(Reuters Health) - Doctors are arguing that the U.S. Food and Drug Administration (FDA) relied on a flawed analysis when it ruled last year that noncancerous growths in the uterus could no longer be removed using mechanical devices that chop them into small pieces for extraction by minimally invasive surgery.
Based on its review of the medical literature, the FDA said 1 in 485 women with so-called uterine fibroids could also have a potentially lethal hidden cancer, called leiomyosarcoma, which might be spread by the use of the devices, known as power morcellators.
But Dr. William H. Parker from UCLA School of Medicine, Los Angeles, California told Reuters Health by email that the FDA’s analysis of how commonly this kind of cancer is lurking in women having surgery for presumed fibroids “was flawed, inadequate, and misleading.”
“Their recommendations were not based on science, but rather on emotional and anecdotal information,” he said.
Writing in Obstetrics and Gynecology, Parker and other top gynecologists in the Leiomyoma Morcellation Review Group say the FDA’s review included studies that lacked credibility. Also, they say, three leiomyosarcoma cases were included that don’t satisfy current definitions of cancer.
If those three cases and the information in the other unreliable studies are excluded, there were only eight cases of leiomyosarcoma among the 12,402 women having surgery for fibroids (leiomyomas, in medical terms). That’s one in 1,550, or 0.07 percent.
Parker and colleagues say the FDA’s restrictions would eliminate all the minimally invasive operations for uterine fibroids and leave open abdominal surgery as the only option.
These doctors claim that forcing women to have open surgery, through a larger incision, instead of laparoscopic surgery could increase surgery-related deaths and complications. They back up their claim with recent information that shows higher rates of surgical complications and hospital readmissions since the FDA put these restrictions in place in November 2014.
Nearly four dozen physicians signed an open letter to FDA that concludes, “Women have a right to self-determination. Modification of the FDA’s current restrictive guidance regarding power-morcellation would empower each woman to consider the pertinent issues and have the freedom to undertake shared decision-making with her surgeon in order to select the procedure which is most appropriate for her.”
Dr. Jason D. Wright from Columbia University College of Physicians and Surgeons in New York City, who wrote an editorial related to this report, thinks the FDA is unlikely to change its policy in the near term. “I think as more data becomes available the FDA should ultimately readdress this topic,” he told Reuters Health.
“I think physicians should understand that there is certainly a safety concern with morcellation and they need to use caution to minimize the risk of inadvertently morcellating a precancerous or cancerous lesion,” Wright said. “The corollary is that in some women the benefits of morcellation may outweigh the risks.”
SOURCE: bit.ly/1ICWvsR Obstetrics and Gynecology, online December 8, 2015.
Our Standards: The Thomson Reuters Trust Principles.