FDA Panel Criticizes All-Metal Implants
An FDA expert panel that recently concluded a two-day meeting to review all-metal hip implant safety had few positive comments to make about the controversial devices. The 18-member panel was chaired by Dr. William Rohr of Mendocino Coast District Hospital, who observed, “I do not use metal-on-metal hips, and I can see no reason to do so.”
The purpose of the meeting was, according to the FDA, to “discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” but one of the problems facing regulators is that there has long been a lack of information about the devices.
Some critics call for a Zimmer hip replacement recall
Because the safety of all-metal implants was not examined before they were introduced into the market nearly a decade ago, regulators are belatedly trying to catch up. In May of 2011, the FDA ordered five manufacturers to submit study plans for analyzing how their devices are functioning in patients, but so far the FDA has rejected four of the proposed plans, including that submitted by Zimmer.
This lack of information has been frustrating for patient advocates and Zimmer hip lawyer teams representing injured plaintiffs, who still want to know why untested medical devices were allowed to be implanted in nearly 500,000 people. Once Zimmer’s study plan is approved, it could still be another decade before the study results are available.
Some critics believe that there should be a broad Zimmer hip replacement recall until the devices can be adequately tested. Diana Zuckerman, president of the National Research Center for Women & Families, told the panel that “Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical.”
Patients advised to undergo regular testing
Current research, through incomplete, suggests that a cause of failure in all-metal hip implants is the shedding of small metallic particles. These particles, generally comprised of cobalt and chromium, can damage bone and tissue surrounding the hip joint, causing the implant to loosen. The particles can also enter the bloodstream, causing a condition known as metallosis, which may have significant long-term health effects.
Medical experts on the FDA panel suggested that patients with all-metal hips should undergo regular X-rays and blood tests to monitor the stability of their implant. Thousands of patients injured by failing implants have already filed a Zimmer hip implant lawsuit.