The U.S. Food and Drug Administration (FDA) is set to hold a two-day meeting this week to scrutinize the safety of metal-on-metal hip implants after numerous reports from patients that these medical devices are failing earlier than expected. According to a news report in The Associated Press, the FDA has received more than 16,800 adverse event reports about metal hips between 2000 and 2011. A number of patients reported that these implants caused pain and swelling and sometimes required the removal of the devices.
For many years, almost all orthopedic implants were manufactured by plastic or ceramic. However, in the last decade or so, some surgeons viewed metal implants more favorably. Lab tests at the time suggested that these metal devices would be more resistant to wear and tear, reduce the chances of dislocation and delay the need for revision surgeries. As it turned out, the opposite occurred.
Increasing Failure Rates
In March, British experts urged doctors to stop using metal-on-metal hip replacements such as those manufactured by DePuy, a subsidiary of Johnson & Johnson. A careful analysis showed that 6 percent of patients with DePuy hip implants and other similar medical devices had to be replaced in less than five years compared with just 2 percent for those with ceramic or plastic joints. On August 26, 2010, DePuy Orthopaedics shocked their consumers with a defective product recall of their ASR XL Acetabular System and the ASR Hip Resurfacing System.
British regulators are recommending that those who have these metal implants get annual blood tests to ensure that no dangerous metals are seeping into their bloodstream as the components deteriorate or rub against each other. Approximately 500,000 patients have received these implants in the United States, but the FDA has released no such warnings. FDA scientists want to consider all available information before making any recommendations. During this week’s meeting, the FDA is expected to ask a panel of experts to recommend the best practices for monitoring patients with the devices. That includes blood tests, lab tests and medical imaging.
Lives Devastated
As the FDA takes its time, unsuspecting patients are suffering the consequences. One patient, 48-year-old Mary Weaver, who had both her hips replaced with Johnson & Johnson’s metal implants in 2007 and 2008, had to have these defective products removed in 2011 due to increasing pain and elevated metal levels in her blood. She not only had to endure the pain of additional surgeries and the medical expenses, but also lost her job due to the time needed to undergo these surgeries. Weaver is not alone. There are thousands of others like her.
Seeking Compensation for your Losses
If you or a loved one needs to pursue compensation from Johnson & Johnson or other companies that manufacture these and other defective medical devices, you will need an experienced California personal injury lawyer who has fought against these manufacturing giants and has a track record of holding negligent corporations accountable. The best product liability law firms always offer a free consultation and comprehensive case evaluation to injured victims and their families.
SLS Consulting