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Last August DePuy Orthopedics announced a recall of its extremely popular ASR hip replacement device after it became apparent that the device had an abnormally high failure rate. Over 96,000 patients have had the device implanted over the past several years, many of which are experiencing problems. One of these unlucky patients is Katie Korgaokar. Read the full story at Mass Device.

Yesterday Korgaokar appeared in front of U.S. Senate hearing on medical device safety to tell her story and hopefully persuade the panel to consider requiring more rigorous testing of medical devices.

Korgaokar was 36 at the time of her total hip replacement surgery. For years she believed the surgery was the best thing she had ever done, but when she learned that the device implanted in her was being recalled, her feelings quickly changed.

Blood tests showed that metal levels in Korgaokar’s body were 1,000 percent higher than normal. These high levels were due to the metal components of the device breaking down and releasing metallic particles into her body.

In fear that she may never be able to have children due to the high levels of cobalt in her body, Korgaokar elected to have implant removed and replaced with a different system from a different manufacturer. The revision surgery cause Korgaokar an immense amount of pain and required her a longer recovery time than her first surgery did.

Korgaokar told the panel that she has her doubts about the motives of her original surgeon after learning that he received over 600,000 in consulting fees from DuPuy.

Korgaokar’s testimony was the central piece of a the two-hour hearing that also featured patient safety advocates, industry representatives, and academics.

The hearing is part of a much larger effort on Capitol Hill to discuss the way that medical devices are cleared for market.

There is a House Oversight and Government Reform Subcommittee on Health Care hearing taking place today address many the same issues covered in yesterday’s Senate hearing. Today’s House hearing is entitled “Pathway to FDA Medical Device Approval: Is there a Better Way?”

Through these types of discussions we will hope fully soon be able to improve the way that medical devices are brought to market, and help minimize the potential risks to patients like Katie Korgaokar, and the thousands of others that suffered from the failure of their medical devices.

One Comment

  1. Gravatar for Ron Black

    "Over 96,000 patients have had the device implanted over the past several years, many of which are experiencing problems." DePuy did reach a large market. As Ms Korgaokar points out, she did not know she had a problem until the blood work was done, and then she had to endure revision surgery. Who knows or cares whether or not her revision surgery will be successful? DePuy, I do not think so.

    DePuy knew there were problems with this hip and they continued to market the product. One of the means they used was to pay surgeons to promote their hip.

    The profit margin on this device like all medical devices is tremendous. DePuy probably realized a gross profit of approximately 1.5 Billion dollars on this device. Their offer to those who relied on their doctors recommendations to receive this defective hip is mear peanuts! I believe surgeons, for the most part were deliberately kept in the dark as to potential problems with this hip by DePuy.

    Any medical device manufacturer seeking to market a medical device should be required among other things to disclose manufacturing costs associated with the device. Regulators should know the profit potential of the device to better assure the safety of the device. When the profit margins are great, there is very little incentive for the manufacturer to issue an early recall.

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