FDA Seeks to Raise Metal-on-Metal Hip Implants to Class III and Issues New Safety Recommendations: Potential Retroactive Requirements

Potential Retroactive Requirements

January 25, 2013

On January 18, FDA used the new Food and Drug Administration Safety and Innovation Act of 2012 to issue a proposed order up-classifying metal-on-metal hip implants as Class III devices requiring either a premarket approval (PMA) or product development protocol before they may be legally marketed. Currently, metal-on-metal hip implants are classified as pre-amendment Class III devices and are determined to be “substantially equivalent” to their predecessors through the 510(k) process.

If the proposed order becomes final, current manufacturers of these devices will be required by FDA to submit data within 90 days showing the safety and effectiveness of the product, or the FDA will deem the device to be adulterated and the device could only be distributed for investigational use only if it meets the IDE requirements.

The following are two key points regarding the proposed order and safety recommendations:

  1. Safety and Effectiveness. In both publications, FDA pointed out that there are additional safety risks to metal-on-metal hip implants beyond the general safety risks of hip implants. FDA recommended that orthopedic surgeons use a metal-on-metal hip implant only after determining that the risk-benefit profile of using a metal-on-metal hip implant outweighs the use of other alternative hip implant systems. In the proposed order, FDA outlined research findings displaying the substantial risk of earlier device failure, corrective surgery and increased metal ion concentrations in metal-on-metal hip implant recipients.
  2. Litigation Considerations. There are several multidistrict litigation cases pending regarding metal-on-metal hip implants. If the proposed order becomes final, manufacturers will have to analyze the risks of continued sales and reporting of clinical data regarding safety and effectiveness of the hip implants versus the potential negative clinical trial results being used in ongoing litigation.

If you have questions regarding the proposed order, safety recommendations or comment period, please contact one of the authors.