DEPUY HIP RECALL UPDATES
PRONE TO FAILURE, SOME ALL-METAL HIP IMPLANTS NEED TO BE REMOVED EARLY
Because older-model artificial hips are usually made of a tough plastic and metal, they can wear out, especially in people who are physically active. Manufacturers of all-metal hips have touted them as the right choice for younger patients but, for thousands of artificial hip patients, they've been a bad choice.... [read NPR article here]
URL: http://www.npr.org/blogs/health/2012/03/19/148769073/prone-to-failure-some-all-metal-hip-implants-need-to-be-removed-early
Posted March 19, 2012
Source: NPR
Original article
by Richard Knox
THE HIGH COST OF FAILING ARTIFICIAL HIPS
The most widespread medical implant failure in decades - involving thousands of all-metal artificial hips that need to be replaced prematurely - has entered the money phase. Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. [Read full New York Times article here...]
Posted December 28, 2011
Source: New York Times
WILL NEW FDA ORDERS LEAD TO A RECALL OF ALL METAL-ON-METAL HIP IMPLANTS?
U.S. Food and Drug Administration orders 21 hip makers to blood test their patients for metal.
What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?
FDA ASKS METAL HIP MAKERS FOR MORE DATA
By Marissa Cevallos, HealthKey / For the Booster Shots blog
May 11, 2011
The FDA issued orders on May 6 to 21 companies that make metal-on-metal
hip systems, asking them to further study the safety of their
devices. In particular, cobalt and chromium may be getting into the
bloodstream. [Read more about the FDA's orders for metal-on-metal hip systems here...]
Source: L.A. Times
URL: http://www.latimes.com/health/boostershots/la-heb-fda-metal-hip-20110511,0,7767788.story
FDA's Role and Activity in Medical Device Safety Assessment
URL: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm
91 LAWYERS GO BEFORE THE JUDGE
The Honorable Judge David Katz is currently deciding which attorneys should be appointed to serve on the Plaintiffs’ Steering Committee (PSC) for the DePuy hip implant product liability litigation. The DePuy cases were recently consolidated in the Northern District of Ohio where the pre-trial litigation will be conducted. The PSC is responsible for litigating on behalf of the Plaintiffs. All of the work they do is for the common benefit of every Plaintiff whose suit is on file in the MDL. Judge Katz, who presides over the MDL, asked for letters from every Plaintiffs’ lawyer interested in serving on the PSC. These lawyers were then given the opportunity to appear before Judge Katz in court on Thursday, January 20, 2011 to tell him why they should be appointed. Ninety-one lawyers made that court appearance. Each lawyer was allowed to speak for two minutes. Judge Katz’s decision is expected within the next few days since there is much work to be done and no time to waste.
COBALT POISONING: DEPUY ASR HIP IMPLANTS ARE A SERIOUS RISK
A person with 1 microgram of cobalt in their bloodstream has nothing to worry about.
Someone whose blood contains more than 25 micrograms has cobalt poisoning.
And a patient whose blood contains more than 100 micrograms? Probably has a DePuy ASR hip implant.
93,000 patients received DePuy ASR hip systems. As more and more of those patients ask their doctors for blood tests, the numbers of those who have extraordinarily high levels of cobalt in their bloodstream becomes staggering. .Many of our own clients have received the worrying news that their cobalt levels are far above normal, and at least one doctor has published a case study of two DePuy hip implant recipients who have cobalt levels that are 100 to 500 times normal.
How Much Cobalt Is Normal?
If you go to a doctor and get a blood test, the amount of metal (including cobalt) in your bloodstream will be calculated in micrograms per deciliter. A healthy person has approximately 0.019 micrograms per deciliter – about one microgram for their entire body. The metal in your bloodstream only presents in very, very small amounts; someone with normal cobalt levels could gather all the cobalt in their system together and come up with an amount smaller than a grain of sand.
Even at highly toxic levels, the actual amount of cobalt looks very, very tiny. 0.5 micrograms per deciliter of cobalt is considered toxic. That’s about five grains of sand in a giant bucket of water. Seems small – but those tiny grains of metal can throw the entire chemistry of your body wildly out of order.
In Britain, there are regulations for keeping patients under close observation when they have metal-on-metal hip implants, including the DePuy ASR hip device. At cobalt levels of 0.7 micrograms per deciliter, patients must be kept under observation. Symptoms at those levels include hip pain, dying tissue, and pseudotumors – masses under the skin. Generally doctors recommend revision surgery if a patient with a hip implant has a cobalt concentration of 1.9 micrograms/deciliter or above.
Revision surgery isn’t suggested until cobalt concentrations are 100 times the mean average – even though levels are considered toxic at 25 times the average.
One patient with severe cobalt poisoning had levels of 6.6 micrograms/deciliter. That’s nearly 350 times the mean average. The dangerous effects of cobalt levels this high were quite apparent: in addition to hip pain, the patient showed declining cognitive function; loss of hearing and vision; and suffered from seizures, heart failure, and multiple other problems.
The amount of cobalt that patient had in his blood was still small enough that it wouldn’t have filled a teaspoon. But the damage was great enough to threaten his life.
What is Cobalt Poisoning?
Cobalt is one of the many metals that is found naturally in the body, but as with all other metals, in excess amounts it becomes toxic and leads to many harmful and potentially permanent side effects. Cobalt poisoning has caused cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the senses. It can cause neuropathy, seizures, blindness, headaches, and liver damage. Cobalt has also been linked to cancer.
For DePuy hip implant recipients, it can also mean that future hip revisions have a lower chance of success. Excess amounts of cobalt in the bloodstream lead to metal sensitivity and metallosis which can seriously damage surrounding tissue and make a second implant less likely to succeed.
Doctors Unaware of Risk
Both patients and doctors may be unaware that a blood test could prove to be as important as a revision surgery.
For many patients with DePuy ASR hip implants, the symptoms of cobalt poisoning either go unnoticed initially or are chalked up to other pain and problems related to the hip implant failure. For example, a patient might have deteriorating mental function, mood disorders, or vertigo - but if the patient is also in a great deal of pain because the hip implant is failing, it is very possible that he might assume the other symptoms are related to his pain and will go away if he has a revision surgery.
Meanwhile, doctors who are fully aware that DePuy ASR XL Acetabular System is failing at inordinate rates may recommend a revision surgery to solve problems of pain and inflammation. Those doctors may not know that the friction of the hip implant is releasing excess amounts of metal ions into the bloodstream and causing potential problems with far more long-reaching effects.
A patient could walk out of surgery with heavy metal poisoning (link to our article What is Heavy Metal Poisoning?”) and not be aware until the symptoms become extreme enough to return to the hospital.
What Should You Do?
If you have a DePuy ASR Acetabular hip implant and are concerned about cobalt poisoning, see your doctor as soon as possible to discuss your options and express your concerns. Our medical crib sheet for DePuy ASR hip implant patients can give you some guidance on questions you may want to ask your doctor and tests you may wish to request.
If you’d like some advice on your legal rights and any potential claims you may have against DePuy because of the danger this implant may present to your current and future health, we’re here to answer any questions you may have. You may be entitled to compensation from DePuy for the damages you have suffered and will continue to experience in the future as a result of receiving a defective hip implant. Call our offices at 1-800-269-3050 or use our online contact form (link to case queries) and we’ll do everything in our power to get you the answers you need.
To learn more about the problems associated with the DePuy ASR Acetabular hip implant, these articles may prove helpful:
DePuy Asks Hip Implant Patients to Sign Away Their Legal Rights
Glossary of Medical Terms Related to the DePuy ASR Acetabular System
How the ASR XL Acetabular System is Constructed
THE IMPLANTS LOOPHOLE
By BARRY MEIER for the New York Times
A recently recalled artificial hip made by a unit of Johnson & Johnson, designed to last 15 years
or more, is failing worldwide at unusually high rates after just a few years. [Read more...]
URL: http://www.nytimes.com/2010/12/17/business/17hip.html?ref=barrymeier
Source: New York Times
December 17, 2010
CHROMIUM POISONING JUST AS DANGEROUS AS COBALT POISONING
Early this year, DePuy issued their recall for the ASR XL Acetabular System sold in the United States. Doctors began recommending revision surgery to those of their patients who reported pain or an overall failure of the DePuy hip implant. In many cases, the doctor was wise enough to run a blood test to determine whether there was excess metal in the bloodstream, as many medical studies have shown that elevated levels of metal are common for patients with metal-on-metal hip implants.
Patient after patient with the ASR Acetabular DePuy hip implant began turning up with cobalt and chromium levels that were well over 100 times normal.
Cobalt poisoning has been getting a great deal of attention and for good reason: the symptoms of cobalt poisoning include many serious side effects including neurological (brain) damage, heart irregularities, and seizures. Cobalt poisoning has also been linked to cancer. It's small wonder that many people, when they first learn that the DePuy hip implant leaks metal ions into the body, are primarily concerned about cobalt poisoning.
However, chromium poisoning is equally dangerous. And the symptoms are just as troubling.
What is Hexavalent Chromium?
When discussing chromium poisoning, the most significant problems have been linked to a particular compound, hexavalent chromium (Chromium (VI)). Hexavalent chromium is the agent that turned up in the water supply of the California town of Hinkley, later made famous by Erin Brockovich's activism work. Many people remember the Erin Brockovich story - if not for the event itself, certainly for the award-winning movie based on it. They remember that there were many cases of cancer in the town; 196, to be precise.
Few of them remember that the problem with the water was hexavalent chromium.
Hexavalent chromium has been deemed a cancer-causing agent by the World Health Organization, which means that both chromium and cobalt can elevate a DePuy hip implant patient's cancer risk. In fact, studies show that elevated levels of any heavy metal increase the risk of cancer.
Our research indicates that hexavalent chromium is the type of chromium being released by the ASR Acetabular system; it degrades in the body into trivalent chromium, or Chromium (III). Anywhere from 18-30% of a typical metal-on-metal implant is composed of chromium; we do not have current numbers on the amount of chromium included in the DePuy hip implant.
Patients with elevated chromium levels show similar symptoms as those with elevated cobalt levels. There are notable differences; cobalt poisoning can cause cardiomyopathy, for example, while elevated chromium levels do not appear to cause heart problems but can cause problems with the reproductive system. The table below gives an overview of the symptoms shown by patients with elevated chromium levels vs. those with elevated cobalt levels.
If a particular type of chromium or cobalt has been specifically linked to a symptom, it is noted in parentheses next to the symptom. For example, mutated DNA is noted as being linked specifically to Chromium III.
Elevated Cobalt (Co) Levels |
Elevated Chromium (Cr) Level |
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Genetic Information |
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Localized tissue around the implant |
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Liver |
|
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Kidney |
|
|
Respiratory System |
|
|
Nervous System |
|
|
Heart and Vascular Systems |
|
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Endocrine System |
|
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Visual and Auditory System |
|
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Reproductive System |
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Carcinogenesis |
|
|
What Does This Mean for My Health?
Chromium poisoning and cobalt poisoning are both very serious; however, there is no way to tell if you have either problem without getting a blood test to find out what your chromium and cobalt levels are. Even if you have elevated levels, you may still not have chromium or cobalt poisoning; slightly elevated levels are normal for patients who have metal-on-metal hip implants and among the doctors we've consulted, they do not consider slightly elevated levels to be cause for alarm.
For those DePuy hip implant patients who have presented with 100 and 500 times the normal level of these two metals in their systems, however, doctors are quite concerned. Cobalt and chromium can both be retained in the bodily tissues for a long period of time, and if the body is subjected to excess levels, it will have a more difficult time processing the metal ions through the normal elimination process, especially if the kidneys are damaged - a problem sometimes caused by chromium poisoning. Little research has been done on the long-term effects of elevated metal ion concentrations.
When speaking to your doctor, we have a medical crib sheet that may be prove useful if you are uncertain what to ask about or worried you may forget important questions. We would also highly recommend you read this article on DePuy trying to get patients to agree to give the company access to their medical records; if you are thinking of pursuing a legal case against DePuy, signing away your medical records can be severely detrimental to your case.
If you have received a DePuy hip implant and are concerned about the effects chromium and cobalt poisoning may have on your health, please give us a call at 1-800- 269-3050 or contact one of our pharmaceutical attorneys through our online system. We're here to answer your questions and help you build a case against DePuy if you think that is the best course of action for you. The health risks you've been asked to shoulder are immense and surely very upsetting; we will do our best to help in any way we can.
Posted December 17, 2010
FOR DEPUY PLAINTIFFS - AND OUR LEGAL TEAM - OHIO IS THE PLACE TO BE.
Two weeks ago, the U.S. Panel on Multidistrict Litigation conducted a hearing to discuss where the DePuy Hip Implant MDL should be placed. Today, the Panel announced that the litigation will take place in the Northern District of Ohio.
Complaints about the DePuy ASR hip implants have been reported throughout the United States, which prompted a hearing to consolidate the cases into multidistrict litigation. Counsel for DePuy Orthopaedics, Inc. did not object to doing so. The Multidistrict Litigation (MDL) Panel determined that the DePuy cases qualified for consolidation and created DePuy Mulitdistrict Litigation.
There were many different courts in the running for the federal district in which the pretrial proceedings would take place, including Kentucky, Indiana, New Jersey, Ohio, and Florida. Counsel for DePuy and several Plaintiffs' lawyers who represent people harmed by the DePuy devices submitted arguments to the Panel as to which court they felt was most appropriate for these cases.
As explained in previous articles, consolidating a case conserves resources for the attorneys as well as the judiciary, and bringing individual lawsuits for each case can make the costs so prohibitive as to present an obstacle to getting a fair settlement for the plaintiffs. The fact that DePuy Multidistrict Litigation has been formed creates a more efficient way for our legal team to pursue claims for our clients and ensures we are better able to give them the individual attention they need.
To better serve our clients in this case, Moriarty Leyendecker is working in conjunction with The Law Offices of Sullo & Sullo and The Law Offices of Howard L. Nations, the latter of whom was among the lawyers who proposed the Northern District of Ohio as the best venue based on that court's current docket and the speed and efficiency at which they move cases to resolution; the convenience of location for all parties; and the experience of the presiding judge.
The Honourable David A. Katz is highly experienced with a successful MDL track record. Judge Katz is exceptionally well qualified to handle a matter of this size and complexity. Mr. Nations and his legal team were recently before Judge Katz in litigation regarding Ortho Evra Products Liability, a matter which was successfully resolved in the same Ohio court.
At Moriarty Leyendecker and the Law Offices of Howard L. Nations, we are looking forward to working with Judge Katz and his staff on this important matter, and we are confident that this choice of district is in the best interest of our clients.
DEPUY ASKS HIP IMPLANT PATIENTS TO SIGN AWAY THEIR LEGAL RIGHTS
December 6, 2010
If you received an ASR XL Acetabular System, your doctor has probably already informed you that DePuy is offering to pay for hip revision surgery.
What they may not have mentioned - and what they may not themselves realize - is that agreeing to DePuy's hip revision offer means that you must agree to sign a waiver that essentially waives your rights in litigation and allows the Johnson & Johson-owned company to access your medical records.
They want to use your own medical records to show that they don't owe you anything for the serious repercussions of the faulty hip implants they allowed to get to market without sufficient testing.
Hip Revision Dependent on Loss of Patient Rights
DePuy sent a letter to health care professionals explaining the recall and informing the doctors and surgeons that they needed to contact their patients about the problems with the ASR XL Acetabular System. In the letter, DePuy said they intended "to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR."
Laying aside for the moment that "reasonable and customary" probably does not mean the same thing to DePuy as it does to the patients, the real problem comes in the next paragraph.
Eligibility for this medical treatment, DePuy says, is dependent on the patient having "consented to provide DePuy with x-rays, explants, and any other requested medical information after the revision surgery."
In other words: DePuy won't pay for your revision surgery unless you sign away your private medical records so they can examine them.
What do they plan to do with your medical records? DePuy states that they will use this information "to process claims efficiently and to help DePuy to better understand the causes of the problems with the ASR Hip System."
If this were true, then the information would surely be scrutinized by their engineers to determine exactly what went wrong with the design of this hip implant. That's commendable, but unfortunately it is far from the most likely scenario, as the history of DePuy's previous encounters with faulty implants shows.
The DePuy professionals that will be scrutinizing your medical information aren't engineers, nor even doctors.
They're lawyers.
What's Wrong With DePuy Having Access to Your Hip Implant Records
To give you an idea of what you can expect from DePuy in litigation about the ASR XL Acetabular System, it may help to look at a previous case about another medical device: the DePuy Limb Preservation System. It's a knee replacement approved by the FDA using the same loophole in the 510(k) process that the ASR hip implant slipped through: DePuy claimed the knee replacement to be "substantially equivalent" to another product.
It later transpired that the product to which the knee replacement was supposed to be substantially equivalent was completely different. The LPS system was never tested. It also had serious design defects.
If all of these problems sound familiar, it's because they are identical to the issues with the ASR XL Acetabular System: cleared through the 510(k) process, claimed "substantially equivalent" to a device that was nothing like the new hip implant, never clinically tested by the FDA, and with serious design problems.
In the knee replacement case, DePuy's defense lawyers avoided talking about any of these issues.
Instead, they pointed the blame at the patients.
The device failed because the patient was overweight. Because the patient was over-active. Because the patient had fallen. Sometimes, they also blamed the surgeon - for improper implementation.
But mostly, they blamed the patient.
What are they going to do with your medical records? They're going to use them to build a case that they did nothing wrong.
They're going to claim that you did.
Where Is This Form Going to Come From?
DePuy sent copies of their Medical Release Form, also called the Authorization to Use or Disclose Information, to each medical professional who implanted an ASR XL Acetabular System.
The form signs over all medical records, explants and x-rays from the original surgery that implanted the ASR XL Acetabular System, the hip revision surgery, and "all follow up visits and records." Records include "telephone message slips," "copies of lab work," "physical therapy reports," "progress records," and other private medical information.
This means your surgeon is likely going to be the one who asks you to sign the form, which in turn means you must stay alert. There is a lot of paperwork surrounding any surgery, and it is important that you make sure you don't accidentally sign a form that causes you to lose your legal rights.
DePuy has offered the surgeons $50 dollars for every Medical Release Form they can get signed. They have good reason to offer incentives: all of this information can be used to build a case against you. More importantly, giving DePuy the explant means that your lawyer no longer has access to it and cannot use that evidence to build a solid case against DePuy.
The surgeon who placed the implant may not be aware that these are DePuy's intentions. In fact, all the communications we have seen between DePuy and the medical professionals who implanted the ASR XL Acetabular System claim that the only reason they want this information is to improve their medical devices. This means your surgeon may have no idea that by encouraging you to sign the form, he or she is also encouraging you to sign away your chance for legal compensation.
Please don't blame your doctor. We certainly don't. They're doing their best to make sure you get the hip revision surgery you need right now.
We're doing our best to make sure you get everything else you need - including just compensation.
Have You Already Signed a Medical Release Form for Your DePuy Hip Implant?
You may have already signed one of these forms. If you have, please don't panic. There are measures we can take to help you get your medical and legal rights back. For example, we can put out a revocation of authorization to use or disclose your medical information, which compels DePuy to stop asking for new information and to return the information they've already received.
If they refuse to respect your rights and don’t comply, we can use that in your case against them.
If you have questions about the ASR XL Acetabular System hip recall or you're concerned that you may have already signed a form giving DePuy access to your medical records or your explanted device, give us a call at 1-800-269-3050 or contact us online. We're here to help.
THEY’VE REACHED A DECISION – DEPUY MDL WILL BE IN OHIO
It was just 2 weeks ago that the U.S. Panel on Multidistrict Litigation conducted a hearing to discuss where the DePuy Hip Implant MDL should be placed. Today they made the announcement that they have picked the Northern District of Ohio.
There were many different courts in the running, including Kentucky, Indiana, New Jersey, Ohio, and Florida. Counsel for DePuy Orthopaedics, Inc. and several Plaintiffs’ lawyers who represent people harmed by the DePuy devices, including our firm, submitted arguments to the Panel as to which court they felt was most appropriate for these cases.
We proposed the Northern District of Ohio as the best venue based on that court’s current docket and the speed and efficiency at which they move cases to resolution; the convenience of location for all parties; and the experience of the presiding judge. The Honorable David A. Katz is highly experienced with a successful MDL track record. Judge Katz is exceptionally well qualified to handle a matter of this size and complexity. Our firm and the attorneys for DePuy were recently before Judge Katz in the Ortho Evra Products Liability litigation, which was successfully resolved in the same Ohio court. We look forward to working with Judge Katz and his staff again as we prosecute our DePuy hip cases.
Posted December 3, 2010
By Cindy L. Nations
WHERE WILL THE DEPUY MDL BE?
Since DePuy Orthopedics announced the global recall of their ASR hip implant devices this summer, the lawsuits have been piling up. With 93,000 devices being recalled, it is expected that there will be thousands of lawsuits against DePuy and their parent corporation Johnson & Johnson. That's why a multidistrict litigation (MDL) will be used to effectively handle the pre-trial litigation of these cases. The U.S. Panel on Multidistrict Litigation will be deciding where the DePuy MDL will be based. The Panel held a hearing on Thursday, November 19, 2010 to discuss this issue. Their decision should be announced soon.
Posted November 22, 2010
By Cindy L. Nations
WHY WOMEN ARE AFFECTED MORE THAN MEN BY THE DEPUY HIP RECALL
Several news sources, among them the New York Times, have already commented on the mounting data that more women than men are reporting problems with the ASR XL Acetabular System. We'd like to explain exactly why that is.
Problem: Hip Implant Not Designed Ideally for Wider Hip Sockets
Women, as you may have heard, are structured differently anatomically than men. The differences aren't merely on the surface, however; they extend into the skeletal structure and particularly in the pelvis region. Women have wider hips with bigger hip sockets to accommodate the process of giving birth, which means they often have more problems in hip implant surgery because those large hip sockets allow the implant to dislocate more easily.
In the DePuy ASR XL Acetabular System, however, the problems go beyond the norm. One of the reasons is that the hip implant was designed to be extremely shallow, exacerbating the problems women already have with hip implants.
Problem: Women More Likely to Require Hip Implants
Women are more prone to osteopenia, osteoporosis, and often have weaker bones overall than men, particularly as they age. The onset of menopause, and the subsequent drop in estrogen, have been linked to rapid bone deterioration. Because of all of these factors, women are more likely than men overall to require a hip implant because of a hip fracture.
Problem: Small, Shallow Hip Implant
The DePuy ASR XL Acetabular System was designed to give patients a greater range of motion. If you'll recall, the design of the hip implant included two parts: an implant inserted into the femur bone with a rounded top that fit into a cup placed in the hip bone.
In the design of the ASR XL Acetabular System, the cup was made very shallow, which meant that the patient could move their leg in a wider arc before the other part of the implant might dislocate.
Good in theory. And if DePuy had tested their product properly, it might have worked quite well. In real life, it went a little differently.
The shallow hip implants meant that all of the friction caused by everyday movement was focused on a much smaller area. There was more force on a smaller amount of material. The hip implant was under more stress and was more prone to the friction that caused small metal ions to break off into the bloodstream. It was also more likely to break altogether.
Especially in women. Their smaller, shallower hip implants meant there was even more strain on the material. Women who have an ASR XL Acetabular System are reporting problems in greater numbers than men in part because their hip implants are simply breaking down faster. They have the same problems, forced upon a smaller area.
Our consulting doctor offered some sobering statistics for smaller hip implants in general: the risk of a hip revision surgery for a hip implant with a head size of 44 mm is five times that of a hip implant with a head size of 55 mm.
Problem: Bone Deterioration Exacerbated in Women's Hip Implants
Because women are more prone to bone deterioration in general and have less bone density than men, the problems caused by the ASR XL Acetabular System are multiplied. We've explained the problem of bone deterioration at length, but here's the issue in a nutshell:
For a non-cemented hip implant like the ASR XL Acetabular System to work properly, the surrounding hip bone needs to be healthy and growing. DePuy's hip implant design caused an inordinate number of metal ions to be released into the bloodstream, causing problems with metallosis, heavy metal poisoning, and metal sensitivity - all of which adversely affect the bone.
One reason why women may be reporting problems with their hip implants sooner than men is because they have less bone to sacrifice to the effects of the metal ions floating in their bloodstream. The symptoms become painful more quickly, and more women are going to their doctor with concerns about the hip implant.
Handicapped with less dense, weaker bones, women now face the additional problem of attempting a hip revision with severely damaged hip bones from the previous DePuy hip implant.
It is already more difficult for a woman to have a successful hip replacement surgery than a man. DePuy's ASR XL Acetabular System made it even more difficult - not to say dangerous.
If you have any questions about your hip replacement surgery or your options moving forward, we'd like to help. Give us a call at 1-800 269-3050 or fill out our online form and we'll explain your legal options and try to answer any of your questions about the DePuy hip implant and how it's affecting your health.
WHY BONE DETERIORATION CAUSES PROBLEMS WITH HIP REVISION SURGERY
As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.
When undergoing hip surgery, there are generally two options for a hip implant: cemented and uncemented. Cemented implants, which involve attaching the implant directly to the surrounding bone by means of a specially constructed bone cement, have been used since the 1960s. Uncemented implants were introduced in the 1980s. The ASR XL Acetabular System is an uncemented implant.
The idea behind an uncemented implant is that healthy bone can grow into its surface, thus holding the implant in place by means of the body's own materials instead of a foreign cement. Medical professionals hoped that this design would mean the patient could have a more active life since the concern of gradually wearing away the cement would be eliminated. Cementless total hip replacements are recommended for younger, more active patients and have shown, so far, better results in long-term studies.
Obviously, healthy bone is essential for an uncemented hip implant. Without healthy bone growth, the hip implant will not be secured into the rest of the skeleton and will not function as a replacement for the removed hip.
Evidence is showing that the DePuy ASR XL Acetabular System may cause serious bone deterioration in a number of ways. One of the most significant is osteolysis, which occurs when the body reabsorbs bone as part of an autoimmune response. Osteolysis has been noted as a side effect of many total hip replacement systems; the more debris that is released into the body, the more common osteolysis becomes. Metal-on-metal hip implants were thought to have less likelihood of debris because they are made of harder materials, but the ASR XL Acetabular System's poor design caused significant friction and a great deal of metal debris, raising the risk of osteolysis.
Another problem is the surgery itself. An uncemented implant requires the surgeon to insert the cup of the hip implant into the hip socket, called the acetabulum. This means some of the bone in the socket must be scraped away to make room for the implant. This is part of any hip implant surgery, but since the DePuy implants only lasted a few years before they were recalled, patients are now forced to undergo hip revision surgery before that bone has had enough time to recover from the initial surgery's trauma.
Hip revision surgery is much less likely than initial hip replacement surgery to succeed. With damaged bone mass, the chance of success is even lower.
In essence, the weaker the bone, the less likely it is that each successive hip replacement surgery will succed. With complications of metal poisoning, metallosis, and trauma to the surrounding bone and tissue, the circumstances for a revision surgery are far from optimal.
If you have a DePuy ASR XL Acetabular System and you are concerned about compensation for the medical trauma you've experienced, we'd like to help answer your questions and advise you of your legal rights. Please give us a call at 1-800 269-3050 or simply fill out our online contact form.
DEPUY RECALLS 93,000 HIP IMPLANTS
DePuy Orthopedics, a subsidiary of Johnson & Johnson, announced a global recall of the following hip implants on August 24, 2010:
ASR™ XL Acetabular System
ASR™ Hip Resurfacing System
The devices were recalled because of a design defect that causes metallic ions to be released into the bloodstream and causes damage to surrounding tissue. The result is severe pain and potentially toxic levels of chromium and cobalt in the blood, the effects of which remains to be seen. The failed implants have to be replaced through revision surgery, which is more complicated than the original hip implant procedure. Although the recall was issued in July 2010, DePuy didn’t send the Dear Doctor Letter until the end of August.
Posted October 18, 2010
By Cindy L. Nations
The Nations Law Firm | A National Pharmaceutical Litigation Firm
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