Racial Disparities in Response to a US Food and Drug Administration Safety Communication Regarding the Use of Power Morcellation for the Treatment of Uterine Leiomyoma

J Minim Invasive Gynecol. 2020 Jan;27(1):178-185.e1. doi: 10.1016/j.jmig.2019.03.019. Epub 2019 Mar 30.

Abstract

Study objective: To investigate whether the rate of increase in the performance of abdominal myomectomy over a laparoscopic approach after the US Food and Drug Administration (FDA) safety communication regarding morcellator use for myomectomy differs among races.

Design: Retrospective cohort study.

Setting: The American College of Surgeons National Surgical Quality Improvement data.

Patients: Patients aged 18 to 55 years who underwent either laparoscopic or abdominal myomectomy, excluding malignant cases, emergency cases, operations performed by nongynecologic specialists, and cases in which myomectomy was performed during cesarean section.

Interventions: None.

Measurements and main results: The odds ratios of abdominal myomectomy over laparoscopic myomectomy before and after the release of the FDA communication were calculated in 3 race categories: white, African American, and other races. In a logistic regression analysis adjusted for possible confounders, including all races, the odds ratio of abdominal myomectomy before and after the FDA communication was 1.30 (95% confidence interval [CI], 1.20-1.41; p <.001). In a logistic regression analysis with a product term of FDA communication exposure and race as a possible effect modifier, the African American population showed a significantly greater change in the odds of abdominal myomectomy over laparoscopic myomectomy in comparison with the white population (1.22; 95% CI, 1.02-1.47; p = .03). In contrast, other races showed no significant change (.83; 95% CI, .64-1.08; p = .17).

Conclusion: After the FDA communication, the odds ratio of abdominal myomectomy was disproportionately increased in the African American population.

Keywords: Abdominal myomectomy; FDA safety communication; Laparoscopic myomectomy; Racial disparity; Uterine morcellation.

MeSH terms

  • Adolescent
  • Adult
  • African Americans / statistics & numerical data
  • Communication
  • European Continental Ancestry Group / statistics & numerical data
  • Female
  • Guideline Adherence / standards
  • Guideline Adherence / statistics & numerical data
  • Healthcare Disparities / ethnology*
  • Healthcare Disparities / standards
  • Healthcare Disparities / statistics & numerical data
  • Humans
  • Hysterectomy / methods
  • Hysterectomy / statistics & numerical data
  • Laparoscopy* / methods
  • Laparoscopy* / statistics & numerical data
  • Laparotomy* / methods
  • Laparotomy* / statistics & numerical data
  • Leiomyoma / ethnology
  • Leiomyoma / surgery*
  • Middle Aged
  • Morcellation / adverse effects
  • Morcellation / methods*
  • Morcellation / statistics & numerical data
  • Patient Safety / standards
  • Patient Safety / statistics & numerical data
  • Retrospective Studies
  • United States / epidemiology
  • United States Food and Drug Administration / standards
  • Uterine Myomectomy / adverse effects
  • Uterine Myomectomy / methods*
  • Uterine Myomectomy / statistics & numerical data
  • Uterine Neoplasms / ethnology
  • Uterine Neoplasms / surgery*
  • Young Adult