An FDA committee’s failure to agree on whether power morcellator use should be banned in the U.S. has prompted a doctor to ask for further investigation into the agency’s process for approving medical devices, according to recent reports.
The written statement was issued shortly after the U.S. Food and Drug Administration (FDA)’s Obstetrics & Gynecology Devices Panel met on July 10th and 11th to discuss the issue, where its members were divided on the possibility that power morcellators may promote the spread of some uterine cancers. The letter was written by the chairman of the Institute of Medicine Committee on the Public Health Effectiveness of the FDA 510(k) Clearance, and pointed to alleged faults of a process that has approved power morcellators since the 1990s. According to the statement, morcellators were approved through the FDA’s 510(k) program, which allows a manufacturer to bypass human testing on products that are proven to be “substantial equivalents” to devices already on the market. Power morcellators are designed to more easily cut up uterine tissue in laparoscopic hysterectomy and fibroid removal procedures so it can be removed via a tiny incision.
According to power morcellator lawsuit claims, these devices have become more frequently associated with the dissemination of cancer cells, which may be especially dangerous since many women have uterine cancer cells that were undiagnosed prior to surgery. According to an FDA warning in April 2014, approximately 1 in every 350 women having their fibroids removed has undetected uterine sarcoma or another cancer that is likely only diagnosed after they are removed and biopsied. As such, doctors were discouraged from conducting uterine morcellation procedures given these risks, until the FDA could adequately review their risk for side effects.
The doctor responsible for drafting the morcellator letter in July says health care providers were not properly made aware of the potential for this device to upstate cancer because they were approved so quickly by the FDA.
“There is great difficulty in detecting many device failures because of our inability to detect, suspect and report “weak” or rare signals from the clinical environment,” he said.
Plaintiffs now involved in power morcellator lawsuits similarly point to supposed problems with the FDA’s 510(k) process. According to claims, manufacturers failed to adequately warn patients and their doctors about their products’ alleged potential to upstage certain uterine cancers. As a result, a woman’s chances of long-term survival may be severely diminished.