DePuy Hip Recall Impacts Implant Patients
DePuy Orthopaedic, Inc., has recalled the ASR XL Acetabular and Hip Resurfacing Systems due to a high revision rate. On August 24, 2010 DePuy announced that they would no longer sell the medical devices in the US. Hip replacement patients were advised to meet with their orthopaedic hip replacement surgeon to determine if they might require to have the hip devise “revised” which means removed and replaced with a different implant.
The DePuy artificial hip was manufactured by DePuy Orthopaedic which is a subsidiary of the medical giant, Johnson & Johnson. Patients who had the device implanted were told that it would last for 15 or more years. However, patients who had the device implanted for a much shorter time started experiencing severe pain, problems walking, loosening, bone fractures, dislocation, swelling, tumors, bone staining, necrosis, nerve damage, tissue damage, and muscle damage. Some surgeons found dead tissue in the thighs of some patients when they went into to remove the implant. There is also concern that the artificial hip may cause metallosis or cobalt/chromium poisoning.
Henretta Law Offices is concerned that some patients with a DePuy hip have become seriously ill due to the device or will soon suffer devastating injury in the future. One study found that the devise has a five year failure rate in 1 of every 8 patients with the implant. With more than 93,000 persons world-wide to have the device implanted, that means approximately 11,000 people will need to undergo a second hip replacement surgery or a “revision.” This number may soar over time.
History of the DePuy ASR XL Acetabular and Hip Resurfacing Systems
The DePuy hip implant first came on the market in the US in 2005. It was targeted to the “younger” patients and those with an active life style including runners, skiers, tennis players and golfers. The devise was brought to market without having gone through clinical trials because of a loophole provided under FDA rule 510 that allows certain similar drugs or medical devices to be approved without undergoing clinical trials.
By 2008, the FDA had already received nearly 400 complaints from patients who received the DePuy hip replacement. DePuy continued selling the implant even with the evidence started mounting that was a high rate of failure with the devices. In fact, DePuy had 5.3 billion in sales in 2009 alone. Starting in 2010, DePuy Orthopaedics announced they were phasing out the ASR device and a recall was announced in August 2010.
How do I know if I have a DePuy Hip Implant?
If you’ve been reading the news, you are probably are aware that DePuy Orthopaedics, Inc., a division of Johnson & Johnson, has recalled the ASR XL Acetabular and Hip Resurfacing Systems. If you had a hip replacement since 2004, you’ll most certainly want to determine whether your hip was manufactured by DePuy and is part of the recall. It’s important that you do so regardless of whether you are having any pain or other symptoms so your health can be monitored.
If you have not received a letter from your orthopaedica surgeon regarding the recall, here are the steps you should take:
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Contact your physician and find out your hip implant manufacturer and model number
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Request your complete medical records including surgical notes
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Contact a law firm that represents clients with product liability issues who can review your records to determine whether your device was one of those recalled. A product liability attorney should provided you with a free and confidental case consultation.
DePuy ASR hip implants were implanted in patients starting in 2005 in the US. Hospitals and physicians are required to keep a record of the manufacturer and serial number of every medical product they implant.
If your hip implant was one of those recalled, you may be asked to register with DePuy or some other hip recall registry. At Henretta Law Offices, we do not recommend that you give your personal medical information to anyone other than your physician or your own personal attorney because you can never be sure how this information will be used.
If it is confirmed that you have a defective DePuy hip implant, you may be entitled to compensation to your continuing medical care, medical bills in case you require another hip implant surgery, loss of income and pain and suffering.
Does my recalled DePuy hip implant need to be replaced?
An Australian study shows that approximately 13% of patients who had either a ASR XL Acetabular System or a ASR Hip Resurfacing System implant required a second surgery, called a “revision”, within five years of the first surgery.
Some patients required a revision because they experienced severe pain, a fracture or a dislocation of the implant.
With ASR implant systems, because of a design flaw, there may be metal-on-metal rubbing which releases cobalt and chromium metal ions. In this case, hip implant patients may not suffer pain in their hip but they might test high for metals in their blood which could do long-term and permanent damage to organs including the heart and the kidneys.
Your othopaedic surgeon can explain the risks of a second hip surgery and explain the outcomes. Generally, a second hip surgery is more challenging and the results may not be as positive because of possible tissue damage caused by teh metal-on-metal ions or the loss of bone.
For more information about metals in the blood read below:
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What does a metallosis diagnosis mean?
Metallosis is a serious medical condition in which metallic debris builds up in the body’s soft tissues. One of the major causes of this condition is medical implants such as hip and knee joint replacement. In 2010, metallosis became a well-know condition when a British study revealed that some patients who had DePuy ASR hip implant experienced adverse reactions to metallic particles while patients implanted with another hip did not experience the same reaction.
When a person has an artifical joint in some implants, the abrasions of metal components caused metal ions to be released and these ions are absorbed in teh surrounding soft tissues near the implant and into the bloodstream. The person’s immune system then reacts to the foreign body — the metal ions– and tissues become inflamed around the debris which can cause severe pain and make it difficult for a person to move the joint. Recent studies have also show that metallosis can cause cancer.
When high levels of metal like cobalt and chromium is released, a person can suffer rashes and nerve damage and also suffer from metal poisoning.
Symptoms of metallosis can include:
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pseudo-tumors — a mass of cells that collects fluid and appears to be a tumor
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necrosis –premature death of tissue
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inflammation
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pain
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dislocation of the implant
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osteolysis — bone resorption
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cancer
For more information, you can read:
Arthoprosthetic Cobaltism: Neurological and Cardiac Manifestation in Two Patients with Metal-On Metal Artholasty: A Case Report, The Journal of Bone and Joint Surgery, Dr. Stephen S. Tower, Dec 2010; 92: 2847-2851
www.ejbjs.org/cgi/content/full/92/17/2847?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=Stephen+Tower&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
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What long-term exposure to cobalt and chromium affect my health?
No one is exactly sure what the long-term health effects of exposure to cobalt and chromium is, but it is clear that these heavy metals are not good for you. Recent studies have revealed that it causes cancer and also contributes to cardiac disease. Bothe of these metals are used in the manufacture of the DePuy ASR hip implant.
In a study published in The Journal of Bone and Joint Surgery Dr. Stephen Tower, reported that two patients who were implanted with a DePuy hip suffer from metallosis and cobalt poisoning (cobaltism). Both of these patients also have cardiac and neurological symptoms. The conclusion of the study is that DePuy hip recipients need to have their blood tested for serum cobalt levels to prevent for permanent neurological and/or cardiac damage.
DePuy recomments that patients implanted with ASR XL Aetabular and Hip Resurfacing Systems contact their surgeon so that the surgeon can evalutate using x-rays, imaging and blood tests that function of the hip and any possible damage to the bone and tissue surround the implant. On their website, DePuy recommends that should blood testing show high levels of metal particles after two blood tests that a replacement or revision surgery is recommended. DePuy has offered to pay for the costs of this testing.
What is a DePuy hip “revision”?
Patients who were implanted with a DePuy Orthopaedics ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System between 2003 and 2010 have had their hip implant recalled. According to DePuy, five years after the intial surgery, 12% of patients with the SR resurfacing device and 13% of patients with the ASR total hip replacement need to have a “revision” or “redo” surgery which entails replacing the DePuy device with another type of hip implant.
What does the recall mean to you?
The recall means that even if you are currently feeling fine you should contact your surgeon so that you can be monitored and tested for metallosis via a blood testing and your surgeon may order imaging of your hip. Your surgeon will also evaluate your over time.
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Should I sign a medical release form?
Henretta Law Offices advises you NOT to sign a medical release form because it could negatively impact your product liability lawsuit. Basically, in asking you to sign the release form, Broadspire (and DePuy) is asking you to sign away your rights. We also do not recommend that you speak on the telephone with a DePuy or Broadspire representative. Sometimes in cases such as this, telephone conversations are recorded and the way you answer questions can negatively impact any lawsuit you might file. Before you sign anything, we recommend that you talk to an experienced personal injury attorney at Henretta Law Offices. We work to protect your rights.
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What should I do if I already signed a release form?
If you have already signed a medical release form, we can help you revoke it and we can inform DePuy that they are only to communicate through your attorney.
Advise to DePuy hip implant recall patients
Hip replacement patients go through a lot. Before undergoing a major hip replacement surgery, most patients have endured a lot of paint. They’ve seen their quality of life deteriorate, avoided activities of everyday life like walking, dancing and playing tennis. They have suffered the embarrassment of walking with a limp or not being able to keep up with their peers. Many patients won’t consider undergoing a hip replacement surgery until they are already walking with a cane and in near or constant pain.
After a hip replacement, most patients resume many activities of everyday life and the things they enjoyed doing before their hip condition deteriorated. For those patients, finding out that they have complications due to a defective hip implant is extremely upsetting. And for those who do not have complications, they live with the worry and fear that complications could set in at any time.
Here’s some advice:
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See your surgeon & if necessary, don’t hesitate to choose a different surgeon
If your surgeon is not proactive on your behalf concerning your recalled hip implant, consider contacting another surgeon. If your surgeon doesn’t seem to be listening to your complaints or share your concerns, then you should seek a second opinion. Choose a surgeon who has no ties to DePuy.
Recommendation: Get a second opinion. Ask your doctor, “how many DePuy devices did you implant?” and “how many DePuy devices have you removed?” If you surgeon answers in the 100s implanted, he may have allegiance to DePuy.
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Get a 3-D CT scan and a blood test for metal
When you contact your doctor about the DePuy Hip Implant Recall, your physician may order an x-ray to determine whether your bone has grown around the implant. Insist on having 3-D CT scan which can provide much more information than an x-ray and can show any loosening. Insist on a blood test for metals such as cobalt and chromium.
Recommendation: If your physician is hesitant about additional testing, tell him you have been reading about tissue necrosis and metallosis. Ask the radiologist for the disc of scan before you leave. Insist on getting a printed copy of your report.
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Don’t allow DePuy device sales people in the operating room
Often in a revision surgery, DePuy Orthopaedics will have the person who sold your hip implant to your surgeon in the operating room during surgery. The salesperson does not undergo the same background checks and have the same qualifications as the other medical personnel in the operating theater.
Recommendation: Ask your surgeon who will be in the room during your revision surgery and ask him for the detailed hospital report. You can request that no DePuy representatives attend your surgery. If necessary, notify the hospital of your decision.
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Keep your own hospital records
Hospital reports may not always include events that occurred during your surgery or during your recovery. If things happen out-of-the ordinary, you should keep a record of them. For example, if you become ill with pneumonia or if you suffered side effects to the anesthesia or a rash because of the adhesive, you should make a note of it.
Recommendation: Keep a diary of your hospitalization and your recovery. Have a close family member or friend assist you.
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Keep a diary and keep your implant
If you have the DePuy ASR hip implant removed, keep a diary about your emotions, your pain levels and what you are going through physically and emotionally. This diary can support your civil case if you claim damages for pain and suffering.
DO NOT SIGN A RELEASE to allow DePuy to take possession of the removed implant.
Inform your surgeon prior to the surgery that you would like photographs during the surgery of your tissue and of the device once it has been removed.
Insist you wish to keep possession of your implant. You can make arrangements prior to the surgery to purchase a Bio Bottle which will keep your hip implant in a condition where it can be inspected by an independent laboratory.
Recommendation: DO NOT ALLOW DEPUY TO HAVE POSSESSION OF YOUR HIP IMPLANT DEVISE. They may destroy the device in their examination of it. This is your devise and you do not have to let them have it. If you have signed a medical release with DePuy or their representatives, you can ask your attorney to write a letter rescinding that permission.
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Get the help of a personal injury attorney who knows hips and knows product liability law such as Henretta Law Offices
There are a lot of attorneys out there and they are advertising on TV, in magazines, and on the internet. Make sure the attorney you hire is passionate about your case and is willing to take it to trial.
Recommendation: Of course, Henretta Law Offices would like you to consider our firm.
DePuy Hip Implant Recall Resources
You may find the following resources helpful if you have a defective DePuy ASR hip implant or if you are seeking more information:
Which Medical Devise ~ Expert Independent Opinion
ASR Hip Resurfacing
New York Times
Search DePuy
The New York Times has written many well-researched articles about the DePuy Hip Implants and their recall.
Wall Street Journal
Search Depuy
The Wall Street Journal has many unbiased news articles about the DePuy Hip Implant Recall.
U.S. Food and Drug Administration
Search Depuy
You can examine all of the Adverse Event Reports.
Australian National Joint Replacement Registry
The Australian Joint Registry was one of the first places to collate data about failing DePuy hip implants.
National Joint Registry – United Kingdom
The National Joint Registry of England and Wales was created in 2002 to and is database of information for patients receiving hip, knee and ankle joint replacement surgery.
http://www.njrcentre.org.uk/njrcentre/Default.aspx
RN Patient Advocates, PLLC
Assists patients in finding the best healthcare and treatment outcomes. Independent RN Patient Advocates.
Patients with DePuy ASR hip implants require specialized legal representation. If you or a family member has had a hip replacement with the ASR XL Acetabular and Hip Resurfacing Systems, contact The Farber Law Group, a personal injury and product liability law firm with 30+ years experience representing patients and their families