AT THE AAGL GLOBAL CONGRESS
ORLANDO (FRONTLINE MEDICAL NEWS) – Following the Food and Drug Administration’s 2014 warning against use of laparoscopic uterine power morcellation, 13% of gynecologic oncologists decreased their use of the technique and another 39% discontinued it altogether, according to survey responses from 199 members of the Society of Gynecologic Oncology.
“This really gives a snapshot about how gynecologic oncologists feel about power morcellation in light of the FDA warning,” said Kerac N. Falk, MD, a resident at the Icahn School of Medicine at Mount Sinai, New York.
About 41% of gynecologic oncologists changed their surgical technique to minimally invasive without power morcellation. Another 20% of respondents who previously used power morcellation have switched to laparotomy.
A more rigorous informed consent process, better attention to patient selection, and enhanced protocols are positive effects emerging since the FDA Safety Communication was issued in April 2014, Dr. Falk said at the meeting sponsored by AAGL.
The 34-item survey included questions about demographics, institutional policies, and attitudes before and after the FDA warning. Among the respondents, 65% were men. Both “early” and “very seasoned” surgeons participated in the survey. The majority of the respondents were moderate- to high-volume surgeons.
Men were significantly more likely to decrease or discontinue use of power morcellation, compared with women (P = .0015). Region of practice, years in practice, or institution type did not significantly influence changes in practice. “Most said it was not a personal choice, but more about patient choice or an institutional policy change,” Dr. Falk said.
There is still a role for power morcellation in carefully selected patients, Dr. Falk added.
In July 2014, AAGL issued a statement in response to the FDA warning, stating that “we should improve but not abandon power morcellation, and that power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.” In addition, the American College of Obstetricians and Gynecologists stated, “Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it.”
Dr. Falk is not a coauthor on the study. He presented the findings on behalf of a colleague unable to attend the meeting. Dr. Falk reported having no relevant financial disclosures.
