An independent review of the FDA's approval of a medical device exposed critical gaps in the agency's infrastructure that require a legislative fix, according to Rep. Brian Fitzpatrick, R-8, Middletown.
The Government Accountability Office this week published the result of a two-year study of the FDA's approval of power morcellators, which are tools used in laparoscopic procedures such as hysterectomies.
A mechanically powered blade spins inside a small tube and chops up tissue, which can then be removed with small incisions, allowing for a shorter recovery time and reducing the risk of infection. In 2013, reports were made public of women who had cancerous tissue in their uterine walls that resembled fibroids. The morcellators shredded the tissue and caused the cancer to spread throughout the body.
"The GAO report confirms what we had long expected: there are serious gaps in the FDA’s device reporting system and that immediate congressional action is needed to reform the process and save lives," said Fitzpatrick in a joint statement with Congresswoman Louise Slaughter, a Democrat representing New York's 25th Congressional District.
In 2013, Slaughter joined with Brian Fitzpatrick's predecessor, his brother Mike Fitzpatrick, to write a letter demanding a review of the FDA's approval of power morcellators. While in Congress, Mike Fitzpatrick was made aware of the problem when Dr. Amy Reed, of Yardley, visited his office and spoke of her experience during a hysterectomy, when a morcellator destroyed a cancerous tumor and spread the disease.
The GAO study starts in 1990, when the FDA reviewed applications for 25 types of morcellators. The agency accelerated the approval process by determining its design and intended use resembled that of an already existing device, an arthroscopic surgical system.
At the time of the device's approval, the FDA was "aware of the potential for spreading tissue when using a power morcellator ... however, the general understanding was that the risk of an unsuspected cancer that could be spread when using the device was low," the GAO report found.
The study says 30 articles had been published between 1980 and 2012 identifying the risk of the spread of tissue after use of a power morcellator or advising surgeons to remove all fragments of tissue. However, the FDA was not aware of any definitive scientific publications regarding the actual risk of cancer in uterine fibroids.
"FDA officials noted that published estimates for an unsuspected cancer (specifically uterine sarcoma) in a woman with a presumed uterine fibroid varied from about 1 in 1,000 women to 1 in about 10,000 women," the GAO report says.
A 2012 study that examined 1,091 instances of uterine morcellation at one hospital reported that the rate of unsuspected cancer was nine times higher than the rate quoted to patients at the time.
The Fitzpatrick brothers have blamed the lack of consistency in the FDA's adverse event reporting system for the agency's failure to become aware of the device's risks before 2013, when the danger become more public.
Increased scrutiny of the device prompted the FDA to issue an updated safety communication — warning against the use of power morcellators for women undergoing surgery to treat uterine fibroids. The FDA also conducted inspections in December 2015 of five facilities to review their compliance with medical device reporting requirements.
According to the GAO, a 2016 study reports a decline in use of power morcellators in hysterectomies since the FDA sent its updated safety communication in 2014, from 13.5 percent to under 3 percent.
"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," said Congressman Fitzpatrick and Congresswoman Slaughter in their joint statement released Wednesday. "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 recently announced plans to work with hospitals to identify a system that quickly identifies life-threatening problems caused by medical devices, the GAO report says. FDA officials also said they will continue to review new technologies, such as morcellation containment systems, and work on a national registry to collect data on the treatment of fibroids.
"In addition," the report says, "FDA is working to establish a national evaluation system for health technology to more efficiently generate better evidence for medical device evaluation and regulatory decision-making."