KOHL: FDA’S POST-MARKET REVIEW OF HIP IMPLANTS WELCOME, BUT MORE SCRUTINY NEEDED
WASHINGTON - Today, 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 13 th Aging Committee hearing is archived online at: http://aging.senate.gov/hearing_detail.cfm?id=332473&
Full text of the letter copied below.
May 24, 2011
Dr. Margaret Hamburg
Commissioner
The Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Commissioner Hamburg:
I applaud your decision to require medical device manufacturers to conduct post-market surveillance for high-risk, metal-on-metal hip implants. The Food and Drug Administration's (FDA) use of its 522 regulatory authority will help improve our understanding of the health risks metal-on-metal implants pose to patients. FDA should continue to advance its surveillance of high-risk devices, especially those that have been approved through the fast-track, 510(k) process.
As you know, last month, the Special Committee on Aging held a hearing entitled, "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process," in which Dr. William Maisel of FDA participated. The hearing highlighted the problems with metal-on-metal hip implants. A victim of the DePuy ASR hip implant recall, Katie Korgaokar, testified to the distress she experienced with revision hip surgery as a result of the faulty hip implant.
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.
Metal-on-metal hip implants are an example of these Class III devices being cleared through 510(k). It is imperative for patient safety that Class III devices like metal-on-metal hip implants have appropriate review before being marketed to patients, and rigorous oversight once the devices are marketed.
Again, I applaud and support FDA's efforts to protect the public health through more vigorous post-market surveillance. I look forward to continue working with FDA to improve post-market device oversight, specifically to ensure that there is adequate post-market surveillance of high-risk devices, like the metal-on-metal hip implants.
Sincerely,
Herb Kohl
United States Senator
