The Stryker hip recall of the company’s Rejuvenate and ABGII hip devices occurred in July, 2012. At the time of the Stryker hip recall Stryker hip recall Stryker noted that the combination of chromium, cobalt and titanium in the neck region of the recalled implants may fret and corrode, leading to serious medical conditions and chronic pain. The tiny metal shards released from the metal implants can inject themselves into the bloodstream of the implant recipient or can lodge within the tissue surrounding the hip. When the metal shards stop in the hip tissue, inflammation, infection and chronic pain can result. These symptoms are known as metallosis and are one reason for the Stryker hip recall.
Should the metal ions make their way to the bloodstream, there are a variety of adverse health issues which can ensue. Patients may develop metal toxicity and suffer loss of hearing and vision, gastrointestinal, neurological, cardiovascular, renal and thyroid disorders, DNA disruption, the development of pseudo-tumors, irritability, anxiety, depression, memory loss and reproductive disorders. The Stryker hip recall brought many of these issues to light, as more and more patients reported their symptoms to the FDA. Although the FDA approved the Rejuvenate and the ABGII in 2008 and 2009, the devices gained approval under a program which has come under intense scrutiny.
Despite the Stryker hip recall, the devices were approved based on their similarity to another hip implant. Clinical trials were not required and there were not an abundance of safety reports. In some cases, the device the approval was based on, actually suffered serious problems of its own. The Stryker hip recall is not an isolated incident as many other metal-on-metal implants have been recalled as well. Following the Stryker hip recall, many patients were left wondering what they needed to do to protect their health and their futures. It is believed, following the Stryker hip recall, that over 20,000 patients currently have Stryker hip implants.
Within a year of gaining FDA approval, adverse reports began filtering in, with patients stating in some cases that they began having health problems soon after their implant surgery. Although some patients are more sensitive to heavy metals and may react negatively to even small amounts of cobalt and chromium, because of the estimated failure rate of the recalled Stryker implants, it is likely that a huge number of Stryker implant recipients will suffer problems. At the time of the Stryker hip recall, the company declined to state the actual failure rate of the Rejuvenate and ABGII, however independent studies done following the Stryker hip recall have placed the number as high as 40%.
For all those affected by the Stryker hip recall, the future may look very shaky. Many of these implant recipients may have to undergo revision surgery—potentially risky and expensive. The recovery time for revision surgery can be as long as six weeks, meaning the patient will not be receiving a regular paycheck and will have medical expenses to deal with as well. Experienced product liability attorneys may be able to put at least some of patients’ fears to rest by offering information regarding the Stryker hip recall as well as potential health problems and how these issues can be resolved.