A federal Food and Drug Administration panel examining the safety of metal-on-metal hip implants is inviting members of the public to comment on the devices.
The FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee has scheduled sessions for June 27 and 28 to examine the question of whether the hip implants should be subject to new testing standards and review requirements before going on the market in the U.S.
The agency is responding to thousands of complaints about the devices, including high early failure rates and metal debris breaking off and getting into the soft tissues.
According to the FDA, the location for the meetings has not yet been determined.
An FDA Web page about the review states: “Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 9, 2012. On June 27, 2012, oral presentations from the public will be scheduled between approximately 9 a.m. and 10 a.m.”
Comments can be sent electronically to https://www.regulations.gov. Written comments can be sent to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments on the hip implants should be identified with the docket number FDA-2012-N-0293.
Contact Lopez McHugh for a free case evaluation if you received a DePuy Orthopaedics hip implant and experienced complications
See the FDA Web page here: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm297884.htm