The U.S. Food and Drug Association’s (FDA) examination of metal-on-metal hip implants, and the wave of litigation against the makers of recalled hip implants, has revealed some disturbing information regarding what the hip implant manufacturers may have known about the safety of all-metal hip implants. Specifically, court documents made public in connection with a lawsuit against Johnson & Johnson reveal that the company may have known about the dangers associated with all-metal hip implants but did not release that information to the public.
Internal company documents of Johnson & Johnson revealed that an internal analysis conducted by the company in 2011 estimated that the all-metal hip implants would fail within five years in nearly 40 percent of patients who received it. Not only did Johnson & Johnson fail to release these daunting projections, but it also continued to downplay similar findings, according to an article in the New York Times.
Pretrial testimony also included statements from a DePuy engineer that company officials knew about reports by an English surgeon that the resurfacing version of the A.S.R. hip implant was releasing high levels of metallic ions, particularly in women, as early as 2008, which caused the company to move quickly to redesign the implant.
DePuy Orthopaedics, a division of Johnson & Johnson, recalled the DePuy ASR XL Acetabular System and the ASR Hip Resurfacing System in 2010, citing higher-than-normal failure rates of the devices. Despite the 2010 recall, however, executives of DePuy have long since downplayed the risks associated with metal-on-metal hip implants, according to the New York Times.
More than 10,000 lawsuits have been filed against Johnson & Johnson by patients who received the recalled DePuy implant systems. About 7,000 of those lawsuits have been consolidated in a federal court in Ohio, with an additional 2,000 cases consolidated in a California state court.
As we reported, the FDA has proposed regulations that would require makers of metal-on-metal hip implants to file approval applications that meet the strictest level of review for medical devices. Last summer, the FDA issued a report indicating that data revealed that metal-on-metal hip replacement systems are more likely to fail than other hip implant devices.
Metal-on-metal hip implants, like the Stryker Rejuvenate and ASR II hip implants, have been associated with significant risk of developing serious complications including tissue damage, device failure, bone and muscle deterioration, necrosis, hip and groin pain, inflammation, numbness, metallosis, or the buildup of metallic ions in the tissues of the body, dislocation of non-cemented implants, pseudotumors, and other medical problems. Some patients may require a subsequent corrective surgery to remove and replace the recalled Stryker hip product.
Patients who have received a recalled metal-on-metal hip implant should consult with their doctor immediately. According to Bloomberg, the FDA recommends that patients receive radiographs at least every two years even if they aren’t experiencing any symptoms that would indicate that the metal-on-metal hip implant is failing.
You may also wish to consult with a skilled hip implant attorney since you may be entitled to compensation for your injuries, including medical expenses, lost wages, and pain and suffering, in a product liability or medical malpractice lawsuit. Contact the Chicago product liability lawyers at Ankin Law Offices, LLC at (312) 600-0000 to learn more about the dangers of all-metal hip implants.