FDA Weighs Risks of Potentially Cancer-Spreading Surgical ToolJul 10, 2014
Proliferating reports of the risks of spreading hidden uterine cancers through the use of the power morcellator surgical tool, prompted to the Food and Drug Administration (FDA) to hold hearings to consider the future of the device.
In April, the FDA issued a safety alert urging doctors to stop using the power morcellator either for the removal of fibroids or for hysterectomy, the Washington Post reports. The FDA warned that the surgery “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.” It also estimated that one in 350 women with fibroid surgery has undetected cancer that can potentially be spread by the morcellator.
A panel of outside FDA advisers is holding hearings this week to consider whether to advise the agency to require a “black box” warning – its most serious category – for the morcellator. Advocates for minimally invasive treatment contend that it is beneficial for most women with fibroids because it reduces the risk of complications from open surgery and reduces recovery time, according to the Post. But critics say the power morcellator carries an unacceptable risk of spreading undetected cancer and should be banned altogether.
The hearing is likely to focus also on the FDA’s 510(k) method of approving medical devices, which allows a manufacturer to secure approval for a device demonstrated to be substantially equivalent to a product already being sold without having to conduct clinical trials. Critics say there isn’t adequate monitoring for devices once they reach the market. The FDA defended the approval process saying the evaluation of medical devices always requires “a balance of benefits and risks and getting important new technologies to patients quickly that are safe and effective,” William Maisel, of the FDA Center of Devices and Radiological Health, told reporters in April, according to the Post.
Ethicon, a subsidiary of Johnson & Johnson, halted sales of morcellators after the April recommendation but has not issued a recall. While the American Congress of Obstetricians and Gynecologists and other groups argue that a ban would deny women minimally invasive treatment that reduces the risks of open surgery, a number of hospitals, including the Cleveland Clinic, have stopped using the morcellator since the FDA’s warning. Dr. Marie Fidela Paraiso, a gynecologist there, who has been using the morcellator since the device’s introduction, said the rates of a “surprise” sarcoma were much higher than she had thought, the Post reports.