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.
READ MORE Hip and Knee LEGAL NEWS
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.