
More than 96,000 patients have been affected by the massive global recall of a total hip replacement system made by DePuy Orthopaedics, Inc. Katie Korgaokar, one of those unlucky patients, spoke for all of them today at a U.S. Senate hearing on medical device safety.
“I thought I was getting good advice. I researched the doctor. I picked him. I just don’t know what I could’ve done differently,” she said. “It still blows me away that something that goes into the body doesn’t get tested properly.”
Korgaokar, who was 36 at the time of her hip replacement surgery, said that for years she felt like the operation was the best thing she had ever done. However, when she found out that her ASR hip replacement system was being recalled, those feelings quickly changed to horror, then anger.
“Recalls were for dishwashers and cars, not body parts,” Korgaokar told the U.S. Senate’s Special Committee on Aging today.
Doctors gave her blood tests that showed metal levels in her body at levels 1,000 percent higher than normal, she said, because the metal-on-metal portion of the implant was breaking down and releasing particles. Fearing she would never be able to have children because of the cobalt levels in her blood, she made the decision to have the faulty implant removed and replaced by a new system (made by a different manufacturer). That operation was not as successful as the first, she said, adding that the pain has been much worse, the recovery time longer and her mobility significantly diminished.
Korgaokar said she now doubts the motives of the surgeon who performed the first hip replacement surgery after finding out that he pulled down more than $600,000 in consulting fees from Warsaw, Ind.-based DuPuy.
Her story was the backbone of most of the panel’s discussion on the FDA and its role in “protecting patient safety as part of the medical device approval process.”
The 21-member committee heard testimony from patient-safety advocates, industry representatives and academics during the two-hour hearing. Most of the dialogue centered around increasing measures to prevent recalls and to improve post-market recognition of products that need to be recalled.
“The FDA has had over 20 years to solve these problems,” chairman Sen. Herb Kohl (D-Wisc.) told the panel. “I believe the FDA needs to develop a more robust post-market surveillance program.”
Kohl said he’s “encouraged” by the FDA’s renewed emphasis on patient safety, but added, “I’m concerned that the agency’s oversight of medical products still remains on the GAO’s ‘high risk’ list. That is unacceptable.”
The hearings are part of a broader effort on Capitol Hill, from both sides of the aisle and from the medical device industry itself, to frame the discussion over the way medical devices are cleared for market. The device industry can expect a more congenial atmosphere in tomorrow’s House panel slated to take up some of the same issues.
The House Oversight & Government Reform Subcommittee on Health Care is scheduled to hold its “Pathway to FDA Medical Device Approval: Is there a Better Way?” hearing April 14 to “study the FDA’s inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators.”
That hearing will feature testimony from Rep. Erik Paulsen (R-Minn.) and CDRH chief Dr. Jeffrey Shuren. The committee will also hear from Jack Lasersohn, a general partner at venture capital firm The Vertical Group and David Gollaher, president and CEO of the California Healthcare Institute. The committee is chaired by Rep. Trey Gowdy (R-S.C.).
No patient safety advocates are slated to appear during the House panel, which will certainly be more industry friendly.
For its part, DePuy took the high road. In a statement emailed to MassDevice, DePuy Orthopaedics director of communications Mindy Tinsley wrote that the company “supports and shares the goals of the Senate Special Committee on Aging, FDA and other organizations of improving patient safety, enhancing regulatory predictability, and fostering medical device innovation.”
“We look forward to learning more about the FDA’s recommendations and to working closely with the FDA to strengthen an already-robust process that has worked well for three decades and evolved, when appropriate, to better serve patients. We also look forward to the independent assessment of the 510(k) process by the Institute of Medicine, expected to conclude in the summer of 2011.
“Post-market surveillance is critical for assessing the long-term performance of medical devices. DePuy supports the development of a national orthopedic joint implant registry in the U.S. to further monitor the safety and performance of joint implants for the benefit of all orthopedic patients.”
Tinsley also addressed the ASR hip implant recall.
“We understand that this recall is concerning for patients, their family members and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need,” she wrote. “DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.”
DePuy Orthopaedics announced in August 2010 that it was voluntarily recalling the ASR hip replacement system after receiving reports that a higher-than-normal number of patients required revision surgeries to correct or remove defective implants. The company said it was pulling the ASR XL Acetabular and ASR Hip Resurfacing systems from the market “due to the number of patients who required a second hip replacement procedure.”
Lawsuits over the ASR implant have piled up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product. DePuy, which introduced the ASR in the U.S. in 2005 after winning 510(k) clearance from the Food & Drug Administration, allegedly knew of design problems with the cup but failed to adequately warn physicians, according to the lawsuits.
DePuy discontinued the cup and had phased it out by March of this year, sending a letter to doctors that month warning that data from the Australian medical device registry showed a “higher-than-expected” failure rate in traditional hip replacements, especially in smaller patients or those with weak bones.