FDA Holds 2-Day Session to Discuss Metal-on-Metal Hip Implants
According to experts, metal-on-metal hip implants may cause serious injuries that require patients to undergo a second surgery, known as revision surgery. Small metal fragments can shed off the implants as the parts rub against each other, causing inflammation and infection in surrounding tissue that can lead to chronic pain. The metal shavings can also lead to high levels of metal in the bloodstream.
To date, more than 500,000 Americans have received a metal-on-metal hip implant.
The U.S. Food and Drug Administration (FDA) will hold a two-day session, starting today, to review problems with these devices.
"Data from recent studies and from FDA’s own review show some patients experiencing complications, including the need for additional surgeries, which could be attributed to metal-on-metal hip implant devices," said FDA spokeswoman Michelle Bolek.
A study by Dr. Joshua Rising of the Pew Charitable Trusts and colleagues, published in the New England Journal of Medicine , suggests that the metal-on-metal hip implants have a higher failure rate than hip implants made from other materials. This creates even more concern of the safety of these implants.
Critics argue that the metal-n-metal devices were approved too quickly, without proper testing. The FDA said it is considering the risks and benefits associated with metal-on-metal hip implants and will address the concerns.
Two metal-on-metal hip implants have already been recalled in the U.S. DePuy Orthopaedics Inc., a division of Johnson & Johnson, recalled the DePuy ASR™ Acetabular System in August 2010 after discovering that the implants were coming loose and failing at an exceptionally high rate.
Zimmer also recalled its Durom Acetabular Component due to unclear instructions.
Problems with the metal-on-metal hip implants are serious, especially since so many patients have been implanted with them.
If you or a loved one suffered severe injuries from a metal-on-metal hip implant that required revision surgery, you may be entitled to seek compensation for your injuries. To schedule a free review of your case, contact our defective hip implant lawyers today.James Flood