Makers of vaginally implanted surgical meshes, including Johnson & Johnson ($JNJ), Endo Pharmaceuticals Holdings and C.R. Bard, could eventually be required to initiate studies on their products of three years or more to show they are safe. An FDA panel also has indicated it thought the meshes should be reclassified as high-risk. The products, which are used to support internal organs and originally cleared under the 510(k) process, are being reviewed during a two-day meeting of the FDA's Obstetrics and Gynecology Device Panel.
If the meshes are reclassified as Class III--a move the FDA is backing--companies would have to conduct clinical trials and then submit an application for approval. Although no formal vote was taken on the question to reclassify, a majority of the members said they supported the proposal, Dow Jones notes.
"We need to change how we do our premarket evaluations of these products," said Colin Pollard, director of the FDA's obstetrics and gynecology devices branch, as quoted by Bloomberg. "We think the current 510(k) paradigm doesn't work for these products because we don't think we know enough about the safety and effectiveness."
Reps from J&J and Endo suggested new versions of the devices should require clinical trials before going on the market. And while they also said existing implants should be tracked for safety, they didn't voice support for reclassifying the products. The meshes are "not the optimal solution for everyone but it will be for some," Piet Hinoul, a director of medical affairs for J&J's Ethicon unit, told the panel, as quoted by Bloomberg.
Public Citizen doesn't believe a reclassification is a strong enough move, however. It told the panel the FDA should recall all surgical mesh products made of non-absorbable synthetic material that are used during transvaginal surgery because they offer no benefits and pose serious risks.
"A grace period allowing continued marketing of these devices would recklessly endanger women," Dr. Daniel Elliott, a urologic surgeon, said in a Public Citizen statement. "There is sufficient data available for the currently marketed mesh products for transvaginal repair of POP indicating that the risks of serious complications from these devices far outweigh their benefits."
- see the Public Citizen statement
- read the Bloomberg report
- get more from Bloomberg
- check out the Dow Jones story