The Food and Drug Administration issued letters to 21 medical-device makers that call for post-market studies of the metal-on-metal hip implants they make.
On May 6, the FDA’s Center for Devices and Radiological Health contacted the medical-device companies, which include Johnson & Johnson, New Brunswick, N.J.; Wright Medical Technology, Arlington, Tenn.; and Zimmer and Biomet, both Warsaw, Ind.
The letter states that the FDA is unclear whether the high ion concentrations of cobalt and chromium found in patients with metal-on-metal hip implants can lead to “increased pain, adverse local tissue reactions or revision.” Among the agency’s recommendations, it says that patients who have received the metal-on-metal hip implants should be studied for at least eight years after receiving them.
High risk medical devices can be approved under the FDA’s expedited 510(k) process if they are deemed “substantially equivalent” to ones already on the market or if they were approved before 1976. Metal-on-metal hip implants were approved before 1976, according to the FDA.
“The agency is currently reviewing all safety and effectiveness data related to these ‘preamendment devices,’ including metal-on-metal hip systems, in an effort to determine their proper risk classification and how these devices should be regulated in the future,” according to a new statement posted to the FDA website.
The FDA is requiring the companies to submit surveillance plans within 30 days.
The FDA also notified: Encore Medical, Stryker Howmedica Osteonics, Link America, Orthopedic Manufacturing Co., Advanced Bioresearch Association, American Ortomed Corp., C.R. Bard Inc., Downs Surgical, Endomedics, Implantology Corp., Joint Medical Products Corp., Med-Tek Corp./Synergy Orthopaedics International, Orthopaedic Device Corp., Osteo Technology, Pfizer, Techmedic and Turnkey Integration USA.