We have heard from hundreds of individuals fitted with all-metal hips, including many women, who have suffered serious complications due to failure of their device.
New York, New York (PRWEB) February 11, 2013
The new metal-on-metal hip implant guidance recently issued by the U.S. Food & Drug Administration (FDA) included a caution that certain patient populations, including women, may face greater risks from all-metal hips, Bernstein Liebhard LLP reports. The FDA has been investigating metal-on-metal hip replacements since February 2011, amid concerns that the friction between their chromium/cobalt ball and cup could cause the devices to shed dangerous amounts of metal ions into surrounding tissue and blood stream.*
“We have heard from hundreds of individuals fitted with all-metal hips, including many women, who have suffered serious complications due to failure of their device. We are pleased that the FDA is acting,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is actively filing lawsuits involving metal-on-metal hip implants marketed by a number of manufacturers, and continues to offer free legal evaluations to alleged victims of all-metal hips. The metal-on-metal hip implant complications detailed by the FDA’s January 17th Safety Communication echo what the Firm has heard from its clients.
Metal-on-Metal Hip Implant Complications
In a Safety Communication issued on January 17th, the FDA said the metal ions shed from metal-on-metal hip replacements may cause damage to bone and/or soft tissue surrounding the implant and joint. As a result, patients may experience pain, implant loosening, device failure and the need for revision surgery. Metal ions released from all-metal hips can also travel through the bloodstream, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions). Among other things, the FDA cautioned doctors to be aware that certain patients may be at risk for increased device wear and/or adverse local tissue reactions and should be followed more closely. In addition to women, these patient populations include:
- Patients with bilateral implants (replacement of both hips)
- Patients with resurfacing systems with small femoral heads (44mm or smaller)
- Patients receiving high doses of corticosteroids
- Patients with evidence of renal insufficiency
- Patients with suppressed immune systems
- Patients with suboptimal alignment of device components
- Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
- Patients who are severely overweight
- Patients with high levels of physical activity
The FDA is now advising doctors to consider metal ion testing if patients are experiencing symptoms of hip implant failure. In addition to the new guidance, the FDA also proposed an order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications, which would make them ineligible for 510(k) clearances. The all-metal hips currently on the market were approved via the 510(k) process, which allows devices to come to market without human testing.
Victims of metal-on-metal hip implant complications may be entitled to compensation for their medical bills, lost wages, pain and suffering, and other damages. The lawyers at Bernstein Liebhard LLP are actively filing claims in the multidistrict litigation established in the U.S. District Court, Northern District of Ohio, for actions involving the DePuy ASR hip implant (MDL No. 2197). Firm partner, Jeffrey Grand, is serving on the Plaintiffs’ Steering Committee for the federal litigation underway in the Northern District of Texas concerning the metal-on-metal DePuy Pinnacle hip device (MDL No. 2244). Free case evaluations are also being offered to patients impacted by the July 2012 Stryker Rejuvenate recall, and the June 2012 Smith & Nephew metal liner recall. In addition, Bernstein Liebhard LLP continues to investigate cases concerning the Biomet M2a Magnum hip implant, as well as Wright Profemur and Conserve metal hip implants.
A wealth of information about metal-on-metal hip implant lawsuits is available at Bernstein Liebhard’s website http://www.consumerinjurylawyers.com/ . For additional information, please contact one of our attorneys today by calling 1-877-779-1414.
About Bernstein Liebhard
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.
Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP