Archive for the ‘ Defective Product ’ Category

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29
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: 2% [?]

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14
Nov

Toyota, Lexus, Cadillac Recalls

The National Highway Traffic Safety Administration (NHTSA) reports that two large car manufacturers have recalled vehicles:

Toyota, Lexus

This recall affects more than 420,000 vehicles. Toyota is recalling several different models because the amount of adhesive applied between the outer ring and inner ring in the crankshaft pulley may be inadequate.The outer ring could become misaligned, and may not rotate properly. In some cases, the belt for the power steering pump may become detached from the pulley, which could result in a loss of power steering and a sudden increase in steering effort. Because this would happen without warning, it could increase the risk of a crash.

The NHTSA says that the recall is expected to begin during early January 2012, but if your vehicle is on the list, you may wish to call your dealership sooner to see if your car can be checked out. If there is a problem, the dealer will replace the pulley with a new one at no charge.

The affected vehicles are:

  • 2004-2005 Lexus ES 330
  • 2004-2005 Lexus RX 330
  • 2006 Lexus RX 400H
  • 2004 Toyota Avalon
  • 2004-2005 Toyota Camry
  • 2004-2005 Toyota Camry Solara
  • 2004-2005 Toyota Highlander
  • 2006 Toyota Highlander Hybrid
  • 2004-2005 Toyota Sienna

If you have questions, you may contact Toyota at 1-800-331-4331, or the NHTSA Vehicle Safety Hotline at 1-888-327-4236.

General Motors Cadillac

This small recall (affecting just 674 cars) is for model year 2012 Cadillac CTS vehicles manufactured from October 21, 2011, through October 26, 2011. A nut in the brake system may not be torqued to the proper specification, which could result in a loss of ability to brake, which could lead to a “crash without prior warning.”

How do you know if your 2012 Cadillac CTS is affected? The best way to is call your dealership. Ask them to inspect the power vacuum brake boost pushrod retention nut. If necessary, they will adjust the torque. If you have questions, contact GM at 1-800-458-8006, or the NHTSA’s Vehicle Safety Hotline at 1-888-327-4236.


Popularity: 3% [?]

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4
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: 4% [?]

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1
Sep

Car Malfunction May Have Killed Teacher In I-85 Crash

September 1, 2011

Students and faculty at Brookside Elementary School grieved this morning as they walked past the flag flying at half-mast in remembrance of the colleague and mentor they lost yesterday in a single-car crash on I-85 in Gaston County.

The 27-year-old victim was a Charlotte woman who had been a teacher in the area for nearly seven years. She was driving southbound along I-85 when the crash occurred. According to the Associated Press, troopers for the North Carolina Highway Patrol said there was an explosion inside the vehicle, which caused the driver to swerve and hit a concrete median in the road. She ricocheted off the structure, and the vehicle apparently accelerated. The Toyota Scion then left the road from the right shoulder before driving into a grove of trees and striking one head-on. The Charlotte Observer reported the woman was airlifted to Carolinas Medical Center but died soon after arrival.

Troopers investigating the incident have pulled the black box from the Toyota to see what may have malfunctioned, if anything, which caused the accident. They expect to have results within several weeks.

In 2009, Toyota recalled millions of cars for faulty accelerator pedals, but to date, no Scions have been affected.

If you have lost a loved one due to a negligently built piece of equipment, contact the North Carolina Wrongful Death Attorneys with HensonFuerst. Our experienced team is available to discuss your case anytime. Just fill out a free online consultation form to get started today!

Popularity: 2% [?]

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23
Aug

Hip Implant Complaints Surge

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.

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:

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 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: 3% [?]

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8
Aug

Failure of Surgical Mesh a Serious Worry for Women

Surgical mesh is a common medical product used to repair conditions in which body organs need extra support. For example, one of the most common uses has been to repair hernias. In women, surgical mesh is also used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), conditions that occur when the muscles and ligaments supporting internal organs weaken. Treatment can include surgery to shore up the organs, with surgical mesh being used to keep the organs from “sagging” inside the body cavity.

Over the past three years, the U.S. Food and Drug Administration (FDA) received nearly 4,000 reports of severe complications (including 3 fatalities) associated with surgical mesh used to treat POP and SUI. The most frequent complications include:

  • erosion through vaginal epithelium (inner wall of the vagina);
  • mesh contraction, leading to vaginal shortening and pain;
  • infection;
  • abscesses;
  • pain;
  • urinary problems;
  • recurrence of prolapse and/or incontinence.

There were also reports of surgical complications when the insertion of the mesh perforated bowel, bladder, or blood vessels. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia (painful sexual intercourse).

A recent study published in the New England Journal of Medicine revealed troubling results with these procedures. Compared with traditional surgery without mesh, women who had a transvaginal mesh (TVM) inserted to treat pelvic organ prolapse suffered higher rates of serious complications, including bladder perforation and pelvic hemorrhage… and they had an increased number of adverse events after the surgery, including newly acquired urinary incontinence.

On July 13, 2011, the FDA issued an update on TVM, which clarified its recommendations:

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. [emphasis added by the FDA]

The FDA recommends that surgeons recognize that most cases of POP can be treated successfully without surgical mesh.

Unfortunately, doctors and the FDA have known about the problems with surgical mesh for at least 3 years, without warning women about the serious risks of the surgery. If you or someone you care about has a transvaginal mesh (TVM) used to correct pelvic organ prolapse or urinary incontinence and suffered any of the above symptoms, our law firm may be able to help. Contact us today to learn how. We are available 24/7 at 1-800-4-LAWMED; or contact us via our website at www.lawmed.com.

Popularity: 3% [?]

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19
May

Avandia Drug Pulled from Shelves

May 18, 2011

The Food and Drug Administration (FDA) has placed restrictions on medications containing the diabetes drug Rosiglitazone, trade name Avandia. GlaxoSmithKline (GSK), the drugs manufacturer, will be required to create a restricted access program that will limit the patients who can take the drug. Only patients who are currently benefiting from treatment of the drug and choose to continue use, or patients whose glucose levels cannot be controlled with any other drug will be eligible for a prescription.

The report states that after November 18, 2011, patients will no longer be able to receive Rosiglitazone medications from retail pharmacies. Eligible patients will be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to receive the medications by mail through a limited number of certified pharmacies.

Read More.

A study in the Journal of the American Medical Association, found an increased risk of cardiovascular events between patients taking Avandia and a similar drug, Actos. The study found a 25% increased risk of heart failure, a 27% increased risk of stroke, and a 14% increased risk of death.

From January of 2010 to October of 2010, over 460,000 prescriptions were filled for these medications. Although, use dropped by half within that time period from 235,500 patients in January to 119,000 patients in October.

If you or someone you know has been taking a Rosiglitazone-based product such as Avandia, you should contact a North Carolina Medical Malpractice Lawyer. Henson Fuerst Attorneys may be able to assist you with your case.

Popularity: 12% [?]

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12
May

Hip Replacements To Be Evaluated for Safety

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. (To read our blog about that announcement, click here: DePuy Hip Replacement Recall Raises More Questions)

Now, the U.S. Food and Drug Administration (FDA) has ordered all producers of “metal-on-metal” hip replacements to study the implants. According to an article published in The New York Times:

Under the order, producers of “metal-on-metal” hips will have to conduct studies of patients who received the device to determine, among other things, whether the implants are shedding high levels of metallic debris. Some patients have encountered that problem, including soft tissue damage that has disabled them.

This means that DePuy may not be the only potentially dangerous hip replacement brand. Other brands that are included in the order are Zimmer, Stryker, Biomet, and Wright Medical.

Under the order, each manufacturer is allowed to determine how to conduct its own research study, as long as they collect information and blood samples from all hip-replacement patients. The overall goals are to determine how often the devices fail, and what other health effects might be due to the metal-on-metal hips.

With HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. If you believe you have been harmed by a metal-on-metal hip replacement, regardless of the brand, 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.

If you have questions, HensonFuerst has answers!

Popularity: 4% [?]

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24
Feb

Toyota Recalls a New Batch of 2.17 Million Cars

Toyota Motor Corp. announced today that it is recalling more than 2 million vehicles in the United States to fix issues with

accelerator pedals that can become jammed under floor matsor in the vehicle’s carpeting. According to USA Today, the specific models affected are:

  • Lexus GS. About 20,000 2006 and early 2007 Lexus GS 300 and GS 350 all-wheel Drive vehicles to modify the shape of the plastic pad embedded in the driver’s side floor carpet.
  • Lexus RX. About 372,000 2004 through 2006 and early 2007 Lexus RX 330, RX 350, and RX 400h vehicles to replace the driver’s side floor carpet cover and retention clips.
  • Toyota Highlander. About 397,000 2004 through 2006 Toyota Highlander and Highlander HV vehicles to fix floor mat issues.
  • Toyota 4Runner. About 603,000 2003 to 2009 4Runners to address floor mats.
  • Lexus LX. 17,000 2009 to 2011 Lexus LXs on floor mats.
  • Toyota RAV4. Some 761,00 2006 through 2010 RAV4 to address floor-mat entrapment issues.

In a press release, Toyota stated that owners of the recalled vehicles will begin receiving notifications by mail “beginning in the near future.” That seems a little vague to us. The possibility of accelerator entrapment is serious and, if it happens while you’re driving, could be dangerous and even life-threatening. There are a few of us here at HensonFuerst Attorneys who own and drive one of the recalled vehicles, and you can be sure we’ll be contacting our dealer to find out what we can do immediately to ensure our safety, and the safety of our families.

Toyota offers that:

Detailed information and answers to questions are available to customers at www.toyota.com/recall or www.lexus.com/recall and the Toyota Customer Experience Center at 1-800-331-4331 or Lexus Customer Satisfaction at 1-800-25-LEXUS or 1-800-255-3987.

If you were injured in a car wreck with one of these recalled vehicles, and want to explore your legal options, please feel free to contact HensonFuerst Attorneys at 1-800-4LAW-MED. The consultation is free. If you have questions, HensonFuerst has answers!

Popularity: 4% [?]

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8
Feb

TMJ Implant Investigation

One of the most-used joints in the body in the temporomandibular joint (TMJ), which connects the lower jaw (the mandible) to the skull. The TMJ allows two kinds of movements: Regular opening and closing, as well as side-to-side movements. The result is a wonderful ability to eat, talk, chew, and make a variety of facial expressions.

Unfortunately, just as with knees, hips, and other joints, the TMJ can wear out or become diseased. And also like knees and hips, there are medical implants available for people whose TMJ has been badly damaged by injury, arthritis, or physical abnormality.

Now, the U.S. Food and Drug Administration (FDA) is ordering the three manufacturers of  TMJ implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons.

The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and August 17, 2010.  The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on mechanical testing.

The TMJ implant postmarket surveillance studies must address the following:

  • Time between initial implant and removal/replacement
  • Association between patient diagnosis and the timeframe between implant and removal/replacement
  • For replacement implants, the time between implant and subsequent removal/replacement
  • Reasons for removal/replacement of the implant
  • Associations between patient demographic and clinical data and the need or removal/replacement
  • Assessment of devices that have been removed from patients

As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices. The FDA is not currently recommending any changes on use of the implants. The agency may revise its recommendations or issue other recommendations after reviewing additional clinical data from the studies.

Patients who have or are considering a TMJ implant should consult with their health care professional. If you have had a TMJ implant that went bad, and you would like to explore your legal options, feel free to contact HensonFuerst Attorneys at 1-800-4LAW-MED. If you have questions, HensonFuerst has answers.

Popularity: 4% [?]