Biomet Metal-on-Metal Hip
While manufacturers, including Biomet, touted metal-on-metal hip replacement devices as a long-lasting solution that was better for younger patients, metal-on-metal hip products turned out to have a high failure rate. They often required revision surgery after a short time and caused serious complications and side effects in many patients.
Biomet is facing lawsuits from patients who experienced problems after having the company’s metal-on-metal hip replacement products implanted. Biomet products account for around 12 percent of all hip implants used in the U.S.
If you or a loved one has been affected by problems with Biomet’s metal-on-metal hip implant devices, you could be entitled to compensation. At Roberts & Roberts, our defective medical device lawyers will evaluate your situation, help you to determine if you have a claim and work with you to pursue your case for monetary damages.
Biomet Metal-on-Metal Hip Implant Products
A hip replacement is a recommended course of treatment when someone’s hip joint has become damaged and worn, causing pain and limiting mobility. To replace the hip joint, a special cup-like device is fitted inside the acetabulum, which is a concave area in the pelvis that the head of the femur slides into. A replacement joint is then attached to the femur to fit inside the acetabulum.
The cup inside the acetabulum was first made from plastic, and the replacement ball joint that attached to the femur was made from either metal or ceramic. Biomet was an early creator of a hip replacement system that included a polyethylene (plastic) cup inside the acetabulum.
Biomet decided to expand into the field of metal-on-metal hip products. Metal-on-metal hip replacement products use a metal cup in the metal acetabulum as well as a metal replacement joint. The idea behind the metal-on-metal products was that they would last longer and that younger and active people would have a reduced chance of breaking the replacement joint.
Biomet made several different metal-on-metal hip replacement products including:
- The M2a Magnum line of implants.
- The Biomet Stanmore
- Exceed ABT
Biomet has claimed that the company produces the widest range of metal-on-metal hip replacement products in the industry. Biomet also stands out from competitors because many of their products are “monoblock” components, which means that the ball, stem and neck of the hip replacement joint are all one piece. Many other metal-on-metal hip implants contain modular interchangeable parts.
Dangers Associated with Biomet Metal-on-Metal Hip Replacement Products
Biomet, like many other manufacturers of metal-on-metal hip implant products, used a special 510(k) clearance program to obtain FDA approval and bring its line of metal-on-metal hip replacement devices to market. This process allows for medical devices to be released with limited testing, provided that the device is substantially similar to one that is already for sale. This means that the Biomet products and metal-on-metal implant products from other manufacturers did not undergo the type of long-term clinical trials that would otherwise be required for a new product.
News of problems with Biomet metal-on-metal hip replacements soon began to surface. For example:
- The FDA received more than 450 adverse-event reports related to problems with the Biomet M2a Magnum hip replacement products.
- A study published in the February 2012 issue of the Journal of Bone & Joint Surgery reported that an estimated 59 percent of patients with metal-on-metal devices developed liquid-filled pseudo-tumors.
- A study was published in the British Medical Journal during the same month warning of the dangers of metallic debris building up in the body due to the metal-on-metal parts rubbing against each other.
- Multiple studies showed that metal-on-metal hip replacement devices have a significantly higher failure rate than devices with polyethylene components. Estimates indicated that between 12 and 15 percent of individuals with a metal-on-metal implant will experience a failure and need replacement within five years instead of the 15-year average for most hip replacements.
These studies and adverse reports from patients revealed that there were many dangerous side effects linked to Biomet and other metal-on-metal hip replacement products. For example, some of the possible side effects include:
- Metallosis, which is caused when excess metal ions build up in the blood, leading to complications including thyroid problems, kidney and liver damage, muscle and lymph node damage, and nervous system damage.
- Osteolysis (bone loss) resulting from metal ions in the body.
- Aseptic loosening or loosening of the components of the replacement hip joint.
- Pseudo tumors or collections of fluid in the body
When these and other side-effects develop, a revision surgery is typically the only answer. These surgeries can be very hard to perform because the metal ball that fits into the acetabulum is typically screwed in or fused with bones and is difficult to remove. Some patients require multiple procedures, and some are unable to completely resolve the health problems caused by Biomet’s metal-on-metal products.
Talk to Our Dangerous Medical Device Lawyers
If you or a loved one has experienced serious problems with a metal-on-metal hip implant produced by Biomet, you may be able to take legal action to obtain monetary compensation for your losses. This could include payment for medical bills and costs, lost income, and compensation for pain and suffering and emotional distress.
The defective medical device attorneys at Roberts & Roberts are currently investigating Biomet-related claims. To have your case reviewed by an experienced attorney, call us today at 903-597-6000 or contact us online. Your consultation is free and there is no obligation. The call costs you nothing … It could mean everything.
- British Medical Journal – How safe are metal-on-metal hip implants?
- FDA – Concerns about Metal-on-Metal Hip Implants
- Journal of Bone & Joint Surgery – Pseudotumors in Association with Well-Functioning Metal-on-Metal Hip Prostheses: A Case-Control Study Using Three-Dimensional Computed Tomography and Magnetic Resonance Imaging
- FDA – MAUDE Adverse Event Report: BIOMET INC.M2A 38MM CUPPROSTHESIS, HIP