In another hit to the safety of metal-on-metal hip replacements, Stryker announced Friday that it is voluntarily recalling two metal-on-metal hip products prompted by fears of corrosion.
The company said that the Rejuvenate and ABG II modular neck him stems are being recalled given the ” potential risks associated with fretting and corrosion at the modular neck junction.”
In late June, the Food and Drug Administration conducted hearings to determine the safety of metal-on-metal hip replacements. The scrutiny comes from mounting evidence that these products appear to fail early, often cause swelling and pain, among other complications. Sometimes surgeons have to perform a revision surgery. The webcasts of the two days of FDA hearings can be seen here and here.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In a website meant to communicate with patients who either have a Stryker hip or one of the two recalled products, Stryker says the incidence of complications arising out of these products is “extremely low.” Still it advised patients who have these implants to contact their surgeon.
In the FDA database that tracks adverse events, there are multiple reports associated with the Rejuvenate neck stem that show that many patients suffered pain, swelling and required revision surgery.
