FDA Expert Panel to Review Metal-on-Metal Hip Implants
In March 2012, the Food and Drug Administration (FDA) responded to thousands of reports, including those of Zimmer hip replacement problems, and announced that it would convene a board of medical experts to review metal-on-metal hip implants. The review panel’s conclusions could affect Zimmer hip replacement lawsuit claims, as new standards may recognize and validate plaintiff complaints of early loosening, metallosis, and the premature need for revision surgery.
Panel to review Zimmer hip replacement problems
The FDA advisory panel is slated to meet June 27-28, 2012, and will hear the opinions of researchers, patients, scientists, and medical professionals. Dr. William Maisel, the deputy director of science at the FDA’s Center for Devices and Radiological Health, explained, “We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations.”
The panel will review device failure rates, patient risk factors, implant complications, the occurrence of metallosis, and other important factors.
After the FDA’s announcement, Zimmer Holdings stock took a 1.1% dive. While no Zimmer hip implant recall has been issued, DePuy Orthopaedics recalled a metal-on-metal hip device in 2010.
Zimmer hip replacement lawsuit actions allege metal poisoning
Zimmer hip replacement lawsuit complaints allege varied Zimmer hip replacement problems, but focus especially on metallosis and premature loosening – and the resulting need for costly, painful and dangerous hip revision surgery.
Metallosis is a form of metal poisoning that can occur when metal-on-metal hip components rub together, causing metal flakes to seep into neighboring organs and the patient’s bloodstream. According to some Zimmer hip replacement lawsuit allegations, metallosis causes bone and tissue death, and may also result in irreversible damage to cellular DNA.
Despite reports, no Zimmer hip implant recall
In May 2011, with the number of Zimmer hip replacement lawsuit actions growing nationwide, the FDA ordered 21 manufacturers of metal-on-metal hip implants, including Zimmer, to conduct safety studies of their devices. The request came after several studies revealed possible health repercussions with these devices. Though no Zimmer hip implant recall has been issued, patients have reported a range of Zimmer hip replacement problems, including premature loosening and metal poisoning.
In fact, research revealed that DePuy’s ASR implant, was recalled in 2010, had a 12% failure rate within five years, while a study by the National Joint Registry of England and Wales found that about 6% of metal-on-metal hip recipients will need revision surgery within five years – a rate much higher than those reported for ceramic (1.7%) or plastic (2.3%) hip replacements.