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Posts Tagged ‘medical device safety’

Seniors and Athletes are Prone to Hip Fracture and Victims of the DePuy Hip Replacement recall

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

Now that the dePuy Hip Replacement is going to trial we can take a look at who is most likely to be a victim of a failed DePuy. Well, it is most likely someone prone to Hip fractures whic eventually result in needing a hip replacement. DePuy Hip replacement helpline is reaching out to seniors and athletes as the time is running short. Each state has a statute of limitations and that is usually going to block your ability to file. You must act quickly.

Everyone is at risk of incurring fractures. On the other hand, people suffer increased risks with conditions like old age, osteoporosis, osteomyelitis, type two diabetes patients and other diseases that make the bone porous, brittle and highly permeable. Unfortunately, falls and hip injuries are common on frail elderly patients, making hip fracture rehabilitation a primary concern. Elderly and other people like athletes and workers who are prone or highly likely to incur hip injuries must establish an ongoing communication with a qualified medical doctor or orthopedic surgeon.

Types and Modes of Fractures that maybe  eventually requiring a hip replacement

There are several types of fractures, which doctors consider before diagnosis is set:

* Comminuted fracture – is the condition where the bones fragment into several pieces. * Oblique fracture – the bone breaks acquired a curved or sloping pattern. * Impacted fracture – otherwise known as the buckle fracture, this is the type of fracture whose ends are driven into each other. * Transverse fracture – the type of fracture forming a right angle to the bone’s axis. * Greenstick fracture – occurs when the bone is just bent and not fully broken. * Other types of fracture include pathologic, compressed, avulsion, depressed, and spiral.

Modes of Hip Fractures

Only a few types of fractures are associated with hip injuries, which cause back pain. With that, several modes of hip fractures and considered to thoroughly evaluate the extent of injury:

* Intertrochanteric hip fracture is the type of fracture that doesn’t involve or cause damage to the blood flow in the bone. It usually doesn’t require   hip replacement for treatment. * Intracapsular hip fracture is the type of bone breakage that occurs within the capsule of the joint. * Extracapsular hip fracture is the type of fracture that occurs at the articular extremity of the bone, which is outside the line of the attachment of the capsular ligament of the hip joint

Causes of Fractures

Bone fracture can happen to anyone. It’s typically caused by various types of trauma on the bone. Bone trauma may result from accidental falls, motor vehicle accidents or a disease that weakens the bone. Hence, hip and back injury, bone fracture may cause back pain, swelling, bruising and internal bleeding.

Assessment of Fracture Risks and Fracture Damage

The risks of getting fractures can be assessed by performing tests and evaluations on bone density, current medications taken, medical conditions, medical history or personal history, and lifestyle or work factors.

To assess actual fractures, doctors usually perform hematology tests and x-rays to evaluate and locate the fracture area. X-ray results will guide them in locating the breaks on the bones while hematology tests help them spot the decreases in HCT and Hgb, which indicative the severity of damage incurred. Doctors may assess the condition by evaluating the pain experienced from motion and the tenderness, immobility, deformity, crepitus, ecchymosis, edema and paresthesia or creeping, tingling and pricking sensations observed and experienced on the affected site

If you are an athlete who has had a Depuy hip replacement and has undergone revision surgery call the dePuy Hip Replacement Helpline today. If you are a senior or child of a senior who has had hip replacement surgery and it has been with one on the metal on metal recalls contact us immediately.

New Updates on DePuy Hip Replcement Lawsuits, DePuy Hip Replacement Lawyers

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

Developer of DePuy ASR Hip Replacement Ignored Safety Warnings
April 20, 2012 |DePuy News | Posted by: Linda Grayling
DePuy Hip Replacement helpline lawyers are accepting cases from people needing revision surgeries from:

  •     DePuy Hip Replacement
  •     ASR Hip Replacement
  •     ASR Hip Recall
  •     ASR Hip metal on Metal toxicity
  •     ASR Hip Lawsuit
  •     Pinnacle Hip Replacement
  •     Depuy Knee replacement
  •     High Flex Knee replacement
  •     Knee Replacement Recalls

One of the primary developers of DePuy’s defective ASR hip replacement, Dr. Thomas Schmalzried, has been questioned in the ongoing legal proceedings against the Johnson & Johnson subsidiary.

“The lawsuit accuses him of assisting in DePuy’s marketing efforts, promoting the devices to his peers and publishing papers that were later used by DePuy sales teams to defer safety concerns raised by other orthopedic surgeons,” according to MassDevice.com.

Schmalzried was a consultant for DePuy, and he received more than $2.4 million in “royalty income for intellectual property and/or product development” in 2010 and 2011. Bloomberg News has reported that in addition to receiving payments for product development, Schmalzried attended DePuy meetings in support of the ASR products and actively promoted them to his peers.
Dr. Thomas Schmalzried – Developer DePuy ASR Hip Replacement

Dr. Thomas Schmalzried – Developer DePuy ASR Hip Replacement

Worse still, Schmalzried is accused of persuading other orthopaedic surgeons that their safety concerns over the ASR hip implants were unfounded. DePuy’s sales team used a paper Schmalzried wrote, “Setting the record straight on metal hypersensitivity,” to overcome such objections, the British Medical Journal reported.

Schmalzried is being named as a defendant in at least one DePuy ASR lawsuit filed by a California man. The plaintiff asserts, “Dr. Schmalzried and the DePuy representatives assured the orthopedic surgeons during these meetings that the ASR System was safe, was the best product on the market, had an excellent track record and a low and acceptable failure rate.”

Schmalzried is among a group of DePuy executives scheduled to be deposed by the end of May, including the Manager of Hip Product Development, the Vice President of U.S. Sales, the Vice President of World Marketing and the Product Director.

According to a press release, these depositions will cover topics such as the design, sale, promotion and marketing of the ASR hip implants, as well as communications relating to complications, post-market surveillance and recall of the devices. The DePuy executives have also been asked to produce documents, notes, outlines, presentation materials, testimonies and oral proposals prepared or given to them that reference or relate to the ASR hip systems.

About 3,500 lawsuits against DePuy have been consolidated in a multidistrict litigation (MDL) presided over by Judge David A. Katz in the U.S. District Court for the Northern District of Ohio. Only six plaintiffs — three in Nevada, one in Wisconsin, one in Florida and one in Utah — have earned the right to be excluded from the slow-moving MDL. Katz has set the next status conference for 11:30 a.m. May 1, 2012, at the Paul G. Rogers Federal Building and United States Courthouse in West Palm Beach, Florida.

DePuy Hip Replacement Helpline lawyers are filing cases on Behalf of people injured by the DePuy metal on Metal Hip Replacement.

You must have been told you need or have gotten revision surgery or have proof of chromium or cobalt toxicity to qualify.

DePuy Hip Recall, DePuy Hip replacement Lawyers

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

It has been approximately 18 months since DePuy recalled two types of its ASR hip implants and The dePuy Hip replacement Helpline is still taking calls from people needing revision surgery from a failed DePuy.

18 Months After DePuy ASR Recall – Now What?
Jackie Fedeli

It has been approximately 18 months since DePuy recalled two types of its ASR hip implants.

What was Recalled and Why

The DePuy ASR ™ XL Acetabular System and the DePuy ASR ™Hip Resurfacing System were recalled amid safety concerns. The recall came after data from the U.K. indicated that 12% of patients who received the ASR ™ Resurfacing System needed revision surgery within five years of implant and that 13% of patients who received the ASR ™ replacement system needed revision surgery within five years of implant. These percentages are higher than revisions surgery rates for other types of hip implant devices.

What Patients with DePuy ASR Hip Systems Should Do Now

As DePuy ASR news continues to break, patients are urged to know their options for fixing a failed DePuy hip replacement. Surgery may be the only option available, though surgery is, of course, not without risks, pain and financial costs. For this reason, patients who received one of the recalled DePuy hip implant systems between July 2003 and August 2010 are encouraged to see their physicians for an evaluation and to learn more about the symptoms that may require prompt medical treatment.

Unfortunately, the 2010 DePuy ASR hip recall does not mean that patients are no longer at risk. Hip failures may still continue to occur and patients may still suffer

DePuy Hip Replacement Helpline, New Updates on Metal on Metal Hip Failures

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

DePuy Hip Replacement Helpline, New Updates on Metal on Metal Hip Failures

Reuters) – New research confirmed that all-metal artificial hips fail more often than other types, fuelling concerns about the devices and prompting a call from researchers on Tuesday for a ban.

The analysis in The Lancet medical journal came two weeks after Britain's medical regulator said nearly 50,000 Britons with metal-on-metal hips needed annual check-ups to monitor for problems, including exposure to toxic metals.

The finding will likely fuel criticism about the regulation of medical devices in the wake of a scandal over French-made breast implants and past problems with other implantable devices, including faulty leads on some heart defibrillators.

Metal-on-metal hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket.

But recent experience suggests they may actually do worse, prompting the recall of one device made by Johnson & Johnson that critics argue should never have been allowed on the market.

Results from the most comprehensive study to date now show that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years – some three times greater than the revision rate seen with older implants.

The rate was particularly high with larger-head implants and those used in women, in whom failure rates were up to four times higher, the researchers said.

The team from the University of Bristol analyzed data from the National Joint Registry of England and Wales covering more than 400,000 hips replacements, including 31,171 all-metal ones, that were undertaken between 2003 and 2011.

The results, they said, were unequivocal: "Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted."

Their analysis did not cover resurfacing systems, which avoid the use of a stem sticking into the bone, such as Smith & Nephew's Birmingham Hip Resurfacing joints.

TIGHTER REGULATION

In recent years, the use of metal-on-metal implants has declined in Britain, but they are still used extensively around the world, including in the United States.

Art Sedrakyan of Cornell University said the problem highlighted weaknesses in the regulatory systems on both sides of the Atlantic due to "outdated and low-threshold regulatory pathways".

In a strongly worded Lancet commentary accompanying the latest research, he called for better studies before implants reach the market.

"We are left with more than 500,000 patients with metal-on-metal prostheses in the USA and more than 40,000 in the UK who are at elevated risk of device failure, which will inevitably result in the burden of further surgical treatment as well as billions of dollars in costs to taxpayers," he said.

Ashley Blom of the University of Bristol said that total hip replacement surgery remained a very successful operation for the vast majority of people but regulators should learn lessons as they seek to balance safety against innovation.

"In this case, with the benefit of hindsight, I think that tighter regulation may have prevented this," he told Reuters.

Under the new guidelines from Britain's Medicines and Healthcare Products Regulatory Agency (MHRA), doctors are being advised to consider removing and replacing implants if patients have abnormal MRI scans or if metal ion levels in the blood reach worrying levels.

With the exception of J&J's DePuy ASR system, which was pulled from the market in 2010, the MHRA decided in its recent ruling against a ban on use, arguing that stemmed metal-on-metal implants could still be good news for some patients.

Other companies that make metal-on-metal hip implants include Zimmer, Stryker, Corin and Biomet

 

DePuy Hip Replacements In the News, DePuy Hip Recall Lawyers

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

Last month, U.S. congressmen Edward Markey (D-Massachusetts), Henry Waxman (D-California) and Jan Schakowsky (D-Illinois), introduced legislation — the Safety Of Untested and New Devices Act of 2012, dubbed SOUND Devices Act — that would give the FDA more authority to reject a manufacturer's application for a new device if it was based on a similar product that was recalled.

Guest said any new law should also require rigorous testing of the devices upfront and a national registry that would track device performance over time. Raising manufacturers' user fees that fund FDA could help fund a registry, he said.

Some 93,000 people have been implanted with DePuy's ASR hip system worldwide and J&J faces more than 2,000 lawsuits in state and federal court.

When clients call, they are livid when they find out how (the device) was approved. They say 'I don't understand how this was able to get on the market in the first place,'" said attorney Felecia Stern of Bernstein Liebhard LLP, a New York law firm handling more than 200 cases against J&J over the ASR hip. However, these patients, she said, are usually too overwhelmed by medical problems to get involved in activism.

Carol Kochhar-Bryant, a 62-year-old professor and senior associate dean at the Graduate School of Education and Human Development at George Washington University, was one recipient of the Consumer Reports' email blast.

She had the ASR implanted in 2009. The joint failed after a couple of years and she said it left her with high chromium and cobalt levels in her bloodstream, a condition known as metallosis that some experts fear could cause cancer and other serious problems. She continued to have pain and recently underwent a second, more extensive surgery to scrape out metal shavings embedded in the surrounding tissues of her hip and replace the entire ball and socket with a new device.

I was assuming there was a much more rigorous process," she said, referring to the approval process of her hip replacement. "I did not quiz my doctors on how these things come to the market. They gave me a lot of pamphlets on it. I went back to look to see what adverse events were listed, but there's nothing in there."

Katie Ayers, 42, also had the ASR hip implanted when she was 36 years old. Blood tests revealed that she also had elevated levels of cobalt and chromium, and she decided to have the device replaced with a J&J ceramic implant.

Ayers is suing J&J and testified before Congress last year. Kochhar-Bryant said she has not yet decided on legal action.

DePuy Hip Recall Disaster, Hip Replacement Lawyers Filing lawsuits

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

DePuy ASR Hip Implant Failures Mount, with Devastating Effects
Posted November 15, 2011 in Products Liability by Arthur Buono

DePuy Hip Replacement Helpline Moniters The DePuy Recalls

DePuy ASR hip implants continue to fail at an alarming rate. Patients who’ve received these systems are presenting about 20 new claims per week on average. About 4,000 cases already have been filed against DePuy and its parent company, Johnson & Johnson, and it seems there’s no end in sight to the trouble.

    
    DePuy ASR hip implants continue to fail, cases continue to mount
    Metal-on-metal design implicated in failure
    Victims face revision surgeries, uncertain complications from metals exposure

Victims Face Painful "Revision" Surgery
To get an update on the problem and the litigation, I spoke with Felecia Stern of the Bernstein Liebhard law firm. Stern’s firm has a substantial number of cases pending in the sprawling complex of lawsuits this defective medical device has spawned.
Felecia L. Stern
First some background. The DePuy ASR artificial hip was approved by the FDA in 2005. More on that in a moment. It’s a so-called metal-on-metal (MOM) design, meaning both the cup of the pelvic component and the ball or head of the femur component are made of metal. When the joint moves, the metal cup and ball are in contact.
As these parts rub together, bits of the metal shear off. As this happens, patients who have these systems begin to suffer from what’s commonly referred to as metallosis. At the site, patients begin to experience pain in their groin and hip. This is caused by necrosis – death – of the surrounding tissue.
Metallosis Toxicity, Cancer Risk Eyed
But that’s not all. These patients also begin to show elevated levels of cobalt and chromium in their blood. No one is sure exactly what effect this will have on patients, but between this and the physical injury to the hip, patients must have "revision" surgery to remove the DePuy system and replace it with another.
As Stern points out, "The revision surgery is much more complicated" than an initial hip replacement. "The necrosis of adjacent tissue caused by the metallosis means the patient has a lot less of everything to which the replacement system can be attached."
The sad irony behind the physical tragedies these patients endure is that J&J aggressively marketed the ASR as a superior design that would last far longer than existing hip replacement systems. "It was aimed at younger, more active people as something that would last for 15 years," Stern says. This was very appealing to people who wanted to continue an active, healthy lifestyle, to play tennis, golf and other active pursuits. Instead, what they got was a physical nightmare and medical uncertainty.
The cases keep mounting. The DePuy ASR system shows a failure rate of 12-13 percent, which, according to Stern, is two-to-three times higher than other systems. And that’s just based on the data available today. The system was only approved for five years in the US, slightly longer elsewhere. As time passes, it’s expected the failure rate will increase.
Stern says 37,000 systems were implanted in patients in the US, and 93,000 worldwide. So as I said at the top, it only seems as though there’s no end in sight to this disaster. But since we know the total number of systems implanted, we also know the ultimate potential number of failures.
What we don’t know, Stern says, are the long-term effects of metallosis on the person as a whole. Now that the barn door’s been closed on new ASR implants by DePuy’s August, 2010 voluntary recall, those patients who’ve received them, their doctors, lawyers and epidemiologists are wondering if they’ll experience any toxicity or perhaps even cancers as a result of this exposure.
Another "Fast-Track" Device Approval Disaster
And the barn door is just the right metaphor for what the FDA and Johnson & Johnson have done in this case. The DePuy ASR system was approved via the FDA’s section 510(k) "fast-track" process. It was not clinically tested in humans prior to approval. The patients who received these implants were the ultimate crash test dummies.
The 510(k) process is under fire and will likely be overhauled. It allows a medical device to be approved based on its "substantial similarity" to an existing, approved device. The existing, approved device, called the "predicate," itself may have been approved by this process without clinical testing, and so on, without limitation, back to an initially approved device which was clinically tested for safety.
Now it appears that the predicate device for the ASR was DePuy’s own "Pinnacle" MOM hip replacement system. And the Pinnacle is now also subject to its own complex of lawsuits in federal court.
These hip systems are not the only devices to bring disrepute to the 510(k) process currently – or to bring disrepute to Johnson & Johnson. As we wrote last week, transvaginal surgical mesh marketed by another J&J subsidiary and rubber-stamped by the FDA under 510(k) is now going to pieces in women who’ve received it.
Complex Litigation to Determine Compensation
As claims mount, the earliest cases are proceeding in a complex process of "multi-district litigation." It’s not a class action but a process in which numerous individual cases are filed and consolidated for certain purposes, like discovery of certain issues and the winnowing of issues for trial. Stern says that certain cases are then agreed upon as "bellwether" claims and trial proceeds as to them. As the results of these trials appear, the plaintiffs and defendants can then come to agreement on the settlement of further claims. The process typically takes from two to six years, and since, as Stern notes, the initial claims are nearing the two-year mark, we could begin to have a clearer picture of what the victims of this mass tort can expect the outcome to be in the no-so-distant future.

DePuy Hip Replacement Helpline counselors are concerned about the mounting DePuy Hip failures. This has had a huge effect on our over 55 population. DePuy Hip Recall lawyers are accepting cases for victims of thge failed DePuy who hace been informed they need revision surgery. Lawyers are also accepting cases for Metal toxicity form chromium and coblt in huge toxic levels in the blood stream.

 

Growing Concern for Medical Device Safety

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Medical Device Safety Improvement Campaign
Tuesday, February 07, 2012 :: Staff infoZine
Consumer group teams up with patient safety activists to urge congress to strengthen medical device oversight

Washington, D.C. – infoZine – As the debate in Congress over reauthorizing the statute governing medical devices intensifies, Consumers Union is stepping up its campaign to strengthen the law to better protect patients from potential safety risks. This week, Consumers Union’s Safe Patient Project is bringing eight patient safety activists from around the country to Washington, D.C. to meet with lawmakers in Congress and press for improvements in the Medical Device User Fee Act (MDUFA).

Consumers Union is urging Congress to require more rigorous testing before all medical implants are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems come to light. The campaign is up against a powerful lobbying effort by the medical device industry, which is using the MDUFA reauthorization process to try to scale back oversight by the Food and Drug Administration (FDA).
“Most Americans would be surprised to learn of the lax oversight of medical implants,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “Too many of these devices are allowed on the market without testing to determine whether they are safe and effective. Innovation is important but patient safety should be our first priority. A medical device isn’t innovative if it doesn’t work and hurts people.”

Among those patient safety activists joining Consumers Union this week in Washington is Lana Keeton of Austin, Texas, who has endured ten years of incapacitating pain from the surgical mesh that was implanted during surgery for a prolapsed bladder. Steven Baker of Bloomington, Minnesota, who has suffered from a faulty elbow implant, will be meeting with lawmakers to urge Congress to adopt stricter medical device safety requirements. And Dan Walter, of Deale, Maryland, will share the story of his wife Pam, who nearly died from a defectively designed device used to treat her heart condition.
Unlike prescription drugs, more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale. According to the General Accounting Office, an average of 700 different medical devices are recalled each year. In 2009 alone, the FDA received reports of nearly 5,000 deaths associated with medical devices.

In addition, the system for monitoring and tracking what happens with devices once they are on the market is weak and does not adequately protect people using them. There is currently no national tracking system to identify and inform patients when safety problems emerge.
The FDA has just completed negotiations with the device industry over the shape of MDUFA reauthorization legislation that must be passed later this year. Industry pressure resulted in an agreement that does not include important safety provisions supported by Consumers Union, such as making sure faulty devices aren’t used to clear similar implants and giving the FDA the authority to require clinical trials after devices go onto market. Instead, the agreement focuses more on how the FDA can better serve the industry.

“The agreement is disappointing because it fails to include critical safety reforms needed to better protect patients and falls short of the resources the FDA needs to keep up with the volume and complexity of device applications,” said Lisa Swirsky, senior policy analyst for Consumers Union. “This year’s legislation will govern the safety and quality of medical devices over the next five years. Congress should strengthen the FDA’s ability to protect consumers.”

For more details on the reforms Consumers Union is urging Congress to adopt, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet link.