Jan. 2012 – Veritas Legal Media – 757-582-1836 – firstname.lastname@example.org
Have you ever had an operation or a surgical procedure that caused more problems than the condition it was meant to rectify? If so, you can probably sympathize with hundreds of women who are taking out lawsuits over vaginal mesh implants.
Litigation on this issue moved forward on Jan. 26, 2012, at a hearing in Miami, FL, when lawyers sought to coordinate the many transvaginal surgical mesh lawsuits that are presently being brought across the USA. Lawyers have filed motions with the U.S. Judicial Panel on Multidistrict Litigation (JPML) representing women who say they suffered injuries after being implanted with vaginal mesh, which has been used for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Massivelawsuits are now being brought against three manufacturers — American Medical Systems, Inc., Boston Scientific Corp. and Ethicon, Inc.
This has been a problemacross the US for some years and it’s not as if the regulators haven’t had time to make patients aware of the dangers. In October 2008, the U.S. Food and Drug Administration issued a notice about transvaginal surgical mesh. It said the FDA had received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices. Painful complications listed by the FDA included bowel, bladder, and blood vessel perforation during insertion of the mesh and pain and discomfort in the wake of operations.
The regulation, or in this case, the lack of regulation of these products, is a cause for concern. These vaginal mesh products were approved through the FDA’s controversial 510(k) fast-track approval process, a system that’s more than 35 years old and under fire. Unlike drugs there is no testing requirement under 510 (k). The only requirement is that a product should be substantially equivalent to a device that has already been approved for sale. This highly controversial approval process was also used for DePuy hip transplants – another device that has led to intense suffering for patients, not to mention multiple lawsuits.
Recently the FDA sent out a letter to manufacturers of mesh products calling for new post-marketing studies on transvaginal mesh. This seems like a clear case of closing the stable door after the horse has bolted, although if it helps bring change in the regulation of surgical devices, some good will have come out of it.
Unfortunately, change has come too late to help many women who have been left in pain by faulty devices that studies have shown provide little clinical benefit.