The FDA has issued new safety warnings about the risk of metal poisoning and early revision surgery from metal-on-metal hip implants.
Need a Texas Encore Hip Implant Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by metal poisoning or needed surgery, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Encore Hip Implant
Encore Medical, now DJO Surgical, manufacturer the Encore hip replacement. The company is one of six device-makers who sell metal-on-metal hip replacements.
Unlike most metal-on-metal hip implants, the implant includes a metal insert on a polyethylene (plastic) liner in the acetabular shell. This is also known as a “poly sandwich” design. The articulating liner is made of cobalt-chromium.
When the patient walks, the metal insert grinds against the metal “ball” on the head of the femoral implant. This creates a metal-on-metal joint.
Over time, tiny particles of chromium and cobalt can accumulate around the hip joint. This can lead to localized tissue reactions, including inflammation, fluid build-up, and soft-tissue growths (pseudotumors).
Systemic reactions in other areas of the body may include metallosis or high levels of metal ions in the bloodstream.
FDA Adverse Event Reports
In October 2011, the FDA received an adverse event report involving the metal-on-metal Encore hip replacement.
According to the report:
“Swelling, pain, and decreased mobility with increased blood serum cobalt … requiring occasional narcotic pain control medications. Continued and frequent pain and swelling at this point.”
FDA Approval
The Encore poly-on-metal inlay design was approved by the FDA under the 510(k) approval process. This allows new devices on the market without requiring new safety studies so long as they are “substantially equivalent” to a pre-existing product.
The 510(k) “fast-track” process allows manufacturers to quickly introduce products that could pose serious safety risks. Today, thousands of people who were implanted with metal-on-metal hips are seeking compensation and justice for their injuries by filing lawsuits.
Side Effects
- Metal poisoning (metallosis)
- Elevated levels of cobalt and chromium in the bloodstream
- Infection
- Loosening or dislocation of the hip
- Chronic pain
- Inflammation and swelling
- Limited mobility or flexibility
- Pseudo-tumors
- Revision surgery
- And more
Need an Encore Hip Implant Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Encore hip implant lawyers for a free lawsuit review.