Over more than two decades, the U.S. Food and Drug Administration approved 25 surgical devices that could spread undiagnosed cancer in women's bodies, according to an investigative government report issued Wednesday.
These machines were deemed so similar to older devices — for surgery on the knee and other joints — that they were approved for use in gynecologic surgeries without rigorous testing, the U.S. Government Accountability Office report found.
The FDA was aware that the newer devices — tissue-cutting tools called power morcellators — could accidentally spread a uterine cancer, but considered the risk too low to warn women and their doctors, the GAO report concluded.
What's more, gaps in the FDA's system for reporting deaths or serious injuries related to medical devices meant that hospitals and doctors either didn't alert the government about problems — or health regulators didn't see the reports, the GAO found.
The FDA finally began studying women's cancer risk in late 2013, after married physicians Hooman Noorchashm and Amy Reed, who live in the Philadelphia area with their six children, launched a high-profile campaign to ban electric morcellators. A morcellator spread Reed's undetected uterine cancer in October 2013 during a hysterectomy in Boston to treat benign growths called fibroids. Despite aggressive treatment, Reed, an anesthesiologist, is still battling leiomyosarcoma that has spread to numerous organs.
In 2014, more than two decades after it approved the first gynecological morcellator, the FDA warned that the device could spread and worsen uterine cancer, estimating the risk at 1 in every 350 women who undergo a hysterectomy or fibroid surgery. Therefore, the agency said, the device should not be used in the vast majority of cases.
"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," Noorchashm said Wednesday.
Former U.S. Rep. Mike Fitzpatrick (R., Pa.) and Rep. Louise Slaughter (D., N.Y.) initially requested the GAO investigation in August 2015. On Wednesday, Fitzpatrick's brother Brian, who now holds his seat in Congress, and Slaughter issued a statement: "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 also issued a statement saying it "agrees with the findings" of the GAO. The agency noted that it continues to warn that morcellators should rarely be used, that the device labeling now has a warning about the cancer risk, and that the system for monitoring safety problems is being improved.
"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 statement said.
When morcellators first came on the market, gynecologists welcomed them as a way to make hysterectomy or fibroid removal less invasive, thus reducing complications and recovery time. Morcellated uterine tissue can be cut up and removed through small abdominal incisions, avoiding the need for traditional cut-open-the-abdomen surgery.
Manufacturers got morcellators approved through a regulatory review process, called 510(k), that allows devices to come to the market without rigorous testing as long as they are "substantially equivalent" to another legally marketed device. The FDA says "substantial equivalence means that the new device is at least as safe and effective as the predicate" device that it is based on.
In the case of morcellators, the GAO found that all 25 morcellators — including ones that added accessories and features over the years — were deemed substantially the same as a single predicate gadget, "an electromechanical system for cutting tissue during minimally-invasive surgeries performed on knees and other joints."
The GAO, which investigates how the government spends tax dollars, said it found 30 medical journal articles published between 1980 and 2013 that mentioned the risk of spewing tissue fragments while using a power morcellator. Yet FDA officials assumed the risk of spreading cancer was low, and "were not aware of any definitive scientific publications regarding the actual risk of cancer in uterine fibroids."
Indeed, until Noorchasm and Reed drew media attention to the problem and prompted new scientific analyses, gynecologists who informed women of the potential danger — and many did not — said the risk was about 1 in 10,000.
"The gynecological literature contained clear indications that this oncological danger of power morcellators exists, but neither practitioners nor the FDA addressed the hazard," Noorchashm, a cardiac surgeon, said Wednesday from his home in Bucks County.
Even though the controversy has sharply curtailed the use of morcellators — the leading brand was pulled from the market and insurers are now wary of coverage — professional gynecological medical groups have continued to defend the value of the device in minimally invasive surgeries.
The American College of Obstetricians and Gynecologists and the society of minimally invasive gynecological surgeons did not immediately respond to a request for comment on the GAO report.
"There are sure to be other hazardous devices causing unreasonable harm to American patients as a result of the failures defined by this report," Noorchashm said, calling for "immediate formal attention" by Congress and the Trump administration.