The following information concerning hip implants will be supplemented later this week in a follow-up products liability post that allows for necessary amplification of the subject matter.
Until last week, there was no indication that metal-on-metal (MOM) hip implant manufacturers would in the future be required to gain in-advance approval from the FDA to market those products in the United States.
Last Thursday ushered in a definite change for MOM implant makers selling their products domestically, though, with the federal regulatory agency issuing a proposed order for what is termed a PMA — premarket approval application.
Judging from statements posted the same day on the FDA website, the agency is clearly unnerved by the underlying history inherent with MOM implants and wants their manufacturers to submit safety and effectiveness data. The PMA (alternatively, the order allows MOM implant makers to submit a PDP, or product development protocol) must prove to regulators that the products are safe as a prerequisite to future sales in the United States.
The FDA will initially allow a three-month comment period on its proposal. After the agency issues a final order, manufacturers will have 90 days within which to file either a PMA or PDP.
The FDA proposal and expectation of a final order and greater exaction on metal-on-metal hip implants certainly did not issue casually. Rather, agency investigators scrutinized more than 100 studies that have been done on such implants, many of those efforts being driven by the clear manufacturing defects that have left many people across the country in significant pain.
A number of recipients have had to undergo subsequent and painful remedial surgeries.
If you or a family member has been injured as the result of using a DePuy ASR or other hip implant, or have any questions or concerns regarding the same, please contact Breslin & Breslin for a free consultation.
Source: MedPage Today, “FDA clamps down on metal-on-metal hips,” Joyce Frieden, Jan. 17, 2013