Friday, April 5, 2013

Unacceptably High Levels of Chromium and Cobalt in Stryker Rejuvenate Hip Implant Patients

With the recent recalls of all-metal and partial metal hip implants due to metal toxicity and implant failure, recipients of the Stryker Rejuvenate could be forced to undergo revision surgery to replace the recalled hip implant device. For the general population, the levels of cobalt and chromium in the bloodstream-from naturally occurring sources—are approximately 0.5 parts per billion. Patients who have been implanted with a device with metal parts could find those levels considerably higher. The generally accepted “danger” level is considered to be anything over 7 parts per billion however many doctors believe that number is much lower—between 2 and 3 parts per billion.

Additionally, each person has a different tolerance level for metals in the body. This means a person with levels at 2 parts per billion could be very sick, exhibiting serious adverse effects from the metals, while another person who tests at 7 parts per billion may not yet be experiencing and significant side effects. Tolerance ranges of these metals are lower for patients with a Stryker Rejuvenate hip implant because the metal readings come from a joint which was not supposed to wear. This means that a level 3 in a patient who has a Rejuvenate implant could indicate the necessity of revision surgery while a patient with an all-metal hip implant might be considered a level 10 yet not be a candidate for revision surgery.

The Rejuvenate experiences corrosion at the metal neck juncture and beneath the metal trunnions where body fluids become trapped. In fact, when Stryker recalled the Rejuvenate and the ABG II, they stated the implants had a higher than normal risk of corrosion, fretting and implant failure. While there are a variety of symptoms of cobalt and chromium toxicity, some of the more frequent symptoms include:

  • Chronic headaches
  • Vertigo
  • Vision and hearing loss
  • Irritability, anxiety and depression
  • Neurological, cardiovascular, renal and thyroid disorders.
  • DNA disruptions
  • Chronic, serious pain
  • Loss of memory
  • Skin disorders
  • Gastrointestinal disorders
  • Pseudotumors

Many question just how cobalt and chromium from such relatively limited surfaces can find its way into the body following implantation of a Stryker Rejuvenate. The Rejuvenate was believed to be an exceptionally innovative design as well as a safer alternative to the all-metal hip implants which had suffered under recalls due to serious health consequences.  Unlike the all-metal implants, the Rejuvenate is designed with a ceramic rather than metal ball. The neck juncture is constructed of cobalt and chromium as are the small metal trundles located on either end of the neck piece. The metal ball and metal cup of the all-metal implants have been found to rub against one another when the patient engages in any activity, even daily activities such as walking. This friction causes tiny metal ions to shear away from the implant, lodging in nearby hip tissues or entering into the bloodstream.

Like the all-metal implants the Rejuvenate has been found to suffer corrosion, releasing toxic cobalt and chromium into the body. Once corrosion of the implant occurs, the levels of toxic metals will likely continue to build up in the body, causing pain, inflammation, bone and tissue loss and even total implant failure as well as the metal toxicity symptoms. Revision surgery may become necessary as the levels of metals increase. Unfortunately, revision surgery for a Rejuvenate is considerably riskier and more complex than for other hip implant devices.

The stem of the Rejuvenate is implanted deeply into the femur; when it becomes necessary to remove the stem it must literally be dug out of the bone in many cases. The recovery time for a Rejuvenate revision surgery is also considerably longer, sometimes as long as six weeks or more. It is important that all recipients of a Rejuvenate hip implant device have regular blood tests as well as MRIs and x-rays to determine whether the patient is experiencing any ill-effects from the implant.

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