Practice Patterns and Complications of Benign Hysterectomy Following the FDA Statement Warning Against the Use of Power Morcellation

Abstract

Importance: 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.

Objective: 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.

Results: 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.

Figure 1.. Routes of Hysterectomy for Benign Gynecologic Indications (N = 75 487) From January 1, 2013, to December 31, 2015

MIS indicates minimally invasive surgery. Shaded region indicates data collected between the US Food and Drug Administration (FDA) statements from March 31, 2014, through September 30, 2014, that were excluded from analyses.

Figure 2.. Routes of Hysterectomy for Uterine Fibroids (n = 25 571 [33.9%]) From January 1, 2013, to December 31, 2015

MIS indicates minimally invasive surgery. Shaded region indicates data collected between the US Food and Drug Administration (FDA) statements from March 31, 2014, through September 30, 2014, that were excluded from analyses.

Figure 3.. Thirty-Day Major and Minor Complication Rates for Hysterectomy for Benign Gynecologic Indications and for Uterine Fibroids Before and After the US Food and Drug Administration (FDA) Statement

The pre-FDA period indicates data from the first quarter (Q1) of 2013 through Q1 2014, and the post-FDA period indicates data from Q4 2014 through Q4 2015. Odds ratios (ORs) were adjusted for age, race/ethnicity, body mass index (≥30 vs <30; calculated as the weight in kilograms divided by the height in meters squared), functional status, corticosteroid use for chronic conditions, preoperative platelet count (reference range of 150-450 × 10³/μL vs lower vs higher [to convert to ×10⁹ per liter, multiply by 1.0]), preoperative hematocrit (reference range of 34.9%-44.5% vs lower vs higher [to convert to proportion of 1.0, multiply by 0.01]), preoperative serum albumin level (reference range of 3.5-5.0 g/dL vs lower vs higher [to convert to grams per liter, by 10]), hypertension requiring medications, preoperative serum creatinine level (reference range of 0.6-1.1 mg/dL vs lower vs higher [to convert to micromoles per liter, by 88.4]), diabetes with oral agent or insulin administration, smoking status within 1 year, American Society of Anesthesiologists class (1-2 vs 3-4), and abdominal, extra-abdominal, upper-abdominal, or other associated procedures (yes vs no). Models, including that for all women with benign indications, were also controlled for hysterectomy indication.