August 6, 2014 — ObGyn News reports that an advisory panel to the FDA is recommending informed consent and stronger warnings about the risk of power morcellators upstaging cancer when they are used in hysterectomies and fibroid surgery.
The Obstetrics and Gynecology Devices Advisory Committee met for two days on July 11-12. They did not vote or make any resolutions, but met to hear testimony from women who were affected. Experts from an array of medical backgrounds also discussed the devices.
The experts said they were aware of at least 130 incidents in which a power morcellator upstaged a patient’s undiagnosed cancer.
One important recommendation was improving informed consent for women. According to Dr. Carol Brown, a gynecologic cancer surgeon:
“There should be some labeling or special controls” to ensure that women who are being considered for treatment with this device and their physicians “get the message that we do believe there is an increased risk.”
The labeling may include a “Black Box” warning on the product information. Women might also be asked to sign a document showing that they understand that power morcellators can spread undiagnosed cancer and greatly worsen the chances of long-term survival.
Earlier this year, the FDA warned against using power morcellators in hysterectomies and fibroid surgery because uterine sarcoma is undiagnosed in about 1 in 350 women who undergo these surgeries. About 1 in 500 has a highly-aggressive version known as leiomyosarcoma (LMS).
Other members of the panel recommended re-classifying power morcellators to Class III (“high-risk”) devices. New devices would not be allowed on the market without clinical trials to assess safety risks and a rigorous pre-market approval process. Most power morcellators were approved without safety studies because manufacturers claimed they were equivalent to hand-operated morcellators.
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