According to The Wall Street Journal (1/18/12), on December 8, 2011, the FDA sent a warning letter to DePuy Orthopaedics, warning that some of its hip, knee and joint replacement devices were improperly marketed. The agency noted that some products did not have the proper applications for premarket approval and further claimed that DePuy did not tell regulators that 14 products would be sold as custom devices.
DePuy defended itself, saying it believes it complied with FDA requirements, but decided not to sell the custom device. The FDA, however, said that the devices were too similar to regular DePuy implants to count as custom implants.
Meanwhile, a study undertaken in Britain by the Sunday Telegraph (1/28/12) confirms concerns about the potential for metallosis in patients with metal-on-metal hip implant devices. The study found that the risks associated with the hip implants could be much more dangerous than the warnings indicate, including a risk of toxic particles coming loose from the implants and causing the devices to fail. The Medicines and Healthcare products Regulatory Agency (MHRA) is set to release a new warning about the hip replacements.
Furthermore, the Telegraph (1/28/12) states, research indicates that the failure rate of the hip implant devices could be has high as 50 percent after six years. Traditional hip implants are generally expected to last up to 15 years. Finally, because of the metallosis, which can cause soft tissue damage, revision surgery for patients whose hip implants have failed can be complicated.
Patients in Britain have been warned that if they have a DePuy ASR or ASR XL they should contact their medical provider. The Telegraph noted that there were concerns that metal-on-metal fragments could slowly poison a patient's nervous system, heart and lungs.
READ MORE DEPUY HIP REPLACEMENT LEGAL NEWS
Lawsuits have been filed in the US alleging patients were harmed by use of the DePuy hip replacement device.