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Vaginal Surgical Mesh Faces Safety Review by FDA Panel as Number of Lawsuits Increase
September 10, 2011
As reported by Bloomberg News, Johnson & Johnson and rival makers of transvaginal meshes proposed to the FDA that they agreed on the need for more safety studies of the implants as well as labelling changes to warn of potential risks.
Manufacturers agreed that new versions of transvaginal meshes require clinical trials before they can be sold and existing implants should be tracked for safety. The manufacturers, however, did not agree with a recommendation from the FDA staff in August 2011 that the mesh be reclassified as high risk and face even more regulatory controls.
Transvaginal mesh was approved as a moderate risk device under the FDA’s controversial 510(k) process. The FDA’s 510(k) process allows for a medical device to be approved for market without clinical data if it is deemed “substantially equivalent” to products already on the market. This “substantially equivalent” approval condition has been criticized as overly lax and responsible for public health nightmares such as DePuy’s recalled ASR hip implant.
Effectiveness 'Not Demonstrated'
"The clinical effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse has not been demonstrated," said William Maisel, deputy director of the FDA Center for Devices and Radiological Health, in an interview with Bloomberg News. "We believe proper studies would need to be done."
While the mesh has been used for more than three decades, mainly for hernias, its use "has evolved over the past few years" as manufacturers expanded into other conditions, Herbert Lerner, an acting director in the FDA's device-approval center, told an FDA panel meeting on the safety of surgical mesh. "As industry modified surgical mesh for these indications, none of the mesh has been evaluated for clinical data."
Learn more about the dangers and complications of vaginal mesh.