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Medical experts indicate that federal health regulators need to tighten up post-marketing surveillance for medical devices that are already on the market, pointing to the recent problems linked to power morcellators, which were not discovered until after hundreds of woman had cancer cells spread by the device used during laparoscopic hysterectomy and uterine fibroid procedures.
In an editorial published last week in the Journal of the American Medical Association (JAMA), the editor of JAMA Internal Medicine, Dr. Rita F. Redberg, cited the power morcellator cancer problems as an example of how the FDA had failed to obtain necessary data through post marketing surveillance; which the FDA is supposed to use to ensure that devices approved for use on patients in the U.S. are safe and effective 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, in conjunction with 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. “This point becomes especially apparent when important data to guide care are lacking, as illustrated by the recent example of power morcellators.”
Morcellators were widely used over the past decade, allowing doctors to cut up and remove the uterus and uterine fibroids through a small incision in the abdomen. The minimally invasive procedures were recommended as a way to limit the risk of surgical complications and reduce recovery time. However, use of the devices has largely been abandoned, since the medical community discovered that morcellators may spread undiagnosed cancer cells contained within the uterus, leading to the rapid upstaging of leiomyosarcoma, endometrial stromal sarcoma and other difficult to treat cancers.
The U.S. Government Accountability Office (GAO) released a report in February, analyzing the FDA’s response to power morcellator cancer risks. The report found that a lack of data led the FDA to likely underestimate the risk that morcellators were spreading uterine cancer among many women, with 25 devices approved before the problems were detected.
In November 2014, the FDA decided to add a black box warning to power morcellators about the cancer problems, and provided guidance on the limited instances where laparoscopic hysterectomies may be warranted.
The editorial notes that the medical community is still conflicted over whether the devices should have been removed from the market entirely and there are still differing views on how the FDA should handle products with emerging safety risks. However, the editorial also notes that the problems are made worse when the FDA fails to first obtain sufficient evidence on the risks and benefits of a medical device before it is approved, and then fails to collect sufficient post-marketing data.
Since the use of morcellation fell into decline, the editorial notes that some studies have shown slight drops in laparoscopic hysterectomies of all kinds, a slight increase in major surgical complications and a slight increase in 30-day hospital readmissions. Other studies have said that the decrease in laparoscopic hysterectomies has occurred without any increase in major surgical complications.
The authors say that many questions about morcellation have gone unresolved because the FDA lacks a comprehensive system of data collection, despite the experiences of thousands of women who have undergone power morcellation.
“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 states. “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 postmarketing 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.”
Morcellator Use In Decline But Questions Remain
Since warnings were first issued by federal regulators in April 2014, the medical community has largely abandoned the use of morcellators, and Johnson & Johnson’s Ethicon unit, which was previously the main manufacturer of the device, stopped selling the tool.
Another FDA-funded study published in February suggested that a system of active surveillance would help to better detect problems linked to medical devices than the current voluntary reporting system.
The editorial notes that despite incidents like those with power morcellators, postmarketing surveillance studies remain infrequent and limited in scope. They acknowledge that the FDA is looking to improve the system, but its plans will take years to come to fruition, according to the authors.
The authors note, however, that not all the blame can be placed on the FDA. They said doctors also failed to ask enough questions, and often resist reporting requirements, and manufacturers often oppose stronger reporting requirements that would make their patient’s safer.
Johnson & Johnson has faced dozens of morcellation cancer lawsuits brought on behalf of women who suffered problems after a laparoscopic procedure, and wrongful death claims by family members who had died of such cancers.
While most of those cases have been resolved through morcellator settlement agreements, a number of other morcellator manufacturers continue to face claims alleging that they failed to warn the medical community about morcellator risks.