New Metal-on-Metal Hip Implant Guidance from FDA Instructs Doctors to Consider Blood Tests for Patients Experiencing Symptoms

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Bernstein Liebhard LLP is currently investigating lawsuits on behalf of individuals injured as a result of metal-on-metal hip replacement devices.

Bernstein Liebhard LLP | Consumer Injury Lawyers
Individuals with all-metal hips who are experiencing pain, swelling or other issues should speak with their doctors as soon as possible.

For patients fitted with metal-on-metal hip implants, federal regulators have instructed doctors to consider metal ion testing if patients are experiencing symptoms of hip implant failure, Bernstein Liebhard LLP reports. In a Safety Communication issued yesterday, the FDA cautioned that metal debris released when the ball and cup of an all-metal hip slide against each other may cause damage to bone and/or soft tissue surrounding the implant and joint. Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body, the agency said*

“This is the first time the FDA has explicitly suggested blood tests for symptomatic metal-on-metal hip replacement patients. Individuals with all-metal hips who are experiencing pain, swelling or other issues should speak with their doctors as soon as possible,” 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.

Metal-on-Metal Hip Implants
The new FDA guidance applies to hip implants that consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys. According to the FDA, follow-up of asymptomatic all-metal hip patients, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years). Patients with metal-on-metal hip 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 is advising that patients consult with their surgeons as soon as possible should they experience new or worsening symptoms, including pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in the ability to walk. The agency has also recommended that patients let their doctors know they have an all-metal hip if they experience changes in their general health, including new or worsening symptoms outside the hip.

The FDA has been reviewing the safety of metal-on-metal hip implants since February 2011. In addition to the guidance announced yesterday, the agency issued a proposed order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications. The proposal would make such devices ineligible for 510(k) clearances, which do not require that a device undergo human testing if it can be shown it is substantially equivalent to a product previously approved by the FDA. If finalized, the new regulations would require manufacturers of all-metal hips to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new metal-on-metal designs **

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.

  • fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm?source=govdelivery

**federalregister.gov/articles/2013/01/18/2013-01006/effective-date-of-requirement-for-premarket-approval-for-two-class-iii-preamendments-devices

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.

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(877) 779-1414

ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. The lawyer responsible for this advertisement in the State of Connecticut is Amy L. Abate. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
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Contact Information:
Felecia L. Stern, Esq.
Bernstein Liebhard LLP
info(at)consumerinjurylawyers(dot)com
http://www.consumerinjurylawyers.com

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Felecia L. Stern
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