Parker Waichman LLP calls on the U.S. Congress to take up this matter with the FDA, and urge the agency in the strongest possible manner to order removal of all-metal hip implants from the market immediately.
New York, New York (PRWEB) March 15, 2012
Parker Waichman LLP is calling on the U.S. Congress to act now to address the serious public health threat posed by metal-on-metal hip implants. According to the firm, an accumulating body of evidence has linked exposure to high levels of toxic metal ions shed by failing metal-on-metal hip implants to serious health threats, including systemic toxicity that could put the nervous system, heart and lungs at risk of being slowly poisoned. In light of these risks, Congress must urge the U.S. Food & Drug Administration (FDA) to order removal of metal-on-metal hip implants from the market. In addition, Parker Waichman calls on Congress to adopt legislation that would reform the way medical devices are approved by the FDA, in order to avoid a repeat of the metal-on-metal hip implant debacle.
Parker Waichman LLP is already representing scores of people allegedly injured by metal-on-metal hip implants, including DePuy Orthopaedics's recalled ASR Acetabular Hip Implant System, as well as a metal-on-metal version of the DePuy Pinnacle Acetabular Cup System. Lawsuits involving the ASR hip implant have been consolidated in a multidistrict litigation in the U.S. District Court for the Northern District of Ohio (MDL 2197). Meanwhile, DePuy Pinnacle hip implant lawsuits have been consolidated in a multidistrict litigation in U.S. District Court for the Northern District of Texas (MDL 2244). According to the firm, its attorneys are hearing from metal-on-metal hip implant recipients who have suffered serious health problems, including the need for revision surgery and permanent disability, on an almost daily basis
In just the past several months, evidence against the use of metal-on-metal hip implants has accumulated at an astounding rate. In a study published in The Lancet on March 12, 2012, researchers from the University of Bristol called for an end to use of these devices in total hip replacement after an analysis of data from the National Joint Registry of England and Wales found that patients with all-metal hip implants were twice as likely to experience early failures as those who receive other types of hip implants. The study covered more than 400,000 hips replacements, including 31,171 all-metal ones, that were implanted between 2003 and [2011.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext]
In early February, the U.K.'s Sunday Telegraph reported that preliminary results from another study conduced at the University of Bristol found that 1 in 5 patients fitted with an all-metal hip implant experienced changes to cells in the bladder that could be precursors of cancer. Just two weeks ago, the U.K.'s Medical and Health Products Regulatory Agency advised that patients with large diameter metal-on-metal hip joints should have annual blood tests and possibly MRI scans for the lifespan of the joint. The British Hip Society has gone even futher, advising surgeons not to use large-diameter metal-on-metal hip implants with bearings 36 mm or larger in total hip replacement procedures. [telegraph.co.uk/health/9061781/Hip-replacement-patients-could-face-increased-risk-of-cancer.html; mhra.gov.uk/NewsCentre/Pressreleases/CON143784; britishhipsociety.com/MoM%20Update.htm]
The scope of the public health threat posed by metal-on-metal hip implants is staggering. According to a report published last month in the British Medical Journal, metal-on-metal hip replacement devices have been implanted in 60,000 patients in England and Wales since 2003. In the U.S. the figure is closer to a million and likely to increase, as device makers continue to promote all-metal implants to doctors. That same report also found that the manufacturers of all-metal hip devices were aware of mounting evidence linking them to serious, long-term health consequences, but for years failed to warn the public about these dangers. [bmj.com/content/344/bmj.e1539/rr/571634]
Last May, as concerns over the safety of metal-on-metal hip implants were growing, the FDA ordered 21 manufacturers of the devices to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metal debris. However, the evidence that has accumulated since then against the use of metal-on-metal hip implants now indicates that nothing short of a ban on the use of these devices will adequately protect patients, according to Parker Waichman LLP. The firm calls on the U.S. Congress to take up this matter with the FDA, and urge the agency in the strongest possible manner to order removal of all-metal hip implants from the market immediately. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm]
Parker Waichman LLP also calls on Congress to pass legislation to reform how medical devices are approved for sale by the agency. According to the British Medical Journal, most of the metal-on-metal hip implant devices currently on the market were approved through the FDA's 510(k) clearance protocols, which do not require human studies if a device is shown to be similar to another already on the market. According to the firm, metal-on-metal hip implants been subjected to more premarket scrutiny, their safety issues may have been detected and their approval prevented. Last summer, the Institute of Medicine issued a report highlighting deficiencies with 510(k) clearances and recommended that the FDA scrap the program entirely. The debacle surrounding metal-on-metal hip implants is just more evidence that the 510(k) process is not sufficient to protect the public from dangerous medical devices and must be reformed, according to Parker Waichman LLP. [iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/Report-Brief.aspx]
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries, including DePuy Orthopaedics' ASR Hip Implant and the metal-on-metal version of the Pinnacle hip replacement device. If you or a loved experienced premature failure of your implant or other health problems associated with metal-on-metal hip replacement devices, please contact their office by visiting the firm's defective hip implant page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding defective hip implant lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Contact: Parker Waichman LLP
Herbert Waichman, Partner