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FDA Proposes Change to Safety Approval Process of Metal-on-Metal Hip Replacement Implants

stethoscope.jpgAs previously reported by Carabin & Shaw, there have been a number of hip replacement recalls in recent years, including recalls of the of the DePuy ASR Hip, the Biomet M2a Hip, the Stryker Rejuvenate and the ABG II, among others. These recalls brought attention to the potentially serious injuries that could be caused by metal-on-metal hip replacement implants.

The Food and Drug Administration (FDA) cites the following general risks for all types of hip devices:

• Hip dislocation
• Bone fractures
• Joint infection
• Nerve damage, including numbness/weakness
• Device breakage or loosening
• Differences in leg length
• Bone loss (osteolysis)

In addition, due to the friction caused between metal components, all-metal hip replacements may shed bits of metal, causing these additional specific injuries:

• Damage to the bone and tissue surrounding the hip joint
• Loose implants and loss of mobility
• Complications from metal in the bloodstream, including damage to the heart, kidneys, nervous system and thyroid
• Severe inflammation
• Pseudotumors
• Infections
According to The New York Times, manufacturers rarely tested metal-on-metal hip replacements before placing the devices on the market. Not surprisingly, the devices failed at high rates soon after being implanted. As a result, many patients were forced to undergo costly and painful procedures to replace the devices. Due in part to the high number of recalls and injuries, in January 2013, the FDA proposed a rule that would require that the manufacturers of metal-on-metal hip replacement implants prove that their devices are safe and effective before they could continue selling existing implants through the premarket approval (PMA) process. The proposal would also require that manufacturers obtain approval for all new metal-on-metal designs.

The new process differs from the current 510(k) approval process, which merely requires that a product be equivalent to another product already on the product. More specifically, the new pre-approval process will also require all-metal hip replacement manufacturers to submit clinical studies to the FDA prior to placing them on the market, something manufacturers are not required to do under the current approval process.

On April 18, 2013, Consumers Union sent a comment letter to the FDA signed by more than 11,000 consumers. The letter expressed support for the proposal’s requirement to necessitate all metal-on-metal to be reviewed through the FDA’s PMA process. At the same time, the letter also strongly urged the FDA to push all manufacturers of metal-on-metal hips to remove their products from the market.


The response to the proposed change to the approval process has not been entirely positive. In a letter submitted to the FDA on April 18, 2013, the American Association for Justice, a plaintiff lawyers’ industry group, stated that it supported the approval process, but expressed concern that the current proposal could shift liability away from hip implant manufacturers.

Notably, the decline in sales of these devices, combined with the proposed rule requiring that all-metal implants be approved through the FDA’s premarket approval process, is causing hip manufacturers apprehension. Only four months after the FDA proposed the change, DePuy Orthopaedics, a division of Johnson & Johnson, announced that it will be phasing out production of all-metal hip replacements.

At this point, it is still unclear whether the proposal will pass and whether manufacturers will use the change to try to shield themselves from liability. However, either way, if you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip, you may be entitled to recovery. Contact the personal injury attorneys at Carabin & Shaw at 1-800-862-1260.

Sources:

J.&J. Unit Phasing Out All-Metal Hip Devices, by Barry Meier, The New York Times

F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants, by Barry Meier, The New York Times

Related Blog Posts:

New Concerns Arise About Biomet Metal Hip Replacement Devices in the Wake of Stryker and Depuy recalls, Texas Injury Lawyers Blog, November 20, 2012