29 June 2012
The Food and Drug Administration (FDA), is the US body that regulates companies that design, manufacture, repackage, re-label, and/or import medical devices
into the country. The Orthopaedic and Rehabilitation Devices Panel
of the Medical Devices Advisory Committee met this week to hear expert scientific and clinical advice on the risks and benefits of metal on metal hip replacement devices
so that the agency can judge whether it needs to change its safety recommendations to patients and health care providers.
It concluded that there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.
The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the UK and other countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.
While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.
"I do not use metal-on-metal hips, and I can see no reason to do so," said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.
FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.
"The truth is there are different types of hips and different types of patients," said Dr. William Maisel, FDA's chief scientist for devices, in an interview last week. "Understanding the characteristics of patients who experience adverse events is very important." Women and overweight people are among the groups that are more likely to have an implant failure.
With little definitive data on US hip implants, the agency 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.
FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the long-term effects of metal particles. But public health advocates say it could take a decade before that information is available.
Metal-on-metal hip devices
Hip joint deterioration can lead to health problems which include pain, stiffness, and lack of mobility. Some people may be advised to undergo total hip replacement or hip resurfacing and may have been fitted with a metal on metal hip implant. Some patients who have been fitted with all metal hip devices have subsequently developed serious health problems including, serious pain, clunking when walking, groin pain, swelling and loss of sensation in the leg. More than 30,000 British people have been fitted with metal-on-metal devices which were often used on younger patients because it was thought the devices would last longer, and be more suitable for active patients.
Metal-on-metal hip claims lawyers
The nationally acclaimed medical devices
claims team at Leigh Day is currently representing over 500 people who have suffered serious health problems after being fitted with the DePuy ASR hip implant
. The team is also investigating claims on behalf of people who have been fitted with Biomet, Pinnacle, Zimmer Durom and Zimmer NexGen knee devices
. To speak to one of the team about a possible claim for compensation please contact Boz Michalowska
on 020 7650 1311 or Jill Paterson
on 020 7650 1219
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