A new report by Bloomberg News has brought to light a troubling trend in complaints received by federal regulators at the FDA. In tracking those involving metal-on-metal hip replacement systems since 2000, it became apparent that there were about 16,800 total filed and that the majority occurred over the last couple of years. The report, which comes before next week’s advisory committee meeting scheduled by the FDA to review the metal-on-metal replacement systems, points to some concerning data.
In comparing the number of adverse event reports for each year, the FDA saw 682 filed in 2008-four times as many as the previous year-but 12,137 filed last year. In addition, more than 14,000 of those complaints filed in the last decade involved people who required surgery to remove the implant. Perhaps most worrisome is the fact that many see these complaints as reflecting only 1% to 10% of all issues actually experienced in the United States.
Much of the concern surrounding the metal-on-metal hip replacement systems has surfaced in recent years due to reports suggesting that they may be prone to early failure, as well as a DuPuy ASR hip recall issued in August 2010 which impacted more than 93,000 systems sold internationally. The early failures are largely a result of the metal parts rubbing against each other, which can cause microscopic shavings of metal to be released in the body.
Many individuals have also filed a product liability lawsuit against Johnson & Johnson and DuPuy, claiming that the company did not do sufficient research on the product. However, use of the design has also declined notably since the DuPuy recall. The FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee is now responsible for discussing the issues and making recommendations to the FDA regarding how to proceed.
FDA probes safety issues with metal hip implants, July 6, 2012, Bloomberg Business Week News