Houston personal injury attorneySome 20 hip implant makers have been ordered by federal health regulators to conduct studies of hip replacement parts, reports say.
The manufacturers are those that use metal-on-metal implants, and the studies are to determine the safety of the components. There have been concerns from the FDA that some of the parts may have a risk of shedding dangerous amounts of metallic debris in patients. The order concerns DePuy Orthopaedics, Zimmer, Stryker, Biomet and Wright Medical.
DePuy has reportedly already recalled its ASR hip implant after data from a United Kingdom study indicated a failure rate of 12 percent within five years of implantation. At least 1,000 DePuy ASR hip implant lawsuits have been filed by victims of the device in the U.S. since that study, reports say.
The claims say that the allegedly faulty implants allow metal shavings to make their way into patients’ bloodstreams, leading to tissue breakdown, bone loss, and even the formation of non-cancerous tumors. Metal-on-metal implants have reportedly been used in about a third of the approximately 250,000 hip replacements performed annually in the U.S.
The recent FDA order allows manufacturers to determine how to conduct their studies of the issues possibly associated with the implants. The FDA will then review their findings.
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