Product News and Recalls

FDA panelists wouldn’t recommend metal implants

According to a story on WLFI out of Indiana, most members of a U.S. FDA panel said they would not recommend metal-on-metal implants for patients who needed hip replacement surgery.

The report quotes a physician on the panel as saying: “I do not use metal-on-metal hips, and I can see no reason to do so.”

At the FDA’s request, the 18-member panel of experts met for two days this week to discuss the all-metal hip implants, which have generated nearly 17,000 reports of problems.

Unlike earlier models that were composed of plastic or ceramic, the all-metal models have both balls and sockets coated with cobalt and chromium. Originally conceived as a more durable model than the older varieties, the all-metal implants proved to have the opposite effect.

Hip replacements are supposed to last 10 to 15 years, but British researchers found that more than 6 percent of patients with metal hips needed them replaced after less than five years, compared with just 2 percent of people who had ceramic or plastic joints.

In addition to reports of the hips breaking down altogether, many of the complaints have centered on toxic metal debris breaking off and getting into patients’ bloodstream and soft tissues.

Johnson & Johnson division DePuy Orthopaedics recalled 93,000 metal hips in 2010. But in more than 6,000 lawsuits, plaintiffs claim the company marketed the implants for years despite being aware of the problems they cause.

According to the report, about 400,000 Americans get a hip replacement each year. Metal hips accounted for about 27 percent of those operations in 2010, dropping from nearly 40 percent in 2008 because of the safety concerns.

The FDA’s panelists said patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. The panel was not tasked with recommending whether or not the implants should be recalled altogether, although the FDA has asked the hip implant manufacturers to conduct long-term studies.

Some public health advocates who testified at the hearing said that may not be enough. The report quotes Diana Zuckerman, president of the National Research Center for Women & Families, as saying: “Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical.”

If you’ve received an all-metal hip implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a DePuy hip lawyer familiar with the case to discuss your legal rights.