FDA Asks Hip Implant Makers to Provide Blood Poisoning Data



Blood poisoning from metal ions released by metal-on-metal hip implants been one of the complications associated with the use of these implants.  Several patients who have been implanted with these implants have reported levels of metals in their blood that far exceeded normal levels.  But the Food and Drug Administration is now asking manufacturers of these hip implants to study whether these hip implants release metal ions, and the possible health effects on the person.

The manufacturers include 20 of the biggest companies in the industry, like Johnson & Johnson, Zimmer and Stryker.  The agency has written to these manufacturers, asking them to conduct studies into blood poisoning incidents associated with their hip implants.  These hip implants, especially those manufactured by Johnson & Johnson’s subsidiary DePuy orthopedics have been at the center of a worldwide scandal after these were linked to high failure rates.  Studies have indicated that the failure rate for these devices is as high as 12%, necessitating painful and complicated revision surgeries to replace these devices.  Johnson & Johnson currently faces hundreds of lawsuits around the country from patients, who had to undergo revision surgeries just a couple of years after being implanted with the device.

The Food and Drug Administration is now focusing on the incidence of blood poisoning associated with the hip implants.  High levels of cobalt and chromium have been found in some of the patients who have been implanted with these devices.  The Food and Drug Administration says it does not have enough information about the levels of metal in the blood that can actually cause health effects, and therefore, the call for the study.

Vuk Vujasinovic is a Houston product liability lawyer, representing persons injured by defective products across Texas and nationwide.

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