According to a press release issued by US Law firm Bernstein Liebhard LLP, FDA has received almost 17,000 adverse event reports from 2000-2011, associated with metal hip implants, such as the DePuy ASR and Pinnacle hip systems. This week FDA has convened an expert panel which has concluded it sees few if any cases where use of a metal-on-metal hip is recommended.
New York law firm Bernstein Liebhard LLP, says it is recognised for its consumer protection and mass tort practices, and as such has to keep more than a weather eye on proceedings. It’s picked up the following snippets from various sources:
- The reports almost quadrupled to 682 in 2008 from the year earlier, and rose again after DePuy, a subsidiary of Johnson & Johnson, issued a worldwide recall of the ASR hip implants in August 2010;
- In 2011, the FDA received 12,137 adverse event reports associated with metal hip implants, compared with 6,332 associated with other types of hip implants, such as ceramic and plastic;
- In 2011, the DePuy ASR hip implants accounted for 74 percent of the incident reports received by the FDA;
- Revision surgery is the most commonly reported adverse event, which requires patients to undergo a second surgery in order to remove the defective hip replacement system; and
- To date, the FDA received 14,131 reports of patients who were forced to undergo revision surgery as well as 8,704 adverse event reports involving hip pain.
Unsurprisingly the lawyers at Bernstein Liebhard LLP continue to carefully monitor developments and reports on the safety of metal hip implants.
FDA advisory committee
The press release was presumably timed to coincide with an advisory panel to the FDA, convened this week and involving input from experts, doctors, medical device manufacturers and patients are offering testimony in order for the FDA to evaluate the safety of the devices. The findings, perhaps unsurprisingly were that the eighteen strong panel concluded they could find “few, if any” cases where metal-on-metal hips would be used in light of the clearly stated problems of particulate debris from wearing of the metal components.
FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.
The AP press release from the event can be found here in full.
Source: San Francisco Chronicle, Bloomberg, AP