Saturday, October 13, 2012

Were Safety Factors Overlooked in the Stryker Rejuvenate and ABG II?

Although Stryker, a Michigan-based corporation issued an Urgent Field Safety Notification to surgeons and hospitals acknowledging the potential dangers of the Stryker Rejuvenate and ABGII hip implants this past April, many believe that crucial safety factors may have been overlooked in the marketing of the device. The FDA approved the Rejuvenate hip implant in June of 2008 and the ABGII followed quickly with its approval coming in November of 2009. Both hip implant devices were approved under a 510(k) FDA procedure which allows medical devices and drugs to be marketed without benefit of clinical trials.

The 510(k) Process

The devices or drugs must only show that they are significantly similar in nature to a device or drug which has already garnered FDA approval. While in theory this sounds like a fairly safe process, in practice, many devices and drugs are gaining approval based on already-approved medical devices and drugs which have been shown to have their own safety issues. For instance, the Stryker Rejuvenate sailed in on the coattails of the Wright Profemur Total Hip System which was, itself, approved based on it being substantially equivalent to yet another hip implant device.

Like the Stryker Rejuvenate and the Stryker ABGII, the Wright hip device uses interchangeable titanium necks which are meant to personalize the implant to the individual. Even though Wright Medical obtained a patent on these particular types of modular neck portions by showing their design was original, they were still allowed to use the 510(k) loophole, allowing them to successfully circumvent the normal requirements of clinical trials. The Stryker models then were approved based on the Wright implants.

The Scope of the Issue

It is believed that over half a million U.S. citizens currently have metal-on-metal hip implants and will deal with the medical fallout for a very long time to come. The failure rate for these hip implants has been estimated to be as high as 50% and even though Stryker does not consider its Rejuvenate and ABGII “true” metal-on-metal implants, in fact the necks of the Stryker hip implants are made of cobalt and chromium, the stems are coated with titanium and there exists a metal-on-metal junction. This means the Stryker Rejuvenate and ABGII may have risks of metal toxicity.

What is Metal Toxicity?

Metal toxicity occurs when the metal components of the hip implant rub against one another during normal physical activity. When this type of friction occurs, microscopic metal ions shear off from the implant, lodging in nearby tissue or entering the bloodstream. While the FDA declined to issue a recall for the Stryker hip implant devices even though other devices with lower failure rates were recalled, Stryker issued a voluntary recall in July, 2012, following their safety warning in April.

Stryker officials admitted to excessive fretting debris in their recalled hip implants stating such fretting could lead to increased levels of metal shards in the joint space which exceeded the normal patient threshold. It was also noted by the company that contact between metal ions and nearby tissue could result in severe inflammation and adverse local tissue reactions which could in turn lead to severe and chronic pain and the need for revision surgery. Stryker also told surgeons and hospitals that there were several factors which could exacerbate the risk of the metallosis from the implants. These included additional femoral offset, factors such as diabetes and infection in individual patients which could negatively affect the ph of the surrounding tissue, inadequate locking or assembly of the tapers and inadequate cleaning of the tapers.

The Perils of Revision Surgery

The modular junction which exists in the Rejuvenate and ABGII hip implants can release significant levels of metal debris in implant patients leading to infection, pain, metal toxicity, kidney and cardiovascular issues and a myriad of other adverse health effects which would lead to necessary revision surgery. Unfortunately, revision surgery is also a very serious matter in those with Stryker Rejuvenate and ABGII hip implants as the neck is implanted deeply into the femur. When it becomes necessary to remove the implant in some cases parts of the femoral bone must be cut away. Many patients who have undergone revision surgery following the implantation of an ABGII or Rejuvenate hip implant have found themselves left with extremely limited mobility and, in some cases are wheelchair bound for the remainder of their life.

What You Must Do

If you or a loved one received a Stryker Rejuvenate or ABGII implant it is important that you contact your physician immediately, then once you have attended to your health, you should contact a qualified Stryker hip recall attorney to determine what your legal options are. Your attorney will thoroughly evaluate your specific case to find whether you are entitled to file a claim against Striker Orthopedics. Even if you have not yet suffered adverse health effects from the Stryker hip implant, remember than in many cases it can take from three to five years for such ill effects to make themselves known. Since most recipients of the Stryker hip implants received the implant after 2009, many of them could already have the beginning of metal toxicity and simply not have had the symptoms yet. Because there is a statute of limitations on cases such as this having an attorney in your corner protecting your rights and watching out for those time limits is an invaluable resource.

Author: Sullo & Sullo Attorneys

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