Did 30-day complication rates change among women undergoing hysterectomy for benign gynecologic indications following the US Food and Drug Administration warning against power morcellation?
In a cohort of 75 487 patients who underwent hysterectomy for benign gynecologic indications, statistically and clinically significant increases in major and minor complications were observed following the warning in a subset of 25 571 women with uterine fibroids.
That potential harms were associated with decreased rates of minimally invasive surgery following reduced morcellation use should be considered by clinicians and patients during shared decision making and by regulatory bodies and medical societies issuing communications on minimally invasive hysterectomy and morcellation among women with uterine fibroids.
In November 2014, the US Food and Drug Administration (FDA) issued a black box warning against the use of power morcellation for excision of uterine fibroids to decrease the risk of disseminating malignant cells and worsening survival outcomes of patients with unexpected malignant neoplasms. After the FDA statement was issued, studies showed decreased rates of minimally invasive surgery and increased rates of open abdominal hysterectomy. However, there are limited and controversial data on the association of these changed rates with 30-day hysterectomy complications.
To assess changes in the rates of 30-day major and minor complications of hysterectomy for benign gynecologic indications following the FDA-issued statement.
Design, Setting, and Participants
This retrospective cohort study 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. Thirty-day posthysterectomy complications were compared before and after the FDA-issued warning. Women who underwent hysterectomy for benign gynecologic indications (n = 75 487), including hysterectomies with indication of uterine fibroids (n = 25 571), were included. Complication rates and procedure distributions between the periods were compared with χ2 tests and multivariable logistic regression controlling for patient and operative factors.
Main Outcomes and Measures
Major and minor 30-day complication rates before (from 2013 through the first quarter of 2014) and after (from the fourth quarter of 2014 through 2015) the FDA-issued warning.
Of 75 487 women (mean [SD] age, 47.8 [10.7] years) who underwent hysterectomy for benign gynecologic indications, 32 186 (42.6%) were treated before and 43 301 (57.4%) after the FDA-issued warning. Non-Hispanic white women comprised most (59.4%) of the total population, followed by African American women (15.1%). Overall, major and minor complications remained stable before and after the FDA-issued warning. By contrast, among a subset of 25 571 women (33.9%) who underwent hysterectomy for uterine fibroids, major complications significantly increased 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 significantly increased from 2.7% to 3.3% (adjusted OR, 1.21; 95% CI, 1.04-1.40; P = .01). In this subgroup, the rate of open abdominal surgery increased from 37.2% to 43.0%, and the rate of minimally invasive surgery (total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, and laparoscopic-assisted vaginal hysterectomy) decreased from 56.1% to 49.7% (P < .001).
Conclusions and Relevance
Major and minor 30-day complication rates among women undergoing hysterectomy for uterine fibroids increased following the FDA-issued statement. This increased risk corresponding with a decreased use of minimally invasive surgery should be balanced against the potential harms of morcellation during a shared decision-making process between clinician and patient. Regulatory bodies and medical societies should consider these findings when issuing relevant communications.
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Multinu F, Casarin J, Hanson KT, et al. Practice Patterns and Complications of Benign Hysterectomy Following the FDA Statement Warning Against the Use of Power Morcellation. JAMA Surg. Published online April 11, 2018. doi:10.1001/jamasurg.2018.0141
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