Tuesday, January 28, 2014

Stryker Cobalt Toxicity

Among those with a recalled Stryker Rejuvenate or ABGII hip implant device, Stryker cobalt toxicity is a very real concern. Even though the Rejuvenate and ABGII have a smaller metal surface area, corrosion and the release of metal ions can occur at the metal neck juncture as well as underneath the small metal trunnions located on either end of the neck piece. Stryker cobalt toxicity can occur when the metal parts of the implant rub against one another during periods of physical activity. The resulting microscopic metal particles which shear away from the implant may either lodge in surrounding tissue or continue to the bloodstream.

Stryker cobalt toxicity can occur from those metal ions which enter the bloodstream, wreaking havoc on the body. The metal ions which enter the hip tissue can be responsible for inflammation, chronic pain, bone loss, tissue damage and failure of the Stryker implant. Different patients may respond quite differently to Stryker cobalt toxicity; some patients with relatively low levels can exhibit serious symptoms of metal poisoning while others with high levels of Stryker cobalt toxicity may exhibit relatively few symptoms of metal poisoning. When cobalt enters the bloodstream, Stryker cobalt toxicity can cause patients to experience such symptoms as: neurological damages, heart irregularities, seizures, impaired liver function, respiratory issues, loss of vision and hearing, pseudo-tumor development, thyroid and renal disorders, memory loss, chronic headaches, irritability, depression and anxiety.

Cobalt does not accumulate in the body, meaning that, theoretically, when the recalled Stryker hip implant is removed, the Stryker cobalt toxicity symptoms should begin to lessen. Cobalt is stored in the liver, therefore in the absence of impaired liver function, Stryker cobalt toxicity should decrease following revision surgery. Many physicians believe there is no truly safe level of cobalt in the human body, other than the microscopic amounts which occur normally. While some doctors believe any cobalt amount over two parts per billion in the body signifies Stryker cobalt toxicity, many scientists maintain that levels up to five parts per billion are relatively safe. Patients with cobalt levels of three parts per billion could have a Stryker hip implant which has experienced serious wear issues even if they are not experiencing symptoms of Stryker cobalt toxicity.

The combination of a titanium-coated stem and a cobalt and chromium neck has been found to cause excessive levels of corrosion where the two metals meet, leading to Stryker cobalt toxicity. At the time the Rejuvenate and ABGII received FDA approval, Stryker cobalt toxicity was not an expected safety issue due to the fact that both hip devices implement a ceramic ball, rather than a metal one. Unfortunately, no clinical trials and little safety data are required for approval through the FDA’s 510(k) process—which is actually more of a clearance than actual approval.

While admitting the two devices had problems at the time of the Stryker recall, there was no mention of the possibility of Stryker cobalt toxicity. In fact, since the flurry of lawsuits has begun, Stryker has attempted to shift the focus in patients with Stryker cobalt toxicity to such issues as the patient’s excess weight or specific body chemistry which caused a hypersensitivity to the cobalt and chromium. Patients who have experienced Stryker cobalt toxicity should have regular blood tests to determine the levels of cobalt in their system and could benefit from speaking to a knowledgeable Stryker hip attorney.

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