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Friday, November 2, 2012

Stryker Rejuvenate and Stryker ABGII Hip Implant Revision Surgery: Few Good Choices Available

The July, 2012 recall of the Stryker Rejuvenate and ABGII hip implant devices followed an Urgent Safety Alert which Stryker Orthopedics issued in April, 2012. The alert went out to physicians and hospitals which then had the burden of notifying all the recipients of the implants. Because there are between 30,000 and 50,000 worldwide recipients of the Rejuvenate and ABGII, the process of notifying each implant patient may end up being very slow and laborious. This means that there could be thousands of implant recipients who are unaware that their hip implant has been recalled.

The Potential Risks of the Stryker Implants

Stryker’s safety alert admitted that these particular two metal implants could have certain potential risks. These risks primarily include fretting and corrosion as well as metal toxicity when the cobalt and chromium parts of the implant rub against one another during periods of activity, shearing off tiny metal ions. These microscopic shards can become lodged in the surrounding tissue causing pain, inflammation, tissue damage and total failure of the implant. The ions can also travel to the bloodstream causing many adverse health issues including cardiovascular, neurological, renal and thyroid problems as well as DNA disruption.

Lifespan of the “Typical” Hip Implant 

The lifespan of a hip implant is expected to be from 10-15 years, and, in fact, the metal-on-metal hip implants were marketed as potentially lasting even longer than 15 years. This was very good news for all the patients who have had hip joint problems yet were told by their doctor to wait as long as they could to receive a hip implant so they could avoid a future revision surgery. Unfortunately, the metal hip implants did not perform as expected. The Rejuvenate was approved by the FDA in June of 2008 while the ABGII received FDA approval in November of 2009. This means that the longest any patient could have had a Stryker hip implant by the time the recall was issued was five years. Despite this short amount of time, many implant recipients have already suffered erosion, fretting, pain, inflammation, total failure or symptoms of metal toxicity resulting from the metal implant.

Revision Surgery Risks

Those patients with adverse symptoms have likely been advised by their physician to undergo revision surgery. Revision surgery is generally believed to carry more risks than the original implant surgery under any circumstances however the Rejuvenate and ABGII bring additional potential complications to the surgical table. The All Symptoms website notes that in order to revise a Stryker Rejuvenate or ABGII implant the surgeon must remove the femoral stem which brings a significant risk of femur fracture. These devices are implanted deeper into the femur than many other hip implant devices, therefore removing them can be challenging.

Revision surgery can often last from four to five hours therefore the risk of infection, excessive blood loss and nerve damage is greater. The recovery period for revision surgery is much longer than the recovery for initial implant surgery with dislocation being a particular problem for patients. The future for those who have been implanted with a Stryker ABGII or a Stryker Rejuvenate hip implant device can look very uncertain. The decision to leave a potentially dangerous device in the body and hope for the best or undergo a revision surgery which brings a completely different set of risks is a difficult one to make. Patients may find it helpful to consult with a knowledgeable legal professional after discussing their options with their physician. 

stryker abg ii recall

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