How do hip implant manufacturers decide to issue a hip recall?

How do hip implant manufacturers decide to issue a hip recall

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Unfortunately, most hip implant recalls are the result of regulatory and economic pressures on the company rather than an outright acknowledgement that the device has an inherent flaw. The August 2010 recall of the DePuy ASR XL Acetabular System illustrates this pattern quite well and goes to show you how much DePuy values profit over the well being of the consumers.

- In 2005, DePuy, the orthopedic branch of Johnson & Johnson, introduced the device in the United States under a 510(k) clearance from the Food and Drug Administration, meaning approval was granted without clinical trials.

- By 2008, the FDA had received more than 400 complaints about device failures with the ASR hips. It appears that in approximately 12-13% of cases, the implants fail within the first five years, leaving 1 in 8 patients facing a costly, painful, and potentially dangerous revision surgery.

- In early 2010, DePuy announced that it was withdrawing the ASR hips from the market due to declining sales and mentioned in a letter to doctors that data from the Australian Medical Registry showed a higher than expected rate of failure with the devices.

- On March 10, 2010, The New York Times published an article exposing the failure with the DePuy artificial hips, followed by a story in The London Times in May disclosing that some 40,000 of the implants were under review in Britain for the presence of medical debris that could cause non-cancerous tumors, muscle damage, and swelling.

- Kathleen Margunau, a woman in Florida who was forced to have her DePuy hip replaced less than a year after her initial surgery, filed the first lawsuit against the company on June 15, 2010.

- On July 17, 2010 the FDA announced the recall of the DePuy hips followed by a worldwide recall statement from the company itself on August 26. At that time, two products were actually taken off the market, the ASR XL Acetabular System, which was sold globally, and the ASR Hip Resurfacing System, which was sold outside the United States only.

Clearly, in this case, the decision to issue the recall was a mixture of "bad press" and regulatory pressure. It should be noted, however, that the recall came almost two full years after the FDA had amassed more than 400 complaints, and that DePuy has continually said that the real fault for the failure rates lies with doctors who have not properly positioned the implant.

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