The existing 510(k) premarket notification process clearly is inadequate to address the substantial number of serious problems associated with metal-on-metal hip implant devices.
Phoenix, Arizona (PRWEB) February 12, 2013
Phoenix attorney Van O’Steen has asked the federal Food and Drug Administration (FDA) to expand its existing regulation of all metal-on-metal (MoM) hip implant devices. O’Steen’s law firm represents patients throughout the United States who have been seriously harmed by the failure of DePuy, Biomet, Stryker and Wright implants.
In a letter to the FDA dated February 12, 2013, O’Steen wrote in support of the FDA’s newly published Proposed Order requiring that metal-on-metal hip athroplasty implant manufacturers submit premarket approval applications to the federal agency. “The existing 510(k) premarket notification process clearly is inadequate to address the substantial number of serious problems associated with metal-on-metal hip implant devices,” O’Steen wrote.
O’Steen noted that a Los Angeles Superior Court judge just unsealed documents revealing that the DePuy ASR metal-on-metal hip implant is expected to fail in 37% of patients within five years of implantation. According to the previously unpublished documents, these alarming data came from a 2011 internal analysis conducted by the device manufacturer, Johnson & Johnson.
“Already, more than 10,000 lawsuits are pending in state and federal courts filed by patients who claim to have been injured by DePuy ASR implants. This is, of course, not surprising in view of the Company’s own failure rate data. Similar suits are pending against the manufacturers of other metal-on-metal hip devices,” O’Steen added.
O’Steen wrote that the problem will become worse as thousands more patients are likely to experience failure of their implants in coming years. He concluded that “existing regulation of metal-on-metal implants is clearly inadequate to protect the public. The FDA’s recently published Proposed Order should be made permanent.”
O’Steen urges all implant patients who are experiencing any symptoms to promptly consult their physicians. Common symptoms include joint pain, inflammation, device dislocation, bone fractures and infections.
About O’Steen & Harrison, PLC
O’Steen & Harrison, PLC has protected the rights of injured accident victims and their family members since 1974. The firm concentrates on personal injury and dangerous products with a special emphasis on harmful drugs and defective medical devices. O’Steen & Harrison is av-rated (the highest rating) by the prestigious Martindale-Hubbell Law Directory. The firm’s attorneys have recovered more than $3 billion dollars for clients. O’Steen & Harrison offers free, confidential consultations to those who have been injured. Call toll free 1-800-883-8888 or see our website at http://www.vanosteen.com.
RESOURCES: Letter from Van O’Steen to the U.S. Food and Drug Administration dated January 28, 2013; Krausky v. DePuy, BC456086, Los Angeles County Superior Court; In re DePuy Orthopedics, Inc., 10-MD-2197, U.S. District Court, Northern District of Ohio; “Maker Aware of 40% Failure in Hip Implant” by Barry Meier, The New York Times, January 22, 2013.