- A group of nearly 50 doctors signed an open letter to the FDA stating the agency's ruling last year relied on a flawed analysis in restricting removal of noncancerous uterine growths to open surgery.
- The agency ruled in November 2014 noncancerous uterine fibroids could no longer be removed by power morcellators that chop up the growths into small pieces for removal by minimally invasive surgery. It stated one in 485 women with fibroids could also have a potentially lethal hidden cancer (leiomyosarcoma) spread by the use of the morcellators.
- However, Dr. William H. Parker from UCLA School of Medicine told Reuters the agency's assessment of the number of women with this cancer having fibroid surgery "was flawed, inadequate and misleading."
The physicians said studies the FDA used in their review lacked credibility. After reviewing the study data, the group said there were only eight cases of leiomyosarcoma in 12,402 fibroid surgeries, which is only 0.07%.
By eliminating minimally invasive surgery for uterine fibroids, the FDA's ruling forces women to have open surgery, which has more risks and complications.
The open letter to the FDA 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 told Reuters Health, "I think as more data becomes available, the FDA should ultimately readdress this topic." However, he said he doubts the FDA will change its policy in the near future.