Articles Posted in DePuy Hip Recall

A recently published study, Neurotoxcity of Cobalt, published in the May 2012 issue of the journal Human & Experimental Toxicology, a peer-reviewed journal, discusses evidence that cobalt in the blood system can cause long term health effects.

This study comes on the heels of the 2010 DePuy hip replacement device recall after it was discovered that the metal-on-metal hip implants were failing in patients at a higher than normal rate and that the rubbing of metal-on-metal caused shedding of cobalt and chromium debris at dangerous levels in patients’ tissue and bloodstream causing a condition referred to as metallosis.

Several studies theorized that cobalt and chromium in patients’ bloodstreams caused inflamed tissues, bone loss, pseudotumors as well as other problems. Now, this later study indicates that some patients with high levels of cobalt from their metal-on-metal prosthesis have experienced side effects including tinnitus, deafness, vertigo, vision problems, optic atrophy, tremors and nerve damage. The journal goes on to say that that cobalt can be toxic to vital organs such as the thyroid and heart and that it has the potential to cause cancer.

Upwards of one million of the metal-on-metal hip implants manufactured by DePuy, a division of Johnson and Johnson, have been implanted in patients in the past 15 years. Now, all of these patients are at risk for cobalt toxicity according to the researchers of the Neurotoxicity of Cobalt study.

seattle depuy hip recall lawyerResearchers found that the shedding of cobalt is at its highest levels up to two years after surgery and then increases again as the hip implant devices start to fail. The devices were marketed to younger patients with active life styles saying that they would last longer.

The civil claims against DePuy have mounted after the recall of the devices in the United States. In England, France and Australia, the devices were banned more than a year before they were recalled in the United States due to high failure rate yet DePuy continued to sell and market them in the U.S.

DePuy recommends that patients implanted with  ASR XL Acetabular and Hip Resurfacing Systems contact their surgeon so that the surgeon can evaluate using xrays, imaging and blood tests the function of the hip and any possible damage to the bone and tissue surround the implant.  On their web-site, 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.
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National Public Radio’s Program Morning Edition aired a story today ““Prone to Failure, Some All-Metal Hip Implants Need to be Removed Early” which explained issues patients are having with the recalled DePuy ASR hip implants.

The feature story highlighted the plight of one patient, Susy Mansfield, a woman who was implanted with an artificial hip at the relatively young age of 57. At the time, her surgeon recommended a metal-on-metal hip because he said they would last longer since the metal-on-plastic hips which have a life span of 10-15 years.

Mansfield’s hip was problematic from day one. She suffered constant pain after the surgery, a pain she described as “terrible” and a “hot pain”. Her hip implant also was loose. When Mansfield found that her hip implant had been recalled, she sought the help of a surgeon who was experienced in replacing faulty hip implants, Young-min Kwon of Massachusetts General Hospital. Amazingly enough, her original surgeon’s office told her that her implant had not been recalled.

The problem with the DePuy ASR hip implants was that they had not been thoroughly tested on humans. The DePuy implants were approved by the FDA with a fast track system known as a FDA 501(k). Dr. Kwon said:

“I think there are lessons for all of us — that you need to have scientific data to support any introduction of any new technology. One might argue that [this one] didn’t have enough.]”

When performing Mansfield’s second hip replacement surgery (known as a revision surgery), Dr. Kwon discovered that the cobalt and chromium metal that was shed by Mansfield’s DePuy hip implant had damaged her muscles and surrounding tissue. In addition, her bone had not grow around her implant as it should have and Dr. Kwon had to perform bone grafting using a cadaver bone.

A British study found that the DePuy hip implants have a five-year failure rate of 1 in 16 patients but it could be higher. The United States has no national joint registry as they do in the U.K. so there are no real estimates of how many American patients are affected.

The good news for Mansfield. Only four days after her 2nd hip replacement surgery, she was able to go up and down stairs with the help of crutches.
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University of California San Diego orthopaedic surgeon, Dr. Scott Ball, has recorded a video available for viewing on YouTube on Metal-on-Metal Hip Replacements. The video is a good one to watch if you or a loved one has had hip replacement surgery with a metal-on-metal device as it provides a lot of information about the implants, how they can affect one’s health and tests to identify if there is a problem.

Hip Implants in the News

 
https://www.youtube.com/watch?v=6y2iZm2U45k
 

Seattle DePuy Hip Replacement LawyerMetal-on-metal hip implants have been in the news ever since DePuy Orthopaedics, a division of the pharmaceutical giant Johnson and Johnson, recalled the ASR XL Acetabular and Hip Resurfacing Systems because of their higher than normal revision rate. It appears as if the design of the DePuy ASR implant systems was faulty causing more wear debris than similar devices made by other manufacturers.

Studies showed that the DePuy ASR metal-on-metal hip implants systems are especially problematic and some studies estimate that the failure rate within in five years is 1 in 8 patients. A British society of orthopedic surgeons estimates up to 60% of the patients implanted with the DePuy ASR device will require a revision or second hip replacement surgery.

Hundreds of patients have filed claims against DePuy Orthopaedics claiming that DePuy was aware of the high failure rate of the device but nevertheless continued to market it in the United States even though it was banned in England and Australia among other countries.

Metal-on-Metal Hip Implant Side Effects

In the video, Dr. Ball states that studies show that metal-on-metal implants for the most part perform “very well.” However, he explains, some patients have adverse reactions to the metal wear debris caused when the implant ball rubs against the cub and small particles of chromium and cobalt are shed. Some patients’ immune systems are sensitive to even a small amount of metal debris and they can experience adverse reactions. An inflammatory reaction can cause problems with the soft tissue surrounding the implant. Symptoms can include:

  • Stiffness
  • Swelling
  • Decreased range of motion
  • Clicking or ratcheting sensation
  • Slipping Sensation

Patients with the recalled DePuy hip implants have been advised by DePuy to contact their orthopaedic surgeon for evaluation. The orthopaedic surgeon may choose to perform the following tests:

  • x-rays – to determine if there is bone resorption
  • Blood tests to check for elevated cobalt and chromium levels in their blood serum which indicates whether there is too much metal debris being shed
  • MRI or Ultrasound to check for fluid or a mass around the hip implant

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The Farber Law Group is engaged in representing several clients who have claims against DePuy Orthopedics, a division of the Pharmaceutical giant Johnson & Johnson. Our clients have suffered some serious injuries after they were implanted with defective metal-on-metal hip implants manufactured by DePuy.

It was of great interest to our firm when we read today’s front page article in The Seattle Times entitled “Failing hip implants will cost billions to replace.” The article discusses at length the money that the failure of metal-on-metal hip implants will cost individuals, the manufacturers of the hip implant devices, the insurance companies, and taxpayers and contribute to the escalating cost of health care. According to The Times’ article, the medical costs to replace the faulty hip devices could be in the billions of dollars.

Thousands of patients who received the DePuy hip implant have filed lawsuits against Johnson & Johnson in hopes of receiving compensation for their damages which include medical costs, loss of wages and pain and suffering. Many patients have medical bills of up to a half million dollars. Medical costs are not the only financial hardship to patients. Many of the patients are younger and have been disabled or been prevented from working.

According to the article in The Times, a half million patients have received a metal-on-metal hip replacement. The DePuy ASR XL Acetabular and Hip Resurfacing Systems were recalled on August 24, 2010 after many patients suffered serious side effects and many required a second “revision” surgery to replace their device. Side effects included severe pain, fractures, dislocation, nerve damage and necrosis, or tissue death.

There is also a heightened concern that the metal-on-metal design of the DePuy artificial hips may cause metallosis, a condition in which the metal shavings from the device are shed into the surrounding tissue and cause inflammation. Some symptoms of metallosis include pseudo-tumors, premature tissue death and even cancer.

The DePuy hip implant devices were marketed to active and younger patients but they were brought to market using a “fast track” approval process under FDA rule 510 without the testing necessary to make sure they were safe. By 2008, the FDA received hundreds of complaints from patients who had serious problems with their implants. The devices were pulled from the market in Australia and France where patients there were requiring revision surgeries at an alarming level but DePuy continued to market and sell the product in the United States even though the evidence was mounting that the devices were defective.

DePuy has engaged a risk management company, Broadspire, to deal with patient’s medical claims. Broadspire has contacted patients with the defective hip and offering to pay co-payments and deductibles of patients requiring revision surgery. Broadspire asks patients to sign a Medical Release Form which allows the company to see a patient’s private medical records. The Farber Law Group recommends that patients not sign such a form until they receive sound advice from a product liability law firm.

This information is provided by Washington Injury Attorney blog, a service of the Seattle product liability law firm, The Farber Law Group. Call us for answers to your questions about your DePuy hip implant device. We provide local representation to patients in the Pacific Northwest. We have a co-counsel relationship with a leading New York law firm in order to maximize your recovery.

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Patients in Washington state and throughout the Northwest are not the only ones mulling over their options after the ASR XL Acetabular and Hip Resurfacing Systems hip implant was recalled after many patients had very serious health repercussions due to the faulty design of the hip implant. Common complications include swelling, loosening of the joint, severe pain and fractures. More serious complications include metallosis which is metal poisoning.

In Australia, their senate is mulling over whether they want to mandate that doctors be forced to report problems that they observe with medical devices. This comes after the DePuy hip implant failed in about 5,000 Australian patients who received the device and these same patients have initiated a class action lawsuit.

One of the Australian senators said that he believes that the Therapeutic Goods Administration (TGA), a consumer watchdog agency which is similar to the Federal Drug Administration here in the U.S., “failed consumers”.

One Australian news agency went so far as to call the massive DePuy failure a “scandal”.

seattle depuy hip recall lawyerThe community affairs committee of their Senate is recommending a couple of major reforms in the Australian healthcare system including:

  • Mandatory reporting — Requires all health practitioners report adverse results from medical devices to the Therapeutic Goods Administration (TGA).
  • Transparency — Eliminates financial incentives paid to doctors by medical device manufacturers and pharmaceutical companies to use their products.

Looking at Australia from the U.S., it seems like their TGA did a better job than the FDA did here in the U.S. as the DePuy hip devices were pulled from their market while they were still being implanted here in the U.S.

Source: “Doctors could be forced to report faults“, news.com.au, 11/22/11
This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are a personal injury law firm representing patients with failed DePuy hip implants in the greater Seattle area and throughout the Pacific Northwest.

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A personal injury is any kind of accident where you are injured. If you have an accident and feel another party is at fault, you may decide to file what is called a personal injury claim in order to be compensated for damages that may occur from medical or emotional costs associated with the accident.

There are many types of personal injury claims, and while you can file a personal injury claim for just about anything, the most common types of claims are those that involve car accidents, work related injuries, slip and fall accidents, accidents in your home and holiday accidents. Others include product liability claims such as when you are injured from a defective product that you have purchased.

When you file a personal injury claim, you are asked to describe the accident, and provide a dollar amount that you think is suitable compensation. This can include medical and dental bills, money lost due to time missed from not being able to work, or even emotional damage if you can prove your accident caused you emotional or psychological stress.

In August 2010, the DePuy Orthopaedic division of Johnson & Johnson recalled the ASR XL Acetabular and Hip Resurfacing Systems due to a high failure rate compared to traditional hip implants. Patients fitted with the DePuy implants were advised to meet with their orthopedic surgeons to determine if they might require a hip “revision” or the replacement of their hip prosthesis.

seattle depuy hip recall lawyerThe DePuy hip implants were touted by the company as the device that should be used in younger and active patients because the metal-on-metal design would have a longer life and the design would allow the patient to remain active.

Unfortunately, studies have shown that the metal-on-metal design of the hip implant caused cobalt and chromium ions, or metal artifacts, to be released into the patient’s tissue which caused a number of complications.

One complication is that metal released in a patient’s system can cause pseudo-tumors or granulomas. A granulomatous reaction can occur when immune cells called macrophages wall off foreign substances that the body is unable to eliminate. In the case of the metal-on-metal hip implants, the masses can form as an immune reaction to metal debris. These pseudo-tumors can also contain necrosis, or dead cells.

If a pseudo-tumor grows large, it can cause loosening of the hip joint and it can eat away at the bone.

What tests can determine the presence of a pseudo-tumor?

Doctors have several tests which they can use to determine what is causing a patient’s symptoms or to see how the hip implant is doing.

Sonography/Ultrasound

Sonograms is a diagnostic tool that is non-invasive and uses sound waves to generate an image that a medical profession can uses to assess and diagnose. It can be used to look at soft tissue masses and bone surfaces. It is often used as an initial screening tool as it is inexpensive and easy to perform.

Magnetic resonance imaging (MRI)

MRI’s can be costly exams but they are able to provide detailed visualizations of internal structures. They can show reactive masses such as pseudotumors because they can show contrast of the different soft tissues of the body.

CT Scans/catScan

A CT scan can also be a useful tool with its 3-D imaging to show pseudo-tumors. However, the MRI provides a greater contrast between the various soft tissue.

Blood Tests

DePuy hip implant replacement patients are also advised to have a blood test which can determine whether there is an excess of metal in the bloodstream. Some patients with the DePuy hip implant have been found to have cobalt and chromium levels at more than 100 times a normal level. Metal at high levels is known to be a cancer causing agent.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represents patients throughout western Washington and the Pacific Northwest who have had their DePuy artificial hip recalled.

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The largest joint database in the wold which tracks more than a million patients with hip, knee and ankle joint surgeries finds that 25% of the patients with DePuy ASR hip implants had their implant fail within six years of implantation.

The National Joint Registry of England and Wales found that the actual rate of hip implant failure was 29% after six years in patients with the DePuy ASR XL Acetabular and Hip resurfacing hip implants. This number can be compared with patients with traditional style hip implants which only have a 9.9% failure rate.

The registry in England and Wales provides definitive research on the outcomes of joint replacement surgery. The U.S. has no such joint registry and therefore lagged behind the UK in discontinuing the metal-on-metal hip implant surgeries.

Johnson & Johnson’s DePuy subsidiary recalled the metal-on-metal hip implants in August 2010 after reports of high failure rates started being logged. The recall affected tens of thousands of patients with many having serious symptoms including severe pain, fractures and metal poisoning caused by the rubbing of the metal-on-metal components in the hip.

This information is provided by The Farber Law Group who provides legal services to patients who had the defective hip implanted.

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Pelvic Organ Prolapse (POP) is a medical condition suffered by women where a woman’s pelvic organs fall from their normal position and protrude into a patient’s vagina. While the condition can occur to any woman, women who have had very long labors or large babies are more prone to the condition. Women who smoke, are obese or have strain injuries are also at increased risk to experience pelvic organ prolapse.

POP was often the cause of a hysterectomy — removal of the uterus — in women. Surgeons also have other surgical options which include repairs to the vaginal wall through a transvaginal procedure.

Surgeons have increasingly been using surgical mesh, implanted through the vagina, to repair the prolapse. Surgeons had an option of using a non-absorbable synthetic, an absorbable synthetic or a biolgic to do the repair. However, in most cases, surgeons used a non-absorbable synthetic polyproplene.

The FDA reports that 300,000 women underwent POP repair in 2010 alone and in 75,000 of those cases, surgeons opted for the mesh repair.

Now it has come to light that some women who have had a repair with non-absorbable surgical mesh have suffered some serious and some time debilitating complications.

On July 13, the U.S. Food and Drug Administration issued a notice that with who had the transvaginal mesh repair have a five fold increase of pain and injuries. Last week Public Citizen, a consumer advocacy group petitioned the FDA to have the medical devices pulled off the market.

Up to 600 women with serious injuries have filed lawsuits against some of the leading manufacturers of the surgical mesh including Johnson & Johnson. The lawsuits claim that the manufacturers were negligent in bringing the product to market and did not do due diligence in testing what they say is a defective product. So far, none of the lawsuits have gone to trial.

The Farber Law Group is closely monitoring news feeds from the FDA and keeping abreast of the latest developments. We are a personal injury law firm and we represent people who have been seriously injured by dangerous or defective products .

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In the past couple of years, quite a few medical devices have either been recalled or come under scrutiny after reports of patients being seriously injured or killed due to a defective device. In the case of DePuy’s artificial hip implant, Johnson & Johnson’s surgical mesh product for pelvic organ prolapse (POP) and the Myxo ETIlogix annuloplasty ring, these devices were approved by the FDA through the 510(k) process which allows new medical devices to come to market through a nominal premarket approval process.

Now, the U.S. Institute of Medicine, a non-governmental non-profit organization which provides unbiased and authoritative advice on science, medical and health issues, is calling for a complete overhaul of the FDA process for approving new medical devices.

A medical device can be a simple tool like a thermometer, bandage or complex such as pace-makers, artificial hips or MRI machines. The FDA is responsible for ensuring that a medical devices have a “reasonable assurance of safety and effectiveness” before it can come onto market. Devices that may pose some risk to patients must be cleared through the Section 510(K) process.

The 510(k) process is a “fast track” through FDA approval and allows manufacturers to claim that a new device is substantially equivalent to other devices and therefore do not require expensive medical scrutiny and clinical trials. In the case of the DePuy hip implant that was recalled, the design was of significant departure from previous hip implant designs but was still given market clearance.

The Archives of Internal Medicine published a study that found that medical devices that resulted in serious patient injury or death were more likely to have been approved by the FDA through the 510(k) process.

On July 29, 2011, the U.S. Institute of Medicine published the results of a study of the FDA approval process which found that the 510(k) process is flawed and rather than trying to fix it, the FDA should develop “an integrated premarket and post market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” (Read the Press Release, “FDA Should Invest in Developing a New Regulatory Framework To Replace Flawed 510(k) Medical Device Clearance Process“)

Pressure is on the FDA to change the approval of medical devices but also to put in place a system in which problems with the devices are tracked and patient symptoms noted.

Hopefully, the FDA will move forward with insuring patient safety from defective medical devices.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who have been seriously injured by defective medical devices and through medical malpractice.

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