FDA Holds Metal-on-Metal Hip Replacement Advisory Committee Meeting, Recommendations Modest
Back in March 2012, the U.S. Food and Drug Administration (FDA) constituted a metal-on-metal hip replacement advisory committee consisting of 18 persons. The agency periodically organizes such committees to solicit recommendations to guide its policy. Due to the DePuy hip recall, and the 17,000 adverse event reports the agency received on account of metal-on-metal hips, the FDA wants to know how it should proceed regarding all-metal hip replacements, and the hip replacement advisory committee meeting did just that on June 27-28, 2012.
Committee Discourages All-Metal Hips’ Use
The advisory committee concluded, “There are few reasons to continue using metal-on-metal hip implants amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.” Despite the criticism the devices received, the committee did not discuss recommending a widespread hip replacement recall, but one orthopedist nevertheless opined, “I do not use metal-on-metal hips, and I can see no reason to do so.”
For more information on the DePuy ASR recall, click here to download this free brochure.
Advisory Committee Drafts Patient Guidelines
Because hundreds of thousands of people underwent hip replacement procedures with all-metal devices over the last decade, many will have to be monitored to see if any problems arise. In the United Kingdom, the government created a set of guidelines for physicians to use when evaluating patients who have received all-metal devices, and the FDA advisory committee did so as well. Recipients experiencing pain or any other symptoms should receive x-rays and blood tests to see if their hips’ metal ions have seeped into other tissues. On the other hand, recipients with no symptoms should undergo x-rays only. The advisory committee’s guidelines are less strict than other countries’.
More Implant and Patient Data Needed
Metal-on-metal hip designs differ among their manufacturers, and they affect some recipient populations worse than others. For example, women, people who are overweight, and people of small stature suffer more problems than other recipients. Consequently, the advisory committee stressed the need for additional research on the different devices and patient populations, something that began in May 2011. The president of the National Research Center for Women & Families, Diana Zuckeman, said, “Keeping these metal-on-metal hips on the market for the next five to 10 years while research is ongoing is not ethical … If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”
RLG Represents ASR Recipients
While it’s good that doctors are less inclined to implant their patients with metal-on-metal hips, data on how those hips affect patients could be years away. If you received a recalled ASR device, it’s inadvisable to wait until results come in to decide how to handle your hip, and the amount of compensation from a DePuy lawsuit might be greater than what DePuy is willing to offer you in its recall reimbursement program. To receive a free, confidential consultation with a lawyer from the Rottenstein Law Group, click on this link or call 1-877-312-3274.