A New Jersey-based hip implant manufacturer is being sued by one woman who claims the medical device has caused long-term, serious injuries, The Pennsylvania Record reports.
According to the media outlet, the woman, Stephanie Teoli from Montgomery County, Pennsylvania, alleges the health problems started after receiving hip replacement surgery at Thomas Jefferson University Hospital in Philadelphia in 2011. In the complaint, Teoli alleges The Rejuvenate System, developed by New Jersey’s Howmedica Osteonics, caused serious pain shortly after the the initial surgery.
Although a follow up found the device had been installed correctly and appeared to be working, a blood test confirmed Teoli had been suffering from heavy metal ion contamination. A subsequent MRI indicated tissue surrounding the hip replacement had reacted with the device, causing serious pain. When surgeons performed corrective surgery on Teoli, they found that the hip insert had experienced significant corrosion, the media outlet stated
In the lawsuit, Teoli alleges Howmedica produced and distributed an entire series of defective medical devices that the manufacturer had already learned may induce heavy metal contamination in humans. When asked, the medical device maker conceded that it had previously heard reports of similar cases. The company also said it released an Urgent Safety Notice to healthcare centers that may be using the product.
In the warning, the company listed the defects and the health problems that had been reported, which were allegedly the same as what Teoli experienced.
“This corrosion and fretting was exactly the same failure mechanism that Defendant had warranted would not occur because of the Rejuvenate System’s design and composition,” the complaint, obtained by the Record, read. “It was also exactly the same failure mechanism that the medical and scientific community had been studying and documenting in modular implant device design since the 1980s.”
The lawsuit uses may instances from the warning letter as examples that showed Howmedica was allegedly aware of the possible side effects the company’s hip implant could come with. These health conditions include tissue necrosis, metallosis, adverse soft tissue reaction and pseudotumor formation.
Howmedica is not alone in being sued, however. For years, the FDA has been warning the public about metal-on-metal hip replacement devices, and met with many manufacturers to develop recalls of a variety of products. This could prompt medical device makers to focus on safety and testing before releasing products to the public, which could significantly lower costs associated with recalls and settlements.