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according to a study published in Obstetrics & Gynecology.
Alexander A. Berger, MD, MPH, of the division of female pelvic medicine and reconstructive surgery at Kaiser Permanente in San Diego, and colleagues performed a retrospective cohort study of 17,030 patients with stress urinary incontinence (SUI) who underwent midurethral sling surgery between 2005 and 2016, examining the reoperation rate at 1 year, 5 years, and 9 years after the procedure, as well as secondary outcomes of mesh revision, mesh removal, and recurrence of SUI.
Overall, the rate of reoperation at 1 year was 2.1% (95% confidence interval, 1.9%-2.4%), was 4.5% at 5 years (95% CI, 4.1%-4.8%) and 6.0% at 9 years (95% CI, 5.5%-6.5%). Compared with white patients, there was a lower rate of reoperation among Asian or Pacific Islander patients.
The rate of reoperation involving mesh removal was 0.7% at 1 year (95% CI, 0.6%-0.8%), 1.0% at 5 years (95% CI, 0.8%-1.1%) and 1.1% at 9 years (95% CI, 0.9%-1.3%).
The rate of recurrent SUI leading to operation was 1.6% at 1 year (95% CI, 1.4%-1.8%), 3.9% at 5 years (95% CI, 3.5%-4.2%) and 5.2% at 9 years (95% CI, 4.7%-5.7%), with more reoperations occurring for patients who received a single-incision sling, rather than a retropubic sling (adjusted hazard ratio, 1.5; 95% CI, 1.06-2.11; P = .03), Dr. Berger and associates wrote.
Urogynecologists, ob.gyns., and urologists who use mesh for slings and reconstructive surgery have struggled to recommend synthetic mesh slings to their patients with SUI, said Patrick J. Woodman, DO, MS, program director of obstetrics and gynecology residency at Providence Health Ascension Macomb-Oakland, Warren (Mich.) Campus, said in an interview. In 2008, the Food and Drug Administration issued a public health notification for transvaginal placement of surgical mesh in patients with pelvic organ prolapse and SUI.
“Although some of the recommendations first made by the FDA were reasoned and reasonable, such as the need for direct, premarket, patient studies instead of the mostly administrative 510(k) ‘similar-to’ process that had been used previously, physicians and patients had been eagerly awaiting the outcomes of some of these clinical studies that would help answer some of the safety and efficacy questions that had been dogging the transvaginal use of mesh material for years,” he said.
“But, to everyone’s surprise, in April [2019] they called for a recall of all vaginal mesh products, even before the study data could be analyzed, written up and released,” added Dr. Woodman. “Companies were forced to halt production, pull stocks from the shelves, and halt and reverse shipments.”
One reason the results by Berger et al. show midurethral slings have had a good safety record is because of a small incision size and low amount of mesh, noted Dr. Woodman, who was not involved with the study. “This article seems to underline and highlight the fact that reoperation is rare for midurethral slings (for all reasons), but particularly for mesh erosion or exposure. This is well within the experience of most female pelvic medicine and reconstructive surgery and urologic surgeons, and incredibly less than the 8%-24% of mesh exposures reported in the variety of mesh exposure literature on vaginal mesh procedures.”
Despite this safety record, some women may still experience adverse events with midurethral slings, admitted Dr. Woodman. “The fact remains, if a surgeon drags a large piece of synthetic fabric through a ‘clean-contaminated’ vaginal environment, and buries this mesh under the skin of the vagina, and then rests this mesh against a long incision, some women’s immune systems will not be able to handle the resultant inflammation and bacterial load, despite antibiotics, vaginal prepping, and any number of coatings or soakings of the mesh.”
The researchers noted the study’s retrospective nature is one potential limitation, and the data has not been compiled by surgeon type or skill, or considered patients with complications that did not choose reoperations.
“But, the flip side is also true,” said Dr. Woodman, an Ob.Gyn News editorial advisor. “There may have been a number of individuals who had a surgical removal who did not need or warrant it due to the societal, family, or legal ‘suggestion’ that the mesh is now ‘dangerous’ and must be removed at all costs.”
Berger et al. “hit the nail on the head” with the study, including a large amount of patients that demonstrates the safety of midurethral slings, he said. “We need a solid body of unquestioned evidence of safety and effectiveness from which to base solid, evidence-based medical decisions. If there is a way to effectively use mesh to reinforce a vaginal repair in a high-risk woman (for example, with previous failed surgeries), then we have to take the stigma away from its use: because no one wants to use it now, even if it could help.
“The best we can hope for, as physicians, is a rehabilitation of reputation for vaginal mesh,” he concluded.
The study was supported by a grant from the Regional Research Committee of Kaiser Permanente Southern California. One coauthor reported receiving royalties from UptoDate and the American Urogynecologic Society Board Member for travel for board meetings. The other authors reported no relevant conflicts of interest. Dr. Woodman said he had no relevant financial disclosures.*
SOURCE: Berger AA et al. Obstet Gynecol. 2019 Oct 10. doi:10.1097/AOG.0000000000003526.
* Updated 10/14/2019
according to a study published in Obstetrics & Gynecology.
Alexander A. Berger, MD, MPH, of the division of female pelvic medicine and reconstructive surgery at Kaiser Permanente in San Diego, and colleagues performed a retrospective cohort study of 17,030 patients with stress urinary incontinence (SUI) who underwent midurethral sling surgery between 2005 and 2016, examining the reoperation rate at 1 year, 5 years, and 9 years after the procedure, as well as secondary outcomes of mesh revision, mesh removal, and recurrence of SUI.
Overall, the rate of reoperation at 1 year was 2.1% (95% confidence interval, 1.9%-2.4%), was 4.5% at 5 years (95% CI, 4.1%-4.8%) and 6.0% at 9 years (95% CI, 5.5%-6.5%). Compared with white patients, there was a lower rate of reoperation among Asian or Pacific Islander patients.
The rate of reoperation involving mesh removal was 0.7% at 1 year (95% CI, 0.6%-0.8%), 1.0% at 5 years (95% CI, 0.8%-1.1%) and 1.1% at 9 years (95% CI, 0.9%-1.3%).
The rate of recurrent SUI leading to operation was 1.6% at 1 year (95% CI, 1.4%-1.8%), 3.9% at 5 years (95% CI, 3.5%-4.2%) and 5.2% at 9 years (95% CI, 4.7%-5.7%), with more reoperations occurring for patients who received a single-incision sling, rather than a retropubic sling (adjusted hazard ratio, 1.5; 95% CI, 1.06-2.11; P = .03), Dr. Berger and associates wrote.
Urogynecologists, ob.gyns., and urologists who use mesh for slings and reconstructive surgery have struggled to recommend synthetic mesh slings to their patients with SUI, said Patrick J. Woodman, DO, MS, program director of obstetrics and gynecology residency at Providence Health Ascension Macomb-Oakland, Warren (Mich.) Campus, said in an interview. In 2008, the Food and Drug Administration issued a public health notification for transvaginal placement of surgical mesh in patients with pelvic organ prolapse and SUI.
“Although some of the recommendations first made by the FDA were reasoned and reasonable, such as the need for direct, premarket, patient studies instead of the mostly administrative 510(k) ‘similar-to’ process that had been used previously, physicians and patients had been eagerly awaiting the outcomes of some of these clinical studies that would help answer some of the safety and efficacy questions that had been dogging the transvaginal use of mesh material for years,” he said.
“But, to everyone’s surprise, in April [2019] they called for a recall of all vaginal mesh products, even before the study data could be analyzed, written up and released,” added Dr. Woodman. “Companies were forced to halt production, pull stocks from the shelves, and halt and reverse shipments.”
One reason the results by Berger et al. show midurethral slings have had a good safety record is because of a small incision size and low amount of mesh, noted Dr. Woodman, who was not involved with the study. “This article seems to underline and highlight the fact that reoperation is rare for midurethral slings (for all reasons), but particularly for mesh erosion or exposure. This is well within the experience of most female pelvic medicine and reconstructive surgery and urologic surgeons, and incredibly less than the 8%-24% of mesh exposures reported in the variety of mesh exposure literature on vaginal mesh procedures.”
Despite this safety record, some women may still experience adverse events with midurethral slings, admitted Dr. Woodman. “The fact remains, if a surgeon drags a large piece of synthetic fabric through a ‘clean-contaminated’ vaginal environment, and buries this mesh under the skin of the vagina, and then rests this mesh against a long incision, some women’s immune systems will not be able to handle the resultant inflammation and bacterial load, despite antibiotics, vaginal prepping, and any number of coatings or soakings of the mesh.”
The researchers noted the study’s retrospective nature is one potential limitation, and the data has not been compiled by surgeon type or skill, or considered patients with complications that did not choose reoperations.
“But, the flip side is also true,” said Dr. Woodman, an Ob.Gyn News editorial advisor. “There may have been a number of individuals who had a surgical removal who did not need or warrant it due to the societal, family, or legal ‘suggestion’ that the mesh is now ‘dangerous’ and must be removed at all costs.”
Berger et al. “hit the nail on the head” with the study, including a large amount of patients that demonstrates the safety of midurethral slings, he said. “We need a solid body of unquestioned evidence of safety and effectiveness from which to base solid, evidence-based medical decisions. If there is a way to effectively use mesh to reinforce a vaginal repair in a high-risk woman (for example, with previous failed surgeries), then we have to take the stigma away from its use: because no one wants to use it now, even if it could help.
“The best we can hope for, as physicians, is a rehabilitation of reputation for vaginal mesh,” he concluded.
The study was supported by a grant from the Regional Research Committee of Kaiser Permanente Southern California. One coauthor reported receiving royalties from UptoDate and the American Urogynecologic Society Board Member for travel for board meetings. The other authors reported no relevant conflicts of interest. Dr. Woodman said he had no relevant financial disclosures.*
SOURCE: Berger AA et al. Obstet Gynecol. 2019 Oct 10. doi:10.1097/AOG.0000000000003526.
* Updated 10/14/2019
according to a study published in Obstetrics & Gynecology.
Alexander A. Berger, MD, MPH, of the division of female pelvic medicine and reconstructive surgery at Kaiser Permanente in San Diego, and colleagues performed a retrospective cohort study of 17,030 patients with stress urinary incontinence (SUI) who underwent midurethral sling surgery between 2005 and 2016, examining the reoperation rate at 1 year, 5 years, and 9 years after the procedure, as well as secondary outcomes of mesh revision, mesh removal, and recurrence of SUI.
Overall, the rate of reoperation at 1 year was 2.1% (95% confidence interval, 1.9%-2.4%), was 4.5% at 5 years (95% CI, 4.1%-4.8%) and 6.0% at 9 years (95% CI, 5.5%-6.5%). Compared with white patients, there was a lower rate of reoperation among Asian or Pacific Islander patients.
The rate of reoperation involving mesh removal was 0.7% at 1 year (95% CI, 0.6%-0.8%), 1.0% at 5 years (95% CI, 0.8%-1.1%) and 1.1% at 9 years (95% CI, 0.9%-1.3%).
The rate of recurrent SUI leading to operation was 1.6% at 1 year (95% CI, 1.4%-1.8%), 3.9% at 5 years (95% CI, 3.5%-4.2%) and 5.2% at 9 years (95% CI, 4.7%-5.7%), with more reoperations occurring for patients who received a single-incision sling, rather than a retropubic sling (adjusted hazard ratio, 1.5; 95% CI, 1.06-2.11; P = .03), Dr. Berger and associates wrote.
Urogynecologists, ob.gyns., and urologists who use mesh for slings and reconstructive surgery have struggled to recommend synthetic mesh slings to their patients with SUI, said Patrick J. Woodman, DO, MS, program director of obstetrics and gynecology residency at Providence Health Ascension Macomb-Oakland, Warren (Mich.) Campus, said in an interview. In 2008, the Food and Drug Administration issued a public health notification for transvaginal placement of surgical mesh in patients with pelvic organ prolapse and SUI.
“Although some of the recommendations first made by the FDA were reasoned and reasonable, such as the need for direct, premarket, patient studies instead of the mostly administrative 510(k) ‘similar-to’ process that had been used previously, physicians and patients had been eagerly awaiting the outcomes of some of these clinical studies that would help answer some of the safety and efficacy questions that had been dogging the transvaginal use of mesh material for years,” he said.
“But, to everyone’s surprise, in April [2019] they called for a recall of all vaginal mesh products, even before the study data could be analyzed, written up and released,” added Dr. Woodman. “Companies were forced to halt production, pull stocks from the shelves, and halt and reverse shipments.”
One reason the results by Berger et al. show midurethral slings have had a good safety record is because of a small incision size and low amount of mesh, noted Dr. Woodman, who was not involved with the study. “This article seems to underline and highlight the fact that reoperation is rare for midurethral slings (for all reasons), but particularly for mesh erosion or exposure. This is well within the experience of most female pelvic medicine and reconstructive surgery and urologic surgeons, and incredibly less than the 8%-24% of mesh exposures reported in the variety of mesh exposure literature on vaginal mesh procedures.”
Despite this safety record, some women may still experience adverse events with midurethral slings, admitted Dr. Woodman. “The fact remains, if a surgeon drags a large piece of synthetic fabric through a ‘clean-contaminated’ vaginal environment, and buries this mesh under the skin of the vagina, and then rests this mesh against a long incision, some women’s immune systems will not be able to handle the resultant inflammation and bacterial load, despite antibiotics, vaginal prepping, and any number of coatings or soakings of the mesh.”
The researchers noted the study’s retrospective nature is one potential limitation, and the data has not been compiled by surgeon type or skill, or considered patients with complications that did not choose reoperations.
“But, the flip side is also true,” said Dr. Woodman, an Ob.Gyn News editorial advisor. “There may have been a number of individuals who had a surgical removal who did not need or warrant it due to the societal, family, or legal ‘suggestion’ that the mesh is now ‘dangerous’ and must be removed at all costs.”
Berger et al. “hit the nail on the head” with the study, including a large amount of patients that demonstrates the safety of midurethral slings, he said. “We need a solid body of unquestioned evidence of safety and effectiveness from which to base solid, evidence-based medical decisions. If there is a way to effectively use mesh to reinforce a vaginal repair in a high-risk woman (for example, with previous failed surgeries), then we have to take the stigma away from its use: because no one wants to use it now, even if it could help.
“The best we can hope for, as physicians, is a rehabilitation of reputation for vaginal mesh,” he concluded.
The study was supported by a grant from the Regional Research Committee of Kaiser Permanente Southern California. One coauthor reported receiving royalties from UptoDate and the American Urogynecologic Society Board Member for travel for board meetings. The other authors reported no relevant conflicts of interest. Dr. Woodman said he had no relevant financial disclosures.*
SOURCE: Berger AA et al. Obstet Gynecol. 2019 Oct 10. doi:10.1097/AOG.0000000000003526.
* Updated 10/14/2019
FROM OBSTETRICS & GYNECOLOGY