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Saturday, October 13, 2012

Is Your Safety Being Ignored in the Approval of Medical Devices and Drugs?



While the FDA declined to require Stryker, a Michigan-based manufacture of medical devices, to recall their Rejuvenate and ABGII hip implants the company made the decision to issue a voluntary recall this past July. The recall came on the heels of an Urgent Field Safety Notice sent out to surgeons and hospitals in April of 2012. That safety notice acknowledged the possibility of metal toxicity from the hip implants admitting to corrosion and wear at the junction of the metal implants.

Adverse Health Effects from Metal Toxicity
Any time two metal surfaces come into contact with one another, corrosion can occur in the form of tiny metal shards shearing away from the implant and lodging in nearby hip tissue or entering into the bloodstream. Extreme inflammation, chronic and severe pain and destruction or death of the tissue can result from those tiny metal ions. Should the metal shards enter into the bloodstream, metal toxicity can occur. Every person will respond differently to varying levels of toxic metals in the body—while some people may have serious adverse reactions to relatively small amounts of metals in the body, others may not have any overt reactions until the levels are extremely high.

For this reason any person who has had a metal-on-metal hip implant should receive regular monitoring to check for metal toxicity. In many cases symptoms of metal toxicity will not show up for several years following the initial hip implant. Medically documented effects from excess metals in the body include cardiovascular issues, kidney and thyroid problems and even disruption of DNA. While not formally medically documented many persons with metal toxicity have noted an inability to distinguish between sweet and salty flavors, a noted loss of memory and neurological functions, dizziness, gastrointestinal disorders, hearing loss and vision disturbances, to name a few. 

The Largest Medical Device Failure in American History?
The US Drug Watchdog believes that metal-on-metal hip implants are possibly the largest medical device failure in American history. They believe that over half a million U.S. citizens have received these metal-on-metal hip implants and while many of them have already suffered adverse effects, many more are like ticking time bombs, just waiting for the metal toxicity to adversely affect their health. Although metal-on-metal implants were designed with a goal of lasting fifteen to twenty years, their failure rate has dictated that they actually last many fewer years than hip implants made of ceramic or polyethylene.

Not a “True” Metal-on-Metal Implant yet the Effects are similar
While the Stryker Rejuvenate and ABGII are not considered “true” metal-on-metal hip implants (unlike the DePuy metal implant which places a metal ball and socket in direct contact with one another) the design of the Stryker implants have resulted in many of the same issues. Even though there is no cobalt and chromium ball and socket rubbing against one another, the necks of the Stryker devices are made of cobalt and chromium, the stems are coated with titanium and there is a metal-on-metal junction which can lead to the same type of shearing off of metal shards. The risks of metal toxicity in the Stryker hip implant models are significant.  Adverse tissue reactions to the heavy metals which have entered the body are known as metallosis and can result in severe pain, loss of mobility, complete failure of the hip joint, pseudo-tumors, bone dissolution, and even chromosomal abnormalities.

When Stryker Hip Implants Fail
Many of the Stryker Rejuvenate hip implants have shown total failure in less than five years post-implant. Those who must undergo hip revision surgery will encounter not only extremely high medical expenses but will also be subjected to an extremely difficult surgical procedure which is not known for positive outcomes. Because the neck of the Stryker Rejuvenate or ABGII is deeply implanted into the femur, removing it can be very tricky. Many of those who undergo revision surgery after having a Stryker hip implant find themselves with extremely limited mobility and in some cases are left unable to walk at all.

Getting the Help You Need
Those who have undergone hip implant surgery with a Stryker Rejuvenate or ABGII should first make an appointment to see their doctor. Your health is the most valuable thing you have in life, and your physician will be able to assess whether or not you have suffered adverse effects from the Stryker hip implant and whether you are a candidate for revision surgery. Following your doctor’s appointment it is crucial that you seek out a highly qualified Stryker hip recall attorney who can assess your specific implant facts and determine whether you should file suit against Stryker. Because of the varying statute of limitations from state to state you don’t want to wake up one day to find your health has been adversely affected by a Stryker hip implant yet you have no recourse because the time limits have run.

stryker abg ii recall | stryker rejuvenate modular recall

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