Wednesday, January 8, 2014

The Impact of the Stryker Hip Implant Recall


The Stryker hip implant recall set off a flurry of lawsuits against the company as well as causing considerable amount of worry among the recipients of the recalled hip implants. Both the Rejuvenate and the ABGII were recalled in July, 2012 after a significant number of patients developed serious health symptoms following their Stryker implant surgery. Stryker issued an Urgent Field Safety Notification to surgeons and hospitals in April, prior to the Stryker hip implant recall, which acknowledged potential dangers of the implants. This field safety notification stated the two hip implants had a higher-than-normal risk of failure due to excessive fretting and corrosion.

The Stryker hip implant recall explained that this fretting and corrosion could cause metal debris to enter the bloodstream or lodge in surrounding hip tissue. The Rejuvenate was approved by the FDA in 2008, and the ABGII in 2009, just two years before the Stryker hip implant recall. Both the Rejuvenate and the ABGII implemented a new design, allowing surgeons more freedom in matching the hip implant to the person’s body type and level of activity. Because the ball of the Rejuvenate and ABGII is made of ceramic, it was believed there would not be the problems displayed by the all-metal hip implants. Unfortunately, as the Stryker hip implant recall demonstrates, this belief proved untrue, and soon patients were contacting the FDA with stories of hip inflammation, chronic pain, infection and symptoms of metal poisoning. 

The Stryker hip implant recall is one of many metal hip implant recalls over the past several years. It is believed that over half a million Americans currently have a metal-on-metal hip implant, and at least 20,000 of those are the Stryker Rejuvenate and ABGII recalled devices. Despite the fact that Stryker does not consider these two implants “true” metal-on-metal devices, the necks are made of cobalt and chromium and the stems are constructed of titanium; this means there is a metal-on-metal neck juncture and small metal trunnions located on either end of the neck piece. In the end, these metal parts may give the Rejuvenate and the ABGII the same risks of metal toxicity as other recalled all-metal implants. 

Cobalt and chromium toxicity can occur when the metal components of the Rejuvenate and ABGII rub against one another during normal physical activity. As stated in the Stryker hip implant recall, when this type of friction occurs, those microscopic metal ion shards can enter the bloodstream or lodge in surrounding tissue. When the cobalt and chromium enter the bloodstream, many adverse health issues can arise including: loss of vision and hearing, DNA disruption, the formation of pseudo-tumors, anxiety, depression, irritability, vertigo, memory loss, cardiovascular issues, neurological disorders, renal and thyroid problems and gastrointestinal disorders.

Communication of the Stryker hip implant recall did not make mention that no clinical trials were performed prior to FDA approval and there was little research which would suggest that consumers would be safe from harm after being implanted with a Stryker Rejuvenate or ABGII. The Stryker hip implant recall left many injured consumers wondering what to do next; many had astronomical medical expenses associated with the Stryker hip implant recall, had been off work for extended periods of time, and were in constant pain. Many more were facing costly and risky revision surgery following the Stryker hip implant recall. For many of those patients, the Stryker hip implant recall warranted a visit to a compassionate, experienced Stryker hip recall attorney in order to pursue compensation for injuries.

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Author: Andrew Sullo
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Andrew Sullo

Andrew SulloAndrew Sullo

Andrew Sullo is a National Trial Lawyer's Top 100 Selection for 2013-2018. He is also a member of the American Association of Justice.

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