The Stryker Rejuvenate and ABGII were recalled in July, 2012 due to a significant risk of fretting and corrosion which can lead to metal debris in the body. Although Stryker has declined to comment on the exact failure rate of the Rejuvenate and ABGII, it is believed that number will continue to rise as more and more patients experience problems with their recalled Stryker hip implant. The metal-on-metal design of the Rejuvenate and ABGII were intended to have a much longer life span—as long as 15 years—yet adverse reports began coming in soon after FDA approval in 2009.
As the metal components of these two recalled hip implants rubbed against one another during activity by the implant recipient, tiny shards of cobalt and chromium can shear away, becoming lodged in the surrounding tissues or entering into the bloodstream. When the metal ions find their way into the hip tissues, inflammation and pain can occur. When the ions enter the bloodstream, symptoms of metal toxicity can occur, some of which include:
· Neurological, cardiovascular, renal, thyroid and gastrointestinal disorder
· Loss of vision and hearing
· DNA disruption
· Irritability, depression and anxiety
· Formation of pseudo-tumors
· Memory loss
· Skin disorders
· Vertigo
ALVAL (aseptic lymphocyte dominated vasculitis associated lesion) is a histological soft-tissue reaction in the body to all-metal implants such as the Rejuvenate or ABGII. ALVAL is not entirely understood however some research points to a link between ALVAL and bone dissolution. Most patients who develop ALVAL suffer pain in the groin area which leads the physician to test for infection. In the absence of infection with increasing groin pain, revision surgery may be indicated. During the revision surgery microbiological and histological tests will confirm the diagnosis of ALVAL.
Most patients who suffer from ALVAL note a painful straight-leg raise. When fluid is aspirated from patients suspected of suffering from ALVAL, it is generally thick and grey-green in color. Some research indicates that ALVAL may be caused by incorrect placement of the hip implant components which leads to undue wear as any misalignment results in additional wear in a specific area, generating excess metal debris.
Metallosis results when there is a build-up of metallic ions in the surrounding hip tissues; this buildup can cause significant tissue, bone and muscle deterioration or death and masses of inflamed tissue which form as a reaction to the ions known as pseudo-tumors. The Telegraph reported that the levels of soft-tissue damage which result from metallosis can make revision surgery extremely complicated. When bone, muscle and tissue have been destroyed by the metal ions, surgeons can have difficulty implanting a second device and the patient can be subjected to a much longer recovery period. Further, a study presented at the British Hip Society conference in March, 2012, linked defective hip implants to a higher risk of kidney and bladder cancer. That particular study suggests the metal debris released from the implant can cause changes to the body’s cells which could be precursors to cancer in at least a fifth of those patients with metal-on-metal hip implants.
Those patients who received a metal-on-metal hip implant device such as the recalled Rejuvenate or ABGII and are suffering adverse symptoms should see their physicians to have tests done for elevated metal levels as well as x-rays and possibly an MRI. The lawsuits against Stryker are mounting since the recall and those who were injured by the implant may be entitled to medical expenses, lost wages and pain and suffering.