August 25th, 2014|
An FDA committee met recently about the safety of laparoscopic power morcellators and seemed to reach a consensus that these devices cannot be used without posing a risk of spreading hidden cancer. A JAMA report also highlighted the risks.
Concerns are mounting over laparoscopic power morcellators, bladed tools used to slice and remove uterine fibroids during hysterectomies and other gynecological surgeries. After a two-day hearing on July 10 and 11, the FDA’s 15-member Obstetrics and Gynecological Medical Device Advisory Committee seemed to reach a consensus that the device cannot be used without posing a risk of spreading hidden cancer. Less than two weeks later, a Journal of the American Medical Association (JAMA) report found that 1 out of 368 women who undergo hysterectomies have an undetected uterine sarcoma, a dangerous cancer that morcellators can spread. The report corroborates data in the FDA’s April safety advisory that the risk is 1 in 350.
The FDA panel reviewed several options at the two-day hearing. Among them: Recall morcellators to make design changes and allow them to remain available but add a “black box” warning and ensure patients are adequately informed of the risk, in writing, if they choose to undergo surgery with the device. The committee rejected the idea of using surgical or specimen bags, because they do not make the procedure safer, and discussed the difficulties of screening women for this rare form of uterine cancer beforehand. Imaging techniques often are unable to distinguish between uterine sarcomas and normal fibroids.
“My instinct is that the devices will be pulled off the market and then undergo some sort of clinical trials and research,” said Washington, D.C., attorney Mark Harris. “Without an accurate way of diagnosing which patients are at the highest risk for these sarcomas pre-surgery, I think that’s the direction the agency will go in.”
On July 30, Johnson & Johnson (J&J), whose Ethicon division is the largest U.S. morcellator manufacturer, withdrew its devices from the market. Highmark, Inc., one of the nation’s largest Blue Cross and Blue Shield insurance providers, announced it will cease coverage for laparoscopic morcellation surgery on Sept. 1. Plaintiff attorneys said these recent developments strengthen their clients’ cases.
Between one dozen and two dozen products liability cases have been filed against morcellator manufacturers, as Trial News previously reported. “The evidence that has come out over the past few months is getting stronger and clearer: These morcellator devices are dangerous, and the medical device manufacturers have known this for a long time,” said Birmingham, Ala., attorney Kristian Rasmussen. “It would not surprise me to see the FDA take strong action.”
In the JAMA report, a group of Columbia University doctors examined insurance records for 232,882 women who had minimally invasive hysterectomies at 500 hospitals from 2006 to 2012. Morcellation was performed in about 15.7 percent of those cases, and 99 uterine cancer cases were identified. Patients considering morcellation should be “adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure,” the report noted.
Harris, who represents one of the plaintiffs, said more people could have developed cancer from the device than the statistics reflect. “A woman at the hearing said she was diagnosed 2 1/2 years after the original procedure. She said there was no idea there was any relationship between the hysterectomy and the diagnosis,” he said. “It’s only because of the recent press and FDA announcements that some women are finding out about this.”
According to news reports, J&J hasn’t decided whether it will put the device back on the market.
“Manufacturers like J&J want to cut off their liability. They realize they are exposed and are on the hook for the injuries and damages consumers have sustained up to this point,” said Rasmussen. “Manufacturers want to put physicians and other health care professionals on notice that they don’t want the liability, and, from this point forward, it’s on them.”
Highmark was the first major health insurer to pull coverage. It owns the West Penn Allegheny Health System, which covers a large area in Pennsylvania. Simultaneously, the University of Pittsburgh Medical Center—a major hospital network in western Pennsylvania—announced that it is suspending power morcellation. Many Boston-area hospitals also banned the devices after the FDA issued its safety advisory.
Rasmussen said he expects many other insurers to cease coverage. “Health insurers realize they will have to pay the costs associated with the medical care and treatment patients require,” he said.
The debate over the device’s risks has reinvigorated calls for the FDA to overhaul its 510(k) process, which is how power morcellators were cleared for sale. The FDA may approve a 510(k) application for a new device based on a previously approved, “substantially equivalent” device, without requiring testing to demonstrate safety and effectiveness. In late July, the FDA issued new guidelines that lay out how the agency should determine whether a device is substantially equivalent to an existing one, but Rasmussen said the guidelines are insufficient.
“Everything that is happening in the context of these morcellation devices and the risks coming to light is really just an example of a more systemic problem,” Rasmussen said. “More and more devices are being submitted for 510(k) approval as substantially equivalent, and they are not.”
He added, “The recent scientific evidence and regulatory action only strengthen the case on behalf of consumers against the medical device manufacturers. I believe, in the months to come, we will see more evidence come to light that substantiates the unjustifiably high risk of death and other life-threatening injuries associated with morcellation devices.”