Personal Injury News

Flaws in FDA Medical Device Approval Process (Part 2)

Methods Currently Used by the FDA May Put Patients At Risk

A further complication in the instance of the DePuy ASR hip implant is that the three components cited as predicate devices had never been used together. At best, individual components of the ASR system, which is a metal-on-metal implant involving both an artificial ball and a socket, may have been similar to other individual components, but there was no predicate “system” of components to which the ASR could be legitimately compared.

Because the 501(K) process does have a requirement for mechanical testing, the ASR was mounted on a robot that simulated human movement. However, based on evidence cited in previous legal actions against DePuy, the robot was not found to accurately duplicate a full range of human motion.

The robot also could not replicate all the reactions of the human body to potential flaws in the implant like the shedding of metal debris. Such fragments have been linked to elevated levels of cobalt and chromium in the blood stream, instances of bone necrosis or death, and benign tumors in surrounding tissue. DePuy, a division of Johnson & Johnson, is one of many medical device companies that opt for the 501(k) approval process because it is substantially less expensive, much faster, and thus more profitable.

The ASR hip has a failure rate of 12-13%, three times the industry standard. It is estimated that 1 in 8 of the approximately 93,000 people who received the hip will require a second revision surgery within five years. The implantation of a replacement hip is a painful operation with a much lower rate of success. Because the United States does not have a national registry of joint recipients, the number of people affected by the ASR hip recall may well be higher and the recall is yet another red flag indicating that the FDA is not adequately testing medical devices before approving them for use in patients.

If you or a loved one have been notified that your hip implant has been recalled, speak with an experienced hip recall attorney right away to discuss your legal options.

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