ASR hip implants, rejected in U.S., still sold overseas (MassDevice)
A new report reveals that Johnson & Johnson continued overseas sales of its metal-on-metal ASR hip implants after the FDA rejected them for the U.S. market.
Johnson & Johnson's metal-on-metal hip implants stayed on the market in Europe and other countries after they were rejected for the U.S. market, according to a report from the New York Times.
The implants were sold to patients overseas for a year after they were prohibited for U.S. patients, until they were recalled in August 2010 amid concerns about high failure rates.
The devices were cleared by European regulators, whose standards are generally less stringent than those set by the FDA, but J&J was not required to disclose the FDA's rejection letter to doctors, patients or regulators outside the U.S.
While perfectly within legal bounds, J&J's decision not to reveal the FDA's concerns may pose a problem for the company's reputation and for ongoing lawsuits, FDA law specialist William Vodra told the Times.
J&J subsidiary DePuy Orthopedics began selling the articular surface replacement implants overseas in 2003. The company submitted r...
