Smith and Nephew Birmingham Hip Recall
Smith and Nephew Birmingham Hip Recall. In 2015, Smith & Nephew issued an urgent field safety notice which warned patients early failure side effects associated with their metal-on-metal hip resurfacing products. Patients are afflicted with serious artificial hip problems that include infections, fractures, dislocations, metallosis, and pseudo-tumors.
Fast forward to 2018, there are now over 200 lawsuits against Smith and Nephew for the allegedly defective Birmingham Hip Resurfacing devices, which are prone to early failure, metallosis and the need for urgent replacement. The lawsuits are concentrated in the consolidated multidistrict federal court action, which was centralized in May 2017 in Baltimore, Maryland.
Problems with the Smith and Nephew line of Birmingham Metal Hips?
Many hundreds of patients who were implanted with the controversial Birmingham Hip replacement device (BHR) as part of the resurfacing procedure for the treatment of advanced osteoarthritis and other degenerative hip problems have reported personal injuries from metal toxicity, pseudotumors, and metallosis leading to early revision surgery.
What is the cause of the premature BHR failure?
The BHR device consists of a metal femoral head component and a metal hemispherical acetabular cup and the device is called a “metal-on-metal” hip implant. The cup fits into the patient’s hip socket, or acetabulum, and grinds against the femoral head during movement of the patient’s hip joint.
Both components are made of special proprietary cobalt and chromium metal alloys. During normal daily movement the grinding effect of the metal components rubbing against each other causes microscopic particles of metal to be released into the patient’s hip joint and body, causing bone and tissue death, cobalt and chromium toxic damage and the formation of pseudotumors. This medical side effect is known as metallosis.
The side effects and complications associated with the BHR are not unique to the company or the device. In fact, over the past ten years, many metal on metal hip manufacturers have come under fire for similar premature hip implant failures and metallosis injuries. DePuy ASR, DePuy Pinnacle (made by the medical device giant Johnson & Johnson), Zimmer Durom Cup, Biomet m2A Magnum, Stryker Rejuvenate/ABG II, Encore, Wright Conserve to name a few.
Part of the problem: No National Registry
We do not have a national registry where we can track the complication and failure rates of metal on metal hip implants and get an early warning of the problems.
But other countries do, according to the National Joint Registry of England and Wales, the Birmingham Hip Resurfacing device has a seven-year revision rate of 11.76 percent, well above the normal acceptable failure rate for a device of this type.
The National Joint Replacement Registry of Australia in 2015 found the BHR has a ten-year revision rate of 14.5 percent for women. Other studies place the failure rate for women as high as 26 percent.
Injured by the Smith and Nephew Birmingham Metal Hip?
If you think you may have Smith & Nephew Birmingham Resurfacing metal hip device and are experiencing pain caused by metal corrosion or have suffered premature hip failure requiring full revision and emergency care, please call Dr. Shezad Malik Law Firm at 888-210-9693. We are based in Dallas, Texas and handle Smith and Nephew premature hip failure injury cases nationwide.
Problems with Metal-on-Metal Hip Replacements
The Smith & Nephew Birmingham hip is a metal-on-metal hip replacement, which features a metal femoral head and a metal acetabular cup. Smith & Nephew introduced the Birmingham hip implant as the first of a new generation of metal-on-metal hip implant designs in the United States.
The Smith & Nephew Birmingham was the first metal-on-metal artificial hip system approved in the United States, with other hip manufacturers soon following to introduce similar models, which have now been linked to an increased risk of failure and other complications.
In the United States, medical experts have indicated that all metal-on-metal hip replacement systems are unsafe and should be recalled from the market. As the metal parts grind against each other, they release microscopic debris of metal which increases the risk of the artificial hip failing within a few years. Smith and Nephew have also issued a recall.
FDA INVESTIGATION AND RECOMMENDATIONS
The FDA convened an advisory panel in June 2012, to evaluate the safety of the metal hip devices. The FDA found no reason for doctors to continue using metal-on-metal hips, and the panel recommended that any individuals who received one of the implants should obtain annual x-rays to check for problems and should also receive blood tests to look for signs of chromium and cobalt blood poisoning in the blood.
Wright Medical, a competing hip manufacturer, filed a citizen’s petition in 2006, to block the approval the Smith & Nephew Birmingham hip, arguing that there was a lack of solid data establishing the safety and efficacy of the metal-on-metal hip design.
Wright Medical claimed that Smith & Nephew was misrepresenting the studies data submitted to the FDA and using bad science. Wright Medical argued that if the FDA approved the Smith & Nephew Birmingham metal hip, it may open the floodgates for companies to introduce potentially unsafe metal-on-metal hip replacement systems, with minimal clinical testing. And in fact, this is exactly what occurred.
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