Robinson Calcagnie Robinson Shapiro Davis, Inc. Investigating Metal-on-Metal Hip Implants as FDA Releases New Safety Recommendations
On January 17, 2013, the U.S. Food and Drug Administration (FDA) announced updated safety data and suggestions regarding the benefits and risks of metal-on-metal hip implants from a June 2012 Orthopedic and Rehabilitation Devices Advisory Panel meeting.
Newport Beach, CA (PRWEB) January 21, 2013
As a national product liability law firm, Robinson Calcagnie Robinson Shapiro Davis, Inc. finds it of the utmost importance for consumers – especially those who have received or are planning to receive hip implants – to be aware of the recent announcement and possible changes. In relation to the release of the FDA hip replacement safety recommendations, which can be found at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm, [The New York Times reported on January 16 that the proposed rules have the potential to force manufacturers to remove metal hip implants from the market and stop them from selling such products.
Proof of Safety & Effectiveness
The FDA proposal explains that all-metal artificial hip manufacturers would be required to prove that the devices are safe and effective before continuing to sell existing products on the market or getting approval for new all-metal designs. This may seem like an extreme request to some; however, as The New York Times points out, approximately 500,000 patients in the United States who received all-metal hip implants have reported hip replacement failure.
So what has the protocol been for hip devices up until now? The New York Times also emphasizes that manufacturers have been required to demonstrate that the hip devices are similar to those already on the market. In addition, hip manufacturers have not been required to carry out clinical studies before selling these devices, as the article states.
With this being said, it is important to note that, according to The New York Times, it could take one year for the FDA's proposed rules for all-metal hip replacements to come to fruition as industry lobbyists may oppose its integration or try to change it. However, according to the article, if the rules do go into effect, manufacturers will be given 90 days to submit clinical data on device safety and effectiveness.
The following are some metal-on-metal hip devices that the law firm is currently investigating whether, based on the FDA's proposed rule, additional clinical data on safety and effectiveness may be required: Biomet M2a (and Magnum); DePuy Pinnacle with metal insert/liner (Pinnacle Ultamet); Wright Profemur; and Smith & Nephew R3 with metal insert/liner.
There may be other metal-on-metal hips that are no longer sold but which may be implanted in current patients. Additionally, Robinson Calcagnie Robinson Shapiro Davis, Inc. is investigating the recently recalled Stryker Rejuvenate model which, although does not have a “metal on metal” ball and socket design, does have metal-on-metal components that can lead to fretting and abrading, which could send chromium and cobalt particles into a client's surrounding tissue and bloodstream.
Concerns over Metal
As the FDA has stated, the design of metal-on-metal hip implants is such that the metal ball and the metal cup rub against each other when a person walks or runs. The FDA has explained that this friction allows for metal to be released from other sections of the implant where the ball and cup connect. When metal is released, as noted by the FDA, tiny metal particles may come off of the device around the implant, putting a patient at risk of suffering bone and/or soft tissue damage near the implant and joint. If this happens, the FDA states that an individual may endure pain, their implant may become loose, or the device may fail altogether, leading to revision surgery.
Another problem experienced by some patients that has been emphasized by the FDA is the release of metal ions into the bloodstream which then travel to other parts of the body, creating the possibility of additional symptoms or illnesses. However, the FDA states that it does not have sufficient scientific data to specify the concentration of metal ions in a person's body or blood that would lead to adverse systemic effects. Also, the side effects appear to be specific to individual patients as different people have experienced different reactions to the metal wear particles. The FDA metal-on-metal hip implant webpage provides additional information for patients who have received a hip implant or are planning to receive one.
A Demand for Change
The national medical device lawyers at Robinson Calcagnie Robinson Shapiro Davis, Inc. are diligent in protecting the rights of their clients to not only help them on their path of recovery but also create widespread change to help prevent others from suffering similar consequences. From successfully handling cases against Toyota to Big Tobacco, Robinson Calcagnie Robinson Shapiro Davis, Inc., has the legal experience and resources necessary to take a stand and make an impact for the greater good.
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