Biomet: Metal on metal hip implants, cobalt poisoning
Metal-on-Metal (MoM) total hip replacement systems consist of a metal ball, a metal femoral stem in the thighbone, and a metal cup in the hip bone. Now that’s heavy metal.
Some of the hip replacement implant manufacturers are – Biomet Orthopedics, DePuy, Smith & Nephew, Stryker, and Zimmer. Both DePuy and Zimmer have voluntarily recalled the metal on metal hip implants. TheDePuy recall involved the ASR™ total hip system and the recall was because of new, unpublished data from the UK joint registry indicating the revision rates (revision = replacement) within 5 years were approximately 13 percent. As for Zimmer, a voluntaryrecall of the Zimmer Durom® Acetabular Component (“Durom Cup”) occurred because the instructions for the surgical technique were inadequate.
Metal on metal hip replacements were supposed to be more beneficial because of being more suitable for younger and physically active patients because the metal is durable enough to last a long time.
Metal on metal hip replacements were once thought to be an improvement over previous versions of metal on polyethylene but recently problems have been under scrutiny about metal ions absorbed into the bloodstream and/or tissues causing serious debilitating health concerns.
Metal on metal hip implants have created an epidemic of FDA adverse reports or complaints. One of the problems of MoM implants is toxic levels of cobalt. Some studies have shown that metal ions in the bloodstream are no cause for worry but with the vast number of people who already have metal on metal hip implants and the vast numbers who will need a hip implant are staggering. Hip implants are supposed to last for 15 to 20 years – all the while slowly imparting metal ions into the bloodstream or body tissues. How can this be considered safe?
What is cobalt poisoning?
Cobalt poisoning is caused by toxic levels of cobalt in the body. Cobalt is essential to health in micro amounts as a component of vitamin B12. Having enough cobalt is rarely a problem. The greater hazard is that excessive cobalt can cause death.
Some of the problems or symptoms associated with cobalt toxicity are:
- cardiomyopathy (heart problems)
- cognitive problems
- optic nerve atrophy
- peripheral neuropathy
If you or a loved one is suffering from one or more of the above serious side effects from a metal on metal hip implant, then you may have a MoM hip implant lawsuit. The lawsuit may be against any of the manufacturers or Biomet Orthopedics.
When do Metal to Metal Hips Fail?
Most artificial joints, such as hips, are designed to last 15 years or more. When everything goes well, patients can expect to enjoy the reduced pain and increased activity hoped for with an artificial hip for well over a decade before they may need to consider another invasive hip replacement surgery.
However, not all hip implants types are the same. For example, one of the problems with biomet mom devices and other metal on metal hip replacements is that they fail earlier than other types of hip replacements. Exactlywhen do metal to metal hips fail? The hips may begin failing within just a few years of surgery, or even sooner in some cases.
At best, a premature hip replacement failure may mean another painful surgery and recovery for a patient. At worst, it may mean death from metal poisoning. Short of that, it may mean a permanent disability if the tissue around the hip replacement is damaged or if the patient is not a candidate for further surgery.
For metal on metal hip replacement patients, the danger is both in the premature failure and the nature of the failure. If you have suffered from a metal hip replacement, please speak to your doctor about your possible physical recovery and your unsafe medical device lawyer about your possible financial recovery.
Smith & Nephew Pulls Metal on Metal Hip Liner Socket from Market Because of Safety Concerns
Smith & Nephew Not Satisfied with Clinical Results of Metal on Metal Socket Liner
A few years ago, Smith & Nephew PLC introduced an optional metal socket liner that could be used with its R3 Acetabular System hip replacement devices. Now, Smith & Nephew announce that it will be pulling the metal liner cup off of the market. It is estimated that approximately 7,700 people have received the metal liner as part of their hip replacement procedure since the liner went on the market.
The Metal Liner of This Hip Replacement is Being Recalled Amidst New Safety Concerns
Smith & Nephew is not the first company to recall ametal on metal hip device because of safety concerns. However, the concerns cited by Smith & Nephew are different than the concerns raised in earlier recalls by other companies. While the main concern in previous recalls has been the metal debris rubbing off, damaging surrounding tissue, and entering the bloodstream, those were not the concerns cited in this recall. Instead, Smith & Nephew is recalling this portion of the hip replacement device because of concerns of infections, fractures, and dislocations. The company says there is currently no evidence of metallosis or a metal build up in the body.
Britain’s National Institute for Health and Clinical Excellence has set a 1% guideline for hip replacement revision surgery. This means that it is expected that no more than 1% of people who receive a hip replacement will need revision surgery within one year. It is estimated that people who received a R3 Acetabular System hip replacement with the optional metal socket liner had a revision surgery rate of 1.6%.
Have You Been, or Will You Be, Affected by the Recall?
If you have received a recent metal on metal hip replacement then you may be directly, or indirectly, affected by the recent recall. If you received an R3 Acetabular System hip device with the optional metal socket liner and you have already experienced a problem then you know that you have already been affected. You know what the problems associated with this device have directly cost you physically, emotionally and financially.
If you have received an R3 Acetabular System hip devices and you have not yet experienced a problem then you should speak with your doctor about the risks, symptoms of a problem, and how best to protect your health. Likewise, if you are a recipient of another type of metal on metal hip replacement it is still important to understand the risks associated with this recall and to talk to your doctor about how best to protect yourself from potential complications.
Hip Device Component Recalled by Smith & Nephew
A billion dollar-earning London-based medical device maker has recalled a metal liner which is a component for R3 Acetabular System hip device.
Smith & Nephew introduced the metal liner into the medical device marketplace in 2009 and about 7,700 have been implanted in patients. The medical device is a multi-bearing acetabular cup system used in total hip replacement procedures. The annual revision rate has been 1.6% but according to the British drug and device regulatory agency, the acceptable revision rate is 1%.
Smith & Nephew sent letters to medical professionals and medical centers alerting them about a “Field Safety Corrective Action” requesting the removal of certain coded affected metal liners from their stock because of a higher number of revisions.
According to the Smith & Nephew website, the R3 Acetabular System has the widest range of advanced bearing options, excellent stability, and is one of the most advanced hip replacement systems. “The multi-bearing cup, in addition to providing flexibility for surgeons, provides a foundation designed to reduce wear and the subsequent need for revision surgery.”
Surgeons will still be able to use the system using alternative non-metal liners.
If you or a loved one has had to suffer through revision surgery because of a voluntarily recalled Smith & Nephew metal liner for your hip replacement – please contact Monheit Law to find out what your legal options are for filing a claim for medical compensation, and pain and suffering.