FDA Proposes Crackdown on Metal-on-Metal Hip Implants
The Jacksonville hip replacement defect attorneys at Farah & Farah have been following the news on metal-on-metal hip implants very closely. Now, the U.S. Food and Drug Administration (FDA) is proposing taking a big step toward keeping these defective devices from reaching the market.
According to Med Page Today, the FDA recently issued a “proposed order” that would require hip replacement manufacturers to show valid scientific evidence that their products are safe before they can be put on the market. Amazingly, scientific tests on many defective hip implants were never thoroughly completed, because the manufacturers only had to show “substantial equivalency” to a previous FDA-approved device to get their products onto the market.
After looking at more than 100 studies on metal-on-metal hip implants, the agency came to the conclusion that these devices may pose problems for women and for patients who had larger-sized hip implants.
A Safety Communication posted on the FDA website notes that metal-on-metal hip replacements have risks over and above the general risks that all hip implants present. The communication cites that metal release can damage the soft tissue or joint surrounding the implant, which can lead to pain, device failure, and the need for revision surgery.
The agency also expresses concerns over metal ions being released into a patient’s bloodstream, which could lead to blood poisoning and other illnesses. The communication also noted several other adverse reactions that may occur in patients who have received the metal-on-metal implants.
In May 2011, the FDA ordered companies that manufacture these hip devices to conduct post-market surveillance after high incidents of device failure were reported and significant recalls of various metal-on-metal devices were issued.
If you believe you or a loved one has suffered injures due to a defective hip implant, the law office of Farah & Farah would like to talk to you about your legal options. We offer a free consultation and can discuss how you can proceed with your case. We aren’t afraid to take on large medical device corporations in order to protect your legal rights. Call us at (800) 533-3555 or contact us online today.