Since power morcellators came into use for fibroid removal surgery in women in 1991, some women have suffered a terrible side effect. The device used to remove uterine tissue and fibroids has caused some of these patients to develop a serious malignant cancer called leiomyosarcoma. The U.S. Food and Drug Administration (FDA) did not warn the public about the risks of this device being used for fibroid surgery until 2014, 23 years after they came on the market. A new report finds that this delay shines a spotlight on some serious flaws in the FDA’s adverse events reporting system.
Power Morcellators, Fibroid Surgery, and Cancer
Fibroids are typically benign growths that can develop in a woman’s uterus. To remove them, most doctors rely on a minimally invasive procedure that involves making a small incision in the abdomen. The surgeon then inserts a device to chop up the tissue so that it can be removed without making a bigger incision. In 1991 a powered version of this device came on the market, called a power morcellator.
While most fibroids are benign, in rare cases they may be harboring a few cancerous cells. When the power morcellator chops up the tissue in the body, it may spread these cancerous cells throughout the abdominal cavity, essentially causing a woman to quickly develop metastatic leiomyosarcoma, an aggressive, malignant type of cancer. This has led to several lawsuits against makers of the device, including Johnson & Johnson.
The FDA’s 2014 Warning
In 2014 the FDA issued a warning about the use of power morcellators in uterine fibroid surgery. It stopped short of recalling the devices, but strongly recommended that surgeons not use them for this kind of surgery because of the small but serious risk of spreading leiomyosaracoma cells. The FDA estimated in this warning that about one in 350 women undergoing surgery with the device had fibroids that were harboring undetectable cancer cells and were at risk of developing the cancer.
Report Highlights Problems in FDA Adverse Events Reporting
The U.S. Government Accountability Office (GAO) recently released a report outlining a study that investigated why it took the FDA 23 years to realize there was a problem with power morcellators and to issue a warning to consumers and doctors. The FDA relies on individuals, patients and doctors, to file adverse event reports to inform the agency of issues with medical devices. A well-publicized report filed by a victim and doctor led to a flood of more reports being filed and finally the FDA’s 2014 warning.
The new report released from the GAO highlights the problem with this reporting system. The FDA relies on people to report adverse events, but if those people do not take initiative and do it, the FDA remains in the dark and cannot issue a warning. It is a passive system. Hospitals and other institutions, the study found, did not report cases of cancer after power morcellator surgery because there was no malfunction in the device itself. The use of the device may have caused cancer, but it performed as it was supposed to, so no reports were filed until the victim in 2013 finally stepped up to take a stand.
The passive reporting system has failed many women who became sick and even died after fibroid surgery with a power morcellator. Hospitals failed to report cases of cancer for a number of reasons, including lack of training to recognize issues caused by medical devices, and the FDA has failed by relying on passive reporting. Changes may be made to how the FDA manages safety with medical devices, but those are likely to be slow to come.