Multinu F, et al. - The authors assessed changes in the rates of 30-day major and minor complications of hysterectomy for benign gynecologic indications following the US Food and Drug Administration (FDA) warning against power morcellation. An increase in the rate of major and minor 30-day complication among women undergoing hysterectomy for uterine fibroids was noted following the FDA-issued statement. During a shared decision-making process between clinician and patient, this increased risk corresponding with a decreased use of minimally invasive surgery should be balanced against the potential harms of morcellation. They emphasized to consider these findings when regulatory bodies and medical societies issue relevant communications.

Methods

• In this retrospective cohort study, researchers used the American College of Surgeons National Surgical Quality Improvement Program database and included 603 hospitals participating between January 1, 2013, and December 31, 2015.
• Comparison of 30-day posthysterectomy complications was performed before and after the FDA-issued warning.
• They included women who underwent hysterectomy for benign gynecologic indications (n = 75,487), including hysterectomies with indication of uterine fibroids (n = 25,571).
• Comparison of complication rates and procedure distributions between the periods was performed using X² tests and multivariable logistic regression controlling for patient and operative factors.

Results

• Hysterectomy for benign gynecologic indications was performed on 75,487 women (mean [SD] age, 47.8 [10.7] years).
• Of these, 32,186 (42.6%) were treated before and 43,301 (57.4%) after the FDA-issued warning.
• Most (59.4%) of the total population was comprised of non-Hispanic white women, followed by African American women (15.1%).
• Before and after the FDA-issued warning, major and minor complications remained stable.
• However, among a subset of 25,571 women (33.9%) who underwent hysterectomy for uterine fibroids, a significant increase was noted in major complications after the FDA-issued warning from 1.9% to 2.4% (adjusted odds ratio [OR], 1.23; 95% CI, 1.04-1.47; P = .02), and minor complications from 2.7% to 3.3% (adjusted OR, 1.21; 95% CI, 1.04-1.40; P=.01).
• This subgroup showed an increase in the rate of open abdominal surgery from 37.2% to 43.0%, and a decrease in the rate of minimally invasive surgery (total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, and laparoscopic-assisted vaginal hysterectomy) from 56.1% to 49.7% (P < .001).