Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myomectomy.

OBJECTIVE

To evaluate whether there was a change in surgical practice immediately after the U.S. Food and Drug Administration (FDA) warning statement discouraging the use of power morcellation in the surgical treatment of uterine leiomyomas.

METHODS

We performed a time-series analysis. Surgical case logs from the Florida Hospital operating room documentation system were used to retrospectively identify patients who underwent a hysterectomy or myomectomy between August 1, 2013, and December 31, 2014. Cases performed during the 8 months before the FDA announcement on April 17, 2014, were compared with cases performed during the 8 months after the FDA announcement. Six hospitals and 98 surgeons were included. We compared the proportion of minimally invasive surgery cases (vaginal, laparoscopic, or robotic-assisted) for each study period.

RESULTS

There was a 5.8% decrease in minimally invasive hysterectomies after the FDA warning statement (85.7% [1,451/1,694] compared with 79.9% [1,350/1,690]; P<.001) and an 8.7% decrease when oncologist cases were excluded (90.2% [985/1,092] compared with 81.5% [834/1,023]; P<.001). There was a 19% decrease in minimally invasive myomectomies (62.7% [64/102] compared with 43.7% [38/87]; P=.009). Analysis by subspecialty showed a significant decrease in minimally invasive hysterectomies by obstetrician-gynecologists (ob-gyns) and minimally invasive gynecologic specialists but not urogynecologists or oncologists and a significant decrease in minimally invasive myomectomies by reproductive endocrinologists and minimally invasive gynecologic specialists but not ob-gyns.

CONCLUSION

There was a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation.

LEVEL OF EVIDENCE: II.