Complication rates rise after decline in uterine fibroid morcellation

The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.

Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.

The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.

Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.

“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.

Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).

However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.

The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).

A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.

The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.

“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.

The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.

SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.

The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.

Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.

The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.

Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.

“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.

Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).

However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.

The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).

A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.

The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.

“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.

The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.

SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.

The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.

Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.

The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.

Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.

“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.

Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).

However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.

The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).

A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.

The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.

“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.

The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.

SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.