|Dr. William Parker|
Last November, the FDA ramped up its oversight of power morcellator devices, recommending against using the tools in most women undergoing a hysterectomy or uterine fibroid removal after finding that the devices may spread hidden cancer in some patients. But not everyone is on board with the agency's move and now some gynecologists are pushing back at its decision, saying that regulators used flawed data to evaluate the device's safety.
The FDA's analysis of women's risk of having a hidden cancer that could be spread by power morcellator tools "was flawed, inadequate, and misleading," Dr. William Parker of the UCLA School of Medicine, told Reuters in an email. And the agency's "recommendations were not based on science, but rather on emotional and anecdotal information," Parker said. Parker and about 48 other top gynecologists are taking the agency to task over its crackdown on morcellator devices, writing an open letter to the FDA and penning a recent article about the issue in the Obstetrics & Gynecology journal.
After reviewing medical literature last year, the FDA found that women having minimally invasive surgeries to remove uterine fibroids had a 1 in 350 risk of having uterine sarcoma and that power morcellator tools could spread cancerous tissue. The agency ordered manufacturers to add boxed warnings and two contraindications for the devices in their product labels that inform patients and providers about morcellator risks. Regulators also said that power morcellators should not be used in older women or patients who could have tissue removed intact through the vagina or a mini-laparotomy incision.
But Parker and other gynecologists in the Leiomyome Morcellation Review Group don't see things in quite the same light. The FDA's analysis of power morcellator devices relied on studies that lacked credibility and included three cases that don't meet the definition of cancer, the physicians said in the journal article.
And recent studies point to a much lower risk of women having hidden cancer who are undergoing uterine fibroid removal, the doctors said. One study found that the risk of finding hidden cancer in women having fibroid surgery was 1 in 1,960, or 0.051. Another study turned up two hidden cancers in 8,720 women having surgery for fibroids, a 1 in 4,360 risk.
Plus, the FDA restricting power morcellator devices could result in fewer options for women undergoing fibroid removal. Patients would be forced to have open surgery through a larger incision, potentially increasing complications or risks, the doctors said in the journal article.
"Our research suggests that, rather than abandon the clear benefits minimally invasive surgery affords women, future research efforts out to focus on better preoperative identification and new techniques, such as placing specimens in bags before removing them," Dr. Matthew Siedhoff, director of UNC Chapel Hill's minimally invasive gynecologic surgery division, said in a statement.
Other doctors are heeding the FDA's advice. Earlier this year, Yale University researchers interviewed 43 high-volume minimally invasive gynecologists and fellowship faculty members at large U.S. teaching hospitals, and found that 78% of physicians switched to mini-laparotomy procedures after the FDA issued its updated warning about power morcellator devices.