The past three decades have seen artificial hip replacements become increasingly common with literally millions of people receiving these implants. The hip joint in the human body is one of its most essential components, allowing us to fully engage in our everyday activities. When this joint no longer functions as it should, physicians often recommend a surgical procedure known as a hip replacement. During this procedure, the hip joint’s diseased cartilage and bone are replaced with an artificial hip ball and socket joint.
Initially hip implants were made of ceramic or polyethylene, but in the interest of creating a hip implant which would give the recipient longer joint life the all-metal hip implant was marketed. Unfortunately, adverse reports regarding these metal-on-metal implants began pouring in and some of the devices were recalled. While the FDA agrees that the risks involved in using all-metal hip implants likely outweighs the benefits, they have yet to actually ban the devices despite data suggesting the implants do not last as long as their ceramic or plastic counterparts and that recipients of the metal-on-metal implants are more likely to require revision surgery.
The Biomet M2A Magnum hip implant has been touted as one of the greatest medical innovations, even receiving the endorsement of former Olympic gymnast, Mary Lou Retton. Biomet claimed the M2A Magnum demonstrated a 99% reduction in wear over the more conventional polyethylene components. Like many other metal-on-metal hip implants, the Biomet M2A Magnum received expedited 510(k) approval which requires only that the device be substantially equivalent to a similar item which has already garnered FDA approval. Therefore there is no need for the medical devices which are approved under this process to undergo clinical trials or extensive safety testing. Just as with the DePuy and Stryker all-metal hip implants, as of October 12th, 2012, over 450 adverse event reports had been received from those with Biomet M2A Magnum hip implants.
The Potential Dangers of the Biomet M2A Magnum
The Biomet M2A Magnum hip implant was approved by the FDA in 2004 and was constructed of a metal femoral head and a metal femoral cup composed of chromium and cobalt. When the hip is in motion, the metal components make contact with one another creating friction and leading to microscopic particles of metal ions to be shed into the surrounding tissues or the bloodstream. Those metal ions can lead to serious and chronic pain, joint and tissue inflammation and damage and, in more serious cases, metal toxicity. Like some other metal-on-metal hip implants the Biomet M2A Magnum is also constructed of a large-diameter femoral head. One study which followed 185 recipients of the all-metal, large-diameter femoral head hip implant concluded the failure rate was as high as 15% with many implants failing within the first three to five years.
Biomet’s line of all-metal hip replacement implants claims to have improved on the mono-block component design (which include the ball, neck and stem as one piece). Unlike modular hip systems which include a number of interchangeable parts, Biomet’s acetabular all-metal hip implant systems come with the liner, cup and ball as one piece. In theory these components are used without screws, pushed into the hip socket. These implants have a porous coating on the outside which encourages bone growth and doesn’t require a locking mechanism to hold the liner in place as the liners are machined into the inside of the cup. The Biomet M2A Magnum was designed for more active people as their larger diameter head theoretically has the potential for more than 160 degrees of motion. The downside to the larger heads is that the surface area which rubs against the inside of the cup is larger, resulting in more surface wear and more metal particles released into the body. Because of the potential dangers of the Biomet M2A Magnum, the number of adverse reports from implant recipients and physicians is expected to continue to grow.
Metal Ions in Tissues and the Bloodstream
When metal debris accumulates in the body, the tissues surrounding the hip joint may be damaged or tissue death can occur. Pockets of fluid known as pseudo-tumors can occur in the hip area as well as groin pain, swelling and loosening of the hip implant which can lead to fractures or dislocation. Should the metal ions build up in the bloodstream, metal toxicity can occur causing neurological, kidney, cardiovascular and thyroid issues as well as other, less-reported, physical symptoms. Some recipients of the metal-on-metal hip implants have reported noticeable memory loss, issues with their balance, diminished hearing or vision, skin disorders and gastrointestinal disorders.
While chromium by itself does not appear to result in heart problems it can cause considerable damage to the reproductive system. Elevated cobalt levels can result in the body’s inability to repair its DNA, and elevated chromium can cause mutated DNA. Both metals can lead to impaired liver functions and can damage the respiratory system, leading to asthma and shortness of breath. When total failure occurs the implant may become loosened from the bone, causing the bearing and cup to misalign.
What to Do If You’ve Experienced Implant Problems
If you are the recipient of a Biomet M2A Magnum hip implant it is important to seek qualified medical and legal advice to protect your future. Lawsuits against Biomet have already been filed and you may be eligible for compensation for injuries related to the Biomet M2A Magnum hip implant. That compensation could relate to medical expenses, lost wages and pain and suffering, therefore you should keep careful records of all expenses you may have incurred as a result of your Biomet M2A Magnum hip implant system. An experienced Sullo & Sullo attorney can assess your individual situation to determine whether you may have a lawsuit against Biomet.