Stryker agreed to pay more than $1 billion to resolve lawsuits involving thousands of hip implants recalled in 2012. Stryker will pay approximately $300,000 to patients who had revision surgery. The revision surgery entails the removal of the medical device. Typically the revision surgery occurs because of pain, swelling and metal debris.
The Stryker Rejuvenate system was approved by the FDA in June 2008 and the ABG II system was approved in November 2009. Unlike many hip implant systems, Stryker’s Rejuvenate and ABG II systems include several neck and stem components. The purpose was to provide surgeons with greater flexibility. The rejuvenate system was targeted towards younger patients looking for a system that would provide greater survivorship.
Stryker withdrew its Rejuvenate and ABG II devices in July 2012 after there were significant concerns regarding the safety of the products. An estimated 5,000 lawsuits have been filed against Stryker.
This settlement comes on the heels of the Johnson & Johnson settlement in which J&J agreed to pay $2.5 billion to resolve its litigation involving the ASR hip implant. Much like Stryker, Johnson and Johnson removed its products from the market after there were concerns regarding the durability of the hip implants.
As we have blogged about previously, there is significant concern over metal-on-metal hip implants. Additionally, cup wear can contribute to the accumulation of metal debris. An adverse reaction to the metal ions can result in an adverse local tissue reaction or an adverse reaction to metal debris. Subsequently, these reactions can cause osteolysis, ALVAL (aseptic lymphomaticvasculitis-associated lesions) and pseudotumors.
Due to widespread concern about the use of metal-on-metal hip implants and injuries associated with the use of these implants, the FDA held an advisory committee meeting in June 2012. The FDA indicated that recent data from orthopaedic implant registries, peer reviewed journal publications and presentations at scientific meetings have shown that these metal-on-metal hip systems have been linked to serious side effects including psuedotumors, early device failure, the need for revision surgery and complications associated with metal ion exposure.