DePuy Hip Implants: Overview & Claims
UPDATED: June 19, 2018
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Artificial hip replacement procedures have become relatively common with well over 300,000 procedures performed every year in the United States. That number, while steadily increasing as our population ages, has led to many new products and technologies entering the field – and not all of them are safe.
DePuy Hip Implants: Metal-On-Metal Technology Not As Safe As Originally Claimed
Metal on metal implants have caused complications for doctors performing surgery and presented a danger to patients. The materials used in the metal-on-metal implants (usually cobalt-chrome and molybdenum) were thought to be more durable than their older-model ceramic counterparts; however, that technology may not be as good or safe as originally claimed. Case in point – DePuy Orthopedics.
The DePuy ASR Acetabular Cup System, DePuy ASR Hip Resurfacing System and DePuy Pinnacle Acetabular Cup System were supposed to be the best of the best. However, the recent DePuy recall of the first two products – and consumer complaints about the latter – tell a different story.
DePuy ASR Hip Implant Claims: Experts Say DePuy Failure Rates Are 12 - 13%
One of the largest manufacturers of metal-on-metal hip replacements, DePuy Orthopedics, recently recalled its metal-on-metal hip replacement systems – the ASR Acetabular Cup System and the ASR Hip Resurfacing System.
Research has shown that, instead of resulting in longer-lasting and durable new hip replacements, these products often sloughed off metal ions into the surrounding tissue, causing tissue damage, bone loss, and immediate and intense pain of metal toxicity in some cases. Even before the DePuy ASR recall, the failure rate for metal-on-metal implants had been high – an astronomical 12 - 13% – resulting in expensive surgeries to isolate the cause and replace the defective part, not to mention the pain and suffering that come with having damaged tissue and bone. Those injured by these products are now searching for the answers to two common questions – what did the company know about these defects and when did they know it?
DePuy Hip Implant Lawsuits Allege That Company Knew About Defects Early On
There is considerable evidence that DePuy Orthopedics knew their implants were defective and inappropriate for the market long before their recall, but failed to warn consumers about those defects. In fact, the U.S. Food & Drug Administration (FDA) had received over 500 complaints about the ASR Acetabular Cup System and the ASR Hip Resurfacing System through its Adverse Event Reporting (AER) over the past few years.
In addition to complaints made through the FDA, studies have shown that the coverage angle range for the acetabular component of the DePuy ASR implant - a critical factor in the likelihood of unsafe levels of toxins entering the body - is unusually sensitive. Similarly, the cup position and design for hip resurfacing is also critically important for preventing the release of metal ions as the cup rotates. So, the question becomes – how was this product ever approved by the FDA in the first place?
Differences Between DePuy ASR & Pinnacle Systems
The DePuy ASR Acetabular Cup System is a metal on metal system which the company claimed was “substantially similar” to it's device already on the market – the DePuy Pinnacle Acetabular Cup System. Therefore, the ASR system did not go through the FDA's PMA, pre-market approval, process which requires extensive clinical trials to prove that the device was not dangerous.
The DePuy Pinnacle Acetabular Cup System, which many surgeons and patients now say is also defective, was designed to be fastened to the bone with screws. However, the DePuy ASR Acetabular Cup System did not offer a fastening option. At all. Instead of having the option to attach the device with screws, metal cement or flanges, the DePuy ASR Acetabular Cup System can only attach to a patient by bone growth – which is not occurring for thousands of hip implant patients. Many of those patients have had to undergo additional painful and expensive hip replacement surgeries – and are looking to DePuy to pay for them.
DePuy Hip Implant Lawsuits Involve Complex Medical & Legal Issues
For injured victims looking for compensation, it's important to understand that while you may have the right to monetary compensation or some other form of legal relief, these issues can be too complex to handle and research without the representation of an experienced DePuy Hip Implant Recall attorney.
It's also important to realize that there are statutes of limitations and other relevant deadlines for filing your DePuy ASR hip implant lawsuit, so don't miss your opportunity to file your claim and receive the compensation you deserve. Unfortunately, DePuy hip injury lawyers say that DePuy representatives do not have your best interests at heart.
DePuy Hip Replacement Lawsuits: Why A DePuy Rep Is Not Your Friend
Although statute of limitations and evidentiary issues are always important reasons to contact an attorney to protect your rights, DePuy hip implant recall lawyers say that it's equally important to realize that the DePuy representative is not your friend. Although they can be helpful to surgeons in the operating room, what tends to happen in these situations is that the orthopedist will take the defective implant out of the patient and hand it to a nurse. The nurse, in turn, gives it to the DePuy rep who says, “I'll take care of it. This is going to go back to the company for analysis.” Then, Boom! It’s gone.
DePuy hip recall lawyers say that this practice is just wrong. The issue is that the metal hip implant is a bio hazard, so you can't give it to the patient. The rep makes it so easy by just taking it. However, what happens it that no real data is given in the FDA's adverse event reports – or worse, false data gets in there such as,“We evaluated this and no real problem.” That's just not the case. It isn't true.
If you got that into the hands of a lab that looks at 500 of these things and analyzes the tissue appearance, statistically correlates that with the metal hip wear debris and can make specific medically helpful statements, that’s totally different. So everything in terms of the patient care, physician education, the patient physician relationship and the legal rights and preservation of the legal case works by it not being sent back to the company. The only person that gets helped by it going back to the company – is the company itself. It helps DePuy's legal case – and may hurt yours.