FDA probes JNJ, Bard and others on transvaginal mesh risks
January 5, 2012 by Arezu Sarvestani
As public pressure mounts over the potential harm caused by transvaginal mesh implants the FDA ordered device makers, including Johnson & Johnson (NYSE:JNJ) and C.R. Bard (NYSE:BCR), to take another look at complication rates associated with their devices.
The watchdog agency asked a total of 33 companies to conduct 3 years of safety and effectiveness trials under growing concerns after deaths and injuries linked to the products spiked in recent years.
The moves follow citizens’ petitions, multi-district lawsuits and FDA panel meetings surrounding the implants, which were catalyzed by warnings issued in July, that the surgical mesh may pose unnecessary risk to women without adding clinical benefit.
During the Sept. 2010 FDA panel meetings, mesh makers including Johnson & Johnson and Endo Pharmaceuticals Holdings Inc. (NSDQ:ENDP), agreed that more safety studies and labeling changes might help warn patients and doctors of potential risks. The watchdog agency asked Endo to conduct new studies for its vaginal mesh products.
The FDA is now asking manufacturers to collect and review all existing data on the safety and efficacy of the devices, and the agency mandated 88 postmarket surveillance studies between the 33 companies, according to an FDA update.
The watchdog agency added that it’s still considering bumping the mesh from a Class II to a the higher-risk Class III device category, a move that was also discussed in the Sept. meeting.
Late last month 3 U.S. Senators probed Bard on its management of the clamor surrounding its transvaginal mesh devices as part of a larger investigation into medical device recalls, including for Medtronic’s (NYSE:MDT) 2007 Sprint Fidelis recall and Zimmer Holdings (NYSE:ZMH) for its NexGen knee implant.
Transvaginal mesh is used to treat pelvic organ prolapse, which occurs when internal support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.
“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 & Radiological Health, in an agency release in July. “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.”
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, 5 times as many as the agency received from 2005 to 2007, according to the release.
In the mean time, lawsuits have piled up against multiple mesh makers, and patient advocacy groups have called for a mandated recall after an internal FDA research group recommended that additional clinical testing be required for new transvaginal mesh products.
The FDA isn’t likely to enforce a recall, Maisel told Bloomberg.
“There’s strong support in the clinical community that mesh serves a role for certain patients,” Maisel said. “Our goal is not to completely remove these products from the market.”
Wall Street didn’t seem to pay much notice, with share prices for JNJ, BCR and fellow mesh-maker Boston Scientific (NYSE:BSX) each losing less than 1% in value since the watchdog agency released its mandate yesterday.
Representatives for Johnson & Johnson subsidiary Ethicon Endosurgery and C.R. Bard did not return requests for comment.
- Update: FDA panel may bump transvaginal mesh up to high-risk without issuing a recall
- FDA may revoke 510(k) clearances for transvaginal mesh products
- Update: Transvaginal mesh makers debate patient groups at the FDA advisory panel
- Mesh lawsuits pile up for C.R. Bard
- FDA prepares panel on pelvic mesh
- FDA Requires Transvaginal Mesh Makers To Conduct Safety Studies (prweb.com)
- Vaginal / Pelvic Mesh lawsuits pile up for C.R. Bard (earlsview.com)
- The Next Medical Device Controversy: Vaginal Mesh (earlsview.com)
- J&J-Led Vaginal Mesh Group Says FDA Should Require More Studies (earlsview.com)
- FDA orders safety studies of women’s surgical mesh (seattlepi.com)
- FDA orders safety studies of women’s surgical mesh (seattletimes.nwsource.com)
- Stricter Labeling Rule for Transvaginal Mesh, Says FDA (ibtimes.com)
- Pelvic Organ Prolapse (incostress1.wordpress.com)
- F.D.A. Orders More Study on Surgical Mesh Risks (nytimes.com)
- Georgia November 2011: Should Transvaginal Mesh Devices Be Recalled? (fdarecalls.wordpress.com)