Medical Devices | HensonFuerst

Archive for the ‘ Medical Devices ’ Category

Feb

Britain Concerned About Hip Implants

For over a year, we’ve been telling you about the problems with metal-on-metal hip replacement devices. Some, such as the DePuy devices by Johnson & Johnson, were recalled due to a higher-than-usual failure rate, causing patients to require second surgeries to replace the replacements. In May 2011, the U.S. Food and Drug Administration (FDA) ordered all producers of “metal-on-metal” hip replacements to study the implants to make sure patients remain as safe as possible.

You can read those earlier blogs here:

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury

Now, according to an article in The New York Times, British help regulators recommend that patients in Britain who received metal-on-metal artificial hips — which were also used widely in the United States — should undergo annual examinations for as long as they have the device to make sure they are not suffering tissue damage or other problems. This recommendation was made out of concern that serious problems could surface 15 or even 20 years after the original surgery.

“By monitoring patients every year, any complications will get picked up earlier and more complex surgery on the patient can be avoided,” said Dr. Susanne Ludgate, the clinical director of the Medicines and Healthcare Products Regulatory Agency.

It has been estimated that about 500,000 people in the United States received an all-metal hip during the past 10 years. Thousands of them have been forced to undergo second surgeries to have the replacements replaced. Hundreds have suffered crippling injuries due to the tissue and muscle tissue damage caused by metallic debris shed by the devices.

In the U.S., the FDA is not changing its recommendation that all hip replacement patients undergo “regular” follow-up with their physicians. That’s good advice…and we recommend that these follow-ups occur even if patients don’t think they have any special problem with their hip replacements. Some people with significant damage to the surrounding muscle tissue don’t have any pain until the injury is severe.

If you have had a metal-on-metal hip replacement that failed early, or if you have had tissue damage due to the device and would like to explore your legal options, feel free to contact the attorneys of HensonFuerst. Someone is available 24 hours a day, 7 days a week at 1-800-4-LAWMED…or view our website at http://www.lawmed.com/.

If you have questions, HensonFuerst has answers.

To read the full article in The New York Times, click here: Britain Extends Monitoring for People with Metal Hips

Popularity: 2% [?]

Feb

DePuy Manufacturer Knew of High Failure Rate

In 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System due to their higher-than-usual failure rates. The failures necessitated that patients have a second surgeries to replace the replacement, but some people still ended up with severe tissue damage that left them in pain.

Before the recall, Johnson & Johnson refused to acknowledge that the medical device was flawed. But now, in an article published in The New York Times, it seems that Johnson & Johnson was aware of the high failure rate—and an email stating so was written by a DePuy vice president and sent to top executives in the corporation. In the email, Pamela Plouhar:

…reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also cautioned that providing the F.D.A. with more data might not change its stance and that it might take years to conduct new studies of the hip, known as the ASR, or articular surface replacement.

In addition, Ms. Plouhar’s email stated that there had been “a significant number of revisions in the ASR group” compared with “very few in the control group.”

That means that the FDA, Ms. Plouhar, and—after the email was sent—other J&J executives all knew that there were significant problems with the hip replacement devices. And yet, the company did not notify doctors or patients about the problems. In fact, they continued marketing and selling the device in the United States and around the world…at least until the recall was announced in August 2010. In all, about 93,000 people received a DePuy hip replacement.

Throughout the episode, DePuy blamed orthopedic surgeons for the model’s failures, saying that doctors were not positioning a component properly. But the clinical findings rejected by the F.D.A. came from A.S.R. studies run by surgeons hand-picked by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.

This new information is not going to help Johnson & Johnson’s reputation, which has recently been turning from gleaming to rusty. Perhaps this is why J&J CEO William C. Weldon announced that he will step down in April. Analysts believe he would rather retire by choice than be forced to resign.

HensonFuerst Video about the DePuy recall: DePuy Orthopaedics Hip Replacement Recall

If you believe you have been injured by a DePuy hip replacement and would like to discuss your legal options, please feel free to call HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at http://www.lawmed.com/. If you have questions, HensonFuerst has answers.

RESOURCES

To read the full story in The New York TImes, click here: Hip Maker Discussed Failures

To read our blog about the DePuy recall, click here: DePuy Hip Replacement Recall

Popularity: 2% [?]

Feb

High-Failure Hip Replacements Sold Overseas

On August 24, 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System. Why? Because they have a higher-than-usual failure rates, causing people to have to have second surgeries to replace the replacement. Since then, we’ve written extensively about DePuy and other metal-on-metal hip replacement devices, and the sometimes-extensive destruction they can cause in the human body.

Now, The New York Times reveals that Johnson & Johnson continued to market the defective devices in Europe and elsewhere overseas. In addition, the company also continued to sell a related model in the United States, which earlier went on the market using a regulatory loophole. However, the U.S. Food and Drug Administration (FDA) wrote a confidential letter to Johnson & Johnson in August 2009 basically saying that the agency couldn’t determine the implant’s safety and effectiveness, and therefore couldn’t approve it for sale in the U.S.

According to the article:

There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.

However, the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants.

There seem to be two moral issues at stake here: The morality of Johnson & Johnson continuing to sell a product that was clearly raising safety flags…and the morality of the FDA, which keeps its evaluations secret and confidential. A lawyer who specializes in FDA regulation said that companies that withhold a non approval letter containing important safety information could face damage to its brand. Funny, that doesn’t seem quite as important as the damage done to the unwitting patients who received these potentially harmful devices. And if the FDA is keeping secrets on behalf of corporations, who is looking out for our health?

To read the full article in The New York Times, click here: Hip Implants U.S. Rejected Sold Overseas

If you believe you have been injured as the result of a metal-on-metal hip implant and would like to investigate your legal options, feel free to contact HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at http://www.lawmed.com/.

Previous HensonFuerst blogs:

DePuy Hip Replacement Recall Raises More Questions

Hip Replacements to be Evaluated for Safety

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury

VIDEO: DePuy Hip Replacement Recall (http://www.youtube.com/watch?v=18BkrJnKf3g)

Popularity: 2% [?]

Jan

Fayetteville Hospital Could Lose Federal Funding

January 19, 2012

A Fayetteville, North Carolina, hospital is at risk of losing it’s funding from Medicaid and Medicare tonight in response to the death of a mentally ill patient. Reports from ABC 13 News say that the 27-year-old patient died after being put in a chokehold by a security guard at the Cape Fear Valley Medical Center in October of last year.

Video from a surveillance camera at the hospital shows the patient being tackled to the ground by security and choked. When the patient stops resisting and is released, he lies on the ground, unconscious for nearly three minutes before any effort is made to resuscitate the man. He was later declared dead, but a criminal investigation did not begin until a coroner ruled the death a homicide.

The hospital could potentially lose as much as $23 million a month if its funding is cut.

This is not the first time the hospital has faced scrutiny. The Fayetteville Observer reports that the State Department of Health and Human Services began investigating the facility in December of last year after a cancer patient died less than an hour after being involuntarily discharged from the facility. The hospital also has numerous complaints for extremely long wait times and mistreatment of patients.

The North Carolina Medical Malpractice Attorneys with HensonFuerst would advise anyone who believes they’ve been harmed by a doctor or staff member to immediately contact a lawyer to discuss the claim.

Popularity: 2% [?]

Dec

FDA Warns Companies of Deceptive Lap-Band Advertising

Almost everyone wants to be thin, and many people would do anything to have the body of their dreams. For people who are “morbidly obese” or who have one or more obesity-related conditions (such as diabetes or high blood pressure), one option is gastric banding.

Gastric banding, such as the popular Lap-Band, is a surgical procedure that reduces the size of the stomach. A silicone band is placed around the upper part of the stomach, creating a small pouch that fills up faster and supposedly makes you feel full much more quickly. The band is not solid like a rubber band–it is more like a balloon that is filled with salt water (saline). The more water in the band, the tighter it squeezes the stomach. The amount of saline in the band can be adjusted because the band is attached to a long tube, ending at a small button-like knob that is placed just below the skin during surgery. A doctor can draw fluid out of the band, or add more fluid in, just by inserting a syringe into the knob.

FDA Warning

Last week, the U.S. Food & Drug Administration (FDA) announced that it has taken action against eight California surgical centers and a marketing firm for misleading advertising of the Lap-Band. At issue is the idea of advertising a very serious surgical procedure without proper warnings and cautions, making gastric banding look like a simple fix for a lifelong problem.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”

According to the FDA, the risks of any surgery—including gastric banding—include the possibility of death. In addition, known complications of gastric banding include:

Nausea

vomiting or spitting-up food you just ate

difficulty swallowing

gastroesophageal reflux disease (GERD)

indigestion or upset stomach

abdominal pain

leaking of the gastric band

stretching of the new stomach pouch, so it no longer restricts the amount of food you can eat

moving of the gastric band from its original position, requiring another surgery to reposition it

erosion of the band through the stomach wall, and into the stomach, requiring additional surgery

stretching of the esophagus

Eating with a Gastric Band

When people hear that gastric banding will force them to eat less, they may not realize exactly what that means. According to the University of California San Diego (UCSD) Bariatric and Metabolic Institute, you need to eat only soft foods (like mashed potatoes or baby food) for the first five weeks after surgery. Then, you will still need to ay close attention to your diet—gastric banding isn’t a miracle fix; you’ll still need to eat well. Many patients have difficulty with solid foods in the morning. In addition, eating too much food or big chunks of food can block the outlet–the outlet is about the size of a dime, so food needs to be eaten in small bits and thoroughly chewed.

In addition, the stomach pouch can only hold about 1/4 cup of food. Visually, that’s about the size of a deck of cards. That’s the total amount of each meal—any more than that can stretch out the pouch and potentially cause health problems.

The Institute also recommends that you avoid high-fiber foods, including (but not limited to):

dried fruits
asparagus
pineapple
corn (especially popcorn)
grapes
nuts and seeds
carbonated beverages

Glamorizing Lap-Band

For some people, gastric banding can be a literal life-saver. But some people are attracted by what might be considered a simple way to lose weight.

“FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”

Gastric banding is anything but simple. In fact, according to an article in the Los Angeles Times, at least four people have died of Lap-Band complications at the eight California surgical centers involved in the FDA warning. This is not a surgery to be undertaken lightly.

If you are considering gastric banding, talk with your doctors about all the pros and cons…and ask to talk with people who have already had the surgery. There may be a support group that meets in your area. Understand that your life will change dramatically after the surgery, and not just because you might lose weight.

Popularity: 4% [?]

Nov

Diagnosing Hip Replacement Injury

You may recall a blog we posted last month called “Hip Replacements Fail, Sometimes Without Symptoms,” which we wrote in response to an article in The New York Times about people who have been injured by DePuy hip replacement devices.

In a nutshell, this is the story to date: In 2010, Johnson & Johnson recalled two DePuy hip replacement devices due to a higher-than-usual failure rate. With the DePuy and other metal-on-metal hip replacements, the devices can shed tiny bits of metallic debris. The human body doesn’t tolerate foreign substances, so it releases scavenger cells to try to get rid of those shards of metal. But the process converts the metal particles into biologically active metallic ions that can slowly destroy healthy body tissue, such as joints and muscle.

What happens is that the hip replacements fail, requiring a second replacement. The goal is to replace the replacement before permanent damage is done to the surrounding muscle and tissue. Sometimes the symptoms are obvious and very painful. But more and more, doctors are discovering that some people can have severe damage without overt symptoms. That could have happened to Cyndi Lafuente, but she caught the problem early. Her story, as told to The New York Times is this:

Cyndi Lafuente, a senior adviser at the Internal Revenue Service, learned last year that the model of artificial hip she got in 2007 was being recalled by its manufacturer, the DePuy division of Johnson & Johnson, because of its high early failure rate. Ms. Lafuente said she contacted her surgeon, who ordered a blood test and diagnostic scans, which came back with normal results. Still concerned, she contacted a British researcher, Dr. David Langton, who had helped sound the alarm about the recalled model.

In January, she met again with her orthopedist, armed with information from that talk and other research. The physician suggested that they run an added test. It showed very high metal levels, she said.

Now, four months after replacement surgery, her recovery has been slow and her leg is still weak, said Ms. Lafuente, who has sued DePuy.

“If I had not played an aggressive role, I think I would have had permanent damage” to muscle or bone, she said.

THE STORY CONTINUES

After our blog was posted, we heard from Ms. Lafuente. She asked if we could provide information that The New York Times left out of their article, and we are happy to do so. This additional information is important to anyone who has had a metal-on-metal hip replacement from DePuy or other manufacturer.

When evaluating patients for possible hip damage due to these devices, doctors commonly use blood test to check for metal ions, and sometimes MRI or CT scans. Ms. Lafuente had those tests, but they all came back “normal.” She was persistent. When she contacted Dr. Langton in Great Britain, he told her that U.S. doctors recommend expensive but noninvasive tests, such as MRIs. However, the British health service opts for an invasive but less expensive test—a hip aspiration.

Aspiration involves putting a large needle into the hip joint and drawing out small amounts of fluid to test for the presence of metal. When Ms. Lafuente had the aspiration, the results were that her metal count was 1703, which she was told was about 10 times higher than normal. She underwent a revision surgery in June 2011, and now, five months later, she is still recovering.

Ms. Lafuente contacted us because she believes that this information could save other hip replacement patients from needless suffering and possible permanent damage. Her advice, in her own words:

Hey! If you have an ASR XL [one of the DePuy hip replacement models], talk to your doc even if you are asymptomatic. Come up with a game plan that makes sense and keeps you from getting permanent damage. Maybe the right thing is to be aspirated once a year, even if just to give you the same peace of mind that my doc gave me.

And if your doc is a jerk, go to a different doc. Trust me. Find someone who knows what they are doing and change docs. The doc who implanted you with an ASR XL may have only done a couple of these, and it just won’t be worth his time to stay up to date on new developments as this thing unfolds. Your hip deserves someone better.

So, the long and short of it is this — asymptomatic ASR XL patients: you need to be especially alert to changes in your body. Be your own advocate and consult with your doc about aspiration.

WHAT TO DO

We agree with Ms. Lafuente that anyone who has had a metal-on-metal hip replacement should speak with their doctor about the risk of possible device failure or injury. We urge you to have this conversation regardless of whether you have symptoms or not. Sometimes the damage is silent, and you may not feel symptoms until massive, permanent damage is done. When you speak with your doctor, arm yourself with as much information as possible. At a bare minimum, print out the articles we’ve listed at the bottom of this blog.

In addition, if you have been injured by a hip replacement, consider speaking with an experienced implant lawyer, someone who can help you get compensation for your injury. The experienced attorneys of HensonFuerst are available to consult with you anytime at 1-800-4-LAWMED. And for more information about the DePuy hip replacement recall, visit our website at www.lawmed.com.

RESOURCES

To read the full article in The New York Times, click here: Remedy is Elusive as Metallic Hips Fail at a Fast Rate

To read our original blog about failing hip replacements, click here: Hip Replacements Fail, Sometimes Without Symptoms

To read more about Cyndi Lafuente’s story click here: Aspiration Revealed My ASR Device Had Failed

Popularity: 10% [?]

Oct

Hip Replacements Fail, Sometimes Without Symptoms

Last year, DePuy Orthopaedics, a division of Johnson & Johnson, recalled two of their hip replacement systems due to a higher-than-usual failure rate, causing patients to have to have second surgeries to replace the replacement.

Then, in May 2011, the U.S. Food and Drug Administration (FDA) ordered all producers of “metal-on-metal” hip replacements to study the implants to make sure patients remain as safe as possible. That means that DePuy may not be the only potentially dangerous brand of hip replacement. Other brands included in the FDA’s order are Zimmer, Stryker, Biomet, and Wright Medical.

Now, according to a new article in The New York Times, the problems reported to date may be just the tip of the injury iceberg. And many people who have hip replacements may not even be aware that their bodies are in the midst of developing serious, potentially permanent damage.

BACKGROUND

Hips are made of two parts: A round, concave socket on the lower part of the pelvis; and a ball-shaped protrusion of bone at the end of the femur (thigh bone) that fits perfectly into the socket. This ball-and-socket joint allows the leg to extend forward, backward, sideways, and around in a circle in fluid motion.

A hip replacement, therefore, also has two parts: Ball and socket. The most common implants are made of metal and plastic, but some—such as those involved in the recall—are known as metal-on-metal, in which a metal ball rotates in a metal socket. According to The New York Times:

More than a decade ago, some researchers had warned that the hips shed tiny pieces of metallic debris that posed potential health threats to patients. But those warnings were not heeded, and now doctors and patients face a growing public health problem as one of the country’s biggest medical device failures unfolds.

The metallic debris triggers the body to release scavenger cells to try to get rid of the particles, but they end up only making the problem worse: A chemical reaction converts the metal particles into biologically active metallic ions. In some patients, this causes a cascade of problems in the body that can end up causing permanent muscle and tissue damage.

A COMPLEX PHENOMENON

Metal-on-metal hip replacement devices don’t always cause health problems, and when they do, the path to diagnosis isn’t clear or straightforward. Some patients have severe symptoms that cause them to seek medical care, but sometimes people with severe damage don’t experience pain at all. Sometimes the metallic ions can be picked up in blood work, but sometimes standard test for the ions are negative even though they exist.

For example, Cyndi Lafuente, a senior adviser at the Internal Revenue Service, learned last year that the model of artificial hip she got in 2007 was being recalled by its manufacturer, the DePuy division of Johnson & Johnson, because of its high early failure rate. Ms. Lafuente said she contacted her surgeon, who ordered a blood test and diagnostic scans, which came back with normal results. Still concerned, she contacted a British researcher, Dr. David Langton, who had helped sound the alarm about the recalled model.

In January, she met again with her orthopedist, armed with information from that talk and other research. The physician suggested that they run an added test. It showed very high metal levels, she said.

Patients are being put in the position of having to take an active role in seeking answers about their metal-on-metal hip replacements. Those who don’t could be risking permanent damage.

WHAT TO DO

If you already know that you received one of the recalled DePuy hip replacement systems or any metal-on-metal hip replacement, we recommend two things:

1. Schedule a follow-up appointment with your surgeon, even if you’re not currently having symptoms. It is possible that you could have early signs of failure before you recognize the pain. Your doctor will be able to evaluate how your hip is functioning and whether the recalled implant is in need of replacement.

In that visit, your orthopaedic surgeon may also want do a blood test that looks at the level of microscopic metal particles around your hip. Metal particles are a sign that recalled implant has failed. If the blood test indicates a high level of these particles, your surgeon may want to do a second blood test three months later. These levels may be high even if you are not experiencing any symptoms, so this blood testing is very important.

2. Call HensonFuerst Attorneys for important information about your rights. If you or someone you care about received one of these defective joint replacement components, we would like to speak with you right away. You may have a legal case and be eligible to collect compensation for the injury caused by this faulty medical device.

What’s most important: DO NOT contact DePuy or other manufacturer, or SIGN ANY RELEASES OF YOUR MEDICAL RECORDS TO DePuy or JOHNSON & JOHNSON or any other manufacturer before you talk with a lawyer. On DePuy’s website, they ask patients to register with them and receive a claim number. DO NOT DO THIS YOURSELF. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed. If Johnson & Johnson was interested in helping patients, they would not have allowed the device to continue to be sold even after they knew it was causing serious problems.

At HensonFuerst, your health is our top priority. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you. Someone is available to take your call 24 hours/day, every day of the year at 1-800-4-LAWMED (1-800-452-9633). Or, visit our website at www.lawmed.com for more information. You can also fill out a free online consultation form for an immediate evaluation of your case.

Life doesn’t wait, and neither should you. If you have questions, HensonFuerst has answers.

RESOURCES

To read the full article in The New York Times, click here: Remedy Is Elusive as Metallic Hips Fail at a Fast Rate

To read our previous blogs about metal-on-metal hip replacement devices, click here:

Hip Replacements to Be Evaluated for Safety

—or here:

Hip Implant Complaints Surge

To watch our video about the DePuy hip replacement device recall, click here: HensonFuerst video about DePuy recall

Popularity: 11% [?]

Sep

Staying Safer After Carotid Stenting

Results of a study just published in the Journal of the American Medical Association (JAMA) suggest guidelines for patients that could help keep them safer after carotid stenting. In fact, this advice might even save lives.

A stent is a tiny tube that acts to keep an artery open, allowing blood to flow properly. Stents are most commonly used to treat blocked arteries around the heart to prevent heart attack, but a newer procedure — carotid stenting — uses stents in the internal carotid artery (which rises to the brain through the neck) to prevent strokes. This is significant because approximately 10% to 15% of ischemic strokes are due to atherosclerosis of the internal carotid artery. Since 2004 when the first carotid stent was placed, the use of this medical procedure has more than doubled in Medicare beneficiaries.

Unfortunately, carotid stenting is quite a demanding procedure that requires a great deal of technical skill on the part of the surgeon. Researchers from the University of Michigan and numerous other medical institutions examined whether a surgeon’s experience performing carotid stenting had any effect on outcomes for patients. Data came from nearly 25,000 patients and about 2300 operators who performed the surgeries between January 1, 2005, and December 31, 2007.

The results show that experience makes a big difference. I’ll even go out on a non-scientific limb and say: Experience makes a ginormous difference… and it is news you can actually use.

Study Results

The researchers categorized operators into 4 groups:

Very low experience: performing fewer than 6 carotid stent procedures per year;
Low experience: performing 6 to 11 procedures per year;
Medium experience: performing 12 to 23 procedures per year;
High experience: performing 24 or more procedures per year.

They found that patients treated by operators with “Very Low” experience were nearly twice as likely to die within 30 days as those treated by operators with “High” experience. In addition–not surprisingly–patients who were treated by operators who were just beginning their experience faired worse than those who had more overall experience. For example, patients receiving one of an operator’s first 10 surgeries were about 70% more likely to die within 30 days than patients who received an operator’s 12th or or higher surgery.

It’s important to note that the overall 30-day death rate was only about 2%. So the differences we’re talking about here in raw numbers is small. Still, most people would like the option of reducing their risk of death after a procedure. In this case, the “fix” is simple: When you talk with a potential surgeon before a carotid stenting, ask how many procedures he or she has performed in total… and how many procedures he or she performs each year. Look for an operator who has performed more than 12 procedures overall, and—if possible—performs at least 24 procedures annually.

If you have an option, remember that “more is better,” and choose the most experienced operator possible.

RESOURCES

Article citation:

Nallamothu BK, Gurm HS, et al. Operator Experience and Carotid Stenting Outcomes in Medicare Beneficiaries. JAMA. 2011; 306(12):1338-1343.

To read a summary of of the JAMA article, click here: JAMA abstract

Popularity: 2% [?]

Aug

Hip Implant Complaints Surge

About 1 in 8 percent of the DePuy replacements will fail within 5 years. What’s worse, the faulty hip replacement causes serious pain and difficulty walking, and recovery from the second hip replacement is often more difficult than after the first. There is also the possibility of metallic particles being shed by the devices. These potentially toxic cobalt-chromium particles may, in high levels, cause heart and/or nervous system problems.

According to a recent article in The New York Times, since January 2011, the U.S. Food and Drug Administration (FDA) has received more than 5,000 reports of problems with metal-on-metal hip replacements… more than they received in the previous four years combined. About 75 percent of the complaints were about the recalled Johnson & Johnson products.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

Many of the metal-on-metal hip replacement products were sold without testing them in patients (a move that, strangely is within FDA guidelines). But in May 2011, the FDA ordered producers to examine the failure rate, the complication rate, and the threat to patients. In addition, researchers are trying to understand exactly how the metal particles cause tissue damage, and why some people experience debilitating pain, while others don’t. According to the article in The New York Times:

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants.

But for patients who already have tissue damage from faulty hip replacements, the idea that the FDA will now begin studying the devices amounts to little more than a cruel joke. According to one patient, physical therapist Ann Morrison, who was interviewed by reporters for The New York Times:

“We will be the little crash test dummies here until they figure out the health ramifications for us down the road,” said Ms. Morrison, who has sued the DePuy division of Johnson & Johnson, which made her implants.

What To Do Now

If you already know that you received one of the recalled DePuy hip replacement systems, or any metal-on-metal hip replacement, we recommend two things:

2. Call HensonFuerst Attorneys for important information about your rights. If you or someone you care about received one of these defective joint replacement components, we would like to speak with you right away. You may have a legal case and be able to collect compensation for the injury caused by this faulty medical device.

What’s most important: DO NOT contact DePuy, or SIGN ANY RELEASES OF YOUR MEDICAL RECORDS TO DePuy or JOHNSON & JOHNSON or any other manufacturer before you talk with a lawyer. On DePuy’s website, they ask patients to register with them and receive a claim number. DO NOT DO THIS YOURSELF. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed. If Johnson & Johnson was interested in helping patients, they would not have allowed the device to continue to be sold even after they knew it was causing serious problems.

At HensonFuerst, your health is our top priority. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you. Our attorneys are available 24 hours/day, every day of the year at 1-800-4-LAW-MED (1-800-452-9633). Or, visit our website at www.lawmed.com for more information. You can also fill out a free online consultation form for an immediate evaluation of your case.

Life Doesn’t Wait, and neither should you. If you have questions, HensonFuerst has answers!

This law firm is not affiliated with, sponsored by, or associated with the Associated Press, DePuy Orthopaedics, Inc., or Johnson & Johnson

To see the HensonFuerst YouTube video about the DePuy hip recall, click here: HensonFuerst YouTube video

To read the full article in The New York Times, click here: Hip Implant Complaints Surge, Even as the Dangers Are Studied

Popularity: 4% [?]

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HensonFuerst | Injury Law Blog

Archive for the ‘ Medical Devices ’ Category

Britain Concerned About Hip Implants

DePuy Manufacturer Knew of High Failure Rate

High-Failure Hip Replacements Sold Overseas

Fayetteville Hospital Could Lose Federal Funding

Top Medical and Drug Stories of 2011

FDA Warns Companies of Deceptive Lap-Band Advertising

Diagnosing Hip Replacement Injury

Hip Replacements Fail, Sometimes Without Symptoms

Staying Safer After Carotid Stenting

Hip Implant Complaints Surge

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