FDA Meeting will Discuss Risks of Power MorcellatorsJun 20, 2014
A U.S. Food and Drug Administration (FDA) expert panel will weigh the risks versus benefits of power morcellators, tools that are used for minimally invasive hysterectomies. Recently, the devices have raised substantial safety concerns because they can spread a hidden cancer in women. The meeting will be held by the FDA’s Obstetrics and Gynecology Devices Panel on July 10-11, Wall Street Journal reports.
Power morcellators are used in about 50,000 minimally invasive hysterectomies annually to remove uterine fibroids, which are painful growths. The tools cut up tissue into smaller pieces so that they can be removed through small incisions more easily.
Morcellators have recently come under scrutiny. In April, the FDA discouraged physicians from using power morcellators in minimally invasive hysterectomies due to the risk that they can spread a hidden cancer. The agency said that about 1 in 350 women undergoing the procedure have a hidden sarcoma that could be spread by morcellation, significantly worsening their prognosis.
"There is a real person attached to that number, that 1 in 350 number, and we don't want other women to meet the same fate," said Margaret Jacobson, a physician and hospice director in Bellingham, Wash. to WSJ. She said that she will recommend a ban at the meeting. Her sister, a lawyer named Elizabeth Jacobson, died at the age of 55 last January after her hysterectomy to remove fibroids. Records show that she had an undetected cancer, and a power morcellator was used in her procedure.
The panel will consider several options, including whether or not to ban the tools altogether. This is considered a radical move that has only been done once before. Usually when products are experiencing safety issues, the manufacturers recall them voluntarily (although there is pressure from the FDA). Supporters of the device claim that it is too important to be banned, while opponents argue that the risk of spreading cancer is too dangerous.
Additionally, the expert panel will discuss whether or not containment bag will reduce the risk of spreading hidden cancer.
According to WSJ, gynecology groups will suggest stricter screening for selecting patients who undergo procedures with a power morcellators. Hal Lawrence, executive vice president of the American College of Obstetricians and Gynecologists pointed out that women under 35 have a very low chance of having a uterine sarcoma.
Morcellators were approved through 510(k), which allows devices to be approved without clinical testing to show that they are safe or effective. The manufacturer is only required to show that the device is similar enough to an older product that has already been approved.
If the FDA decides to reclassify morcellators from “moderate risk” to “high risk”, then manufacturers would have to conduct ongoing clinical trials.