How the Stryker Rejuvenate Modular May Have Affected Your Health
Many people have been injured by the Stryker Rejuvenate and ABGII modular hip implant, however because neither implant is considered a “true” metal-on-metal implant, it is expected that these people may have a more difficult time filing a lawsuit than those who received implants such as the DePuy ASR. Nonetheless there is evidence that prior to the safety warning and recall of the ABGII and Rejuvenate, Stryker had received notice from at least two orthopedic surgeons who reported adverse reactions on the part of their patients implanted with the hip devices. In FDA summaries, one of the surgeons stated at least six of his patients had developed symptoms of metal sensitivity within a short time period following their implantation surgery. The second surgeon listed at least ten patients who experienced adverse health issues following implantation.
Specific Symptoms of Metallosis
Whenever metal components come into contact with one another, there is the potential for friction and the release of metal debris and metal ions into the body. When this occurs, the tissues closest to the implant can become inflamed, leading to tissue and bone destruction as well as the formation of pseudo-tumors. Should the ions enter the bloodstream, renal, thyroid, cardiovascular and neurological issues can occur as well as loss of hearing and vision, gastrointestinal problems, skin disorders, disruption of DNA, vertigo, memory loss, depression, irritability and anxiety.
The FDA Stryker Recall
Stryker issued an urgent field safety notice in April prior to the recall which informed physicians and hospitals of the potential for the neck juncture to suffer corrosion and fretting, subsequently releasing metal ions or debris into the body. Since the time of the recall, last July, it has additionally been found that the Stryker hip implants are constructed using metal trunnions on either end of the neck piece. These metal trunnions allow the neck to snap into the stem and femoral head however body fluids can also be trapped beneath the trunnions, leading to corrosion. The bulletin sent to hospitals listed a variety of factors which Stryker asserts will increase the likelihood of the patient suffering problems such as excess weight, a history of diabetes, the individual patient’s pH levels, incorrect implantation techniques, patient infection as well as a device which fails to adequately lock into place.
Is it Time to Call Experienced Stryker Rejuvenate Attorneys?
Like most all of the hip implant designs which are made from metal—either completely or partially—the Stryker Rejuvenate and ABGII were approved through the FDA’s process known as the 510(k). This process allows medical devices to gain FDA approval simply by asserting they are substantially equivalent to a device which is already on the market. The problem with this system is that many of the devices which gained approval in this way were based on devices which had suffered safety issues of their own. Lawyers who have experience with metal hip implant lawsuits can offer valuable information regarding the options each individual patient may have. Product liability attorneys have the necessary knowledge to ensure their clients are not left out in the cold with expenses relating to the hip implant and revision surgery.