Biomet Inc. is an Indiana-based medical device manufacturer.Among the products sold by Biomet is the M2A Magnum metal-on-metal hip replacement. Brought to market in 2004, the M2A Magnum quickly became a top seller and was the second-most widely used metal-on-metal hip replacement system, following only the DePuy Orthopaedics products.
Unfortunately, Biomet’s metal-on-metal device is, like most similar devices, a flawed product. The M2A Magnum can cause serious health complications when the device begins to release metal debris into the blood.Most patients who suffer complications will need revision surgery and, in some cases, may never fully recover from the injury caused by the metal-on-metal hip device.
About Biomet Metal-on-Metal Hip Products
Within the pelvis, there is a concave, cup-shaped area that is referred to as the acetabulum. The head of the femur fits snugly inside of this acetabulum, making up the hip joint. With age or injury, some people begin to develop pain and limited mobility in the hip joint, and a hip implant or hip replacement may be recommended. This involves carving out the femur bone and putting an artificial joint or femoral head onto the bone. Typically, a cup is also fitted inside of the acetabulum and the new hip joint fits inside.
For a long time, the cup inside of the acetabulum was made of a plastic material called polyethylene.The femoral head was made from a variety of products such as ceramic or metal. In the past decade, Biomet and many other medical device manufacturers brought a different product to market: metal-on-metal hip implants. Biomet’s M2A was one such product.The M2A Magnum had a metal femoral head and a metal cup that fit inside the acetabulum. Both were made of cobalt and chromium.
The Biomet products and other metal-on-metal hip implants were brought to market under special FDA rules called 510(k) rules. Essentially, the FDA allows a product to be released with fast-tracked approval and minimal testing if it is substantially similar to a medical device that has already been approved.
Metal-on-metal hip implants such as the Biomet device were widely sold to consumers and marketed especially to people who were younger and more active. The products were advertised as being less likely to break and more likely to last longer.According to a 2011 article in the British Medical Journal, approximately 10 percent of all hip implant operations from 2006 to 2009 used metal-on-metal devices. For patients under 50, around half of all procedures involved the use of metal-on-metal devices.
Complications and Problems with Biomet Hips
Problems began to develop very quickly with metal-on-metal devices.Those who had undergone hip implant surgery with the Biomet M2A Magnum products reported more than 450 adverse events to the Food and Drug Administration (FDA).
Scientific studies also began to identify significant problems with metal-on-metal hips.
- A February 2012 study in the British Medical Journal indicated that patients with a metal-on-metal device were potentially being exposed to dangerous levels of metallic debris.
- A February 2012 study published in the Journal of Bone & Joint Surgery indicated that pseudo-tumors developed in 59 percent of participating patients who had metal-on-metal hip implant devices.
- A study published in The Lancet in March 2012 indicated that metal-on-metal hip implants had a much higher rate of failure than other hip implant devices with polyethylene or ceramic components.
- An article in Nursing Times indicated that between 12 and 15 percent of patients who had a metal-on-metal device would need to have the device replaced within five years. In normal situations, hip implants are expected to last for 15 years or longer.
Patients with a Biomet metal-on-metal hip implant may experience many different complications, including:
- Asceptic loosening--A situation where the acetabular cup or other components of the replacement hip start to come loose.
- Osteolysis--Bone loss resulting from a build-up of metal ions in the body. The number of cases of osteolysis is expected to significantly increase within the next 5-10 years.
- Metallosis--A build-up of metal ions in the blood due to the friction of metal components and/or the degradation of metal parts. The FDA reports that metallosis can create problems with the thyroid, heart and nervous system.The British Medical Journal indicates the build-up can lead to long-term disability, kidney problems, liver damage, muscle problems and lymph node damage.
- Pseudo-tumors--A build-up of fluid stained with metal, which resembles a tumor.
When complications develop, corrective surgery is almost always the solution. Unfortunately, correction can be extremely difficult. The symmetry of the metal shell in the acetabular cup is often destroyed as the metal parts rub against each other, necessitating removal. However, the cup is either screwed into the pelvis during the implant or fused with the pelvis as the bone grows into it. The shell of the cup will typically be firmly adhered to the bone and a major reconstruction of the area may be required in order to achieve removal.
Ongoing health problems may also persist due to complications caused by metal in the body, even after the defective metal-on-metal hip implant has been removed. Some evidence suggests there may even be an increased risk of cancer as a result of the build-up of metal ions in the body.
Problems with a Biomet Hip? Talk to Our Defective Medical Device Lawyers
If you are experiencing complications from a Biomet metal-on-metal hip implant, you should consult with your physician right away.
Symptoms that can indicate a problem include:
The FDA recommends that patients in danger of developing problems due to the Biomet device should undergo routine imaging and blood tests to identify problems early so that they can minimize the potential dangers they face.
If you experience complications and need surgery or additional treatment, Biomet Inc. could be held responsible for your losses. You could be able to file a lawsuit to obtain compensation for medical costs, pain and suffering, lost wages, emotional distress and other damages. Many patients have already filed claims against Biomet over metal-on-metal hip replacements and implants.
An experienced Biomet hip implant attorney at Roberts & Roberts can help you to explore your options for obtaining compensation. To learn more, contact us today to set up a free consultation. You can reach us at 903-597-6000 or contact us online. The call costs you nothing… It could mean everything.