From Mesh Medical Device News Desk – a resource for news and information on this dark chapter in women’s health.
It appears women are the recipients of many sketchy medical devices that bypass any safety checks we assume are being conducted by the Food and Drug Administration before entering the market.
That is a faulty assumption. If you are to be implanted with a medical device in the U.S. first ask- Was it approved under the FDA’s antiquated safety loophole- the 510(k)? If so, know you are part of the great experiment that will test its efficacy and safety in patients, not in clinical trials prior to marketing.
That’s what’s happened to hundreds of thousands of unsuspecting women not only in the States but around the world. There have been so many complications reported, that even the FDA had to admit in 2012 that complications are “not rare” and that a mesh implant to treat prolapse and incontinence might not be a first-line treatment.
Still it is used. And most meshes remain on the market.
The dissatisfaction with this loophole in the patient safety net is enough to bring out women in protest this June 2, as lawyers from both sides converged for a status hearing on the 80,000 or so lawsuits consolidated in federal court in Charleston, WV. While there were no solutions announced, the women tell MND the sisterhood felt among the women present was amazing and made them feel as though their voices do matter. They do. Manufacturers do not like to see powerful women they’ve harmed up close I’ve observed in the courtroom when mesh-injured watch the proceedings.