Famed U.S. Radio Show Questions Status of Transvaginal Mesh Recall
The hope for a future industry-wide transvaginal mesh recall is finally starting to gain traction in the world of mass media and the public sphere, and has everybody—including political activist Robert F. Kennedy Jr.—talking.
On Oct. 8, the syndicated American radio program he co-hosts, Ring of Fire, blogged the question, “One Year After the FDA’s Meeting on Transvaginal Mesh: Where Are We Now?” on its website.
The editorial comments on one form of transvaginal mesh in particular: the Perigee System, manufactured by American Medical Systems. In describing the device, which was created in 2004 and comes pre-packaged in a box, Price refers to its curved “trocars,” as eerily resembling “the metal hooks used by butchers in the meat industry.” Yikes.
The author then goes on to say that this individual device was never individually approved by the FDA—it was cleared by way of a 510(k) process, which allows a product to be approved for marketing if the manufacturer can prove it is substantially equivalent to another that is already on the market.
This article was published a year after the U.S. Food and Drug Administration (“FDA”)’s Obstetrics & Gynecology Devices Advisory Committee met to discuss the controversial health issue. After that September 2011 meeting, experts agreed that more rigorous testing needed to be implemented before the FDA clears these products, and that the devices should be re-classified as Class III, which requires manufacturers to get pre-market approval for all future products.
The editorial also pointed out that more than 5,000 transvaginal mesh lawsuits have been filed in federal court, and many manufacturers—such as C.R. Bard Inc., American Medical Systems, Boston Scientific Corp. and Ethicon are now involved in various multidistrict litigations (“MDL”).
In fact, Ethicon filed its Answer to the First Amended Master Complaint in the federal Ethicon transvaginal mesh lawsuit MDL on August 31, 2012, where it admitted that a number of its products are named in the pending lawsuits filed in the U.S. District Court, Southern District of West Virginia. (In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation – MDL No. 2327)
In other words, plaintiffs are claiming to have incurred injuries after being implanted with Ethicon’s Prolene Mesh/Prolene Soft Mesh, Gynemesh, Gynemesh PS, TVT, TVT-Obturator, TVT-Secur, TVT Exact, TVT Abbrevo, Prolift + M, Prolift, and Prosima devices.