Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed

Contact: Joe Bonfiglio, (202) 224-5364

WASHINGTON – U.S. Senator Herb Kohl, Chairman of the Special Committee on Aging, wrote Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA) commending her Agency’s recent decision to require medical device manufacturers to conduct post-market surveillance for high-risk, metal-on-metal hip implants. In his letter to Hamburg, Kohl suggests that more surveillance of high-risk devices is still necessary, particularly for devices that were approved through the FDA’s fast-track review process.

Last month Kohl held a hearing examining the FDA’s role in protecting patient safety as part of the medical device approval process. The hearing featured testimony from Ms. Katie Korgaokar, a Denver resident who received a DePuy ASR hip implant to treat a congenital condition called Perthes disease. In 2010, the DePuy hip was recalled and Korgaokar endured a second hip-replacement surgery in early 2011. Korgaokar was one of 96,000 patients affected by the DePuy hip recall.

Kohl writes: “As stated in the hearing, it is unacceptable that so many high risk, Class III devices continue to be approved through the 510(k) process.

“However, it is encouraging that, during our hearing, FDA pledged to finish either reclassifying the devices or requiring Premarket Approvals (PMAs) for Class III devices currently considered through the 510(k) process.  Completing this review is essential to protect the public health.”

The April 13th Aging Committee hearing is archived online at: http://aging.senate.gov/hearing_detail.cfm?id=332473&