We've got some bad news for British patients who are stuck with the controversial and potentially unsafe metal-on-metal artificial hips. The U.K.'s Medicines and Healthcare products Regulatory Agency warns that as many as 50,000 of them will need annual blood tests for the life of the implants, Reuters reports.
Of particular concern: Patients may face swelling, tissue damage and toxicity-related side effects from metal exposure, the article notes. Doctors are facing recommendations to possibly remove and replace any metal-on-metal implant if its user has an abnormal MRI, or metal ion levels in the blood climb too high.
As many as 65,000 U.K. patients carry all-metal hips. So the warning is not a total catastrophe, but it illustrates continued concern in the face of Johnson & Johnson's ($JNJ) massive recall in 2010 of its DePuy ASR all-metal hip implant system, which failed at much higher rates than expected, Reuters reminds us. The problems aren't things you'd typically want to think about: inflammation, tissue damage, and metal fragments breaking off into the body.
The tougher regulations and recommendations come after U.K. regulators announced last month they would investigate how safe the metal-on-metal hip implants actually are. The Sunday Telegraph had estimated that more than 30,000 patients in Britain alone had received the implants. Looks as if the overall number for the U.K. is far higher. Meanwhile, in the U.S., the FDA has asked manufacturers to look at the safety of their implants, including Stryker ($SYK) and Zimmer ($ZMH), as well as J&J.
- read the Reuters story