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The DePuy ASR Hip: Perhaps the Greatest Disaster in Orthopedic History
Hundreds of thousands of patients around the world may have been exposed to toxic substances after being implanted with poorly regulated and potentially dangerous hip devices… Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment.
Cohen D., How safe are metal-on-metal hip implants? BMJ 2012;344:e1410 (February 28, 2012)
Total hip replacements – also called hip arthroplasty – are common medical procedures performed on approximately 230,000 patients in the United States every year. In this procedure, the body’s natural joint is replaced with an artificial ball and socket. Traditionally, a surgeon would insert a cup with a smooth lining made from polyethylene into the patient’s pelvic socket. This lining was intended to replace natural cartilage and allow the femoral head to move smoothly. The natural femoral head was then replaced by an artificial femoral head, which is affixed on a metal femoral stem and fits into the femur.
During the mid-2000s, DePuy Orthopaedics, Inc., a subsidiary of global giant Johnson & Johnson, began marketing a new metal-on-metal hip implant called the ASR XL Acetabular Hip Replacement System – which is a different design than many other hip replacement systems. The ASR system has three components: a metal femoral stem, a metal femoral head that connects to the stem, and a one-piece metal acetabular cup to replace the acetabulum, made up of a cobalt-chrome molybdenum alloy. There are no separate polyethylene liner components to the ASR hip.
DePuy aggressively marketed the ASR hip to physically active individuals and claimed that it had many advantages over other hip replacement systems. For example, DePuy claimed that “today’s advanced techniques and technologies have revolutionized hip replacements. That means more patients can consider treatment at an earlier stage than they could in the past, potentially allowing them to return to their more active lifestyles.”
Importantly, however, no clinical trials were reported in connection with DePuy’s submission to the FDA. DePuy represented to the FDA that the ASR hip was similar to previously-approved devices, and it persuaded the FDA that no additional review and investigation was necessary.
Despite DePuy’s claims of safety and a “revolutionary” design, the DePuy ASR hip is failing at an alarming rate, which some have estimated to be in excess of 30%! A failure in the hip implant can cause hip and groin pain and instability, and require the patient to undergo a revision surgery to replace the ASR components with the traditional polyethylene-lined cup and smaller femoral head. Although a hip replacement is intended to last for approximately 15 years, a significant number of ASR hip recipients have had to undergo hip revision surgery after only a couple of years.
But the problem with the DePuy ASR system is potentially far more serious than premature failure of the hip. Because of the design of the metal-on-metal ASR system, the metal ball and cup abrade against one another, causing particles of chromium and cobalt to shed from the parts and enter the patients’ tissues and bloodstream. The build-up of metal debris in the soft tissues is called “metallosis”, and can lead to the formation of “pseudocysts” (a collection of fluid and dead tissue) and destruction of the surrounding muscle and bone.
Even more concerning are recent studies suggesting that the cobalt and chromium debris increase the risk of cancer (particularly in the kidneys and bladder), and increase the risk of genetic damage.
Shockingly, the tendency of chromium and cobalt to increase a person’s cancer risk has been known for more than 30 years. In fact, an internal DePuy memo in July of 2005 indicates the company considered the long-term potential for its metal-on-metal hip replacements to cause cancer, but it continued to market them anyway.
In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic.
Cohen D., How safe are metal-on-metal hip implants? BMJ 2012;344:e1410 (February 28, 2012) (quoting DePuy memo).
Instead of informing the sales staff, physicians, and potential patients of DePuy’s internal concerns regarding the possibility that its hip implant could cause cancer, DePuy merely handed its sales teams a document written by one of the orthopedists who designed the ASR, titled “Setting the record straight on metal hypersensitivity”, which apparently downplayed the cancer risk.
Finally, on August 24, 2010, after making hundreds of millions of dollars on 93,000 patients who received the device, Johnson & Johnson decided to recall the ASR hip system from the U.S. market. Nevertheless, the company continued to market the ASK hip system to patients overseas.
If you received a DePuy ASR hip replacement – even if it has not yet failed or caused noticeable problems – you may have a compensable claim to bring against DePuy and Johnson & Johnson. Our law firm represents many DePuy patients in Minnesota and across the country, and we are available for a free consultation to answer questions about chromium and cobalt poisoning, where to go for testing, “what Johnson & Johnson knew and when they knew it,” and how to pursue a claim for compensation against DePuy. We have recovered tens of millions for our clients in similar cases, and we would be honored to represent you in this matter. When we recover compensation for you, our fee is one-third of the recovery – which is a far smaller percentage than many law firms change. And you will not pay us a single penny if we do not receive compensation on your behalf.
Please note that the problem with metal-on-metal hip implants is not limited to the DePuy ASR implant. Therefore, if you were implanted with another device, including the DePuy Pinnacle hip, Zimmer Durom cup, or other metal-on-metal device, please call us for a free consultation.
Remember that each state has deadlines called Statutes of Limitations which dictate how long a person may wait before commencing a lawsuit against another party. Therefore, if you received a metal-on-metal implant – even if it has not yet caused you any perceivable problem – it is urgent that you contact us immediate so that we can protect your legal rights.
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