Parker Waichman LLP Applauds FDA Decision to Convene Advisory Panel Meeting to Further Review the Risks of Metal-on-Metal Hip Implant Side Effects and Complications

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FDA Announced Two-Day Meeting of its Orthopaedic and Rehabilitation Devices Panel for June 27 and 28, 2012, to Discuss the Risks and Benefits of Metal-on-Metal Hip Implant Systems, and Make Patient and Practitioner Recommendations for their Use.

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Parker Waichman LLP is hopeful the outcome of this meeting will be strong regulations aimed at protecting patients from the potentially catastrophic health consequences that may be associated with the use of metal-on-metal hip implants.

Parker Waichman LLP, a national law firm representing victims of defective hip implants and other medical devices, applauds the decision of the Food & Drug Administration (FDA) to convene a meeting of its Orthopaedic and Rehabilitation Devices Panel to discuss the risks and benefits of metal-on-metal hip implants, and make recommendations for their use. Parker Waichman LLP is hopeful that this meeting, scheduled for June 27 and 28, 2012, will ultimately result in much more stringent regulation of metal-on-metal hip replacement devices. [fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297745.htm]

Parker Waichman LLP is already representing scores of plaintiffs in personal injury lawsuits filed against the makers of all-metal hip implants, including DePuy Orthopaedics's recalled ASR Acetabular 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 before Judge David A. Katz in the U.S. District Court for the Northern District of Ohio (MDL 2197). DePuy Pinnacle hip implant lawsuits have been consolidated in a multidistrict litigation before Judge James E. Kinkeade in the U.S. District Court for the Northern District of Texas (MDL 2244).

Metal-on-metal hip implants have been the subject of growing concerns since the August 2010 worldwide recall of the DePuy Orthopaedics' ASR Hip Resurfacing System and ASR Acetabular System. The recall was issued after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. According to Parker Waichman LLP, since the DePuy ASR hip implant recall, evidence has mounted that such devices can shed potentially dangerous amounts of metal debris into patients' blood streams, leading to serious health risks, including tissue damage, device failure, additional surgeries, disability, and possibly cancer.

Earlier this month, a large study published in The Lancet showed that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years. The revision rate for patients with all-metal hip replacements was three times greater than the revision rate seen with other types of implants. The risk of early failure was particularly high for patients with larger-head implants and those used in women. "Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted," the study authors wrote. [thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext]

In February, a report in the British Medical Journal revealed that metal-on-metal hip implant manufacturers were aware of mounting evidence linking the devices to serious, long-term health consequences, but for years failed to warn the public about these dangers. The report warned that hundreds of thousands of people around the world may have been exposed to dangerously high levels of toxic and potentially cancer-causing metals from failing metal-on-metal hip implants.[bmj.com/content/344/bmj.e1410]

Last May, the FDA directed 21 companies that market all-metal hip replacement devices to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. The scheduling of the June advisory panel meeting was announced by the FDA yesterday. The panel of outside medical and scientific experts will discuss metal-on-metal hip implants used in total hip replacement surgeries, as well as hip resurfacing. Topics to be discussed include failure rates and modes; metal ion testing; imaging methods; local and systemic complications; patient risk factors; and considerations for follow-up after surgery, the announcement said. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm]

Parker Waichman LLP supports the FDA's decision to subject metal-on-metal hip implants to further review. The firm is hopeful the outcome of this meeting will be strong regulations aimed at protecting patients from the potentially catastrophic health consequences that may be associated with the use of metal-on-metal hip implants.

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 one 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
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

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Herb Waichman, Partner
Parker Waichman LLP
(800) 529-4636
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