Time for a Reckoning on Medical Devices
80,000 Deaths. 2 Million Injuries. How the FDA fails to adequately screen or monitor (drugs and) products.
When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh.
The mesh, which is used to hold pelvic organs in place when muscles become too weak to do the job, has long been tied to life-altering injuries, including nearly 80 deaths as of 2018. In the past decade, seven companies have spent a collective $8 billion to resolve more than 100,000 patient claims — making litigation over vaginal mesh (or pelvic mesh, as it is sometimes called) one of the largest mass tort cases in United States history. As those lawsuits have made clear, most of these medical devices were approved for market with nearly no clinical data.
It seems incredible that products meant to reside inside the human body would be used on patients without any proof of safety or efficacy. But thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact.
Problems can take years to emerge and can be impossible to correct, in part because permanent implants are not easily extracted from the body. (Removing mesh from pelvic tissue has been likened to removing chewing gum from long, thick hair). When trouble does arise, device makers often equivocate, regulators dither and patients seeking redress are forced into lengthy and expensive court battles. In the end, faulty products can remain on the market for years.
The FDA finally pulled the remaining vaginal mesh products off the market last month (although most companies had already stopped selling them because of all those lawsuits). But on Thursday, the agency said it would not ban a breast implant linked to a rare form of cancer and so many other side effects that doctors have coined a new term — “breast-implant illness.” Like mesh, the breast implant was approved years back, based on meager safety evidence. Regulators now say there is not enough proof of harm to justify reversing that decision.
The risks of waiting loom large: In the past decade, nearly two million injuries and more than 80,000 deaths have been linked to faulty medical devices, many approved with little to no clinical testing, according to a global investigation by the International Consortium of Investigative Journalists.
Women are particularly well acquainted with this cycle. Essure, a permanent birth control device consisting of two metal coils injected into the fallopian tubes, has been linked to autoimmune disorders and more than 800 pregnancy losses. The product was pulled from the market last year — by the device maker, which cited declining sales, not by the FD. And the power morcellator — a spinning blade that shreds uterine tissue so it can be more easily extracted from the body — has proved deadly for some women, whose cancer was spread by the device.
As The Times has reported, the morcellator was widely used for 20 years before regulators realized there was a problem.
But that’s not to suggest that only women are affected: There have been metal hips that released poisonous debris into the body, implantable defibrillators that shock people at random (causing indescribable terror) and artificial heart valves with questionable shelf lives. In operating rooms, there have been staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim patients.
In every one of these cases, a combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.
After searing investigations by journalists and patient advocates, the FDA has promised to make “transformative” changes to medical device regulation. But so far, the agency’s suggestions have been meager at best. And in the meantime, regulators have accelerated the device approval process, not slowed it down.
It’s not solely those laws that give medical device makers influence over regulators. The industry maintains a well-oiled revolving door wihth the FDAt — as The Associated Press has noted, the last four people to hold the position of Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration have gone on to lucrative industry gigs. Device makers also spent more than $300 million lobbying Congress in the decade ending in 2017, according to the Center for Responsive Politics. What’s more, they pay doctors and hospitals hundreds of millions in consulting fees every year, according to the National Center for Health Research. None of this violates any rule, but all of it contributes to the current crisis.
Medical institutions and professional societies should establish, or amplify, guidelines discouraging such payments. Stronger laws that provide more funding for the work of device regulation — so that the FDA is not as reliant on industry dollars — would also help the agency to fulfill its mission.
That mission is to protect patients.
[Excerpted from NYT editorial, May 4, 2019]