FDA Recalls and Warnings For Defective Hip Implants
The United States Food and Drug Administration (FDA) is the federal agency charged with protecting the American public from harm that can be caused by unsafe drugs, medical devices and other consumer products.
When an FDA regulated product appears to be either defective or has the potential to harm the public it is the FDA's job to warn the public of the potential for harm, work with the manufacturer to correct the problem and, in the most serious cases, request that the product be recalled. While most recalls are voluntary, the FDA does have the right to seek the assistance of the legal system to force a recall that it deems necessary to protect the public interest.
In order to help the public more effectively understand the gravity of a particular recall the FDA divides the recalls into 3 categories based upon the degree of potential harm:
- Class I: Products that can cause serious bodily injury or death.
- Class II: Products that pose only a potential short term injury or that pose an overall slight risk of injury.
- Class III: Products that are unlikely to pose a health risk but that contain a false or misleading element in the promotion of the product.
Hip Implant Recalls
In an attempt to increase mobility for hip replacement patients, many of the leading device manufacturers, using the FDA's controversial 510(k) provision, began offering hip replacement devices using metal components nearly a decade ago. Some of the new products used a metal-on-metal (MOM) design while others used varying degrees of metal in the manufacturing process. It is estimated that over 500,000 patients have received hip products with metal parts in the years since their introduction.
Beginning within a few years after their introduction voluntary recalls citing potential class one injuries have grown for the MOM devices as well as some using individual metal components.
DePuy's Recalled Hip Implants
In 2010 DePuy Othopaedics issued a voluntary recall for it's ASR Hip device. Out of the estimated 93,000 patients that have received the ASR device it is estimated that over 10,000 people have made claims for product failure or bodily injury associated with the device.
Complaints include product loosening and dislocation, as well as damage to tissue and organs caused by the release of metal ions into the body as a result of friction or fretting of the metal parts.
Stryker's Recalled Hip Implants
In 2012 the Stryker Corporation was forced to recall both its Rejuvenate and ABG II devices for much the same reasons that caused the Depuy recall, including metallosis, which is the name for the problems caused when the devices shed metal ions into the body and blood stream of the patient.
Other Recalled Hip Products
The list of other manufacturers who have voluntarily or otherwise recalled any of their hip replacement products include:
- Smith and Nephew
- Wright Medical
- Zimmer Holdings
If you or a loved one have been implanted with a recalled hip device or had a hip replacement but are not sure as to whether your device has been recalled feel free to contact our Patient Advocates for help in sorting out what you need to know. Further, if you would like to speak with an attorney from a nationally renowned law firm that specializes in hip replacement lawsuits, simply ask our Patient Advocate to set up a free consultation for you.
Statistics suggest that patients that are represented by an experienced attorney recover on average three times as much compensation for their losses over those that deal directly with the manufacturer or its paid representative. From the perspective of what is best for the treatment of your injuries and what is best for your economic interests it is imperative that you speak with someone who's sole interest is protecting your rights.