FDA Moves to Classify Metal-on-Metal Hip Replacements as “High Risk” Medical Devices, Tells Doctors to Consider Blood Tests to Detect Metal Ion Levels for Patients Experiencing Problems with All-Metal Hips
Wright & Schulte LLC, an experienced defective medical device law firm, is warning recipients of metal-on-metal hip implants that they may be at risk for metallosis and other health issues. In a Safety Communication issued January 17th, the U.S. Food & Drug Administration (FDA) cautioned that metal ions shed from metal-on-metal hip replacements can cause soft-tissue damage and pain, possibly leading to revision surgery to replace the implant. This warning includes metal-on-metal hip replacement implants such as the DePuy ASR Hip Replacement Implants, DePuy Pinnacle Hip Replacements (all-metal version that utilizes the Ultamet liner), and Stryker Rejuvenate and ABG II Modular-Neck Replacement Hip Stems. The FDA further warned that these metal ions can make their way into the blood stream, where they may cause systemic reactions in other tissue and organs.
Contact Wright & Schulte LLC’s hip replacement lawyers regarding your recalled hip or inquire about a free metal-on-metal hip replacement lawsuit evaluation for those individuals who suffered serious complications due to metal hip replacement implants, including:
- DePuy ASR Hip Replacement Implants
- DePuy Pinnacle Hip Replacements (all-metal version that utilizes the Ultamet liner)
- Stryker Rejuvenate and ABG II Modular-Neck Replacement Hip Stems
For more information on filing a metal-on-metal replacement hip implant lawsuit, or to arrange for a free legal consultation, please visit yourlegalhelp.com.
According to the FDA’s January 17th Safety Communication, adverse event reports related to metal-on-metal hip systems include:
- Pain near or around the metal-on-metal hip replacement implant
- Malposition of the metal-on-metal hip replacement implant
- Adverse local tissue reaction near or around the metal-on-metal hip replacement implant
- Metallosis or metal ions in the bloodstream
- Hypersensitivity near or around the metal-on-metal hip replacement implant
- Loosening of the metal-on-metal hip replacement implant
- Dislocation of the metal-on-metal hip replacement implant
The FDA began reviewing the safety of metal-on-metal hip replacement implants in February 2011, in the wake of the August 2010 DePuy ASR hip replacement implant recall. An all-metal device, the ASR hip replacement was pulled from the market after it was found to be failing in 12% of patients within five years of implantation. Last July, an FDA advisory panel concluded that there were few reasons for using all-metal hip replacements, as their benefits did not outweigh their risks. According to the FDA Safety Communication, information from that advisory panel meeting was instrumental in the formulation of its new recommendations.
Among other things, the FDA is urging metal-on-metal hip replacement implant recipients to consult their doctor if they experience new or worsening pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in their ability to walk. Because of the risk of systemic reactions, the agency is also recommending that patients inform their doctors that they have an all-metal replacement hip if they experience changes in general health, including new or worsening symptoms outside of their hip. Patients with metal-on-metal hip replacement implants who develop any symptoms or physical findings that indicate their device may not be functioning properly should be considered for metal ion testing, the FDA said.
The FDA has also proposed new regulations that would classify metal-on-metal replacement hip implants as “high-risk” medical devices. The proposed rules would require manufacturers of all-metal hip replacements to submit premarket approval applications in order to continue selling them, or to bring new designs to market. Metal-on-metal hip replacements currently on the market were approved via the FDA’s 510(k) process, which does not require a device to undergo human testing if it is similar to a product already approved by the FDA. The new regulations being proposed by the agency would make metal-on-metal replacement hips ineligible for 510(k) approval.
About Wright & Schulte LLC
Wright & Schulte LLC, a metal-on-metal replacement hip implant injury law firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright Schulte LLC stand up for the rights of people who have been injured or wronged, and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free metal-on-metal hip replacement implant lawsuit evaluations are available through yourlegalhelp.com, or call 1-888-365-2602.