If you have a DePuy Pinnacle hip implant and are aware of the recall of the DePuy ASR, you may wonder whether your Pinnacle—particularly when paired with an Ultamet metal-on-metal Pinnacle liner—can be a danger to your health. The Pinnacle has not yet been recalled, however sales of the Ultamet metal liner were discontinued in August, 2013. Over 150,000 Pinnacle hip implant devices were sold between the time the FDA granted clearance for sales of the Pinnacle in 2000, and the present. In fact, the Pinnacle hip implant device is still available for implantation. As with other metal-on-metal hip implants, the Pinnacle, used in conjunction with the metal Ultamet liner, has the potential to release microscopic metal ions into the body.
Cobalt and chromium ions which enter the surrounding hip tissues can cause chronic pain in the hip, groin or thigh, inflammation, loosening of the Pinnacle implant, deterioration of the bone and tissue, and the necessity for revision surgery. Despite the fact that the FDA has received over 1300 adverse reports related to the Pinnacle, DePuy and its parent company, Johnson & Johnson, continue to maintain the Pinnacle is safe and the design is unflawed. The DePuy ASR gained FDA approval in 2005, based on its “substantial similarity” to the Pinnacle model, and while there are some differences between the two, the designs are very similar. The ASR was recalled in 2010, and in late November, 2013, DePuy agreed to pay $2.75 billion in damages to those harmed by the ASR.
Can the Ultamet Metal-on-Metal Pinnacle Liner Cause Cobalt and Chromium Poisoning?
Many Pinnacle recipients have experienced severe inflammatory reactions or metal poisoning due to high levels of cobalt and chromium in their systems. Such continuously elevated levels of metal ions in the bloodstream, due to friction in the metal-on-metal Pinnacle implant—can lead to serious complications. Slightly elevated cobalt and chromium levels are normal for patients with a metal-on-metal hip implant, however higher, continuous levels of these heavy metals can indicate chromium and cobalt poisoning. Symptoms of metal toxicity associated with cobalt and chromium include:
· Hypothyroidism (considered by some experts to be the most sensitive indicator of cobalt toxicity)
· Cardiovascular issues such as fatal cardiomyopathy
· Neurological issues including hearing loss, tinnitus, atrophy of the optic nerves, visual impairment, vertigo, chronic headaches, decline of cognitive functions, depression, anxiety and irritability
· Fatigue and poor concentration
· Renal issues
· Changes to nails and skin, including rashes
· Atrophy of muscles
· Seizures, convulsions and tremors
· An increase in certain types of cancers
· Disorders of the reproductive system
· DNA alterations
· The development of pseudo-tumors
· Inflammation and hypersensitivity
· Liver necrosis when high levels of chromium are present
· Respiratory issues including shortness of breath and asthma
· Hearing loss and vision impairment
· Short-term nerve impairment
Whether you are experiencing problems with your DePuy Pinnacle hip implant yet or not, you should definitely see a physician and have blood tests, x-rays and MRIs done to determine whether you have any symptoms of chromium and cobalt poisoning or DePuy Pinnacle metallosis. You should then consider speaking to a knowledgeable DePuy Pinnacle hip lawyer regarding a potential DePuy Pinnacle lawsuit.