The FDA released summaries from last week’s two-day transvaginal mesh advisory panel, revealing general disagreement between mesh makers patient groups.
While consumer advocacy groups demanded an industry-wide recall of all transvaginal mesh devices until more testing can demonstrate safety and efficacy, industry lobby AdvaMed and companies making transvaginal mesh products asked the FDA to leave the regulatory status for the products alone.
Industry, including med-tech lobby AdvaMed, Johnson & Johnson (NYSE:JNJ) and Endo Pharmaceuticals Holdings Inc., was generally supportive of clinical safety testing and postmarket review for new transvaginal mesh products, but argued that the safety and efficacy of existing mesh devices was well established, according to a newly released FDA panel summary.
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Nearly 40 people speaking during an open public hearing leaned toward a recall for the devices, with individual patients recounting "mostly adverse" personal experiences and women’s groups breaking down the clinical data available on the products.
The FDA’s own internal research group recommended that surgical mesh devices be reclassified to the highest risk category, forcing new products as well as existing mesh devices to undergo testing.
Consumer watchdog group Public Citizen filed a petition with the FDA last monthasking the agency to issue a recall for all transvaginal mesh products.
Meeting conclusions have yet to be issued, but the panel appeared to lean heavily toward requiring new devices applications to undergo clinical testing while allowing existing products to stay on the market.
The meeting follows a recent report from the FDA’s Obstetrics & Gynecology Devices Panel which recommended bumping the devices, which are used to treat pelvic organ prolapse, into a higher risk category given rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.
Johnson & Johnson and C.R. Bard (NYSE:BCR) and are the target of nearly 500 lawsuits filed by patients claiming the meshes caused internal injuries.
Last month Boston Scientific Corp. and American Medical Systems Holdings Inc. (NSDQ:AMMD) found themselves at the center of a lawsuit claiming that transvaginal mesh products sold by the companies were defective and caused severe injuries to a patient. Lawsuits were filed against C.R. Bard Inc. (NYSE:BCR) for its Avaulta transvaginal mesh, filed earlier this month.
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.
"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency release. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications."