Stryker Hip Recall Suit Spurs New FDA Regulations

 Posted on November 07,2013 in Defective Medical Devices

In late September, spurred by the massive Stryker hip recall earlier this year, “the U.S. Food and Drug Administration (FDA) is launching a new system for identifying high-risk medical devices… that is says will target product problems more quickly and improve patient safety,”according to Newsday. The Stryker hip recall, the firm announced in late October and reported by PRWeb.com, will cost “anywhere from $700 million to $1.13 billion.” The devices affected some 20,000 patients across the country, and the company is now answering to more than 600 lawsuits from patients who are “alleging pain, swelling, metallosis and other complications” in one of the largest defective medical device recalls in history. Cases allege that “Stryker failed to adequately warn about the potential for this complication,” according to PRWeb.com.

All patients who received the implant have been advised by the manufacturer to “undergo routine cross-sectional imaging and blood testing to monitor for elevated metal levels in the blood stream,” according to PRWeb.com. This is being advised whether patients are feeling symptoms of the endemic to the recall or not.

According to Newsday, the Stryker lawsuits were first brought forth in July 2012. The new FDA regulations, according to Newsday, “will allow federal regulators to efficiently identify medical devices and improve the accuracy of adverse event reports indicating possible issues with each one.” This doesn't necessarily mean that all FDA approved medical devices will be free from complications, but that patients will rather be more aware of the risks they take when using them.

The FDA offers a comprehensive rundown of its advisories for medical devices and products on its website. The agency does, in fact, have a detailed listing of risks associated with metal-on-metal hip implants, stating recommendations for patients, tips for follow-up, and suggested additional procedures of which patients should be aware.

If you or someone you know has been affected by a defective medical device, don't go through it alone. The most important first step is to contact an experienced defective medical device attorney today.