A Victim of the recalled DePuy ASR hip implant described her painful ordeal yesterday during a hearing before the U.S. Senate’s Special Committee on Aging. The hearing, entitled “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process,” examined the Food & Drug Administration’s (FDA) role in protecting patient safety through the medical device approval process.
According to a report on DOTmed.com, the committee heard from a Denver woman who received one of the defective DePuy ASR hip implants. Katie Korgaokar testified that blood tests showed she had cobalt and chromium shedding from the implant. Because of her complications, Korgaokar was required to undergo a second surgery to replace the device. Because of the problems caused by the DePuy ASR hip implant, Korgaokar said she has put off starting a family.
Korgaokar also told the Senators that she had never been told that the surgeon who implanted her DePuy ASR hip replacement had received $600,000 in consulting fees from the maker of the device, DePuy Orthopaedics.
A metal-on-metal device made of chromium and cobalt, the DePuy ASR Hip Implant System consists of a cup implanted into the hip with a ball joint that connects to the leg. In August, DePuy Orthopaedics issued a recall for the ASR XL Acetabular Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving the surgery. A hip implant should last for roughly 15 years, but many DePuy ASR hip implant recipients have had to undergo new surgeries just a few years after implantation.
The DePuy ASR hip implant was approved by the FDA via the 510(K) process. As we’ve reported in the past, this process allows a manufacturer to obtain market approval with very little clinical testing of the device – including no human testing – if a manufacturer can prove it is “substantially similar” to another product already on the market.
The 510(k) approval process has received a great deal of criticism in recent years. In fact, shortly after the DePuy hip implant recall was issued, an internal FDA review found numerous flaws with the process. Just this past February, a study published in the Archives of Internal Medicine found that the majority of high risk medical device recalls over the past five years involved products subject to the streamlined 510(K) approval process.
According to the DOTmed.com report, implantable hips fall are among 26 higher-risk device types currently cleared through the 510(k) process. In 2009, the Government Accountability Office (GAO) requested that all 26 high-risk devices be moved to a more stringent approval category. At yesterday’s hearing, the GAO revealed that the FDA has yet to reclassify any of the medical devices cited in the 2009 report.