Monday, November 15, 2010

Early Reports of Concerns with the Depuy Hip to FDA

Excerpts from other web sites that I found of interest:
In 2009 nearly one million patients received either a knee or hip implant in the United States. Artificial joint implants are a highly lucrative business worth $6.7 billion to medical device manufacturers. No warranties are offered on these products and because the U.S. lacks a national joint registry, early detection of defective implants rarely occur.
Approximately 200,000 of those annual surgeries [20% of the implants above]  are for the replacement of the hip joint. The number of hip replacement surgeries performed in the U.S. is expected to rise with the aging population of baby boomers. The recent hip replacement recall of the ASR XL Acetabular System, a metal-on-metal implant made by DePuy Orthopaedics, a division of Johnson & Johnson, has raised serious questions about how such prosethitics are tested and how thier real life performance  is tracked.

DePuy Orthopaedics issued a full recall of all ASR hip implant devices on August 26, 2010 when Great Britain’s National Joint Registry released a research report that found the hip implant to fail at a rate of 12-13%. (The industry standard is 5%.) Disturbingly [it has been reported that] the implant remained on the market and was used for two years after the first complaints were filed with the FDA in 2008. [It has been reportered that]Nearly 400 DePuy ASR hip implant patients registered complaints with the FDA before the recall was issued, prompting calls from industry insiders, physicians, and patients to reform the federal organization’s medical device tracking processes.

No comments:

Post a Comment