FDA Will Require Makers To Prove Safety Of Metal-on-metal Hip Implants
On behalf of Brown & Crouppen, P.C. posted in Defective Products on Friday, January 25, 2013
The Food and Drug Administration (FDA) has issued Proposed Order that would require manufacturers of hip replacement implants to demonstrate the safety of the medical devices.
These types of implants have been subject to two major recalls and have resulted in thousands of patients needing revision surgery to replace the defective metal-on-metal hip replacement implants. The order will “require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP)” for metal-on-metal hip implants.
A manufacturer of a hip replacement implant will have to include in the PMA any known risks, the effectiveness of the device and full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the hip replacement.
The manufacturer must also demonstrate with “scientific evidence” the safety and effectiveness of the hip replacement implant for its intended purpose. Prior to this FDA order, manufacturers could bring a hip replacement to market without a PMA.
Zimmer’s Durom Acetabular Component had been recalled in 2008 and the DePuy ASR Total Hip in 2010. The DePuy recall was due to high rates of revision surgery made necessary by metal particles from the implant causing damage to the bone and tissue surrounding the implant. A significant number of medical malpractice lawsuits involve the DePuy implant.
The FDA also issued a Safety Communication that makes clear that doctors should carefully determine that metal-on-metal hip replacement implants are right for a particular patient, that they need to provide full disclosure to the patient of the risks, and that patients with the implants need to be closely followed by the doctors for symptoms caused by the implants.
Source: MedPage Today, “FDA Clamps Down on Metal-on-Metal Hips,” Joyce Frieden, January 17, 2013