william staton's Blurty
 
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Below are the 6 most recent journal entries recorded in william staton's Blurty:

    Tuesday, December 6th, 2011
    11:27 pm
    430 Patients in Australia Affected by Failed ASR Hip Implants
    Some 430 patients who received the DePuy Articular Surface Replacement (ASR) hip implants in Australia have reportedly experienced device failure and other complications, according to an article published in the Sydney Morning Herald. The DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson, in August of 2010 called for a worldwide recall of two of its hip replacement systems, the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing Platform. Australia was the first country to withdraw the two DePuy hip implants in December 2009 followed by Europe a year later. Lawsuits followed in the aftermath of the worldwide recall with at least 300 hip replacement lawsuits filed in Britain.

    The 430 patients had required a revision surgery to remove the implants, said the news report. Including the 430 patients, there are about 5,500 Australians who received the apparently defective ASR hip implant devices of DePuy. As an aid to affected patients, an Australian Senate committee has called for the immediate and better action from the Australian Department of Health and Ageing as well as from the DePuy Orthopaedics with thousands of Australians having received the device.

    Among the actions suggested by the Australian committee which conducted an investigation on the DePuy recall is for their health officials to focus on informing doctors, patients and the general public to the DePuy device recall, its adverse effects on patients, and the options for treatment. According to the committee, the health department should also exert effort in searching for effective ways to monitor the cobalt and chromium levels in patients who had the metal-on-metal hip implants. Sometimes, only a blood test would alert the patients that they already have high levels of cobalt and chromium in their blood stream.

    DePuy’s ASR XL Acetabular System and ASR Hip Resurfacing System became available in the Australian market in July 2003. The Australian National Joint Registry was the first medical body to release data showing that the DePuy ASR devices have a premature failure rate between eight and 11 percent. Study conducted by the British Joint Registry confirmed the findings after it also determined that 12 to 13 percent of the DePuy’s ASR devices fail within five years. The recent study forced the worldwide recall of the DePuy hip systems.

    Medical experts told the New York Times that the device fails five years after it was first implanted contrary to its supposed lifespan of 15 to 20 years because of the hip implants’ design. With the intention of giving patients a wider range of motion, Depuy had designed a shallower cup and removed the plastic liner from the inside of the implant. However, the friction of the ball portion of the hip implant against the socket wears away cobalt and chromium particles from the device and into the soft tissue around the area leading to complications. Despite the Depuy Lawsuit, some 93,000 patients have already been implanted with the apparently defective device.


    References:
    smh.com.au/national/health/faulty-hip-implants-senate-inquiry-wants-action-on-ticking-time-bomb-20111122-1nsyc.html#ixzz1eY3Ru9qH

    hip-recall-lawyer.com/news/2011/11/28/australian-committee-seeks-better-action-in-helping-depuy-hip-implant-patients/

    depuy.com/aupatient
    Friday, November 4th, 2011
    12:50 pm
    Manufacturer of ASR Hip Replacements Waited for a Long Time to Issue a Recall
    Annually, about 250,000 hip replacement procedures are commonly performed in the United States. Only 1-3 percent of those procedures will require corrective surgery. A small percentage like this should facilitate the identification and tracking of defective hip replacements by regulators.It is unfortunate that the U.S. does not have any type of national artificial joint registration implemented.

    This lack of a regulatory system along with the prolonged amount of time it takes for a hip replacement to malfunction has allowed DePuy to sell 93,000 hip replacements worldwide unregulated. Consequently, the DePuy hip recall has caused deleterious effects to thousands of recipients. Additionally, the company faces more scrutiny over the ‘kickback’ scandal which says that DePuy pays consultants for them to use its products.

    Australia and the United Kingdom are two countries that do have artificial joint registries in effect and were able to detect the defective implants immediately. The National Joint Registry in Australia reported the DePuy hip replacements as having higher than normal failure rates as early as 2007. By 2009, DePuy voluntarily withdrew its products from the market.

    Parallel to this, the National Joint Registry of England and Wales quickly detected the defective hip replacements as well. Published studies by researchers at Oxford University presented statistically that 3.4 percent of patients out of 660 who received DePuy metal-on-metal hip implants suffered from signs and symptoms of metallosis. These studies also showed that 155 patients who received another company’s metal hip implants did not experience any similar side effects.

    Coincidentally, the U.S. Food and Drug Administration was busy processing the several hundred complaints due to the metal-on-metal implants, but did nothing in the absence of a regulatory national registry.
    Many surgeons have also come forth, claiming that they alerted DePuy as to the complications caused by their implants early on, but received little to no response from the company. It wasn’t until the media began reporting the failure rates of these devices in 2010 that the public became aware of the gravity of the situation. With increasing pressure from the public and the FDA, DePuy finally initiated a recall in August of 2010.

    The company was aware of its defective products and was negligent in initiating a DePuy hip replacement recall. It is apparently clear that it disregarded the health and safety of the consumer in order to avoid having more defective products undergo a public recall.

    Current Mood: accomplished
    Wednesday, September 14th, 2011
    2:58 pm
    FDA Process Used To Approve DePuy Hip Replacement Is Deemed Defective
    The New England Journal of Medicine has joined calls for the overhauling of the U.S. Food and Drug Administration’s (FDA’s) medical device approval following the high failure rate of some of the medical equipment it had recently approved for marketing. By showing that it is similar to previous ones already approved, FDA’s 510(k) medical device approval program allows manufacturers to introduce new medical devices without conducting rigorous pre-market testing to ensure the product is safe and effective before being approved. This is the same process that approved the DePuy’s hip Articular Surface Replacement (ASR) systems which have been recalled last year due to a high failure rate. After hiring the services of Broadspire to handle it, DePuy continues to be under fire for outsourcing the recall.

    Two committee members of the Institute of Medicine (IOM), which recently determined that the program could not be effectively updated, wrote the editorial published in the New England Journal of Medicine that called for an end to FDA’s 510(k) medical device approval program. The move is done to make medical equipment safer for consumers. Many experts and agencies have indicated for several years that the 510(k) approval process is broken, and has allowed a number of dangerous and defective products to reach consumers, some of which were subsequently recalled after causing serious injuries and deaths.

    Also approved by the 510(k) approval process, aside from the DePuy ASR, is the Bard G2 IVC filter. The two are allegedly faulty after a study by the National Joint Registry (NJR) of England and Wales suggesting that the five-year failure rate of the DePuy ASR is approximately 13 percent, or one in every eight patients receiving one of the hip implants. With the Bard G2 IVC filter, on the other hand, the FDA had warned that inferior vena cava (IVC) filters, which are implanted to prevent a pulmonary embolism, may be prone to fracturing in the body, sending debris into the heart, lungs and other organs.

    According to Drs. David R. Challoner and William W. Vodra, “Today, we have a system in which a new moderate-risk device can enter the market because it is substantially equivalent to another device that may have been cleared for marketing 2 years ago because its manufacturer showed that it was substantially equivalent to yet another device cleared in 2003, and so on, all the way back to a device that was being marketed when the law was enacted in 1976.” They added “But that original device might never have been assessed for safety or effectiveness, nor perhaps would any subsequent ones in the family tree.”

    Some in the medical industry have argued that the 510(k) process encourages innovation and to require all devices to go through more exacting review would stifle the creation of new medical devices. With all the sufferings they have gone through since having been implanted with the defective medical devices, the thousands affected with the DePuy hip replacement recall may not agree.
    Monday, February 28th, 2011
    11:13 pm
    Modern Hip Replacement Materials Still Far From Perfect As Shown By DePuy Hip Recall
    Throughout the past years numerous inventions were introduced to alleviate orthopaedic conditions that affect the hip such as osteoarthritis and osteoporosis, to name a few. A number of materials have been used to make implants including ivory and metal during the early attempts at manufacturing them. Although more advanced devices being made are using better materials ensuring improved results, the implants aren't completely flawless. As evidenced by the recent DePuy hip replacement recall of their ASR XL Acetabular and the ASR Hip Resurfacing System, hip implants still need a lot of work. Even the most common materials used to manufacture them have their pros and cons.

    Ceramic-on-ceramic hip implants: Prostheses using ceramics are targeted mainly against the wear and tear that is usually noted in plastic and metal implants. Although very smooth, this type of implant is susceptible to the “catastrophic failure” and could lead to breakage.

    Metal-on-plastic hip implants: Highly popular among hip replacement procedures, this type of implant features a metal stem and ball set inside the femur bone with a plastic liner in between. Nevertheless, this prosthesis wears down easily. The particles produced by the wear can cause irritation to the tissue and damage to the bone.

    Metal-on-highly crosslinked polyethelene: This type of implant is somewhat similar to metal-on-plastic devices but its crosslinking configuration makes it stronger. Since plastic is highly vulnerable to wearing, especially to younger, more active patients, this implant might be a better option for the elderly recipients or for patients who are not as active. Metal-on-metal hip implants: A metal ball and socket would consist these kinds of implants. The DePuy ASRs are made of metal-on-metal materials. This type of prosthesis is extremely strong and durable. However, the devices are highly prone to deposit metal ions in the body as the metals wear. Particles released by the implants cause pain and swelling in the hip area. This could then lead to more serious side effects such as muscle, nerve and bone damage.

    With the DePuy hip implants, experts have discovered a flaw DePuy hip implants, experts have discovered a flaw in the design making the devices hard to implant properly and causing it to jut out in a certain angle. Health implications for these devices still remain unknown. What is clear is that the pain and associated losses should be compensated. You should consider filing a hip replacement lawsuit if you've ever been a recipient of a DePuy ASR.
    Wednesday, February 23rd, 2011
    4:26 am
    Johnson & Johnson Experience Decrease In Revenue After DePuy Hip Replacement Recall
    Joint reconstruction and sports medicine product manufacturer DePuy Orthopaedics is currently in a legal battle with hundreds of victims of their defective hip replacement recall. Johnson & Johnson, the company which owns DePuy may have to ultimately shell out a hefty price to serve as compensation to these recipients who underwent tremenduous physical pain and losses and are filing DePuy lawsuits. If their medical device sales is any indication, the company is suffering a downturn in their revenue.

    In 2010, the company's first quarter sales figures showed a total of $4.53 billion in net earnings-- a $1.02 billion increase from their earnings in 2009. Significantly, the majority of this increase is attributed to their medical device division. A 12.5 percent increase was seen in the sales of their medical devices in the first quarter.

    From a revenue of $3.21 billion in 2009, it shot up to $3.4 billion in the second quarter of 2010. Medical devices have shown a 4.1 percent increase over last year as well.

    The most recent sales figure reports before the DePuy hip replacement recall in August were in the third quarter of 2010 which posted quite a different story. The earnings from by the company was down by 0.7 percent. The medical device sales also slowed for a second straight quarter.

    Representatives of Johnson & Johnson blames the recession for the decrease in sales for the third quarter. A new reform law on health-care, weak consumer sales and currency exchange rate changes all account for the company's slow growth. In addition to the DePuy hip replacements, several more products from Johnson & Johnson have been recalled as well which includes Tylenol, Motrin and Velcade among others.

    In the wake of the recall DePuy Orthopaedics made on their ASR XL Acetabular System and ASR Hip Resurfacing System, recipients have been searching for ways to acquire compensation. To communicate with a with a competent hip lawyer and know more about the DePuy hip replacement lawsuits, you could visit the DePuy Hip Replacement Lawsuit Center.
    Thursday, February 3rd, 2011
    1:52 am
    An Overview of Past Hip Replacement Lawsuits
    There were other hip replacement-related lawsuits in the past that plaintiffs or would-be plaintiffs of the DePuy case might want to take a look at. DePuy Orthopaedics' ASR XL Acetabular System and ASR Hip Resurfacing System are not the only hip replacement implants that garnered attention due to the injury they have caused recipients.

    One such case was in Suffolk County, New York wherein a victim was given a $1 million settlement because of an unsuccessful hip replacement surgical procedure. In 2000, Sulzer manufactured artificial hips that was defective. The flaws were due to oil found in the devices that did not let the implant stick to the bone as it was supposed to. Even a 15,000th of a drop of mineral oil could destroy the hip prosthesis. When lawsuits against hip replacement manufacturers come up, the Sulzer case is likely to surface. A class action group received a hefty $1 billion settlement from Sulzer. Three thousand five hundred plaintiffs who have had revision hip replacement prodcedures each received $206,000.

    Nobody can say whether the DePuy litigation could come up with the same amount in compensation as Sulzer. But the fact that Johnson & Johnson reserved about a billion dollars for the sole purpose of handling the DePuy lawsuits is a clear indication that the company is willing to grant a settlement to those who filed for compensatory damages against DePuy.

    In a New York Post, one Sulzer victim narrates, “Every day, I curse and cry because of the pain. I don’t sleep for an hour without having to get up because of the pain.” This situation would prove hard on anybody. If you have been affected by the recall, it is best you speak with an experienced hip lawyer immediately. For information regarding the ongoing lawsuits, visit the DePuy hip replacement website.
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