The U.S. Food and Drug Administration asked Johnson & Johnson, which is already facing more than 1,000 lawsuits over hip replacements, to study whether its implants raise the level of metal in patients’ blood to dangerous levels.
The FDA on May 6 sent the request to J&J and 20 other device makers, including Biomet Inc., Stryker Corp. and Zimmer Holdings Inc., asking them to study the levels of cobalt and chromium in patients for at least eight years after implantation. The request focuses on all-metal devices whose failure rates have prompted recalls and increased scrutiny from regulators.
The agency “is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems,” Karen Riley, an FDA spokeswoman, said in an e-mail to Bloomberg News. “There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”
The request comes nine months after DePuy Orthopaedics, a unit of New Brunswick, New Jersey-based J&J, recalled a hip-replacement system that had been implanted in 93,000 patients worldwide. DePuy cited unpublished data from the U.K. national joint registry that indicated a failure rate of 12 percent within five years of implantation.
DePuy “is seeking further clarification from the FDA and considering how to best meet the agency’s requirements,” Lorie Gawreluk, a spokeswoman, said in an e-mail.
Scope of Request
Garry Clark, a spokesman for Warsaw, Indiana-based Zimmer, said in an e-mail that his company was “working to understand the scope of the agency’s request.”
Stryker doesn’t make metal-on-metal implants, Russell Weigandt, a spokesman for the Kalamazoo, Michigan-based company, said in an e-mail. He declined to comment further.
The leading hip makers behind J&J are Zimmer and Stryker, according to a BMO Capital Markets report in February that said the worldwide hip replacement market would grow 3.2 percent this year from $5.28 billion in 2010.
J&J rose 81 cents, or 1.2 percent, to $66.57 at 4 p.m. in New York Stock Exchange composite trading. Zimmer fell 54 cents to $69.15 and Stryker rose 84 cents, or 1.4 percent, to $61.84.
The American Academy of Orthopaedic Surgeons and the leading makers of hip and knee implants last year started a pilot program designed to duplicate joint registries that track patients’ health in the U.K., Australia and other countries.
The FDA launched a website in February devoted to concerns about all-metal hips. It cites reports in medical literature of “a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.”
The May 6 letter says high metal concentrations in the blood may also be related to increased pain, tissue damage and the need for repeat surgeries to fix failing hip implants.
Closely held Biomet “is supportive of FDA’s efforts to gather additional data in the interest of patient safety, and will comply fully with FDA’s requests,” the company said in a statement provided by Bill Kolter, a spokesman for the Warsaw-Indiana-based company. Biomet approached the agency last year seeking help for a study of the devices’ health impact, the statement said.
About 23,000 of Biomet’s M2a hips have been used worldwide, the company said. “To date, our monitoring of the performance of Biomet’s all-metal bearing products, and our careful review of currently available evidence, indicate that our products are safe and effective,” the statement said.
---Editors: Andrew Dunn, Andrew Pollack