Stryker Rejuvenate and ABGII—Getting the Legal Help You Need

A short time after the FDA approved the Stryker Rejuvenate metal hip implant in June of 2008, adverse reports from recipients of the implant began coming in. The implant remained on the market, and in November of 2009 the FDA approved another Stryker metal hip implant, the ABGII. Both models of the metal hip implants came in under the FDA 510(k) approval process which allows medical devices and drugs to gain approval if the manufacturer can prove they are substantially similar to a device or drug which has already garnered FDA approval. While in theory this process sounds reasonable, in practice, many of these drugs and devices were able to be approved based on prior devices or drugs which also had their own problems.

Problems with the 510(k) Process

In the case of the Stryker Rejuvenate, it gained FDA approval based on being substantially similar to the Wright Profemur—which has made the news because of harm to its recipients. In some cases one defective medical device or drug after another can find their way onto the market—and into the bodies of unsuspecting people who likely believe there doctor would not be able to implant a device into their body unless it were safe. Over 500,000 people in the United States alone have metal hip implants in their body despite the fact that a recent FDA panel met to discuss the merits of the metal-on-metal implant and stated that given the many problems which have surfaced on particular metal implants, there was really no reason for surgeons to continue to implant the metal devices.

Problems with Metal Implants

This is likely little comfort for the thousands of those who already have a metal-on-metal hip device implanted in their body. Metal parts of a hip implant can rub against one another causing friction which leads tiny metal ions to shear away from the device. These ions can either lodge in the tissue surrounding the hip where they can lead to varying levels of inflammation, infection, tissue damage and even tissue death. In these cases the device will have to be removed during a revision surgery which doctors consider to be especially tricky with the Rejuvenate and ABGII because of the longer neck implanted into the femur.

The metal ions can also find their way into the bloodstream where they can wreak havoc on many levels. Metal toxicity can lead to cardiovascular issues, kidney, thyroid and neurological disorders, vision and hearing disturbances, memory loss, gastrointestinal disorders, dizziness, nausea and even an inability to distinguish between sweet and salty tastes. In some cases metal toxicity has even been found to lead to DNA disruption.

Finding the Help You Deserve

As you can see, the metal-on-metal hip implants can have very serious consequences for the recipients. Unfortunately, in many cases the full effects of the metal hip implant may not manifest for two, three or even five years. When this much time has passed, the hip implant recipient may find they are no longer able to bring suit against Stryker because too much time has passed and the statute of limitations has run. For the person who is facing expensive and potentially dangerous revision surgery, learning they cannot hold the responsible party accountable can be a serious blow. Those with a Stryker ABGII or Rejuvenate should take care to ensure they are not barred from recovery because of a statute of limitation issue. Whether you have suffered overt symptoms as this point or not, you should consult with an experienced Stryker recall hip attorney who can thoroughly evaluate your specific case. Your health is crucial, so see your physician then seek legal assistance.

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