It’s time for a reckoning on medical devices.
Vaginal mesh, breast implants, permanent birth control devices have harmed millions of patients who thought they could trust their doctors
Patients suffer as the F.D.A. fails to adequately screen or monitor products
New York Times – 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). Physicians Are Cashing In Twice Per Patient on Breast Implants
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 … Read more.
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