September 8, 2011 Bloomberg Article — In a public advisory committee meeting today, manufacturers and FDA officials agree on the need for additional study of transvaginal mesh products, but disagree on its classification. Meanwhile, the number of lawsuits filed against transvaginal mesh manufacturers continues to increase.
In today’s presentations given to the panel, transvaginal mesh manufacturers agree with members of the Food and Drug Administration, surgeons, and other experts that additional studies need to be done on transvaginal mesh implants in pelvic organ prolapse repairs. Manufacturers, including Johnson & Johnson and Endo Pharmmaceuticals Holding, Inc., recommended new versions of transvaginal mesh devices require clinical trials, while existing products undergo tracking. The new studies would establish concretely if the benefits of transvaginal mesh devices outweigh the risks.
Unfortunately, the FDA and manufacturers disagree on one key aspect of transvaginal mesh: its classification.
Prior to the September 8 panel, the FDA made a recommendation that transvaginal mesh products be reclassified as Class III, instead of Class II products.
As a Class II device, transvaginal mesh products are approved under the abbreviated approval 510(k) process, where by manufacturers only had to prove the products resembled already-cleared devices. Since mesh products had been used on the market for years in hernia repair, new vaginal mesh products resembling hernia mesh did not have to undergo extensive pre-market study. A higher classification would give the FDA higher control of the pre-market clinical studies. As Julia Corrado, a clinical reviewer for the FDA stated:
Keeping the devices in the 510(k) systems “would mean a new device only needs to be as good as a device currently on the market and we are concerned that is not good enough.”
Additionally, William Maisel, deputy director of the FDA Center for Devices and Radiological Health said:
“The clinical effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse has not been demonstrated. We believe proper studies would need to be done.”
While the FDA is pushing a reclassification, the transvaginal mesh industry is encouraging a continuation of the Class II classification. They argue that the products can continue as “moderate-risk” devices, but can also require additional study or labeling changes. Transvaginal mesh companies say reclassifying them as “high-risk,” or Class III, places too much burden on the companies, which would have to undergo approval of manufacturing procedures, plan inspections and longer review times.
The industry of manufacturers acknowledges the need for additional study, but believes existing studies have already proven the devices safe and effective, leaving the “high-risk” classification unnecessary.
After the panel is done deliberating, the FDA will poll the panel of researchers and physicians about their opinions as to the reclassification of transvaginal mesh devices, as well as gather their thoughts on additional clinical studies. If the panel decides to reclassify transvaginal mesh products from Class II to Class II, it would require manufacturers to provide additional data, in order to keep their product on the market.
In the meantime, national surgeon groups told the panel the transvaginal mesh devices should only be used in limited numbers and only by well-trained physicians on carefully-chosen patients.
Meanwhile, patients who claim they experienced injury after mesh implantation have filed over 500 lawsuits against Johnson & Johnson and C.R. Bard. One New Jersey attorney has represented about 100 women in claims made against Johnson & Johnson and Bard.
Do I Have a Transvaginal Mesh Lawsuit?
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