By Emily Cox
Medical experts suggest that the FDA needs to revamp its medical device post-marketing surveillance, highlighting power morcellator cancer problems that the agency did not address until after hundreds of women had cancer cells spread by the device during hysterectomy and uterine fibroid procedures.
The Journal of the American Medical Association (JAMA) published the editorial this past week. JAMA’s editor, Dr. Rita Reberg, indicated the power morcellator cancer debacle is a prime example of the FDA’s failure to obtain necessary information from post-marketing surveillance. The agency needs this data to ensure the safety and efficacy of devices in the real world.
“The clinical community depends on high-quality evidence about medical products, and regulatory oversight is a key mechanism for ensuring collection of that evidence,” Redberg wrote along with fellow experts.
Dr. Alison Jacoby of the University of California, San Francisco’s Department of Obstetrics and Gynecology and Dr. Joshua Sharfstin of the Department of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health joined Redberg in her review of the FDA’s surveillance failures.
“This point becomes especially apparent when important data to guide care are lacking, as illustrated by the recent example of power morcellators,” the editorial continued
Morcellators enjoyed widespread popularity during the past decade. They allow doctors to cut up and remove the uterus and uterine fibroids though a small incision in the abdomen. Surgeons valued the devices as a way to limit surgical complication risks, while reducing recovery time. However, the medical community discovered that these morcellators may spread undiagnosed uterine cancer cells. This led to rapid upstaging of leiomyosarcome, endometrial stromal sarcoma, and other difficult to treat cancers. Consequently, physicians have largely abandoned using these devices. Unfortunately, this discovery came too late for many women.
FDA Response to Power Morcellator Cancer Risks
In February, the U.S. Government Accountability Office (GAO) released a report regarding the FDA’s response to power morcellator cancer risks. The GAO found that the lack of data led the agency to underestimate the risk of morcellators spreading uterine cancer in many women. The FDA approved 25 of these devices before it detected these problems.
The FDA added a black box power morcellator cancer warning in November 2014. The agency also indicated limited circumstances that may warrant the device’s use. Regardless, the medical community is still divided over whether the FDA should have removed the devices from the market entirely. Furthermore, there are still conflicting views on how the FDA should handle products with emerging safety concerns. The editorial also noted that FDA needs to identify risks and benefits before approval to avoid these types of devastating problems. When the agency still fails to obtain adequate post-approval date, these problems are amplified. Despite thousands of women’s power morcellation experiences, the FDA still failed to identify the problems too late in the game to help many women. The editorial authors suggest that the FDA’s lack of a comprehensive system of data collection is to blame.
“Morcellators, like many devices cleared through the 510K pathway, entered the market based on their ‘substantial equivalence’ to prior devices; in this case, the equivalence was to a device used in arthroscopic joint surgery,” the editorial stated. “Even though the risk of potentially spreading cancer was known at the time of FDA clearance of the first of these devices in 1991, no clinical studies to assess the issue were required and no post-marketing requirements for data collection were put into place. Without such requirements, there was little incentive for the industry sponsors of the device to voluntarily gather such data.”
Power Morcellator Cancer Risks Prompt FDA to Reevaluate Post-Market Surveillance
Since the FDA first issued warning in April 2014, the medical community has mostly abandoned morcellation. In fact, the main manufacturer of the device, Johnson & Johnson’s Ethicon unit, stopped selling the device entirely.
In February, the FDA released a study indicating that a system of active surveillance would be better suited to detect medical device problems than the current voluntary reporting system.
Editorial authors suggest that post marketing surveillance studies are still infrequent and limited. They acknowledge that the FDA is trying to improve the system. However, it will take years to implement these measures. In the meantime, medical devices continue to harm countless individuals right under the agency’s nose.
However, the editorial does make some concessions toward federal regulators. Doctors also failed to ask enough questions and generally don’t fulfill reporting requirements. Furthermore, manufacturers often oppose stronger reporting requirements to keep patients safer.
Dozens of individuals have brought claims against Johnson & Johnson’s power morcellators. These claims allege that the conglomerate’s devices spread cancer, leading to serious illness and even death. Settlement agreements have resolved most of these claims. But, a number of morcellator manufacturers continue to face lawsuits over failing to warn the medical community over the device’s risks.