Washington, DCThe US Senate Special Committee on Aging recently met to discuss FDA oversight of medical devices, including the recently recalled DePuy hip replacement device. During the meeting, the committee heard the story of one DePuy hip replacement patient who underwent revision surgery after problems were discovered with her hip implant.
The witness at the hearing was Katie Korgaokar, who received a DePuy ASR hip implant to treat a congenital condition called Perthes disease, which causes premature deterioration of the bones in the hip joint. Her orthopeadic surgeon recommended she have total hip replacement surgery.
"I was one of the 96,000 unlucky people who received the DePuy ASR prosthetic hip that was recently recalled in August 2010," Korgaokar told the panel.
Prior to receiving the hip replacement, Korgaokar discussed the new device with her surgeon, who told her that the implant was a state-of-the art, metal-on-metal device, designed for young, active people. Korgaokar was told that the ASR was superior to other hip replacement devices and was expected to last 20 years or more.
Initially following the surgery, the hip device seemed like a success. Within three months she was essentially pain free and had her mobility back. Less than four years after receiving the hip replacement device, however, she received a letter from her surgeon informing her about the DePuy hip replacement recall and recommending she come in for an examination.
At that examination, Korgaokar learned there were problems with the ASR, such as wear and tear on the metal that could release metal debris into the body. She was told she would need a blood test to see if she had high levels of cobalt and chromium. If her levels were elevated, that indicated excessive wear and tear on her hip device.
A blood test revealed that her cobalt and chromium levels were 1,000 percent higher than they should have been. Her doctor recommended having the DePuy hip device replaced as soon as possible, which she did. At age 41, she had her second hip replacement surgery, although this surgery was much more difficult than the first. Korgaokar says she has had much more pain and limited mobility the second time around and was confined to her home for three months to recover. She also says she was told that with additional revision surgeries comes an increased risk of dislocation of the hip and other problems because the surgeries affect the hip, making the muscle less stable.
Perhaps the most shocking aspect of this story, aside from the DePuy ASR being approved for the market without prior testing, was that Korgaokar's doctor reportedly received more than $600,000 in consulting income from DePuy, but did not disclose that prior to the surgery.
As Korgaokar says, she wants to believe that income did not affect his decision to use the DePuy ASR device, but now she will always have doubts.
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