Healthcare Agencies Investigating DePuy Pinnacle Hip Implants
DePuy Orthopaedics, the company that recalled 93,000 ASR hip replacements last August, is now under scrutiny from the FDA, Britain's Medicines and Healthcare Products Regulatory Agency ("MHRA") and even the Alaska Department of Health. These agencies, based on numerous adverse event reports, are investing DePuy's hip replacement systems.
The hip replacement systems under review include DePuy's ASR and
Pinnacle Systems among
others. The implants are being studied to track metallosis and biologic toxicity. The implants made with parts that connect metal-on-metal appear to be releasing dangerous levels of cobalt and chromium into patients' bloodstreams leading to severe inflammation, severe pain, lack of mobility, tissue death, bone erosion and development of tumors.
Both Britain's MHRA and Alaska's Department of Health are calling on doctors to close monitor their patients with metal-on-metal hip implants by monitoring the boalt and chromium ion levels in their blood.
The FDA is conducting ongoing studies on the relative safety and effectiveness of the metal-on-metal hip implant devices.
More than 1,000 cases are on file in an MDL in Ohio regarding injuries to patients with faulty DePuy ASR implants and a new MDL was recently created in the Northern District of Texas for the DePuy Pinnacle hip implant lawsuits.