FDA Investigates Potentially Dangerous Devices Used for Fibroid Surgery
On July 11th, the Food and Drug Administration stated that they would create a panel to investigate the potential safety, and danger, of laparoscopic power morcellators (LPM’s), which have been called dangerous devices by patients who believe their fibroid surgery contributed to uterine cancer.
On day 2 of a 2-day meeting, the Obstetrics and Gynecology Devices Advisory Committee recommended that the FDA investigate the dangerous device and uterine cancer claims, suggesting that the morcellation process for fibroid removal surgery could inadvertently disseminate cancerous tissue through the uterus, leading to “upstaging” of the tumor and worsening patients’ cancers.
The first LPM was cleared for use by the FDA in 1991. After the committee’s recommendation, the FDA is reconsidering whether to classify the medical devices into a more restrictive regulatory category, and possibly adding a “black box” warning label, the strongest warning available for doctors and patients.
The FDA also said that the agency would require written consent from women who undergo fibroid surgery, stating that they understand the potential serious side effects of the morcellation procedure.
Morcellation is supposed to be a simple, non-invasive procedure in which the laparoscopic device is used to find fibroid tissue in the uterus, and grind fibroids down to be removed through a small incision in the abdomen. Uterine fibroids can cause pain and annoyance with menstruation, so many women choose to undergo the surgery to reduce those complications. However, grinding down fibroids, which are assumed to be non-cancerous, could actually cause the spread of cancer when a tumor is ground down.
“There’s no evidence that the bags or any containment devices prevent the outcome we are trying to prevent,” said Dr. Craig Shriver of the Walter Reed Medical Center, in the press release.
“It doesn’t sound like anyone has confidence that those will be able to predict the vast majority of leiomyosarcomas,” said Dr. Michael Diamond, of Georgia Regents University.
According to FDA estimates, as many as 1 in 350 women have undetected uterine cancer that can look like fibroids, and the cancerous tissue can be ruptured with morcellation surgery. The previous rate was estimated at 1 in every 7,000 women.
Johnson & Johnson, producers of the morcellation devices, have ceased production while the FDA investigates the potential cancer-causing problem.
The FDA stated that they would seek to warn doctors and patients about risk related to the potentially dangerous devices and surgery, but would leave the door open for other companies to develop alternatives to the fibroid surgery.
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