FDA Advisers Against Metal-on-Metal Hip Replacements

July 1, 2012, 6:00PM. By Jane Mundy

Washington, DCIt’s about time. After about 17,000 reports to the FDA from patients suffering problems with their metal-on-metal hip and/or knee replacements, the agency is finally listening. On June 28, 2012 an 18-member advisory panel said there were few reasons to continue using metal-on-metal hip implants. The panel recommended surgeons discontinue their use, citing mounting evidence that they are more likely to break down than the other older ceramic and plastic models, exposing patients to dangerous metallic particles.

Of those 17,000 reports, approximately 14,000 patients required revision surgery. And about one third of 250,000 hip replacements done annually in the US involve metal-on-metal implants, according to The New York Times. The panel’s advice is hardly news to many in the medical community. In March of 2010 The Journal of Arthroplasty urged doctors to use the metal-on-metal devices only with "great caution, if at all."

The FDA asked its panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements.

Still, the FDA fell short of a recall, even though the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee said there were few, if any, cases where they would recommend implanting the devices. They recommended that, regardless of symptoms, all patients implanted with metal-on-metal devices should get annual x-rays to monitor the state of their implants. Some panelists went so far as to say that labeling for metal-on-metal hip implants should warn about potentially serious side effects linked with these devices. Obviously this would be a warning for surgeons, but what about patient warnings?

Health officials in the UK have advised some patients to have a yearly blood test and also MRI scans. And Health Canada warned patients in May 2012 to be aware of the problems and adverse effects related to metal hip replacements. (Canada has already recalled the metal-on-metal Stryker hip implant.)

Thankfully, many doctors are aware of the many adverse events that come from these defective devices (metal hips replacements tallied close to 27 percent of all hip implants in 2010, a decrease of nearly 40 percent in 2008), from pain and inflammation to possible long-term effects of elevated metal levels in the bloodstream. Some some studies have even suggested links to neurological and heart problems.

"Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting and reported by The Associated Press(June 29, 2012). "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first."

Meanwhile, the FDA has asked manufacturers such as Johnson & Johnson, Zimmer Holdings Inc., and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market. The results of those studies might be too late for some patients needing hip implants.