Morcellator Cancer Warning Delay Leads Lawmakers To Call For GAO Probe of FDA Practices

A dozen lawmakers have asked the Government Accountability Office (GAO) to investigate the FDA approval and oversight process for power morcellators, which are medical devices used during laparoscopic surgery that have been linked to a risk of spreading undiagnosed cancer in women. 

The letter was sent to the GAO on Friday, by a bipartisan group of House Representatives, including Republican Mike Fitzpatrick, of Pennsylvania, and Democrat Louise Slaughter of New York.

It does not appear that the letter has yet been made available to the public, but the Wall Street Journal reports that the the law makers are asking for an investigation because the FDA’s power morcellator warnings came decades after some studies suggested their may be a cancer risk.

Power morcellators are medical devices that have been widely used in recent years to allow surgeons to cut up and remove uterine fibroids through a minimally invasive incision in the abdomen. However, they have been largely abandoned over past year, as the medical community has recognized that the devices may pose a serious safety risk for many women.

Estimates suggest that about one out of every 350 women who undergo a laparoscopic hysterectomy or myomectomy for uterine fibroids may have unsuspected sarcoma, where undiagnosed cancer cells are hidden within the uterus. For these women, morcellators may spread the cancerous tissue throughout the body, rapidly disseminate the cancer to an aggressive and often fatal stage.

Questions have been raised by many critics about the FDA’s oversight and how the devices remained on the market for so long without adequate morcellator cancer warnings.

The letter from lawmakers reportedly calls for the GAO to investigate the FDA’s approval process in allowing power morcellators on the market. The probe would involve not just looking at the actual approval, but how manufacturers trained doctors, post-market monitoring, and the FDA’s current course of action, which was essentially to place more label warnings on morcellators.

The representatives said they want to know how it took so long for the FDA to realize there was a problem, since some studies conducted years before suggested there was a problem with the potential spread of cancer cells.

It usually takes the GAO several weeks to review a request and decide whether an investigation is feasible and would be productive.

Power Morcellator Lawsuits

A number of families throughout the United States are now pursuing power morcellator lawsuits against manufacturers of the devices after women were diagnosed with the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers following use of the medical device.

The complaints allege that power morcellators are unreasonably dangerous and that the manufacturers should have provided warnings about the potential risks associated with the device, so that women and the medical community could have decided whether the benefits provided by the minimally invasive laparoscopic procedure justify the potential risk.

The FDA has estimated that about out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed and unsuspected sarcoma contained within the uterus. For these women, morcellators may rapidly spread cancerous cells throughout the body, rapidly upstaging the cancers to an advanced stage that is difficult to treat and often fatal. This may greatly reduce the likelihood of long-term survival and the woman’s overall quality of life.

While the FDA has allowed laparoscopic morcellators to remain on the market, much stronger warnings are now provided about the potential cancer risks and many hospitals have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.