- Little Benefit and Great Risk Seen With Metal-on-Metal Hips, Panelists and Patients State at FDA Hearing
- July 11, 2012
- Law Firm: Lieff Cabraser Heimann Bernstein LLP - San Francisco Office
With evidence mounting that metal-on-metal artificial hips are more likely to fail than traditional plastic or ceramic implants and expose patients to dangerous metallic particles, government health experts said there are are few reasons to continue the devices. As reported by the Associated Press, the Food and Drug Administration asked an 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. "I do not use metal-on-metal hips, and I can see no reason to do so," stated Dr. William Rohr of Mendocino Coast District Hospital yesterday during a hearing in Washington, D.C., on the use of all-metal hip replacement implants.
About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J's recall by its subsidiary DePuy of the ASR metal hip implant in 2010.
Recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals. The impact of a hip implant failure can be devastating on patients. One client represented by Lieff Cabraser testified at the FDA hearing, stating "I have never experienced such excruciating pain. After attempts by two surgeons at two hospitals and a wait of 17 hours, my hip was finally reset. I was forced to wear a large waist-to-thigh brace for six weeks. I have not experienced a pain-free day since my revision surgery and continue to take medication to manage it. The intense recovery has placed severe strain on my other hip that now needs to be replaced."
In the U.S. there are no national registries that track medical device fails. With little definitive data on U.S. hip implants, the FDA has asked manufacturers like 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.
Public health advocates have criticized the FDA's response, observing it could take a decade before that information is available. "Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," the Associated Press noted that Diana Zuckerman, president of the National Research Center for Women & Families, stated during a public comment session at the meeting. "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first."