The FDA, concerned over the safety of metal-on-metal hip implants, convened an advisory panel Wednesday to adjudge whether ceramic and/or plastic implants are less prone to fail.
The metal devices, according to new reports, were not tested sufficiently before approved for use. Currently, as many as half-a-million Americans have such implants, according to the New York Times.
In a report issued last week by the FDA, the agency said metal-on-metal replacements have been tied to nearly 17,000 adverse events, leading to thousands of patient lawsuits. Adverse event reports in 2011 totaled 12,137 for the metal-on-metal devices, compared with 6,332 associated with other types of hip implants, according to an FDA document.
"There was not enough data to support" their widespread use, said Dr. Henrik Malchau, an orthopedic surgeon at Massachusetts General Hospital in Boston, told the New York Times.
For comments and feedback: editorial@rttnews.com