Sunday, April 1, 2012
UPDATE 2-FDA seeks more advice on metal hip implants
*Advisory panel review set for June 27-28
* Review could lead to more rigorous standards
March 29 (Reuters) - The U.S. Food and Drug Administration responded to mounting concerns about the safety of metal-on-metal hip implants, saying it would subject the devices to a two-day expert review that could lead to rigorous new standards.
The FDA announced on Thursday an advisory panel for June 27-28 that will gather input from scientists, researchers, patients and medical practitioners to help regulators decide whether to impose new testing standards and review requirements to be met before a device can be sold in the United States.
"We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations," Dr. William Maisel, deputy director of science at FDA's Center for Devices and Radiological Health, said in a statement.
Shares in orthopedic device manufacturers were lower after the announcement, with Stryker Corp down 0.7 percent, Zimmer Holdings Inc down 1.1 percent and Johnson & Johnson off 0.3 percent.
Hip replacement surgery is a common, costly procedure intended to provide greater mobility and alleviate pain for people with joint problems, including arthritis.
About 270,000 hip replacements are performed each year in the United States, accounting for nearly 40 percent of all joint replacements, according to the British Medical Journal. Analysts say the procedure can cost upwards of $17,000.
But evidence has been growing for years that all-metal hip implants fail at higher rates than systems that use other materials. Patients who receive them have also been shown to have high concentrations of metal ions in their blood.
A recent study from the National Joint Registry of England and Wales showed that about 6 percent of people with the metal-on-metal variety needed additional surgery to replace or repair them after five years, compared with 1.7 to 2.3 percent of people who had ceramic or plastic systems.
The FDA's announcement on Thursday followed a May 2011 order from the agency requiring manufacturers of metal-on-metal implants to collect more safety data on the devices.
Manufacturers have been plagued by recalls. In January, J&J announced it would take a $3 billion charge to cover the cost of recalling metal hips produced by its DePuy Orthopedics unit.
The FDA said the upcoming advisory panel meeting would look at failure rates, metal ion testing, imaging methods, patient risk factors, follow-up surgery and complications associated with metal-on-metal hip replacement and resurfacing systems.
Posted by Connie at 1:15 PM