Kate Johnson

October 19, 2016

SALT LAKE CITY — Rates of myomectomy decreased by almost 64% after the US Food and Drug Administration (FDA) issued a communication warning against the use of laparoscopic power morcellation, according to a new study.

Concerns about laparoscopic power morcellation began building after a study suggested that malignancy unexpectedly found during the procedure could be disseminated (PLoS One. 2012;7:e50058), as reported by Medscape Medical News.

But the new study, reported here at the American Society for Reproductive Medicine 2016 Scientific Congress, shows that laparoscopic morcellation was not abandoned in favor of abdominal myomectomy; in fact, the use of both procedures has taken a steep nose dive.

"I was not at all surprised that there was a decrease in laparoscopic myomectomies, but was definitely surprised to see the decrease in abdominal myomectomies. You would not necessarily have expected that," said Natalie Clark Stentz, MD, from the University of Pennsylvania in Philadelphia.

"You might have actually expected an increase in abdominal myomectomies to compensate for the decrease in laparoscopic procedures," she told Medscape Medical News.

Dr Stentz and her team used the American College of Surgeons National Surgical Quality Improvement Program database to compare myomectomy rates in two time periods: April to December 2013 (before the FDA communication) and April to December 2014 (after the communication).

They identified 1823 women who underwent the procedure before the communication and 659 who underwent the procedure after the communication.

The 63.9% drop is "a significant decrease overall" (P < .001), Dr Stentz explained.

It is possible that more patients are being expectantly managed, some of the smaller single fibroids are being left alone, and some patients are just afraid of undergoing myomectomy, she pointed out.

As expected, laparoscopic procedures accounted for the bulk of the decline, dropping by 70.9%; however, abdominal myomectomy dropped by 56.3%.

Drop in Abdominal Myomectomy

Before the communication, laparoscopic myomectomy was more common than the abdominal route (52.8% vs 47.2%), whereas after the communication, it was less common (42.9% vs 57.1%).

Consequences resulting from this shift from a minimal to a more invasive procedure were surprisingly insignificant, Dr Stentz reported.

"We hypothesized that there may be more surgical morbidity, but none of that bore out in our analysis," she said. "There was a trend toward longer stays, but that did not hold up in our multivariate analysis. There was also a trend toward an increased rate of sepsis, but our numbers were small. And there was really no difference in blood transfusion, wound infection or dehiscence, operative time, or other parameters."

This study is noteworthy because "rates of both laparoscopic and open myomectomies have decreased since the FDA warning," said Deirdre Lum, MD, from the Stanford University School of Medicine in California.

Dr Lum was involved in a recent survey of members of two organizations — the American College of Obstetricians and Gynecologists Collaborative Ambulatory Research Network and the AAGL Advancing Minimally Invasive Gynecologic Surgery Worldwide — which showed a sharp decline in the use of morcellation as a result of the FDA warning (J Minim Invasive Gynecol. 2016;23:548-556).

"Many of the existing studies evaluating the impact of the FDA warning against power morcellation have shown a decrease in use of power morcellation," she told Medscape Medical News. "This influence on practice patterns has been demonstrated in direct survey studies, and retrospective studies have revealed decreased rates of laparoscopic procedures with a subsequent increase in laparotomy since 2014."

But "what is the reason for the abandonment of myomectomies altogether?" she asked.

"If the explanation is purely due to the risk of power morcellation, then presumably the rate of open myomectomies would increase. Perhaps patients, and maybe their surgeons, have certain fears about tissue disruption in general because of heightened media coverage, and are opting for other treatment options for fibroids," she said.

Dr Stentz and Dr Lum have disclosed no relevant financial relationships.

American Society for Reproductive Medicine (ASRM) 2016 Scientific Congress: Abstract P-300. Presented October 18, 2016.


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