Almost 16,800 adverse events associated with metal-on-metal hip implants were reported in the U.S. from 2000-2011, regulators said.
The reports almost quadrupled to 682 in 2008 from the year earlier, and rose again after a unit of Johnson & Johnson (JNJ) began recalling hip devices in 2010, according to report posted today on the Food and Drug Administration’s website. 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 the FDA document.
J&J faces more than 6,000 lawsuits related to the hip devices in federal and state courts. The ASR hips from the New Brunswick, New Jersey-based company account for 9,006, or 74 percent, of the incident reports in 2011, according to the FDA’s document. J&J recalled 93,000 ASR hips worldwide in 2010, including 37,000 in the U.S., saying more than 12 percent of the devices failed within five years.
The FDA plans to convene advisers on June 27 and 28 to examine the safety of metal-on-metal hip implants. The agency is expected to release additional documents June 25.
The most-reported side effect was revision, meaning surgery to remove or replace the implant. Revisions totaled 14,131 in metal-on-metal hip implants followed by 8,704 reports of pain.
Metal-on-metal hip implant use peaked in 2006 and 2007 at an estimated 30 percent of the market and is now about 10 percent, Matthew Taylor an analyst at Barclays Capital Inc., said in a telephone interview. Other implants include those made of ceramic and polyethylene.
If the FDA restricts metal-on-metal implants, companies such as Biomet Inc., based in Warsaw, Indiana, won’t be significantly affected, Taylor said.
“Most of the companies have a full line of hip products they can sell so they’d just be swapping it out with the other hip products,” he said.
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