FIGO [International Federation of Gynecology and Obstetrics] stage II–IV) as compared with only 48% in those aged 21 to 64. Five-year relative survival rates also were lower in the older cohort—23% to 37%, compared with 42% to 52% in the younger patients. In a sensitivity analysis, late-stage disease was associated with older age, increasing medical comorbidities, and nonadenocarcinoma histology.

Interestingly, older women of Hispanic ethnicity were less likely to be diagnosed with late-stage disease when compared with non-Hispanic White women.

Study strengths and limitations

Although this study’s conclusions—that patients with advanced-stage cancer are more likely to do poorly than those with early-stage cancer—may seem obvious to some even without the proven data, it is still important to highlight what a clinician may intuit with data to support that intuition. It is particularly important to emphasize this risk in older women in light of the aging population in the United States, with adults older than age 65 expected to account for more than 20% of the nation’s population by 2030.⁹

The study by Cooley and colleagues adds value to the existing literature due to its large study population, which included more than 12,000 patients diagnosed with cervical cancer.⁸ And although its results may not be completely generalizable as the data were gathered from only a California-specific population, the sample was diverse with significant portions of Hispanic and Black patients. This study supports previous data that showed high rates of advanced cervical cancer in women older than age 65, with resultant worse 5-year relative survival in this population of older women specifically.⁴ ●

MASTER CLASS

Prepare for endometriosis excision surgery with a multidisciplinary approach

Iris Kerin Orbuch, MD

Director, Advanced Gynecologic Laparoscopy Center, Los Angeles and New York City.

Series introduction

Charles Miller, MD

Professor, Obstetrics and Gynecology, Department of Clinical Sciences, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois.
 

As I gained more interest and expertise in the treatment of endometriosis, I became aware of several articles concluding that if a woman sought treatment for chronic pelvic pain with an internist, the diagnosis would be irritable bowel syndrome (IBS); with a urologist, it would be interstitial cystitis; and with a gynecologist, endometriosis. Moreover, there is an increased propensity for IBS and IC in patients with endometriosis. There also is an increased risk of small intestine bacterial overgrowth (SIBO), as noted by our guest author for this latest installment of the Master Class in Gynecologic Surgery, Iris Orbuch, MD.

Like our guest author, I have also noted increased risk of pelvic floor myalgia. Dr. Orbuch clearly outlines why this occurs. In fact, we can now understand why many patients have multiple pelvic pain–inducing issues compounding their pain secondary to endometriosis and leading to remodeling of the central nervous system. Therefore, it certainly makes sense to follow Dr. Orbuch’s recommendation for a multidisciplinary pre- and postsurgical approach “to downregulate the pain generators.”

Dr. Orbuch is a minimally invasive gynecologic surgeon in Los Angeles who specializes in the treatment of patients diagnosed with endometriosis. Dr. Orbuch serves on the Board of Directors of the Foundation of the American Association of Gynecologic Laparoscopists and has served as the chair of the AAGL’s Special Interest Group on Endometriosis and Reproductive Surgery. She is the coauthor of the book “Beating Endo —How to Reclaim Your Life From Endometriosis” (New York: HarperCollins; 2019). The book is written for patients but addresses many issues discussed in this installment of the Master Class in Gynecologic Surgery.

https://www.mdedge.com/obgyn/master-class
 

GYNECOLOGIC ONCOLOGY CONSULT

The perils of CA-125 as a diagnostic tool in patients with adnexal masses

Katherine Tucker, MD

Assistant Professor of Gynecologic Oncology at the University of North Carolina at Chapel Hill.
 

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

https://www.mdedge.com/obgyn/gynecologic-oncology-consult

LATEST NEWS

Few women identify breast density as a breast cancer risk

Walter Alexander
 

A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

CDC recommends universal hepatitis B screening of adults

Lucy Hicks
 

Adults should be tested for hepatitis B virus (HBV) at least once in their lifetime, according to updated guidelines from the Centers for Disease Control and Prevention.

This is the first update to HBV screening guidelines since 2008, the agency said.

“Risk-based testing alone has not identified most persons living with chronic HBV infection and is considered inefficient for providers to implement,” the authors write in the new guidance, published in the CDC’s Morbidity and Mortality Weekly Report. “Universal screening of adults for HBV infection is cost-effective, compared with risk-based screening and averts liver disease and death. Although a curative treatment is not yet available, early diagnosis and treatment of chronic HBV infections reduces the risk for cirrhosis, liver cancer, nd death.”

An estimated 580,000 to 2.4 million individuals are living with HBV infection in the United States, and two-thirds may be unaware they are infected, the agency said.

The virus spreads through contact with blood, semen, and other body fluids of an infected person.

The guidance now recommends using the triple panel (HBsAg, anti-HBs, total anti-HBc) for initial screening.

“It can help identify persons who have an active HBV infection and could be linked to care; have [a] resolved infection and might be susceptible to reactivation (for example, immunosuppressed persons); are susceptible and need vaccination; or are vaccinated,” the authors write.
 

Ectopic pregnancy risk and levonorgestrel-releasing IUD

Diana Swift
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
 

EPA seeks to limit ‘forever’ chemicals in U.S. drinking water

Lisa Nainggolan
 

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water.

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

https://www.mdedge.com /obgyn/latest-news

MASTER CLASS

Prepare for endometriosis excision surgery with a multidisciplinary approach

Iris Kerin Orbuch, MD

Director, Advanced Gynecologic Laparoscopy Center, Los Angeles and New York City.

Series introduction

Charles Miller, MD

Professor, Obstetrics and Gynecology, Department of Clinical Sciences, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois.
 

As I gained more interest and expertise in the treatment of endometriosis, I became aware of several articles concluding that if a woman sought treatment for chronic pelvic pain with an internist, the diagnosis would be irritable bowel syndrome (IBS); with a urologist, it would be interstitial cystitis; and with a gynecologist, endometriosis. Moreover, there is an increased propensity for IBS and IC in patients with endometriosis. There also is an increased risk of small intestine bacterial overgrowth (SIBO), as noted by our guest author for this latest installment of the Master Class in Gynecologic Surgery, Iris Orbuch, MD.

Like our guest author, I have also noted increased risk of pelvic floor myalgia. Dr. Orbuch clearly outlines why this occurs. In fact, we can now understand why many patients have multiple pelvic pain–inducing issues compounding their pain secondary to endometriosis and leading to remodeling of the central nervous system. Therefore, it certainly makes sense to follow Dr. Orbuch’s recommendation for a multidisciplinary pre- and postsurgical approach “to downregulate the pain generators.”

Dr. Orbuch is a minimally invasive gynecologic surgeon in Los Angeles who specializes in the treatment of patients diagnosed with endometriosis. Dr. Orbuch serves on the Board of Directors of the Foundation of the American Association of Gynecologic Laparoscopists and has served as the chair of the AAGL’s Special Interest Group on Endometriosis and Reproductive Surgery. She is the coauthor of the book “Beating Endo —How to Reclaim Your Life From Endometriosis” (New York: HarperCollins; 2019). The book is written for patients but addresses many issues discussed in this installment of the Master Class in Gynecologic Surgery.

https://www.mdedge.com/obgyn/master-class
 

GYNECOLOGIC ONCOLOGY CONSULT

The perils of CA-125 as a diagnostic tool in patients with adnexal masses

Katherine Tucker, MD

Assistant Professor of Gynecologic Oncology at the University of North Carolina at Chapel Hill.
 

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

https://www.mdedge.com/obgyn/gynecologic-oncology-consult

LATEST NEWS

Few women identify breast density as a breast cancer risk

Walter Alexander
 

A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

CDC recommends universal hepatitis B screening of adults

Lucy Hicks
 

Adults should be tested for hepatitis B virus (HBV) at least once in their lifetime, according to updated guidelines from the Centers for Disease Control and Prevention.

This is the first update to HBV screening guidelines since 2008, the agency said.

“Risk-based testing alone has not identified most persons living with chronic HBV infection and is considered inefficient for providers to implement,” the authors write in the new guidance, published in the CDC’s Morbidity and Mortality Weekly Report. “Universal screening of adults for HBV infection is cost-effective, compared with risk-based screening and averts liver disease and death. Although a curative treatment is not yet available, early diagnosis and treatment of chronic HBV infections reduces the risk for cirrhosis, liver cancer, nd death.”

An estimated 580,000 to 2.4 million individuals are living with HBV infection in the United States, and two-thirds may be unaware they are infected, the agency said.

The virus spreads through contact with blood, semen, and other body fluids of an infected person.

The guidance now recommends using the triple panel (HBsAg, anti-HBs, total anti-HBc) for initial screening.

“It can help identify persons who have an active HBV infection and could be linked to care; have [a] resolved infection and might be susceptible to reactivation (for example, immunosuppressed persons); are susceptible and need vaccination; or are vaccinated,” the authors write.
 

Ectopic pregnancy risk and levonorgestrel-releasing IUD

Diana Swift
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
 

EPA seeks to limit ‘forever’ chemicals in U.S. drinking water

Lisa Nainggolan
 

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water.

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

https://www.mdedge.com /obgyn/latest-news

MASTER CLASS

Prepare for endometriosis excision surgery with a multidisciplinary approach

Iris Kerin Orbuch, MD

Director, Advanced Gynecologic Laparoscopy Center, Los Angeles and New York City.

Series introduction

Charles Miller, MD

Professor, Obstetrics and Gynecology, Department of Clinical Sciences, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois.
 

As I gained more interest and expertise in the treatment of endometriosis, I became aware of several articles concluding that if a woman sought treatment for chronic pelvic pain with an internist, the diagnosis would be irritable bowel syndrome (IBS); with a urologist, it would be interstitial cystitis; and with a gynecologist, endometriosis. Moreover, there is an increased propensity for IBS and IC in patients with endometriosis. There also is an increased risk of small intestine bacterial overgrowth (SIBO), as noted by our guest author for this latest installment of the Master Class in Gynecologic Surgery, Iris Orbuch, MD.

Like our guest author, I have also noted increased risk of pelvic floor myalgia. Dr. Orbuch clearly outlines why this occurs. In fact, we can now understand why many patients have multiple pelvic pain–inducing issues compounding their pain secondary to endometriosis and leading to remodeling of the central nervous system. Therefore, it certainly makes sense to follow Dr. Orbuch’s recommendation for a multidisciplinary pre- and postsurgical approach “to downregulate the pain generators.”

Dr. Orbuch is a minimally invasive gynecologic surgeon in Los Angeles who specializes in the treatment of patients diagnosed with endometriosis. Dr. Orbuch serves on the Board of Directors of the Foundation of the American Association of Gynecologic Laparoscopists and has served as the chair of the AAGL’s Special Interest Group on Endometriosis and Reproductive Surgery. She is the coauthor of the book “Beating Endo —How to Reclaim Your Life From Endometriosis” (New York: HarperCollins; 2019). The book is written for patients but addresses many issues discussed in this installment of the Master Class in Gynecologic Surgery.

https://www.mdedge.com/obgyn/master-class
 

GYNECOLOGIC ONCOLOGY CONSULT

The perils of CA-125 as a diagnostic tool in patients with adnexal masses

Katherine Tucker, MD

Assistant Professor of Gynecologic Oncology at the University of North Carolina at Chapel Hill.
 

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

https://www.mdedge.com/obgyn/gynecologic-oncology-consult

LATEST NEWS

Few women identify breast density as a breast cancer risk

Walter Alexander
 

A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

CDC recommends universal hepatitis B screening of adults

Lucy Hicks
 

Adults should be tested for hepatitis B virus (HBV) at least once in their lifetime, according to updated guidelines from the Centers for Disease Control and Prevention.

This is the first update to HBV screening guidelines since 2008, the agency said.

“Risk-based testing alone has not identified most persons living with chronic HBV infection and is considered inefficient for providers to implement,” the authors write in the new guidance, published in the CDC’s Morbidity and Mortality Weekly Report. “Universal screening of adults for HBV infection is cost-effective, compared with risk-based screening and averts liver disease and death. Although a curative treatment is not yet available, early diagnosis and treatment of chronic HBV infections reduces the risk for cirrhosis, liver cancer, nd death.”

An estimated 580,000 to 2.4 million individuals are living with HBV infection in the United States, and two-thirds may be unaware they are infected, the agency said.

The virus spreads through contact with blood, semen, and other body fluids of an infected person.

The guidance now recommends using the triple panel (HBsAg, anti-HBs, total anti-HBc) for initial screening.

“It can help identify persons who have an active HBV infection and could be linked to care; have [a] resolved infection and might be susceptible to reactivation (for example, immunosuppressed persons); are susceptible and need vaccination; or are vaccinated,” the authors write.
 

Ectopic pregnancy risk and levonorgestrel-releasing IUD

Diana Swift
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
 

EPA seeks to limit ‘forever’ chemicals in U.S. drinking water

Lisa Nainggolan
 

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water.

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

https://www.mdedge.com /obgyn/latest-news

Have you ever looked at the operating room (OR) trash bin at the end of a case and wondered if all that waste is necessary? Since I started my residency, not a day goes by that I have not asked myself this question.

In the mid-1990s, John Elkington introduced the concept of the triple bottom line—that is, people, planet, and profit—for implementation and measurement of sustainability in businesses.¹ The health care sector is no exception when it comes to the bottom line! However, “people” remain the priority. What is our role, as ObGyns, in protecting the “planet” while keeping the “people” safe?

According to the World Health Organization (WHO), climate change remains the single biggest health threat to humanity.² The health care system is both the victim and the culprit. Studies suggest that the health care system, second to the food industry, is the biggest contributor to waste production in the United States. This sector generates more than 6,000 metric tons of waste each day and nearly 4 million tons (3.6 million metric tons) of solid waste each year.³ The health care system is responsible for an estimated 8% to 10% of total greenhouse gas emissions in the United States; the US health care system alone contributes to more than one-fourth of the global health care carbon footprint. If it were a country, the US health care system would rank 13th among all countries in emissions.⁴In turn, pollution produced by the health sector negatively impacts population health, further burdening the health care system. According to 2013 study data, the annual health damage caused by health care pollution was comparable to that of the deaths caused by preventable medical error.⁴

Aside from the environmental aspects, hospital waste disposal is expensive; reducing this cost is a potential area of interest for institutions.

As ObGyns, what is our role in reducing our waste generation and carbon footprint while keeping patients safe?

Defining health care waste, and disposal considerations

The WHO defines health care waste as including “the waste generated by health-care establishments, research facilities, and laboratories” as well as waste from scattered sources such as home dialysis and insulin injections.⁵ Despite representing a relatively small physical area of hospitals, labor and delivery units combined with ORs account for approximately 70% of all hospital waste.³ Operating room waste consists of disposable surgical supplies, personal protective equipment, drapes, plastic wrappers, sterile blue wraps, glass, cardboard, packaging material, medications, fluids, and other materials (FIGURE 1).

Photo: Courtesy of Golnaz Namazi, MD

The WHO also notes that of all the waste generated by health care activities, about 85% is general, nonhazardous waste that is comparable to domestic waste.⁶ Hazardous waste is any material that poses a health risk, including potentially infectious materials, such as blood-soaked gauze, sharps, pharmaceuticals, or radioactive materials.⁶

Disposal of hazardous waste is expensiveand energy consuming as it is typically incinerated rather than disposed of in a landfill. This process produces substantial greenhouse gases, about 3 kg of carbon dioxide for every 1 kg of hazardous waste.⁷

Red bags are used for hazardous waste disposal, while clear bags are used for general waste. Operating rooms produce about two-thirds of the hospital red-bag waste.⁸ Waste segregation unfortunately is not accurate, and as much as 90% of OR general waste is improperly designated as hazardous waste.³ Drapes and uncontaminated, needleless syringes, for example, should be disposed of in clear bags, but often they are instead directed to the red-bag and sharps container (FIGURE 2).

Photo: Courtesy of Golnaz Namazi, MD

Recycling in the OR

Recycling has become an established practice in many health care facilities and ORs. Studies suggest that introducing recycling programs in ORs not only reduces carbon footprints but also reduces costs.³ One study reported that US academic medical centers consume 2 million lb ($15 million) each year of recoverable medical supplies.⁹

Single-stream recycling, a system in which all recyclable material—including plastics, paper, metal, and glass—are placed in a single bin without segregation at the collection site, has gained in popularity. Recycling can be implemented both in ORs and in other perioperative areas where regular trash bins are located.

In a study done at Oxford University Hospitals in the United Kingdom, introducing recycling bins in every OR, as well as in recovery and staff rest areas, helped improve waste segregation such that approximately 22% of OR waste was recycled.¹⁰ Studies show that recycling programs not only decrease the health care carbon footprint but also have a considerable financial impact. Albert and colleagues demonstrated that introducing a single-stream recycling program to a 9-OR day (or ambulatory) surgery center could redirect more than 4 tons of waste each month and saved thousands of dollars.¹¹

Despite continued improvement in recycling programs, the segregation process is still far from optimal. In a survey done at the Mayo Clinic by Azouz and colleagues, more than half of the staff reported being unclear about which OR items are recyclable and nearly half reported that lack of knowledge was the barrier to proper recycling.¹² That study also showed that after implementation of a recycling education program, costs decreased 10% relative to the same time period in prior years.¹²

Blue wraps. One example of recycling optimization is blue wraps, the polypropylene (No. 5 plastic) material used for wrapping surgical instruments. Blue wraps account for approximately 19% of OR waste and 5% of all hospital waste.¹¹ Blue wraps are not biodegradable and also are not widely recycled. In recent years, a resale market has emerged for blue wraps, as they can be used for production of other No. 5 plastic items.⁹ By reselling blue wraps, revenue can be generated by recycling a necessary packing material that would otherwise require payment for disposal.

Sterility considerations. While recycling in ORs may raise concern due to the absolute sterility required in procedural settings, technologic developments have been promising in advancing safe recycling to reduce carbon footprints and health care costs without compromising patients’ safety. Segregation of waste from recyclable packaging material prior to the case, as well as directing trash to the correct bin (regular vs red bin), is one example. Moreover, because about 80% of all OR waste is generated during the set up before the patient arrives in the OR, it is not contaminated and can be safely recycled.¹³

Continue to: Packaging material...

A substantial part of OR waste consists of packaging material; of all OR waste, 26% consists of plastics and 7%, paper and cartons.¹⁴ Increasing use of disposable or “single use” medical products in ORs, along with the intention to safeguard sterility, contributes significantly to the generation of medical waste in operating units. Containers, wraps and overwraps, cardboard, and plastic packaging are all composed of materials that when clean, can be recycled; however, these items often end up in the landfill (FIGURE 3).

Photo: Courtesy of Golnaz Namazi, MD

Although the segregation of packaging material to recycling versus regular trash versus red bin is of paramount importance, packaging design plays a significant role as well. In 2018, Boston Scientific introduced a new packaging design for ureteral stents that reduced plastic use in packaging by 120,000 lb each year.¹⁵ Despite the advances in the medical packaging industry to increase sustainability while safeguarding sterility for medical devices, there is still room for innovation in this area.

Reducing overage by judicious selection of surgical devices, instruments, and supplies

Overage is the term used to describe surgical inventory that is opened and prepared for surgery but ultimately not used and therefore discarded. Design of surgical carts and instrument and supply selection requires direct input from ObGyns. Opening only the needed instruments while ensuring ready availability of potentially needed supplies can significantly reduce OR waste generation as well as decrease chemical pollution generated by instrument sterilization. Decreasing OR overage reduces overall costs as well (FIGURE 4).

Photo: Courtesy of Golnaz Namazi, MD

In a pilot study at the University of Massachusetts, Albert and colleagues examined the sets of disposable items and instruments designated for common plastic and hand surgery procedures.¹¹ They identified the supplies and instruments that are routinely opened and wasted, based on surgeons’ interview responses, and redesigned the sets. Fifteen items were removed from disposable plastic surgery packs and 7 items from hand surgery packs. The authors reported saving thousands of dollars per year with these changes alone, as well as reducing waste.¹¹ This same concept easily could be implemented in obstetrics and gynecology. We must ask ourselves: Do we always need, for example, a complete dilation and curettage kit to place the uterine manipulator prior to a minimally invasive hysterectomy?

In another pilot study, Greenberg and colleagues investigated whether cesarean deliveries consistently could be performed in a safe manner with only 20 instruments in the surgical kit.¹⁶ Obstetricians rated the 20-instrument kit an 8.7 out of 10 for performing cesarean deliveries safely.¹⁶

In addition to instrument selection, surgeons have a role in other supply use and waste generation: for instance, opening multiple pairs of surgical gloves and surgical gowns in advance when most of them will not be used during the case. Furthermore, many ObGyn surgeons routinely change gloves or even gowns during gynecologic procedures when they go back and forth between the vaginal and abdominal fields. Is the perineum “dirty” after application of a surgical prep solution?

In an observational study, Shockley and colleagues investigated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus at distinct time points during total laparoscopic hysterectomy.¹⁷ They showed that in 98.9% of cultures, the overall bacterial concentrations did not exceed the threshold for infection. There was no bacterial growth from vaginal cultures, and the only samples with some bacterial growth belonged to the surgeon’s gloves after specimen extraction; about one-third of samples showed growth after specimen extraction, but only 1 sample had a bacterial load above the infectious threshold of 5,000 colony-forming units per mL. The authors therefore suggested that if a surgeon changes gloves, doing so after specimen extraction and before turning attention back to the abdomen for vaginal cuff closure may be most effective in reducing bacterial load.¹⁷

Surgical site infection contributes to medical cost and likely medical waste as well. For example, surgical site infection may require prolonged treatments, tests, and medical instruments. In severe cases with abscesses, treatment entails hospitalization with prolonged antibiotic therapy with or without procedures to drain the collections. Further research therefore is warranted to investigate safe and environmentally friendly practices.

Myriad products are introduced to the medical system each day, some of which replace conventional tools. For instance, low-density polyethylene, or LDPE, transfer sheet is advertised for lateral patient transfer from the OR table to the bed or stretcher. This No. 4–coded plastic, while recyclable, is routinely discarded as trash in ORs. One ergonomic study found that reusable slide boards are as effective for reducing friction and staff muscle activities and are noninferior to the plastic sheets.¹⁸

Steps to making an impact

Operating rooms and labor and delivery units are responsible for a large proportion of hospital waste, and therefore they are of paramount importance in reducing waste and carbon footprint at the individual and institutional level. Reduction of OR waste not only is environmentally conscious but also decreases cost. Steps as small as individual practices to as big as changing infrastructures can make an impact. For instance:

• redesigning surgical carts
• reformulating surgeon-specific supply lists
• raising awareness about surgical overage
• encouraging recycling through education and audit
• optimizing surgical waste segregation through educational posters.

These are all simple steps that could significantly reduce waste and carbon footprint.

Bottom line

Although waste reduction is the responsibility of all health care providers, as leaders in their workplace physicians can serve as role models by implementing “green” practices in procedural units. Raising awareness and using a team approach is critical to succeed in our endeavors to move toward an environmentally friendly future. ●

Have you ever looked at the operating room (OR) trash bin at the end of a case and wondered if all that waste is necessary? Since I started my residency, not a day goes by that I have not asked myself this question.

In the mid-1990s, John Elkington introduced the concept of the triple bottom line—that is, people, planet, and profit—for implementation and measurement of sustainability in businesses.¹ The health care sector is no exception when it comes to the bottom line! However, “people” remain the priority. What is our role, as ObGyns, in protecting the “planet” while keeping the “people” safe?

According to the World Health Organization (WHO), climate change remains the single biggest health threat to humanity.² The health care system is both the victim and the culprit. Studies suggest that the health care system, second to the food industry, is the biggest contributor to waste production in the United States. This sector generates more than 6,000 metric tons of waste each day and nearly 4 million tons (3.6 million metric tons) of solid waste each year.³ The health care system is responsible for an estimated 8% to 10% of total greenhouse gas emissions in the United States; the US health care system alone contributes to more than one-fourth of the global health care carbon footprint. If it were a country, the US health care system would rank 13th among all countries in emissions.⁴In turn, pollution produced by the health sector negatively impacts population health, further burdening the health care system. According to 2013 study data, the annual health damage caused by health care pollution was comparable to that of the deaths caused by preventable medical error.⁴

Aside from the environmental aspects, hospital waste disposal is expensive; reducing this cost is a potential area of interest for institutions.

As ObGyns, what is our role in reducing our waste generation and carbon footprint while keeping patients safe?

Defining health care waste, and disposal considerations

The WHO defines health care waste as including “the waste generated by health-care establishments, research facilities, and laboratories” as well as waste from scattered sources such as home dialysis and insulin injections.⁵ Despite representing a relatively small physical area of hospitals, labor and delivery units combined with ORs account for approximately 70% of all hospital waste.³ Operating room waste consists of disposable surgical supplies, personal protective equipment, drapes, plastic wrappers, sterile blue wraps, glass, cardboard, packaging material, medications, fluids, and other materials (FIGURE 1).

Photo: Courtesy of Golnaz Namazi, MD

The WHO also notes that of all the waste generated by health care activities, about 85% is general, nonhazardous waste that is comparable to domestic waste.⁶ Hazardous waste is any material that poses a health risk, including potentially infectious materials, such as blood-soaked gauze, sharps, pharmaceuticals, or radioactive materials.⁶

Disposal of hazardous waste is expensiveand energy consuming as it is typically incinerated rather than disposed of in a landfill. This process produces substantial greenhouse gases, about 3 kg of carbon dioxide for every 1 kg of hazardous waste.⁷

Red bags are used for hazardous waste disposal, while clear bags are used for general waste. Operating rooms produce about two-thirds of the hospital red-bag waste.⁸ Waste segregation unfortunately is not accurate, and as much as 90% of OR general waste is improperly designated as hazardous waste.³ Drapes and uncontaminated, needleless syringes, for example, should be disposed of in clear bags, but often they are instead directed to the red-bag and sharps container (FIGURE 2).

Photo: Courtesy of Golnaz Namazi, MD

Recycling in the OR

Recycling has become an established practice in many health care facilities and ORs. Studies suggest that introducing recycling programs in ORs not only reduces carbon footprints but also reduces costs.³ One study reported that US academic medical centers consume 2 million lb ($15 million) each year of recoverable medical supplies.⁹

Single-stream recycling, a system in which all recyclable material—including plastics, paper, metal, and glass—are placed in a single bin without segregation at the collection site, has gained in popularity. Recycling can be implemented both in ORs and in other perioperative areas where regular trash bins are located.

In a study done at Oxford University Hospitals in the United Kingdom, introducing recycling bins in every OR, as well as in recovery and staff rest areas, helped improve waste segregation such that approximately 22% of OR waste was recycled.¹⁰ Studies show that recycling programs not only decrease the health care carbon footprint but also have a considerable financial impact. Albert and colleagues demonstrated that introducing a single-stream recycling program to a 9-OR day (or ambulatory) surgery center could redirect more than 4 tons of waste each month and saved thousands of dollars.¹¹

Despite continued improvement in recycling programs, the segregation process is still far from optimal. In a survey done at the Mayo Clinic by Azouz and colleagues, more than half of the staff reported being unclear about which OR items are recyclable and nearly half reported that lack of knowledge was the barrier to proper recycling.¹² That study also showed that after implementation of a recycling education program, costs decreased 10% relative to the same time period in prior years.¹²

Blue wraps. One example of recycling optimization is blue wraps, the polypropylene (No. 5 plastic) material used for wrapping surgical instruments. Blue wraps account for approximately 19% of OR waste and 5% of all hospital waste.¹¹ Blue wraps are not biodegradable and also are not widely recycled. In recent years, a resale market has emerged for blue wraps, as they can be used for production of other No. 5 plastic items.⁹ By reselling blue wraps, revenue can be generated by recycling a necessary packing material that would otherwise require payment for disposal.

Sterility considerations. While recycling in ORs may raise concern due to the absolute sterility required in procedural settings, technologic developments have been promising in advancing safe recycling to reduce carbon footprints and health care costs without compromising patients’ safety. Segregation of waste from recyclable packaging material prior to the case, as well as directing trash to the correct bin (regular vs red bin), is one example. Moreover, because about 80% of all OR waste is generated during the set up before the patient arrives in the OR, it is not contaminated and can be safely recycled.¹³

Continue to: Packaging material...

A substantial part of OR waste consists of packaging material; of all OR waste, 26% consists of plastics and 7%, paper and cartons.¹⁴ Increasing use of disposable or “single use” medical products in ORs, along with the intention to safeguard sterility, contributes significantly to the generation of medical waste in operating units. Containers, wraps and overwraps, cardboard, and plastic packaging are all composed of materials that when clean, can be recycled; however, these items often end up in the landfill (FIGURE 3).

Photo: Courtesy of Golnaz Namazi, MD

Although the segregation of packaging material to recycling versus regular trash versus red bin is of paramount importance, packaging design plays a significant role as well. In 2018, Boston Scientific introduced a new packaging design for ureteral stents that reduced plastic use in packaging by 120,000 lb each year.¹⁵ Despite the advances in the medical packaging industry to increase sustainability while safeguarding sterility for medical devices, there is still room for innovation in this area.

Reducing overage by judicious selection of surgical devices, instruments, and supplies

Overage is the term used to describe surgical inventory that is opened and prepared for surgery but ultimately not used and therefore discarded. Design of surgical carts and instrument and supply selection requires direct input from ObGyns. Opening only the needed instruments while ensuring ready availability of potentially needed supplies can significantly reduce OR waste generation as well as decrease chemical pollution generated by instrument sterilization. Decreasing OR overage reduces overall costs as well (FIGURE 4).

Photo: Courtesy of Golnaz Namazi, MD

In a pilot study at the University of Massachusetts, Albert and colleagues examined the sets of disposable items and instruments designated for common plastic and hand surgery procedures.¹¹ They identified the supplies and instruments that are routinely opened and wasted, based on surgeons’ interview responses, and redesigned the sets. Fifteen items were removed from disposable plastic surgery packs and 7 items from hand surgery packs. The authors reported saving thousands of dollars per year with these changes alone, as well as reducing waste.¹¹ This same concept easily could be implemented in obstetrics and gynecology. We must ask ourselves: Do we always need, for example, a complete dilation and curettage kit to place the uterine manipulator prior to a minimally invasive hysterectomy?

In another pilot study, Greenberg and colleagues investigated whether cesarean deliveries consistently could be performed in a safe manner with only 20 instruments in the surgical kit.¹⁶ Obstetricians rated the 20-instrument kit an 8.7 out of 10 for performing cesarean deliveries safely.¹⁶

In addition to instrument selection, surgeons have a role in other supply use and waste generation: for instance, opening multiple pairs of surgical gloves and surgical gowns in advance when most of them will not be used during the case. Furthermore, many ObGyn surgeons routinely change gloves or even gowns during gynecologic procedures when they go back and forth between the vaginal and abdominal fields. Is the perineum “dirty” after application of a surgical prep solution?

In an observational study, Shockley and colleagues investigated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus at distinct time points during total laparoscopic hysterectomy.¹⁷ They showed that in 98.9% of cultures, the overall bacterial concentrations did not exceed the threshold for infection. There was no bacterial growth from vaginal cultures, and the only samples with some bacterial growth belonged to the surgeon’s gloves after specimen extraction; about one-third of samples showed growth after specimen extraction, but only 1 sample had a bacterial load above the infectious threshold of 5,000 colony-forming units per mL. The authors therefore suggested that if a surgeon changes gloves, doing so after specimen extraction and before turning attention back to the abdomen for vaginal cuff closure may be most effective in reducing bacterial load.¹⁷

Surgical site infection contributes to medical cost and likely medical waste as well. For example, surgical site infection may require prolonged treatments, tests, and medical instruments. In severe cases with abscesses, treatment entails hospitalization with prolonged antibiotic therapy with or without procedures to drain the collections. Further research therefore is warranted to investigate safe and environmentally friendly practices.

Myriad products are introduced to the medical system each day, some of which replace conventional tools. For instance, low-density polyethylene, or LDPE, transfer sheet is advertised for lateral patient transfer from the OR table to the bed or stretcher. This No. 4–coded plastic, while recyclable, is routinely discarded as trash in ORs. One ergonomic study found that reusable slide boards are as effective for reducing friction and staff muscle activities and are noninferior to the plastic sheets.¹⁸

Steps to making an impact

Operating rooms and labor and delivery units are responsible for a large proportion of hospital waste, and therefore they are of paramount importance in reducing waste and carbon footprint at the individual and institutional level. Reduction of OR waste not only is environmentally conscious but also decreases cost. Steps as small as individual practices to as big as changing infrastructures can make an impact. For instance:

• redesigning surgical carts
• reformulating surgeon-specific supply lists
• raising awareness about surgical overage
• encouraging recycling through education and audit
• optimizing surgical waste segregation through educational posters.

These are all simple steps that could significantly reduce waste and carbon footprint.

Bottom line

Although waste reduction is the responsibility of all health care providers, as leaders in their workplace physicians can serve as role models by implementing “green” practices in procedural units. Raising awareness and using a team approach is critical to succeed in our endeavors to move toward an environmentally friendly future. ●

Have you ever looked at the operating room (OR) trash bin at the end of a case and wondered if all that waste is necessary? Since I started my residency, not a day goes by that I have not asked myself this question.

In the mid-1990s, John Elkington introduced the concept of the triple bottom line—that is, people, planet, and profit—for implementation and measurement of sustainability in businesses.¹ The health care sector is no exception when it comes to the bottom line! However, “people” remain the priority. What is our role, as ObGyns, in protecting the “planet” while keeping the “people” safe?

According to the World Health Organization (WHO), climate change remains the single biggest health threat to humanity.² The health care system is both the victim and the culprit. Studies suggest that the health care system, second to the food industry, is the biggest contributor to waste production in the United States. This sector generates more than 6,000 metric tons of waste each day and nearly 4 million tons (3.6 million metric tons) of solid waste each year.³ The health care system is responsible for an estimated 8% to 10% of total greenhouse gas emissions in the United States; the US health care system alone contributes to more than one-fourth of the global health care carbon footprint. If it were a country, the US health care system would rank 13th among all countries in emissions.⁴In turn, pollution produced by the health sector negatively impacts population health, further burdening the health care system. According to 2013 study data, the annual health damage caused by health care pollution was comparable to that of the deaths caused by preventable medical error.⁴

Aside from the environmental aspects, hospital waste disposal is expensive; reducing this cost is a potential area of interest for institutions.

As ObGyns, what is our role in reducing our waste generation and carbon footprint while keeping patients safe?

Defining health care waste, and disposal considerations

The WHO defines health care waste as including “the waste generated by health-care establishments, research facilities, and laboratories” as well as waste from scattered sources such as home dialysis and insulin injections.⁵ Despite representing a relatively small physical area of hospitals, labor and delivery units combined with ORs account for approximately 70% of all hospital waste.³ Operating room waste consists of disposable surgical supplies, personal protective equipment, drapes, plastic wrappers, sterile blue wraps, glass, cardboard, packaging material, medications, fluids, and other materials (FIGURE 1).

Photo: Courtesy of Golnaz Namazi, MD

The WHO also notes that of all the waste generated by health care activities, about 85% is general, nonhazardous waste that is comparable to domestic waste.⁶ Hazardous waste is any material that poses a health risk, including potentially infectious materials, such as blood-soaked gauze, sharps, pharmaceuticals, or radioactive materials.⁶

Disposal of hazardous waste is expensiveand energy consuming as it is typically incinerated rather than disposed of in a landfill. This process produces substantial greenhouse gases, about 3 kg of carbon dioxide for every 1 kg of hazardous waste.⁷

Red bags are used for hazardous waste disposal, while clear bags are used for general waste. Operating rooms produce about two-thirds of the hospital red-bag waste.⁸ Waste segregation unfortunately is not accurate, and as much as 90% of OR general waste is improperly designated as hazardous waste.³ Drapes and uncontaminated, needleless syringes, for example, should be disposed of in clear bags, but often they are instead directed to the red-bag and sharps container (FIGURE 2).

Photo: Courtesy of Golnaz Namazi, MD

Recycling in the OR

Recycling has become an established practice in many health care facilities and ORs. Studies suggest that introducing recycling programs in ORs not only reduces carbon footprints but also reduces costs.³ One study reported that US academic medical centers consume 2 million lb ($15 million) each year of recoverable medical supplies.⁹

Single-stream recycling, a system in which all recyclable material—including plastics, paper, metal, and glass—are placed in a single bin without segregation at the collection site, has gained in popularity. Recycling can be implemented both in ORs and in other perioperative areas where regular trash bins are located.

In a study done at Oxford University Hospitals in the United Kingdom, introducing recycling bins in every OR, as well as in recovery and staff rest areas, helped improve waste segregation such that approximately 22% of OR waste was recycled.¹⁰ Studies show that recycling programs not only decrease the health care carbon footprint but also have a considerable financial impact. Albert and colleagues demonstrated that introducing a single-stream recycling program to a 9-OR day (or ambulatory) surgery center could redirect more than 4 tons of waste each month and saved thousands of dollars.¹¹

Despite continued improvement in recycling programs, the segregation process is still far from optimal. In a survey done at the Mayo Clinic by Azouz and colleagues, more than half of the staff reported being unclear about which OR items are recyclable and nearly half reported that lack of knowledge was the barrier to proper recycling.¹² That study also showed that after implementation of a recycling education program, costs decreased 10% relative to the same time period in prior years.¹²

Blue wraps. One example of recycling optimization is blue wraps, the polypropylene (No. 5 plastic) material used for wrapping surgical instruments. Blue wraps account for approximately 19% of OR waste and 5% of all hospital waste.¹¹ Blue wraps are not biodegradable and also are not widely recycled. In recent years, a resale market has emerged for blue wraps, as they can be used for production of other No. 5 plastic items.⁹ By reselling blue wraps, revenue can be generated by recycling a necessary packing material that would otherwise require payment for disposal.

Sterility considerations. While recycling in ORs may raise concern due to the absolute sterility required in procedural settings, technologic developments have been promising in advancing safe recycling to reduce carbon footprints and health care costs without compromising patients’ safety. Segregation of waste from recyclable packaging material prior to the case, as well as directing trash to the correct bin (regular vs red bin), is one example. Moreover, because about 80% of all OR waste is generated during the set up before the patient arrives in the OR, it is not contaminated and can be safely recycled.¹³

Continue to: Packaging material...

A substantial part of OR waste consists of packaging material; of all OR waste, 26% consists of plastics and 7%, paper and cartons.¹⁴ Increasing use of disposable or “single use” medical products in ORs, along with the intention to safeguard sterility, contributes significantly to the generation of medical waste in operating units. Containers, wraps and overwraps, cardboard, and plastic packaging are all composed of materials that when clean, can be recycled; however, these items often end up in the landfill (FIGURE 3).

Photo: Courtesy of Golnaz Namazi, MD

Although the segregation of packaging material to recycling versus regular trash versus red bin is of paramount importance, packaging design plays a significant role as well. In 2018, Boston Scientific introduced a new packaging design for ureteral stents that reduced plastic use in packaging by 120,000 lb each year.¹⁵ Despite the advances in the medical packaging industry to increase sustainability while safeguarding sterility for medical devices, there is still room for innovation in this area.

Reducing overage by judicious selection of surgical devices, instruments, and supplies

Overage is the term used to describe surgical inventory that is opened and prepared for surgery but ultimately not used and therefore discarded. Design of surgical carts and instrument and supply selection requires direct input from ObGyns. Opening only the needed instruments while ensuring ready availability of potentially needed supplies can significantly reduce OR waste generation as well as decrease chemical pollution generated by instrument sterilization. Decreasing OR overage reduces overall costs as well (FIGURE 4).

Photo: Courtesy of Golnaz Namazi, MD

In a pilot study at the University of Massachusetts, Albert and colleagues examined the sets of disposable items and instruments designated for common plastic and hand surgery procedures.¹¹ They identified the supplies and instruments that are routinely opened and wasted, based on surgeons’ interview responses, and redesigned the sets. Fifteen items were removed from disposable plastic surgery packs and 7 items from hand surgery packs. The authors reported saving thousands of dollars per year with these changes alone, as well as reducing waste.¹¹ This same concept easily could be implemented in obstetrics and gynecology. We must ask ourselves: Do we always need, for example, a complete dilation and curettage kit to place the uterine manipulator prior to a minimally invasive hysterectomy?

In another pilot study, Greenberg and colleagues investigated whether cesarean deliveries consistently could be performed in a safe manner with only 20 instruments in the surgical kit.¹⁶ Obstetricians rated the 20-instrument kit an 8.7 out of 10 for performing cesarean deliveries safely.¹⁶

In addition to instrument selection, surgeons have a role in other supply use and waste generation: for instance, opening multiple pairs of surgical gloves and surgical gowns in advance when most of them will not be used during the case. Furthermore, many ObGyn surgeons routinely change gloves or even gowns during gynecologic procedures when they go back and forth between the vaginal and abdominal fields. Is the perineum “dirty” after application of a surgical prep solution?

In an observational study, Shockley and colleagues investigated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus at distinct time points during total laparoscopic hysterectomy.¹⁷ They showed that in 98.9% of cultures, the overall bacterial concentrations did not exceed the threshold for infection. There was no bacterial growth from vaginal cultures, and the only samples with some bacterial growth belonged to the surgeon’s gloves after specimen extraction; about one-third of samples showed growth after specimen extraction, but only 1 sample had a bacterial load above the infectious threshold of 5,000 colony-forming units per mL. The authors therefore suggested that if a surgeon changes gloves, doing so after specimen extraction and before turning attention back to the abdomen for vaginal cuff closure may be most effective in reducing bacterial load.¹⁷

Surgical site infection contributes to medical cost and likely medical waste as well. For example, surgical site infection may require prolonged treatments, tests, and medical instruments. In severe cases with abscesses, treatment entails hospitalization with prolonged antibiotic therapy with or without procedures to drain the collections. Further research therefore is warranted to investigate safe and environmentally friendly practices.

Myriad products are introduced to the medical system each day, some of which replace conventional tools. For instance, low-density polyethylene, or LDPE, transfer sheet is advertised for lateral patient transfer from the OR table to the bed or stretcher. This No. 4–coded plastic, while recyclable, is routinely discarded as trash in ORs. One ergonomic study found that reusable slide boards are as effective for reducing friction and staff muscle activities and are noninferior to the plastic sheets.¹⁸

Steps to making an impact

Operating rooms and labor and delivery units are responsible for a large proportion of hospital waste, and therefore they are of paramount importance in reducing waste and carbon footprint at the individual and institutional level. Reduction of OR waste not only is environmentally conscious but also decreases cost. Steps as small as individual practices to as big as changing infrastructures can make an impact. For instance:

• redesigning surgical carts
• reformulating surgeon-specific supply lists
• raising awareness about surgical overage
• encouraging recycling through education and audit
• optimizing surgical waste segregation through educational posters.

These are all simple steps that could significantly reduce waste and carbon footprint.

Bottom line

Although waste reduction is the responsibility of all health care providers, as leaders in their workplace physicians can serve as role models by implementing “green” practices in procedural units. Raising awareness and using a team approach is critical to succeed in our endeavors to move toward an environmentally friendly future. ●

Possibly. Elevated body mass index (BMI) is associated with an increased risk for stillbirth (strength of recommendation (SOR), B; Cohort studies and meta-analysis of cohort studies). Three studies found an association between elevated BMI and stillbirth and one did not. However, no studies demonstrate that antenatal testing in pregnant people with higher BMIs decreases stillbirth rates, or that no harm is caused by unnecessary testing or resultant interventions.

Still, in 2021, the American College of Obstetricians and Gynecologists (ACOG) suggested weekly antenatal testing may be considered from 34 weeks' 0 days' gestation for pregnant people with a BMI ≥ 40.0 kg/m² and from 37 weeks' 0 days' gestation for pregnant people with a BMI between 35.0 and 39.9 kg/m² (SOR, C; consensus guideline). Thus, doing the antenatal testing recommended in the ACOG guideline in an attempt to prevent stillbirth is reasonable, given evidence that elevated BMI is associated with stillbirth.

Evidence summary

Association between higher maternal BMI and increased risk for stillbirth

The purpose of antenatal testing is to decrease the risk for stillbirth between visits. Because of the resources involved and the risk for false-positives when testing low-risk patients, antenatal testing is reserved for pregnant people with higher risk for stillbirth.

In a retrospective cohort study of more than 2.8 million singleton births including 9,030 stillbirths, pregnant people with an elevated BMI had an increased risk for stillbirth compared with those with a normal BMI. The adjusted hazard ratio was 1.71 (95% confidence interval (CI), 1.62-1.83) for those with a BMI of 30.0 to 34.9 kg/m²; 2.04 (95% CI, 1.8-2.21) for those with a BMI of 35.0 to 39.9 kg/m²; and 2.50 (95% CI, 2.28-2.74) for those with a BMI ≥ 40 kg/m².¹

A meta-analysis of 38 studies, which included data on 16,274 stillbirths, found that a 5-unit increase in BMI was associated with an increased risk for stillbirth (relative risk, 1.24; 95% CI, 1.18-1.30).²

Another meta-analysis included 6 cohort studies involving more than 1 million pregnancies and 3 case-control studies involving 2,530 stillbirths and 2,837 controls from 1980-2005. There was an association between increasing BMI and stillbirth: the odds ratio (OR) was 1.47 (95% CI, 1.08-1.94) for those with a BMI of 25.0 to 29.9 kg/m² and 2.07 (95% CI, 1.59-2.74) for those with a BMI ≥ 30.0, compared with those with a normal BMI.³

However, a retrospective cohort study of 182,362 singleton births including 442 stillbirths found no association between stillbirth and increasing BMI. The OR was 1.10 (95% CI, 0.90-1.36) for those with a BMI of 25.0 to 29.9 and 1.09 (95% CI, 0.87-1.37) for those with a BMI ≥ 30.0 kg/m2, compared with those with a normal BMI.⁴ However, this cohort study may have been underpowered to detect an association between stillbirth and BMI.

Recommendations from others

In 2021, ACOG suggested that weekly antenatal testing may be considered from 34 weeks' and 0 days' gestation for pregnant people with a BMI ≥ 40.0 kg/m² and from 37 weeks' and 0 days' gestation for pregnant people with a BMI between 35.0 and 39.9 kg/m².⁵ The 2021 ACOG Practice Bulletin on obesity in pregnancy rates this recommendation as Level C—based primarily on consensus and expert opinion.⁶

A 2018 Royal College of Obstetricians and Gynecologists Green-top Guideline recognizes “definitive recommendations for fetal surveillance are hampered by the lack of randomized controlled trials demonstrating that antepartum fetal surveillance decreases perinatal morbidity or mortality in late-term and post-term gestations…. There are no definitive studies determining the optimal type or frequency of such testing and no evidence specific for women with obesity.”⁷

A 2019 Society of Obstetricians and Gynecologists of Canada practice guideline states “stillbirth is more common with maternal obesity” and recommends “increased fetal surveillance … in the third trimester if reduced fetal movements are reported.” The guideline notes “the role for non-stress tests … in surveillance of well-being in this population is uncertain.” Also, for pregnant people with a BMI > 30 kg/m², “assessment of fetal well-being is … recommended weekly from 37 weeks until delivery.” Finally, increased fetal surveillance is recommended in the setting of increased BMI and an abnormal pulsatility index of the umbilical artery and/or maternal uterine artery.⁸

Editor’s takeaway

Evidence demonstrates that increased maternal BMI is associated with increased stillbirths. However, evidence has not shown that third-trimester antenatal testing decreases this morbidity and mortality. Expert opinion varies, with ACOG recommending weekly antenatal testing from 34 and 37 weeks’ gestation, respectively, for pregnant people with BMIs of ≥ 40 kg/m² and of 35 to 39.9 kg/m². ●

Possibly. Elevated body mass index (BMI) is associated with an increased risk for stillbirth (strength of recommendation (SOR), B; Cohort studies and meta-analysis of cohort studies). Three studies found an association between elevated BMI and stillbirth and one did not. However, no studies demonstrate that antenatal testing in pregnant people with higher BMIs decreases stillbirth rates, or that no harm is caused by unnecessary testing or resultant interventions.

Still, in 2021, the American College of Obstetricians and Gynecologists (ACOG) suggested weekly antenatal testing may be considered from 34 weeks' 0 days' gestation for pregnant people with a BMI ≥ 40.0 kg/m² and from 37 weeks' 0 days' gestation for pregnant people with a BMI between 35.0 and 39.9 kg/m² (SOR, C; consensus guideline). Thus, doing the antenatal testing recommended in the ACOG guideline in an attempt to prevent stillbirth is reasonable, given evidence that elevated BMI is associated with stillbirth.

Evidence summary

Association between higher maternal BMI and increased risk for stillbirth

The purpose of antenatal testing is to decrease the risk for stillbirth between visits. Because of the resources involved and the risk for false-positives when testing low-risk patients, antenatal testing is reserved for pregnant people with higher risk for stillbirth.

In a retrospective cohort study of more than 2.8 million singleton births including 9,030 stillbirths, pregnant people with an elevated BMI had an increased risk for stillbirth compared with those with a normal BMI. The adjusted hazard ratio was 1.71 (95% confidence interval (CI), 1.62-1.83) for those with a BMI of 30.0 to 34.9 kg/m²; 2.04 (95% CI, 1.8-2.21) for those with a BMI of 35.0 to 39.9 kg/m²; and 2.50 (95% CI, 2.28-2.74) for those with a BMI ≥ 40 kg/m².¹

A meta-analysis of 38 studies, which included data on 16,274 stillbirths, found that a 5-unit increase in BMI was associated with an increased risk for stillbirth (relative risk, 1.24; 95% CI, 1.18-1.30).²

Another meta-analysis included 6 cohort studies involving more than 1 million pregnancies and 3 case-control studies involving 2,530 stillbirths and 2,837 controls from 1980-2005. There was an association between increasing BMI and stillbirth: the odds ratio (OR) was 1.47 (95% CI, 1.08-1.94) for those with a BMI of 25.0 to 29.9 kg/m² and 2.07 (95% CI, 1.59-2.74) for those with a BMI ≥ 30.0, compared with those with a normal BMI.³

However, a retrospective cohort study of 182,362 singleton births including 442 stillbirths found no association between stillbirth and increasing BMI. The OR was 1.10 (95% CI, 0.90-1.36) for those with a BMI of 25.0 to 29.9 and 1.09 (95% CI, 0.87-1.37) for those with a BMI ≥ 30.0 kg/m2, compared with those with a normal BMI.⁴ However, this cohort study may have been underpowered to detect an association between stillbirth and BMI.

Recommendations from others

In 2021, ACOG suggested that weekly antenatal testing may be considered from 34 weeks' and 0 days' gestation for pregnant people with a BMI ≥ 40.0 kg/m² and from 37 weeks' and 0 days' gestation for pregnant people with a BMI between 35.0 and 39.9 kg/m².⁵ The 2021 ACOG Practice Bulletin on obesity in pregnancy rates this recommendation as Level C—based primarily on consensus and expert opinion.⁶

A 2018 Royal College of Obstetricians and Gynecologists Green-top Guideline recognizes “definitive recommendations for fetal surveillance are hampered by the lack of randomized controlled trials demonstrating that antepartum fetal surveillance decreases perinatal morbidity or mortality in late-term and post-term gestations…. There are no definitive studies determining the optimal type or frequency of such testing and no evidence specific for women with obesity.”⁷

A 2019 Society of Obstetricians and Gynecologists of Canada practice guideline states “stillbirth is more common with maternal obesity” and recommends “increased fetal surveillance … in the third trimester if reduced fetal movements are reported.” The guideline notes “the role for non-stress tests … in surveillance of well-being in this population is uncertain.” Also, for pregnant people with a BMI > 30 kg/m², “assessment of fetal well-being is … recommended weekly from 37 weeks until delivery.” Finally, increased fetal surveillance is recommended in the setting of increased BMI and an abnormal pulsatility index of the umbilical artery and/or maternal uterine artery.⁸

Editor’s takeaway

Evidence demonstrates that increased maternal BMI is associated with increased stillbirths. However, evidence has not shown that third-trimester antenatal testing decreases this morbidity and mortality. Expert opinion varies, with ACOG recommending weekly antenatal testing from 34 and 37 weeks’ gestation, respectively, for pregnant people with BMIs of ≥ 40 kg/m² and of 35 to 39.9 kg/m². ●

Possibly. Elevated body mass index (BMI) is associated with an increased risk for stillbirth (strength of recommendation (SOR), B; Cohort studies and meta-analysis of cohort studies). Three studies found an association between elevated BMI and stillbirth and one did not. However, no studies demonstrate that antenatal testing in pregnant people with higher BMIs decreases stillbirth rates, or that no harm is caused by unnecessary testing or resultant interventions.

Still, in 2021, the American College of Obstetricians and Gynecologists (ACOG) suggested weekly antenatal testing may be considered from 34 weeks' 0 days' gestation for pregnant people with a BMI ≥ 40.0 kg/m² and from 37 weeks' 0 days' gestation for pregnant people with a BMI between 35.0 and 39.9 kg/m² (SOR, C; consensus guideline). Thus, doing the antenatal testing recommended in the ACOG guideline in an attempt to prevent stillbirth is reasonable, given evidence that elevated BMI is associated with stillbirth.

Evidence summary

Association between higher maternal BMI and increased risk for stillbirth

The purpose of antenatal testing is to decrease the risk for stillbirth between visits. Because of the resources involved and the risk for false-positives when testing low-risk patients, antenatal testing is reserved for pregnant people with higher risk for stillbirth.

In a retrospective cohort study of more than 2.8 million singleton births including 9,030 stillbirths, pregnant people with an elevated BMI had an increased risk for stillbirth compared with those with a normal BMI. The adjusted hazard ratio was 1.71 (95% confidence interval (CI), 1.62-1.83) for those with a BMI of 30.0 to 34.9 kg/m²; 2.04 (95% CI, 1.8-2.21) for those with a BMI of 35.0 to 39.9 kg/m²; and 2.50 (95% CI, 2.28-2.74) for those with a BMI ≥ 40 kg/m².¹

A meta-analysis of 38 studies, which included data on 16,274 stillbirths, found that a 5-unit increase in BMI was associated with an increased risk for stillbirth (relative risk, 1.24; 95% CI, 1.18-1.30).²

Another meta-analysis included 6 cohort studies involving more than 1 million pregnancies and 3 case-control studies involving 2,530 stillbirths and 2,837 controls from 1980-2005. There was an association between increasing BMI and stillbirth: the odds ratio (OR) was 1.47 (95% CI, 1.08-1.94) for those with a BMI of 25.0 to 29.9 kg/m² and 2.07 (95% CI, 1.59-2.74) for those with a BMI ≥ 30.0, compared with those with a normal BMI.³

However, a retrospective cohort study of 182,362 singleton births including 442 stillbirths found no association between stillbirth and increasing BMI. The OR was 1.10 (95% CI, 0.90-1.36) for those with a BMI of 25.0 to 29.9 and 1.09 (95% CI, 0.87-1.37) for those with a BMI ≥ 30.0 kg/m2, compared with those with a normal BMI.⁴ However, this cohort study may have been underpowered to detect an association between stillbirth and BMI.

Recommendations from others

In 2021, ACOG suggested that weekly antenatal testing may be considered from 34 weeks' and 0 days' gestation for pregnant people with a BMI ≥ 40.0 kg/m² and from 37 weeks' and 0 days' gestation for pregnant people with a BMI between 35.0 and 39.9 kg/m².⁵ The 2021 ACOG Practice Bulletin on obesity in pregnancy rates this recommendation as Level C—based primarily on consensus and expert opinion.⁶

A 2018 Royal College of Obstetricians and Gynecologists Green-top Guideline recognizes “definitive recommendations for fetal surveillance are hampered by the lack of randomized controlled trials demonstrating that antepartum fetal surveillance decreases perinatal morbidity or mortality in late-term and post-term gestations…. There are no definitive studies determining the optimal type or frequency of such testing and no evidence specific for women with obesity.”⁷

A 2019 Society of Obstetricians and Gynecologists of Canada practice guideline states “stillbirth is more common with maternal obesity” and recommends “increased fetal surveillance … in the third trimester if reduced fetal movements are reported.” The guideline notes “the role for non-stress tests … in surveillance of well-being in this population is uncertain.” Also, for pregnant people with a BMI > 30 kg/m², “assessment of fetal well-being is … recommended weekly from 37 weeks until delivery.” Finally, increased fetal surveillance is recommended in the setting of increased BMI and an abnormal pulsatility index of the umbilical artery and/or maternal uterine artery.⁸

Editor’s takeaway

Evidence demonstrates that increased maternal BMI is associated with increased stillbirths. However, evidence has not shown that third-trimester antenatal testing decreases this morbidity and mortality. Expert opinion varies, with ACOG recommending weekly antenatal testing from 34 and 37 weeks’ gestation, respectively, for pregnant people with BMIs of ≥ 40 kg/m² and of 35 to 39.9 kg/m². ●

The vast majority of symptomatic breast conditions are benign, with the most common symptoms being palpable mass and breast pain. Clinicians, including primary care clinicians and gynecologists, play a crucial role by performing the initial assessment and subsequent therapies and referrals and serve as the mediator between the specialists and by being the patient’s spokesperson. It is therefore important for clinicians to be aware of the various possible causes of these breast symptoms, to know which imaging tests to order, and also to understand the indications for biopsies and surgical referral.

Common types of breast lumps: Imaging workup and management

Accounting for 8% of women who present with breast symptoms, breast lump is the second most common symptom after breast pain.¹ The positive likelihood ratio of finding breast cancer is highest among women with breast lumps compared with any other breast symptoms. Therefore, anxiety is related to this symptom, and a thorough evaluation is recommended.¹ Cysts, fibroadenoma, and fat necrosis are 3 common benign causes of breast lumps.²

In this section, we review clinical presentation, imaging workup, and management strategies for common types of breast lumps.

CASE 1 Woman with tender breast lump

A 45-year-old woman presents with a breast lump of 6 months’ duration that is associated with a change in size with the menstrual cycle and pain. Clinical examination reveals a 4 x 4.5–cm mass in the right breast in the retroareolar region, which is smooth with some tenderness on palpation.

Breast cyst

According to the American College of Radiology appropriateness criteria for an adult woman 40 years of age or older who presents with a palpable breast mass, the initial imaging study is diagnostic mammography with or without digital tomosynthesis, usually followed by a directed ultrasound. If the mammogram is suspicious or highly suggestive of malignancy, or in cases where the mammogram does not show an abnormality, the next recommended step is breast ultrasonography. Any suspicious findings on ultrasound or mammogram should be followed by an image guided biopsy. Ultrasonography also may be appropriate if the mammogram findings are benign or probably benign.

For an adult woman younger than age 30 who presents with a palpable breast mass, breast ultrasonography is the appropriate initial imaging study. If the ultrasound is suspicious or highly suggestive of malignancy, then performing diagnostic mammography with or without digital tomosynthesis or ultrasound-guided core needle biopsy of the mass are both considered appropriate. However, no further imaging is recommended if the ultrasound is benign, probably benign, or negative. Breast ultrasonography or mammography is appropriate as the initial imaging test for adult women aged 30 to 39 years who present with a palpable breast mass.^3,4

Approximately 50% of women after age 30 may develop fibrocystic breast disease, and 20% of them can present with pain or lump due to a macrocysts. Simple cysts must be distinguished from complex cysts with the help of ultrasound as the latter are associated with 23% to 31% increased risk of malignancy.

In this 45-year-old patient, the initial mammogram demonstrated a circumscribed mass underneath the area of palpable concern (FIGURE 1a, 1b). Targeted breast ultrasonography was performed for further assessment, which depicted the mass as a benign simple cyst (FIGURE 1c).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Continue to: CASE 2 Painless breast mass in a young woman...

CASE 2 Painless breast mass in a young woman

A 22-year-old woman presents with a 2-month history of breast lump, which is not associated with pain or nipple discharge. On examination, there is a 2 x 2–cm mass in the right breast at 12 o’clock, 2 cm from the nipple, which is mobile, smooth, and nontender on palpation.

Fibroadenoma

In this 22-year-old, the initial imaging of choice is breast ultrasonography. Breast ultrasonography can differentiate a cystic mass from a solid mass, and it does not involve radiation. Right breast targeted ultrasound showed a circumscribed oval homogeneous hypoechoic mass that is wider than tall (FIGURE 2). The patient desired surgical removal, and a pre-lumpectomy core needle biopsy revealed a fibroadenoma.

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Fibroadenoma is the most common benign tumor of the breast. It is most often encountered in premenopausal women. Patients present with a painless breast lump, which is smooth and mobile on palpation. Fibroadenoma can be followed expectantly with repeat ultrasound (to assess over time for growth) if it is small and asymptomatic. No further action is needed if it remains stable. If a patient desires surgical excision, a core needle biopsy is usually performed before lumpectomy.

Excisional biopsy or removal of the mass is recommended if the mass is greater than 3 or 4 cm, is symptomatic, or if there is an increase in size that raises clinical concern for phyllodes tumor. Imaging features that are concerning for phyllodes tumors are size greater than 3 cm, indistinct or microlobulated margins, and heterogeneous echo pattern.^7,8 In cases in which the imaging features are concerning for phyllodes tumor and a core needle biopsy is not definitive, wide surgical excision is recommended for definitive diagnosis.⁸

CASE 3 Patient develops breast mass post-surgery

A 45-year-old woman presents with a tender left breast mass that she noticed 2 months after breast reduction surgery. It has been increasing in size since. On clinical examination, a 4 x 4–cm mass is found at the surgical scar site, which is indurated on palpation and tender.

Fat necrosis

In this 45-year-old, the initial test of choice is diagnostic mammography, which showed a somewhat circumscribed area with fat under the palpable marker (FIGURE 3a). Breast ultrasonography was performed for further evaluation, which was inconclusive as the ultrasound showed ill-defined areas of mixed echogenicity (FIGURE 3b). Breast magnetic resonance imaging (MRI) clearly demonstrated fat necrosis in the area of the palpable lump (FIGURE 3c).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Fat necrosis of the breast is an inflammatory process that is seen after breast trauma or surgery. It can present as an incidental mammogram finding or a palpable mass. The patient may give a history of trauma, breast reduction surgery, or breast cancer surgery followed by radiation treatment. On clinical examination, fat necrosis occasionally can present as a firm mass with skin retraction or swelling concerning for cancer. Imaging features are variable depending on the stage of fat necrosis and inflammation.^9-11

A mammogram may demonstrate a circumscribed fat-containing mass, an ill-defined mass, asymmetry or calcified oil cyst, and dystrophic calcifications. On ultrasound, fat necrosis can appear as anechoic or hypoechoic or as a complicated cyst or a mixed cystic, solid mass. MRI demonstrates a circumscribed or irregular fat-containing mass, with or without enhancement, and architectural distortion.

When the imaging features are clearly benign—for example, a circumscribed fat-containing mass on mammogram or on ultrasound or, on MRI, marked hypointensity of fat in the center of a circumscribed mass when compared with surrounding fat (keyhole sign)—no further follow-up is needed. When the imaging features are indeterminate, however, a short-interval follow-up can be considered. In cases with irregular fat-containing mass with enhancement, core needle biopsy is indicated to exclude cancer. If the workup remains inconclusive and the level of clinical suspicion is high, surgical excision can be performed for a definitive diagnosis.¹²

Continue to: Investigating breast pain: Imaging workup and management...

Investigating breast pain: Imaging workup and management

Breast pain, or mastalgia, is the most common concern of women presenting to a breast clinic and accounts for approximately half of such encounters.¹³ Causes of breast pain include hormonal changes, fibrocystic changes, musculoskeletal causes (such as costochondritis), lack of support, infection, and injury. While mastalgia often causes patient concern, the risk of malignancy in a woman presenting with breast pain alone is low. Still, it is essential to rule out other findings suspicious for cancer (mass, skin changes, or nipple discharge) with a thorough history and breast examination.

In this section, we review clinical presentation, imaging workup, and management for breast pain.

CASE 4 Woman with noncyclic breast pain

A 26-year-old woman presents to the clinic with mastalgia. The pain is noncyclic and primarily located in the upper outer quadrant of her left breast. There is no history of breast cancer in her family. She has no suspicious findings on the breast examination.

Mastalgia

The test of choice for this 26-year-old with focal left breast pain is targeted breast ultrasound. The patient’s ultrasound image showed no suspicious findings or solid or cystic mass (FIGURE 4).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Two important characteristics of breast pain are whether it is noncyclical and whether it is focal. According to the American College of Radiology, no breast imaging is recommended for clinically insignificant cyclical, nonfocal (greater than 1 quadrant)/diffuse pain, as this type of mastalgia is not associated with malignancy.¹⁴

For patients age 40 or older, if they are not up to date with their annual screening mammogram, then a mammogram should be performed. An imaging workup is warranted for clinically significant mastalgia that is noncyclical and focal. Even then, no malignancy is identified in most patients with clinically significant mastalgia; in patients with breast pain as their only symptom, the prevalence of breast cancer is 0% to 3.0%.^15-19

The initial imaging modality differs by patient age: younger than 30 years, ultrasonography; between 30 and 40 years, mammography or ultrasonography; and older than 40 years, mammography first followed by ultrasonography.¹⁴

Treatment of breast pain is primarily symptomatic, and evidence for specific treatments is generally lacking. Cyclical breast pain resolves spontaneously in 20% to 30% of women, while noncyclical pain responds poorly to treatment but resolves spontaneously in half of women.²⁰ Reassurance is important and wearing a supportive bra often can alleviate breast pain. In addition, reducing caffeine intake can be helpful.

As a first-line treatment, both topical (diclofenac) and oral nonsteroidal anti-inflammatory drugs effectively can relieve breast pain. Supplements and herbal remedies (for example, evening primrose oil, vitamin E, flaxseed) have varying effectiveness and are of questionable benefit as few have trials to support their effectiveness.⁴ Danazol and tamoxifen have been shown to have some benefits but they also have adverse effects.²⁰ Surgery does not play a role in the treatment of mastalgia.

CASE 5 Breastfeeding woman with breast pain

A 27-year-old postpartum woman presents with concerns for redness and pain in the upper inner left breast. She has been breastfeeding for the past few months. Breast examination demonstrates a 5-cm area of erythema and warmth but no fluctuance or masses.

Lactational mastitis

Targeted ultrasonography is the test of choice for this 27-year-old patient with focal breast pain, and the imaging revealed edema of subcutaneous tissues and ill-defined hypoechoic areas, likely inflamed fat lobules (FIGURE 5). These findings suggest uncomplicated lactational mastitis, which can be treated with antibiotics. Generally, the mastitis will improve within days of starting the antibiotics; if it does not improve, repeat examination and ultrasound should be performed to look for formation of an abscess that may require aspiration.

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Continue to: CASE 6 Woman with painful periareolar mass...

A 42-year-old perimenopausal woman describes having pain near the nipple of her right breast. She is a smoker and has no history of breast cancer in her family. Examination demonstrates a palpable, erythematous, painful, 3-cm periareolar fluctuant mass.

Nonpuerperal periareolar abscess

Appropriate initial imaging for this 42-year-old patient with focal pain is a diagnostic mammogram, which showed skin thickening and a retroareolar mass (FIGURE 6a). Further evaluation with targeted ultrasound showed a thick-walled anechoic collection with echoes compatible with an abscess (FIGURE 6b).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Mammographic findings in a patient with mastitis may be normal or demonstrate skin and trabecular thickening. Ultrasound imaging may show dilated ducts and heterogeneous tissue secondary to inflammation and edema without a discrete fluid collection. In cases with breast abscess, in addition to the mammographic findings described above, a mass, or an asymmetry, may be seen, most commonly in a subareolar location. On ultrasound, a hypoechoic collection with mobile debris, no internal flow on Doppler, and thick hypervascular walls can be seen with abscess, occasionally giving the appearance of a complicated cyst or a mixed cystic, solid mass.

The most important differential for mastitis is inflammatory breast cancer. Most cancers appear solid but can have central necrosis, mimicking a complicated cystic mass on ultrasound. The location for mastitis or abscess is most frequently subareolar. The presence of microcalcifications in a mass indicates the possibility of cancer.

Contrast-enhanced MRI can be helpful to differentiate between infection and cancer, with cancers showing initial early enhancement and washout kinetics compared with infected collections that show no enhancement or peripheral enhancement with a plateau or persistent enhancement curves. When clinical and imaging findings are unchanged after treatment of mastitis and abscesses, a core needle biopsy should be performed.^21,22

There are 2 categories of mastitis and breast abscess: lactational and nonpuerperal (all mastitis that occurs outside the lactational period). The World Health Organization definition of puerperal mastitis includes pain, local redness, warmth and swelling of the breast (usually unilateral), fever, and malaise.⁴ Concerning etiology, epithelial lesions in the nipple area caused by breastfeeding can allow pathogens to enter and cause infection. The most common microorganism is Staphylococcus aureus.⁴ Continued emptying of the breast is important, combined with early antibiotic therapy (dicloxacillin is often the first line; if the patient is penicillin allergic, use a macrolide such as clindamycin). If no improvement is seen in 48 to 72 hours, imaging should be performed.

In most cases, continuation of breastfeeding is possible. If mastitis has evolved into an abscess in a lactating woman, it can be aspirated under ultrasound guidance. Incision and drainage should be avoided unless the abscess persists after multiple aspiration attempts, it is large, or if the overlying skin is thin or otherwise appears nonviable.

Nonpuerperal mastitis includes peripheral, periductal, and idiopathic granulomatous mastitis (IGM). Peripheral mastitis behaves like infections/abscesses in other soft tissues, responds well to treatment (antibiotics and percutaneous drainage), and is less likely to recur than periductal mastitis and IGM.^21,23

Periductal mastitis and abscess, also known as Zuska disease, has a pathogenesis distinct from other forms of mastitis. Squamous metaplasia of the usual cuboidal epithelium of the breast ducts leads to keratin plugging that can cause infection.²³ Risk factors include obesity, smoking, and macromastia. The typical presentation of Zuska disease is a woman with a history of chronic smoking and/or a congenital cleft in the central nipple.²³ Periareolar signs of inflammation (redness, swelling, warmth) may be accompanied by an abscess. These can recur and lead to chronic fistula formation, especially if there is a history of intervention (such as aspiration, incision, and drainage).

Treatment of Zuska disease includes symptom relief and antibiotics. If S aureus is present, infection with methicillin-resistant S aureus is likely, and treatment with clindamycin or amoxicillin/clavulanic acid is preferred. If abscess is present, aspiration (preferred, often under ultrasound guidance) or incision and drainage (if the skin is compromised) may be required. If disease is recurrent or associated with a chronically draining fistula, surgical intervention may be warranted, in which resolution requires removing the keratin-plugged ducts in and immediately below the central core of the nipple. Given the association between Zuska disease and smoking, cessation should be encouraged, although there is no guarantee that this will resolve the issue.²³

Continue to: CASE 7 Patient with breast pain and swelling...

CASE 7 Patient with breast pain and swelling

A 39-year-old woman presents with left breast swelling and pain of 1 month’s duration. On examination, there is a 6-cm area of edema, induration, and erythema.

Granulomatous mastitis

A diagnostic mammogram and ultrasound demonstrated an ill-defined hypoechoic mass (FIGURE 7a). Ultrasound-guided biopsy was performed, which showed granulomatous mastitis, negative for fungus and acid-fast bacilli. The patient was treated with prednisone and gradually improved (FIGURE 7b).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Granulomatous mastitis (GM) is a rare benign inflammatory process, with etiologies that include fungal infections, tuberculosis, Wegener granulomatosis, sarcoidosis, and idiopathic causes. Imaging can be nonspecific and show variable features. Mammograms can appear normal or show asymmetry or mass and skin thickening. Ultrasound can show heterogeneous parenchyma, ill-defined hypoechoic collection, or a mass with margins that can be circumscribed or indistinct or with tubular extensions, with or without overlying skin thickening, fistulas, and reactive lymph nodes.²⁴

In this clinical setting, the differential diagnosis includes infectious mastitis, inflammatory breast cancer, foreign body injection granulomas, and diabetic mastopathy. Treatment involves drainage and fluid culture if there is a collection on imaging. A core biopsy is performed if imaging demonstrates a solid mass or fluid culture is negative and symptoms persist or recur. Oral steroids represent the mainstay of treatment if a core biopsy shows GM. However, immunosuppressants, including methotrexate, and surgery are options if initial treatment is not helpful.^25,26

Conclusion

Breast symptoms are common reasons for patient visits to obstetricians and gynecologists. With a good understanding of the various symptomatic breast diseases and conditions, and by having a close collaboration with radiologists and breast surgeons, clinicians can provide excellent care to these patients and thereby improve patient outcomes and satisfaction. ●

The vast majority of symptomatic breast conditions are benign, with the most common symptoms being palpable mass and breast pain. Clinicians, including primary care clinicians and gynecologists, play a crucial role by performing the initial assessment and subsequent therapies and referrals and serve as the mediator between the specialists and by being the patient’s spokesperson. It is therefore important for clinicians to be aware of the various possible causes of these breast symptoms, to know which imaging tests to order, and also to understand the indications for biopsies and surgical referral.

Common types of breast lumps: Imaging workup and management

Accounting for 8% of women who present with breast symptoms, breast lump is the second most common symptom after breast pain.¹ The positive likelihood ratio of finding breast cancer is highest among women with breast lumps compared with any other breast symptoms. Therefore, anxiety is related to this symptom, and a thorough evaluation is recommended.¹ Cysts, fibroadenoma, and fat necrosis are 3 common benign causes of breast lumps.²

In this section, we review clinical presentation, imaging workup, and management strategies for common types of breast lumps.

CASE 1 Woman with tender breast lump

A 45-year-old woman presents with a breast lump of 6 months’ duration that is associated with a change in size with the menstrual cycle and pain. Clinical examination reveals a 4 x 4.5–cm mass in the right breast in the retroareolar region, which is smooth with some tenderness on palpation.

Breast cyst

According to the American College of Radiology appropriateness criteria for an adult woman 40 years of age or older who presents with a palpable breast mass, the initial imaging study is diagnostic mammography with or without digital tomosynthesis, usually followed by a directed ultrasound. If the mammogram is suspicious or highly suggestive of malignancy, or in cases where the mammogram does not show an abnormality, the next recommended step is breast ultrasonography. Any suspicious findings on ultrasound or mammogram should be followed by an image guided biopsy. Ultrasonography also may be appropriate if the mammogram findings are benign or probably benign.

For an adult woman younger than age 30 who presents with a palpable breast mass, breast ultrasonography is the appropriate initial imaging study. If the ultrasound is suspicious or highly suggestive of malignancy, then performing diagnostic mammography with or without digital tomosynthesis or ultrasound-guided core needle biopsy of the mass are both considered appropriate. However, no further imaging is recommended if the ultrasound is benign, probably benign, or negative. Breast ultrasonography or mammography is appropriate as the initial imaging test for adult women aged 30 to 39 years who present with a palpable breast mass.^3,4

Approximately 50% of women after age 30 may develop fibrocystic breast disease, and 20% of them can present with pain or lump due to a macrocysts. Simple cysts must be distinguished from complex cysts with the help of ultrasound as the latter are associated with 23% to 31% increased risk of malignancy.

In this 45-year-old patient, the initial mammogram demonstrated a circumscribed mass underneath the area of palpable concern (FIGURE 1a, 1b). Targeted breast ultrasonography was performed for further assessment, which depicted the mass as a benign simple cyst (FIGURE 1c).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Continue to: CASE 2 Painless breast mass in a young woman...

CASE 2 Painless breast mass in a young woman

A 22-year-old woman presents with a 2-month history of breast lump, which is not associated with pain or nipple discharge. On examination, there is a 2 x 2–cm mass in the right breast at 12 o’clock, 2 cm from the nipple, which is mobile, smooth, and nontender on palpation.

Fibroadenoma

In this 22-year-old, the initial imaging of choice is breast ultrasonography. Breast ultrasonography can differentiate a cystic mass from a solid mass, and it does not involve radiation. Right breast targeted ultrasound showed a circumscribed oval homogeneous hypoechoic mass that is wider than tall (FIGURE 2). The patient desired surgical removal, and a pre-lumpectomy core needle biopsy revealed a fibroadenoma.

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Fibroadenoma is the most common benign tumor of the breast. It is most often encountered in premenopausal women. Patients present with a painless breast lump, which is smooth and mobile on palpation. Fibroadenoma can be followed expectantly with repeat ultrasound (to assess over time for growth) if it is small and asymptomatic. No further action is needed if it remains stable. If a patient desires surgical excision, a core needle biopsy is usually performed before lumpectomy.

Excisional biopsy or removal of the mass is recommended if the mass is greater than 3 or 4 cm, is symptomatic, or if there is an increase in size that raises clinical concern for phyllodes tumor. Imaging features that are concerning for phyllodes tumors are size greater than 3 cm, indistinct or microlobulated margins, and heterogeneous echo pattern.^7,8 In cases in which the imaging features are concerning for phyllodes tumor and a core needle biopsy is not definitive, wide surgical excision is recommended for definitive diagnosis.⁸

CASE 3 Patient develops breast mass post-surgery

A 45-year-old woman presents with a tender left breast mass that she noticed 2 months after breast reduction surgery. It has been increasing in size since. On clinical examination, a 4 x 4–cm mass is found at the surgical scar site, which is indurated on palpation and tender.

Fat necrosis

In this 45-year-old, the initial test of choice is diagnostic mammography, which showed a somewhat circumscribed area with fat under the palpable marker (FIGURE 3a). Breast ultrasonography was performed for further evaluation, which was inconclusive as the ultrasound showed ill-defined areas of mixed echogenicity (FIGURE 3b). Breast magnetic resonance imaging (MRI) clearly demonstrated fat necrosis in the area of the palpable lump (FIGURE 3c).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Fat necrosis of the breast is an inflammatory process that is seen after breast trauma or surgery. It can present as an incidental mammogram finding or a palpable mass. The patient may give a history of trauma, breast reduction surgery, or breast cancer surgery followed by radiation treatment. On clinical examination, fat necrosis occasionally can present as a firm mass with skin retraction or swelling concerning for cancer. Imaging features are variable depending on the stage of fat necrosis and inflammation.^9-11

A mammogram may demonstrate a circumscribed fat-containing mass, an ill-defined mass, asymmetry or calcified oil cyst, and dystrophic calcifications. On ultrasound, fat necrosis can appear as anechoic or hypoechoic or as a complicated cyst or a mixed cystic, solid mass. MRI demonstrates a circumscribed or irregular fat-containing mass, with or without enhancement, and architectural distortion.

When the imaging features are clearly benign—for example, a circumscribed fat-containing mass on mammogram or on ultrasound or, on MRI, marked hypointensity of fat in the center of a circumscribed mass when compared with surrounding fat (keyhole sign)—no further follow-up is needed. When the imaging features are indeterminate, however, a short-interval follow-up can be considered. In cases with irregular fat-containing mass with enhancement, core needle biopsy is indicated to exclude cancer. If the workup remains inconclusive and the level of clinical suspicion is high, surgical excision can be performed for a definitive diagnosis.¹²

Continue to: Investigating breast pain: Imaging workup and management...

Investigating breast pain: Imaging workup and management

Breast pain, or mastalgia, is the most common concern of women presenting to a breast clinic and accounts for approximately half of such encounters.¹³ Causes of breast pain include hormonal changes, fibrocystic changes, musculoskeletal causes (such as costochondritis), lack of support, infection, and injury. While mastalgia often causes patient concern, the risk of malignancy in a woman presenting with breast pain alone is low. Still, it is essential to rule out other findings suspicious for cancer (mass, skin changes, or nipple discharge) with a thorough history and breast examination.

In this section, we review clinical presentation, imaging workup, and management for breast pain.

CASE 4 Woman with noncyclic breast pain

A 26-year-old woman presents to the clinic with mastalgia. The pain is noncyclic and primarily located in the upper outer quadrant of her left breast. There is no history of breast cancer in her family. She has no suspicious findings on the breast examination.

Mastalgia

The test of choice for this 26-year-old with focal left breast pain is targeted breast ultrasound. The patient’s ultrasound image showed no suspicious findings or solid or cystic mass (FIGURE 4).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Two important characteristics of breast pain are whether it is noncyclical and whether it is focal. According to the American College of Radiology, no breast imaging is recommended for clinically insignificant cyclical, nonfocal (greater than 1 quadrant)/diffuse pain, as this type of mastalgia is not associated with malignancy.¹⁴

For patients age 40 or older, if they are not up to date with their annual screening mammogram, then a mammogram should be performed. An imaging workup is warranted for clinically significant mastalgia that is noncyclical and focal. Even then, no malignancy is identified in most patients with clinically significant mastalgia; in patients with breast pain as their only symptom, the prevalence of breast cancer is 0% to 3.0%.^15-19

The initial imaging modality differs by patient age: younger than 30 years, ultrasonography; between 30 and 40 years, mammography or ultrasonography; and older than 40 years, mammography first followed by ultrasonography.¹⁴

Treatment of breast pain is primarily symptomatic, and evidence for specific treatments is generally lacking. Cyclical breast pain resolves spontaneously in 20% to 30% of women, while noncyclical pain responds poorly to treatment but resolves spontaneously in half of women.²⁰ Reassurance is important and wearing a supportive bra often can alleviate breast pain. In addition, reducing caffeine intake can be helpful.

As a first-line treatment, both topical (diclofenac) and oral nonsteroidal anti-inflammatory drugs effectively can relieve breast pain. Supplements and herbal remedies (for example, evening primrose oil, vitamin E, flaxseed) have varying effectiveness and are of questionable benefit as few have trials to support their effectiveness.⁴ Danazol and tamoxifen have been shown to have some benefits but they also have adverse effects.²⁰ Surgery does not play a role in the treatment of mastalgia.

CASE 5 Breastfeeding woman with breast pain

A 27-year-old postpartum woman presents with concerns for redness and pain in the upper inner left breast. She has been breastfeeding for the past few months. Breast examination demonstrates a 5-cm area of erythema and warmth but no fluctuance or masses.

Lactational mastitis

Targeted ultrasonography is the test of choice for this 27-year-old patient with focal breast pain, and the imaging revealed edema of subcutaneous tissues and ill-defined hypoechoic areas, likely inflamed fat lobules (FIGURE 5). These findings suggest uncomplicated lactational mastitis, which can be treated with antibiotics. Generally, the mastitis will improve within days of starting the antibiotics; if it does not improve, repeat examination and ultrasound should be performed to look for formation of an abscess that may require aspiration.

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Continue to: CASE 6 Woman with painful periareolar mass...

A 42-year-old perimenopausal woman describes having pain near the nipple of her right breast. She is a smoker and has no history of breast cancer in her family. Examination demonstrates a palpable, erythematous, painful, 3-cm periareolar fluctuant mass.

Nonpuerperal periareolar abscess

Appropriate initial imaging for this 42-year-old patient with focal pain is a diagnostic mammogram, which showed skin thickening and a retroareolar mass (FIGURE 6a). Further evaluation with targeted ultrasound showed a thick-walled anechoic collection with echoes compatible with an abscess (FIGURE 6b).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Mammographic findings in a patient with mastitis may be normal or demonstrate skin and trabecular thickening. Ultrasound imaging may show dilated ducts and heterogeneous tissue secondary to inflammation and edema without a discrete fluid collection. In cases with breast abscess, in addition to the mammographic findings described above, a mass, or an asymmetry, may be seen, most commonly in a subareolar location. On ultrasound, a hypoechoic collection with mobile debris, no internal flow on Doppler, and thick hypervascular walls can be seen with abscess, occasionally giving the appearance of a complicated cyst or a mixed cystic, solid mass.

The most important differential for mastitis is inflammatory breast cancer. Most cancers appear solid but can have central necrosis, mimicking a complicated cystic mass on ultrasound. The location for mastitis or abscess is most frequently subareolar. The presence of microcalcifications in a mass indicates the possibility of cancer.

Contrast-enhanced MRI can be helpful to differentiate between infection and cancer, with cancers showing initial early enhancement and washout kinetics compared with infected collections that show no enhancement or peripheral enhancement with a plateau or persistent enhancement curves. When clinical and imaging findings are unchanged after treatment of mastitis and abscesses, a core needle biopsy should be performed.^21,22

There are 2 categories of mastitis and breast abscess: lactational and nonpuerperal (all mastitis that occurs outside the lactational period). The World Health Organization definition of puerperal mastitis includes pain, local redness, warmth and swelling of the breast (usually unilateral), fever, and malaise.⁴ Concerning etiology, epithelial lesions in the nipple area caused by breastfeeding can allow pathogens to enter and cause infection. The most common microorganism is Staphylococcus aureus.⁴ Continued emptying of the breast is important, combined with early antibiotic therapy (dicloxacillin is often the first line; if the patient is penicillin allergic, use a macrolide such as clindamycin). If no improvement is seen in 48 to 72 hours, imaging should be performed.

In most cases, continuation of breastfeeding is possible. If mastitis has evolved into an abscess in a lactating woman, it can be aspirated under ultrasound guidance. Incision and drainage should be avoided unless the abscess persists after multiple aspiration attempts, it is large, or if the overlying skin is thin or otherwise appears nonviable.

Nonpuerperal mastitis includes peripheral, periductal, and idiopathic granulomatous mastitis (IGM). Peripheral mastitis behaves like infections/abscesses in other soft tissues, responds well to treatment (antibiotics and percutaneous drainage), and is less likely to recur than periductal mastitis and IGM.^21,23

Periductal mastitis and abscess, also known as Zuska disease, has a pathogenesis distinct from other forms of mastitis. Squamous metaplasia of the usual cuboidal epithelium of the breast ducts leads to keratin plugging that can cause infection.²³ Risk factors include obesity, smoking, and macromastia. The typical presentation of Zuska disease is a woman with a history of chronic smoking and/or a congenital cleft in the central nipple.²³ Periareolar signs of inflammation (redness, swelling, warmth) may be accompanied by an abscess. These can recur and lead to chronic fistula formation, especially if there is a history of intervention (such as aspiration, incision, and drainage).

Treatment of Zuska disease includes symptom relief and antibiotics. If S aureus is present, infection with methicillin-resistant S aureus is likely, and treatment with clindamycin or amoxicillin/clavulanic acid is preferred. If abscess is present, aspiration (preferred, often under ultrasound guidance) or incision and drainage (if the skin is compromised) may be required. If disease is recurrent or associated with a chronically draining fistula, surgical intervention may be warranted, in which resolution requires removing the keratin-plugged ducts in and immediately below the central core of the nipple. Given the association between Zuska disease and smoking, cessation should be encouraged, although there is no guarantee that this will resolve the issue.²³

Continue to: CASE 7 Patient with breast pain and swelling...

CASE 7 Patient with breast pain and swelling

A 39-year-old woman presents with left breast swelling and pain of 1 month’s duration. On examination, there is a 6-cm area of edema, induration, and erythema.

Granulomatous mastitis

A diagnostic mammogram and ultrasound demonstrated an ill-defined hypoechoic mass (FIGURE 7a). Ultrasound-guided biopsy was performed, which showed granulomatous mastitis, negative for fungus and acid-fast bacilli. The patient was treated with prednisone and gradually improved (FIGURE 7b).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Granulomatous mastitis (GM) is a rare benign inflammatory process, with etiologies that include fungal infections, tuberculosis, Wegener granulomatosis, sarcoidosis, and idiopathic causes. Imaging can be nonspecific and show variable features. Mammograms can appear normal or show asymmetry or mass and skin thickening. Ultrasound can show heterogeneous parenchyma, ill-defined hypoechoic collection, or a mass with margins that can be circumscribed or indistinct or with tubular extensions, with or without overlying skin thickening, fistulas, and reactive lymph nodes.²⁴

In this clinical setting, the differential diagnosis includes infectious mastitis, inflammatory breast cancer, foreign body injection granulomas, and diabetic mastopathy. Treatment involves drainage and fluid culture if there is a collection on imaging. A core biopsy is performed if imaging demonstrates a solid mass or fluid culture is negative and symptoms persist or recur. Oral steroids represent the mainstay of treatment if a core biopsy shows GM. However, immunosuppressants, including methotrexate, and surgery are options if initial treatment is not helpful.^25,26

Conclusion

Breast symptoms are common reasons for patient visits to obstetricians and gynecologists. With a good understanding of the various symptomatic breast diseases and conditions, and by having a close collaboration with radiologists and breast surgeons, clinicians can provide excellent care to these patients and thereby improve patient outcomes and satisfaction. ●

The vast majority of symptomatic breast conditions are benign, with the most common symptoms being palpable mass and breast pain. Clinicians, including primary care clinicians and gynecologists, play a crucial role by performing the initial assessment and subsequent therapies and referrals and serve as the mediator between the specialists and by being the patient’s spokesperson. It is therefore important for clinicians to be aware of the various possible causes of these breast symptoms, to know which imaging tests to order, and also to understand the indications for biopsies and surgical referral.

Common types of breast lumps: Imaging workup and management

Accounting for 8% of women who present with breast symptoms, breast lump is the second most common symptom after breast pain.¹ The positive likelihood ratio of finding breast cancer is highest among women with breast lumps compared with any other breast symptoms. Therefore, anxiety is related to this symptom, and a thorough evaluation is recommended.¹ Cysts, fibroadenoma, and fat necrosis are 3 common benign causes of breast lumps.²

In this section, we review clinical presentation, imaging workup, and management strategies for common types of breast lumps.

CASE 1 Woman with tender breast lump

A 45-year-old woman presents with a breast lump of 6 months’ duration that is associated with a change in size with the menstrual cycle and pain. Clinical examination reveals a 4 x 4.5–cm mass in the right breast in the retroareolar region, which is smooth with some tenderness on palpation.

Breast cyst

According to the American College of Radiology appropriateness criteria for an adult woman 40 years of age or older who presents with a palpable breast mass, the initial imaging study is diagnostic mammography with or without digital tomosynthesis, usually followed by a directed ultrasound. If the mammogram is suspicious or highly suggestive of malignancy, or in cases where the mammogram does not show an abnormality, the next recommended step is breast ultrasonography. Any suspicious findings on ultrasound or mammogram should be followed by an image guided biopsy. Ultrasonography also may be appropriate if the mammogram findings are benign or probably benign.

For an adult woman younger than age 30 who presents with a palpable breast mass, breast ultrasonography is the appropriate initial imaging study. If the ultrasound is suspicious or highly suggestive of malignancy, then performing diagnostic mammography with or without digital tomosynthesis or ultrasound-guided core needle biopsy of the mass are both considered appropriate. However, no further imaging is recommended if the ultrasound is benign, probably benign, or negative. Breast ultrasonography or mammography is appropriate as the initial imaging test for adult women aged 30 to 39 years who present with a palpable breast mass.^3,4

Approximately 50% of women after age 30 may develop fibrocystic breast disease, and 20% of them can present with pain or lump due to a macrocysts. Simple cysts must be distinguished from complex cysts with the help of ultrasound as the latter are associated with 23% to 31% increased risk of malignancy.

In this 45-year-old patient, the initial mammogram demonstrated a circumscribed mass underneath the area of palpable concern (FIGURE 1a, 1b). Targeted breast ultrasonography was performed for further assessment, which depicted the mass as a benign simple cyst (FIGURE 1c).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Continue to: CASE 2 Painless breast mass in a young woman...

CASE 2 Painless breast mass in a young woman

A 22-year-old woman presents with a 2-month history of breast lump, which is not associated with pain or nipple discharge. On examination, there is a 2 x 2–cm mass in the right breast at 12 o’clock, 2 cm from the nipple, which is mobile, smooth, and nontender on palpation.

Fibroadenoma

In this 22-year-old, the initial imaging of choice is breast ultrasonography. Breast ultrasonography can differentiate a cystic mass from a solid mass, and it does not involve radiation. Right breast targeted ultrasound showed a circumscribed oval homogeneous hypoechoic mass that is wider than tall (FIGURE 2). The patient desired surgical removal, and a pre-lumpectomy core needle biopsy revealed a fibroadenoma.

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Fibroadenoma is the most common benign tumor of the breast. It is most often encountered in premenopausal women. Patients present with a painless breast lump, which is smooth and mobile on palpation. Fibroadenoma can be followed expectantly with repeat ultrasound (to assess over time for growth) if it is small and asymptomatic. No further action is needed if it remains stable. If a patient desires surgical excision, a core needle biopsy is usually performed before lumpectomy.

Excisional biopsy or removal of the mass is recommended if the mass is greater than 3 or 4 cm, is symptomatic, or if there is an increase in size that raises clinical concern for phyllodes tumor. Imaging features that are concerning for phyllodes tumors are size greater than 3 cm, indistinct or microlobulated margins, and heterogeneous echo pattern.^7,8 In cases in which the imaging features are concerning for phyllodes tumor and a core needle biopsy is not definitive, wide surgical excision is recommended for definitive diagnosis.⁸

CASE 3 Patient develops breast mass post-surgery

A 45-year-old woman presents with a tender left breast mass that she noticed 2 months after breast reduction surgery. It has been increasing in size since. On clinical examination, a 4 x 4–cm mass is found at the surgical scar site, which is indurated on palpation and tender.

Fat necrosis

In this 45-year-old, the initial test of choice is diagnostic mammography, which showed a somewhat circumscribed area with fat under the palpable marker (FIGURE 3a). Breast ultrasonography was performed for further evaluation, which was inconclusive as the ultrasound showed ill-defined areas of mixed echogenicity (FIGURE 3b). Breast magnetic resonance imaging (MRI) clearly demonstrated fat necrosis in the area of the palpable lump (FIGURE 3c).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Fat necrosis of the breast is an inflammatory process that is seen after breast trauma or surgery. It can present as an incidental mammogram finding or a palpable mass. The patient may give a history of trauma, breast reduction surgery, or breast cancer surgery followed by radiation treatment. On clinical examination, fat necrosis occasionally can present as a firm mass with skin retraction or swelling concerning for cancer. Imaging features are variable depending on the stage of fat necrosis and inflammation.^9-11

A mammogram may demonstrate a circumscribed fat-containing mass, an ill-defined mass, asymmetry or calcified oil cyst, and dystrophic calcifications. On ultrasound, fat necrosis can appear as anechoic or hypoechoic or as a complicated cyst or a mixed cystic, solid mass. MRI demonstrates a circumscribed or irregular fat-containing mass, with or without enhancement, and architectural distortion.

When the imaging features are clearly benign—for example, a circumscribed fat-containing mass on mammogram or on ultrasound or, on MRI, marked hypointensity of fat in the center of a circumscribed mass when compared with surrounding fat (keyhole sign)—no further follow-up is needed. When the imaging features are indeterminate, however, a short-interval follow-up can be considered. In cases with irregular fat-containing mass with enhancement, core needle biopsy is indicated to exclude cancer. If the workup remains inconclusive and the level of clinical suspicion is high, surgical excision can be performed for a definitive diagnosis.¹²

Continue to: Investigating breast pain: Imaging workup and management...

Investigating breast pain: Imaging workup and management

Breast pain, or mastalgia, is the most common concern of women presenting to a breast clinic and accounts for approximately half of such encounters.¹³ Causes of breast pain include hormonal changes, fibrocystic changes, musculoskeletal causes (such as costochondritis), lack of support, infection, and injury. While mastalgia often causes patient concern, the risk of malignancy in a woman presenting with breast pain alone is low. Still, it is essential to rule out other findings suspicious for cancer (mass, skin changes, or nipple discharge) with a thorough history and breast examination.

In this section, we review clinical presentation, imaging workup, and management for breast pain.

CASE 4 Woman with noncyclic breast pain

A 26-year-old woman presents to the clinic with mastalgia. The pain is noncyclic and primarily located in the upper outer quadrant of her left breast. There is no history of breast cancer in her family. She has no suspicious findings on the breast examination.

Mastalgia

The test of choice for this 26-year-old with focal left breast pain is targeted breast ultrasound. The patient’s ultrasound image showed no suspicious findings or solid or cystic mass (FIGURE 4).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Two important characteristics of breast pain are whether it is noncyclical and whether it is focal. According to the American College of Radiology, no breast imaging is recommended for clinically insignificant cyclical, nonfocal (greater than 1 quadrant)/diffuse pain, as this type of mastalgia is not associated with malignancy.¹⁴

For patients age 40 or older, if they are not up to date with their annual screening mammogram, then a mammogram should be performed. An imaging workup is warranted for clinically significant mastalgia that is noncyclical and focal. Even then, no malignancy is identified in most patients with clinically significant mastalgia; in patients with breast pain as their only symptom, the prevalence of breast cancer is 0% to 3.0%.^15-19

The initial imaging modality differs by patient age: younger than 30 years, ultrasonography; between 30 and 40 years, mammography or ultrasonography; and older than 40 years, mammography first followed by ultrasonography.¹⁴

Treatment of breast pain is primarily symptomatic, and evidence for specific treatments is generally lacking. Cyclical breast pain resolves spontaneously in 20% to 30% of women, while noncyclical pain responds poorly to treatment but resolves spontaneously in half of women.²⁰ Reassurance is important and wearing a supportive bra often can alleviate breast pain. In addition, reducing caffeine intake can be helpful.

As a first-line treatment, both topical (diclofenac) and oral nonsteroidal anti-inflammatory drugs effectively can relieve breast pain. Supplements and herbal remedies (for example, evening primrose oil, vitamin E, flaxseed) have varying effectiveness and are of questionable benefit as few have trials to support their effectiveness.⁴ Danazol and tamoxifen have been shown to have some benefits but they also have adverse effects.²⁰ Surgery does not play a role in the treatment of mastalgia.

CASE 5 Breastfeeding woman with breast pain

A 27-year-old postpartum woman presents with concerns for redness and pain in the upper inner left breast. She has been breastfeeding for the past few months. Breast examination demonstrates a 5-cm area of erythema and warmth but no fluctuance or masses.

Lactational mastitis

Targeted ultrasonography is the test of choice for this 27-year-old patient with focal breast pain, and the imaging revealed edema of subcutaneous tissues and ill-defined hypoechoic areas, likely inflamed fat lobules (FIGURE 5). These findings suggest uncomplicated lactational mastitis, which can be treated with antibiotics. Generally, the mastitis will improve within days of starting the antibiotics; if it does not improve, repeat examination and ultrasound should be performed to look for formation of an abscess that may require aspiration.

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Continue to: CASE 6 Woman with painful periareolar mass...

A 42-year-old perimenopausal woman describes having pain near the nipple of her right breast. She is a smoker and has no history of breast cancer in her family. Examination demonstrates a palpable, erythematous, painful, 3-cm periareolar fluctuant mass.

Nonpuerperal periareolar abscess

Appropriate initial imaging for this 42-year-old patient with focal pain is a diagnostic mammogram, which showed skin thickening and a retroareolar mass (FIGURE 6a). Further evaluation with targeted ultrasound showed a thick-walled anechoic collection with echoes compatible with an abscess (FIGURE 6b).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Mammographic findings in a patient with mastitis may be normal or demonstrate skin and trabecular thickening. Ultrasound imaging may show dilated ducts and heterogeneous tissue secondary to inflammation and edema without a discrete fluid collection. In cases with breast abscess, in addition to the mammographic findings described above, a mass, or an asymmetry, may be seen, most commonly in a subareolar location. On ultrasound, a hypoechoic collection with mobile debris, no internal flow on Doppler, and thick hypervascular walls can be seen with abscess, occasionally giving the appearance of a complicated cyst or a mixed cystic, solid mass.

The most important differential for mastitis is inflammatory breast cancer. Most cancers appear solid but can have central necrosis, mimicking a complicated cystic mass on ultrasound. The location for mastitis or abscess is most frequently subareolar. The presence of microcalcifications in a mass indicates the possibility of cancer.

Contrast-enhanced MRI can be helpful to differentiate between infection and cancer, with cancers showing initial early enhancement and washout kinetics compared with infected collections that show no enhancement or peripheral enhancement with a plateau or persistent enhancement curves. When clinical and imaging findings are unchanged after treatment of mastitis and abscesses, a core needle biopsy should be performed.^21,22

There are 2 categories of mastitis and breast abscess: lactational and nonpuerperal (all mastitis that occurs outside the lactational period). The World Health Organization definition of puerperal mastitis includes pain, local redness, warmth and swelling of the breast (usually unilateral), fever, and malaise.⁴ Concerning etiology, epithelial lesions in the nipple area caused by breastfeeding can allow pathogens to enter and cause infection. The most common microorganism is Staphylococcus aureus.⁴ Continued emptying of the breast is important, combined with early antibiotic therapy (dicloxacillin is often the first line; if the patient is penicillin allergic, use a macrolide such as clindamycin). If no improvement is seen in 48 to 72 hours, imaging should be performed.

In most cases, continuation of breastfeeding is possible. If mastitis has evolved into an abscess in a lactating woman, it can be aspirated under ultrasound guidance. Incision and drainage should be avoided unless the abscess persists after multiple aspiration attempts, it is large, or if the overlying skin is thin or otherwise appears nonviable.

Nonpuerperal mastitis includes peripheral, periductal, and idiopathic granulomatous mastitis (IGM). Peripheral mastitis behaves like infections/abscesses in other soft tissues, responds well to treatment (antibiotics and percutaneous drainage), and is less likely to recur than periductal mastitis and IGM.^21,23

Periductal mastitis and abscess, also known as Zuska disease, has a pathogenesis distinct from other forms of mastitis. Squamous metaplasia of the usual cuboidal epithelium of the breast ducts leads to keratin plugging that can cause infection.²³ Risk factors include obesity, smoking, and macromastia. The typical presentation of Zuska disease is a woman with a history of chronic smoking and/or a congenital cleft in the central nipple.²³ Periareolar signs of inflammation (redness, swelling, warmth) may be accompanied by an abscess. These can recur and lead to chronic fistula formation, especially if there is a history of intervention (such as aspiration, incision, and drainage).

Treatment of Zuska disease includes symptom relief and antibiotics. If S aureus is present, infection with methicillin-resistant S aureus is likely, and treatment with clindamycin or amoxicillin/clavulanic acid is preferred. If abscess is present, aspiration (preferred, often under ultrasound guidance) or incision and drainage (if the skin is compromised) may be required. If disease is recurrent or associated with a chronically draining fistula, surgical intervention may be warranted, in which resolution requires removing the keratin-plugged ducts in and immediately below the central core of the nipple. Given the association between Zuska disease and smoking, cessation should be encouraged, although there is no guarantee that this will resolve the issue.²³

Continue to: CASE 7 Patient with breast pain and swelling...

CASE 7 Patient with breast pain and swelling

A 39-year-old woman presents with left breast swelling and pain of 1 month’s duration. On examination, there is a 6-cm area of edema, induration, and erythema.

Granulomatous mastitis

A diagnostic mammogram and ultrasound demonstrated an ill-defined hypoechoic mass (FIGURE 7a). Ultrasound-guided biopsy was performed, which showed granulomatous mastitis, negative for fungus and acid-fast bacilli. The patient was treated with prednisone and gradually improved (FIGURE 7b).

Art Credit: Images courtesy of Leigh Neumayer, MD, MS, MBA

Granulomatous mastitis (GM) is a rare benign inflammatory process, with etiologies that include fungal infections, tuberculosis, Wegener granulomatosis, sarcoidosis, and idiopathic causes. Imaging can be nonspecific and show variable features. Mammograms can appear normal or show asymmetry or mass and skin thickening. Ultrasound can show heterogeneous parenchyma, ill-defined hypoechoic collection, or a mass with margins that can be circumscribed or indistinct or with tubular extensions, with or without overlying skin thickening, fistulas, and reactive lymph nodes.²⁴

In this clinical setting, the differential diagnosis includes infectious mastitis, inflammatory breast cancer, foreign body injection granulomas, and diabetic mastopathy. Treatment involves drainage and fluid culture if there is a collection on imaging. A core biopsy is performed if imaging demonstrates a solid mass or fluid culture is negative and symptoms persist or recur. Oral steroids represent the mainstay of treatment if a core biopsy shows GM. However, immunosuppressants, including methotrexate, and surgery are options if initial treatment is not helpful.^25,26

Conclusion

Breast symptoms are common reasons for patient visits to obstetricians and gynecologists. With a good understanding of the various symptomatic breast diseases and conditions, and by having a close collaboration with radiologists and breast surgeons, clinicians can provide excellent care to these patients and thereby improve patient outcomes and satisfaction. ●

Photo: Shutterstock

Telemedicine (or telehealth) originated in the early 1900s, when radios were used to communicate medical advice to clinics aboard ships.¹ According to the American Telemedicine Association, telemedicine is namely “the use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status.”² These communications use 2-way video, email, smartphones, wireless tools, and other forms of telecommunications technology.

During the COVID-19 pandemic, many ObGyns—encouraged and advised by professional organizations—began providing telemedicine services.³ The first reported case of COVID-19 was in late 2019; the use of telemedicine was 38 times higher in February 2021 than in February 2020,⁴ illustrating how many physicians quickly moved to telemedicine practices.

CASE Dr. TM’s telemedicine dream

Before COVID-19, Dr. TM (an ObGyn practi-tioner) practiced in-person medicine in his home state. With the onset of the pandemic, Dr. TM struggled to switch to primarily seeing patients online (generally using Zoom or Facebook Live), with 1 day per week in the office for essential in-person visits.

After several months, however, Dr. TM’s routine became very efficient. He could see many more patients in a shorter time than with the former, in-person system. Therefore, as staff left his practice, Dr. TM did not replace them and also laid off others. Ultimately, the practice had 1 full-time records/insurance secretary who worked from home and 1 part-time nurse who helped with the in-person day and answered some patient inquiries by email. In part as an effort to add new patients, Dr. TM built an engaging website through which his current patients could receive medical information and new patients could sign up.

In late 2022, Dr. TM offered a $100 credit to any current patient who referred a friend or family member who then became a patient. This promotion was surprisingly effective and resulted in an influx of new patients. For example, Patient Z (a long-time patient) received 3 credits for referring her 3 sisters who lived out of state and became telepatients: Patient D, who lived 200 hundred miles away; Patient E, who lived 50 miles away in the adjoining state; and Patient F, who lived 150 miles away. Patient D contacted Dr. TM because she thought she was pregnant and wanted prenatal care, Patient E thought she might have a sexually transmitted infection (STI) and wanted treatment, and Patient F wanted general care and was inquiring about a medical abortion. Dr. TM agreed to treat Patient D but required 1 in-person visit. After 1 brief telemedicine session each with Patients E and F, Dr. TM wrote prescriptions for them.

By 2023, Dr. TM was enthusiastic about telemedicine as a professional practice. However, problems would ensue.

Medical considerations

Telemedicine is endorsed by the American College of Obstetricians and Gynecologists (ACOG) as a vehicle for delivering prenatal and postpartum care.⁵ This represents an effort to reduce maternal and neonatal morbidity and mortality,⁵ as well as expandaccess to care and address the deficit in primary care providers and services, especially in rural and underserved populations.^5,6 For obstetrics, prenatal care is designed to optimize pregnancy, childbirth, and postpartum care, with a focus on nutrition and genetic consultation and patient education on pregnancy, childbearing, breastfeeding, and newborn care.⁷

Benefits of telemedicine include its convenience for patients and providers, its efficiency and lower costs for providers (and hopefully patients, as well), and the potential improved access to care for patients.⁸ It is estimated that if a woman inititates obstetric care at 6 weeks, over the course of the 40-week gestation period, 15 prenatal visits will occur.⁹ Ultimately, the number of visits is determined based on the specifics of the pregnancy. With telemedicine, clinicians can provide those consultations, and information related to: ultrasonography, fetal echocardiography, and postpartum care services remotely.¹⁰ Using telemedicine may reduce missed visits, and remote monitoring may improve the quality of care.¹¹

Barriers to telemedicine care include technical limitations, time constraints, and patient concerns of telehealth (visits). Technical limitations include the lack of a high speed internet connection and/or a smart device and the initial technical set-up–related problems,¹² which affect providers as well as patients. Time constraints primarly refer to the ObGyn practice’s lack of time to establish telehealth services.¹³ Other challenges include integrating translation services, billing-related problems,¹⁰ and reimbursement and licensing barriers.¹⁴

Before the COVID-19 pandemic, obstetrics led the way in telemedicine with the development of the OB Nest model. Designed to replace in-person obstetrics care visits with telehealth,¹⁵ it includes home management tools such as blood pressure cuffs, cardiotocography, scales for weight checks, and Doppler ultrasounds.¹⁰ Patients can be instructed to measure fundal height and receive medications by mail. Anesthesia consultation can occur via this venue by having the patient complete a questionnaire prior to arriving at the labor and delivery unit.¹⁶

Legal considerations

With the COVID-19 pandemic, temporary changes were made to encourage the rapid adoption of telemedicine, including changes to licensing laws, certain prescription requirements, Health Insurance Portability and Accountability Act (HIPAA) privacy-security regulations, and reimbursement rules that required in-person visits. Thus, many ObGyns started using telemedicine during this rarified period, in which the rules appeared to be few and far between, with limited enforcement of the law and professional obligations.¹⁷ However, now that many of the legal rules that were suspended or ignored have been (or are being) reimposed and enforced, it is important for providers to become familiar with the legal issues involved in practicing telemedicine.

First, where is the patient? When discussing the legal issues of telemedicine, it is important to remember that many legal rules for medical care (ie, liability, informed consent, and licensing) vary from state to state. If the patient resides in a different state (“foreign” state) from the physician’s practice location (the physician’s “home” state), the care is considered delivered in the state where the patient is located. Thus, the patient’s location generally establishes the law covering the telemedicine transaction. In the following discussion, the rules refer to the law and professional obligations, with commentary on some key legal issues that are relevant to ObGyn telemedicine.

Continue to: Reinforcing the rules...

Licensing

During the height of the COVID-19 pandemic, the federal government and almost all states temporarily modified the licensing requirement to allow telemedicine based on an existing medical license in any state—disregarding the “where is the patient” rule. As those rules begin to lapse or change with the official end of the pandemic declared by President Biden as May 2023,¹⁷ the rules under which a physician began telemedicine interstate practice in 2020 also may be changing.

Simply put, “The same standards for licensure apply to health care providers regardless of whether care is delivered in-person or virtually through telehealth services.”¹⁸ When a physician is engaged in telemedicine treatment of a patient in the physician’s home state, there is generally no licensing issue. Telemedicine generally does not require a separate specific license.¹⁹ However, when the patient is in another state (a “foreign” state), there can be a substantial licensing issue.²⁰ Ordinarily, to provide that treatment, the physician must, in some manner, be approved to practice in the patient’s state. That may occur, for example, in the following ways: (1) the physician may hold an additional regular license in the patient’s state, which allows practice there, or (2) the physician may have received permission for “temporary practice” in another state.

Many states (often adjoining states) have formal agreements with other states that allow telemedicine practice by providers in each other’s states. There also are “compacts”, or agreements that enable providers in any of the participating states to practice in the other associated states without a separate license.¹⁸ Although several websites provide information about compact licensing and the like, clinicians should not rely on simple lists or maps. Individual states may have special provisions about applying their laws to out-of-state “compact” physicians. In addition, under the Interstate Medical Licensure Compact, “physicians have to pay licensing fees and satisfy the requirements of each medical board in the states where they wish to practice.”²¹

Consequences. Practicing telemedicine with a patient in a state where the physician does not have a license is generally a crime. Furthermore, it may be the basis for license discipline in the physician’s home state and result in a report to the National Practi-tioner Databank.²² In addition, reimbursement often depends on the practitioner being licensed, and the absence of a license may be a basis for denying payment for services.²³ Finally, malpractice insurance generally is limited to licensed practice. Thus, the insurer may decline to defend the unlicensed clinician against a malpractice claim or pay any damages.

Prescribing privileges

Prescribing privileges usually are connected to licensing, so as the rules for licensing change postpandemic, so do the rules for prescribing. In most cases, the physician must have a license in the state where care is given to prescribe medication—which in telemedicine, as noted, typically means the state where the patient is located. Exceptions vary by state, but in general, if a physician does not have a license to provide care, the physician is unlikely to be authorized to prescribe medication.²⁴ Failure to abide by the applicable state rules may result in civil and even criminal liability for illegal prescribing activity.

In addition, the US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA, which enforces laws concerning controlled substances) also regulate the prescription and sale of pharmaceuticals.²⁵ There are state and federal limits on the ability of clinicians to order controlled substances without an in-person visit. The Ryan Haight Online Pharmacy Consumer Protection Act, for example, sets limits on controlled substance prescriptions without an in-person examination.²⁶ Federal law was modified due to COVID-19 to permit prescribing of many controlled substances by telemedicine if there is synchronous audio and visual examination of the patient. Physicians who write such prescriptions also are required to have a DEA registration in the patient’s state. This is an essential consideration for physicians considering interstate telemedicine practice.²⁷

HIPAA and privacy

Governments waived some of the legal requirements related to health information during the pandemic, but those waivers either have expired or will do so soon. Federal and state laws regarding privacy and security—notably including HIPAA—apply to telemedicine and are of particular concern given the considerable amount of communication of protected health information with telemedicine.

HIPAA security rules essentially require making sure health information cannot be hacked or intercepted. Audio-only telemedicine by landline (not cell) is acceptable under the security rules, but almost all other remote communication requires secure communications.²⁸

Clinicians also need to adhere to the more usual HIPAA privacy rules when practicingtelehealth. State laws protecting patient privacy vary and may be more stringent than HIPAA, so clinicians also must know the requirements in any state where they practice—whether in office or telemedicine.²⁹

Making sure telemedicine practices are consistent with these security and privacy rules often requires particular technical expertise that is outside the realm of most practicing clinicians. However, without modification, the pre-telemedicine technology of many medical offices likely is insufficient for the full range of telemedicine services.³⁰

Reimbursement and fraud

Before COVID-19, Medicare and Medicaid reimbursement for telemedicine was limited. Government decisions to substantially broaden those reimbursement rules (at least temporarily) provided a substantial boost to telemedicine early in the pandemic.²³ Federal regulations and statutes also expanded telemedicine reimbursement for various services. Some will end shortly after the health emergency, and others will be permanent. Parts of that will not be sorted out for several years, so it will likely be a changing landscape for reimbursement.

One motivation for tightening the rules is the substantial fraud associated with the loosened regulations, including telemedicine.³¹ Current laws apply to such fraud, including, for example, Anti-Kickback Statutes and federal and state False Claims Acts (FCAs). FCAs have “whistleblower” provisions that encourage private citizens to bring fraud actions. Government agencies and private insurance companies will undoubtedly tighten reimbursement regulations to make fraud less common.³²