GAO Report Says Morcellator Issue Stemmed from Lax Regulations. Power morcellators are tools used during gynecologic procedures; they cut up tissue into smaller pieces so they can be more easily removed during uterine fibroid removal or hysterectomy. Power morcellators have come under scrutiny after it was discovered that they can spread an undetected cancer in women with fibroids. Now, a recent report issued by the Government Accountability Office (GAO) has found that lax regulations allowed the now-controversial devices onto the market.
The national medical device attorneys at Parker Waichman LLP represent numerous clients in personal injury lawsuits. The firm continues to offer free legal consultations to anyone with questions about filing a power morcellator lawsuit.
According to the GAO report released Feb. 8, 2017, the U.S. Food and Drug Administration (FDA) approved 25 morcellators for gynecologic procedures in women. All of these devices were approved through 510(k), which means that manufacturers did not have to perform rigorous clinical testing to prove that the morcellators are safe and effective. 510(k) is a fast-track route that only requires device makers to show that their new product is “substantially equivalent” to a previously approved device, known as a predicate. To the FDA, “substantial equivalence means that the new device is at least as safe and effective as the predicate.”
The GAO report found that all 25 morcellators cited a single product as a predicate, “an electromechanical system for cutting tissue during minimally-invasive surgeries performed on knees and other joints.”
Although the FDA knew that morcellators could spread an undetected uterine cancer in women, the agency believed the risk was too low to issue a warning to patients and their doctors. Previously, it was believed that the risk of a hidden cancer in women with symptomatic fibroids was 1 in 10,000. In 2014, the FDA warned that the risk was 1 in 350 women.
The GAO report said there were 30 medical journals published between 1980 and 2013 showing that morcellators can spray tissue fragments during use. FDA officials, however, believed the risk was low and “were not aware of any definitive scientific publications regarding the actual risk of cancer in uterine fibroids.”
Furthermore, the GAO highlighted lapses in the FDA’s system for reporting injuries related to medical devices.
Power Morcellators can Spread Hidden Uterine Cancers
The cancer-spreading risks of power morcellators were brought to light by husband-and-wife physicians Hooman Noorchashm and Amy Reed. Dr. Reed had her undetected uterine cancer worsened, or “upstaged” after undergoing a hysterectomy using a power morcellator. According to Philly.com, she continues to fight the leiomyosarcoma that has spread to multiple organs. The couple has since advocated to increase awareness over the devices and have morcellators banned from the market.
Noorchashm commented on the new report, stating “This GAO report is de facto confirmation that hundreds, if not thousands, of American women have been harmed or died because of this regulatory failure and the failure of the reporting system,”
“There are sure to be other hazardous devices causing unreasonable harm to American patients as a result of the failures defined by this report,” said Noorchashm.
The GAO investigation was requested in August 2015 by former U.S. Rep. Mike Fitzpatrick (R., Pa.) and Rep. Louise Slaughter (D., N.Y.). Slaughter and Fitzpatrick’s brother Brian, who has taken his seat, released a statement saying, “The release of this long-awaited report won’t do anything to help women battling cancer who have had their lives devastated by power morcellators, or provide much comfort to the families of those already lost. It does, however, shed light on the broken system that allowed this devastation to happen and include a road map to address it.”
The FDA has commented that it “agrees with the findings” in the GAO report. Regulators continue to advise against power morcellation in most women. The agency is also making efforts to improve its system for monitoring safety problems with medical devices.
“The FDA has noted the shortcomings of the current passive post-market surveillance system and has been taking steps to establish a better system to evaluate device performance in clinical practice,” the agency stated.
Power morcellators now carry a boxed warning that discloses a risk of spreading hidden uterine cancers, which cannot be reliably detected prior to surgery.