On August 24, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System. Why? Because they have a higher-than-usual failure rates, causing people to have to have second surgeries to replace the replacement.
Second “revision” surgeries because of a defective device? If you or someone you know has had hip replacement surgery, then this recall has to make you want to cry. Hip replacement surgery is difficult, with a long, painful recovery.
The two hip replacement products DePuy recalled are the ASR Hip Resurfacing System and the ASR XL Acetabular System. Compared with other hip replacements, the recalled DePuy ASR products are more likely to fail, and fail early—about 1 in 8 percent of the replacements will fail within 5 years. What’s worse, the faulty hip replacement causes serious pain and difficulty walking, and recovery from the second hip replacement is often more difficult than after the first. There is also the possibility of metallic particles, potentially toxic cobalt-chromium particles, which, in high levels, may cause heart and/or nervous system problems.
Some experts feel that this recall was long overdue, and wonder why it took so long. In fact, the same devices were withdrawn from the market in Australia in December 2009. In an interview with The Health Report (Australia), Dr. Stephen Graves, director of the Australian Orthopaedic Association’s National Joint Replacement Registry, said that the registry had known for many years that the ASR device had a higher rate of failure. He said:
In our 2007 annual report we identified the resurfacing part of this device as having at least twice the risk of revision compared to other resurfacing devices….after three years [there] was four to five times the risk of being revised compared to other devices.
In the same interview, he very tactfully said that DePuy was lying when they claimed that international joint registries showed that the ASR devices were performing in line with other devices. In the words of Dr. Graves:
I’ve noticed that comment in the press release and I couldn’t quite understand that because that’s simply not correct because DePuy were fully aware of the Australian registry data. So I’m not quite sure why they’ve said that because it’s simply not true.
Signs of early failure in 2007…withdrawn from Australia in 2009: Why did DePuy allow them to be implanted into people in the United States until August 2010?
What Happens Now?
Orthopedic surgeons who used these particular devices have been sending letters out to their patients to advise them of the recall by the manufacturer, so check your mailbox. If you have moved since your surgery, please contact your surgeon and they will be able to advise you on whether you were given one of the problem hip replacement units. If your surgeon has retired or left the practice, you can request a copy of your actual operative report of that surgery from the hospital. Those records will contain the implant name, type, serial or other identification number.
If you already know that you received one of the recalled DePuy hip replacement systems, we recommend two things:
1. Schedule a follow-up appointment with your surgeon, even if you’re not currently having symptoms. It is possible that you could have early signs of failure before you recognize the pain. Your doctor will be able to evaluate how your hip is functioning and whether the recalled implant is in need of replacement.
In that visit, your orthopaedic surgeon may also want do a blood test that looks at the level of microscopic metal particles around your hip. Metal particles are a sign that recalled implant has failed. If the blood test indicates a high level of these particles, your surgeon may want to do a second blood test three months later. These levels may be high even if you are not experiencing any symptoms, so this blood testing is very important.
2. Call HensonFuerst Attorneys for important information about your rights. If you or someone you care about received one of these defective joint replacement components, we would like to speak with you right away. You may have a legal case and be able to collect compensation for the injury caused by this faulty medical device.
What’s most important: DO NOT contact DePuy, or SIGN ANY RELEASES OF YOUR MEDICAL RECORDS TO DePuy or JOHNSON & JOHNSON before you talk with a lawyer. On DePuy’s website, they ask patients to register with them and receive a claim number. DO NOT DO THIS YOURSELF. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed. If DePuy was interested in helping patients, they would not have allowed the device to continue to be sold even after they knew it was causing serious problems.
We have a lot of questions for DePuy. We’ve searched, but we can’t find answers to these questions:
- Why are patients being asked to submit medical bills to their own insurance company? Why isn’t DePuy taking responsibility for all costs, without trying to push the costs off on private insurance or Medicare?
- If high levels of metal are found in the blood, why does DePuy recommend waiting and retesting in 3 months? Why isn’t this considered a health emergency?
- DePuy knows that the metal particles can cause necrosis (death) of the soft tissue around the hip implant…that’s what makes the revision more difficult than the original surgery. If a person wants to avoid the potential extra damage, can they replace their DePuy hip with a non-failing hip? What about people who had their hip replacement in the last couple months…do they have to wait years to see if their hip replacement fails?
- Why did U.S. surgeons continue to use DePuy hip replacements, even after the international medical community raised questions about their safety? Were there any financial incentives involved? Should surgeons who implanted these recalled products in 2010 (after they were withdrawn from Australia) be held responsible for their part in the recall?
If you think you have a DePuy hip replacement…
And if you want us to ask these and other questions on your behalf, call us.
If you are worried about your future health, call us.
If you can’t get straight answer from your surgeon or hospital, call us.
With HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you. Our attorneys are available 24 hours/day, every day of the year at 1-800-4-LAW-MED (1-800-452-9633). Or, visit our website at www.lawmed.com for more information. You can also fill out a free online consultation form for an immediate evaluation of your case.
This law firm is not affiliated with, sponsored by, or associated with the Associated Press, DePuy Orthopaedics, Inc., or Johnson & Johnson