• Vena Cava IVC Filter Lawyers- IVC Filter Helpline:   Bard and Cook IVC Filter Lawyers Lawsuits are being filed  because the IVC (Inferior Vena Cava) Filters have been linked to migration and perforation of various organs in the body. An IVC (In...

  • Omni Life Hip Apex Arc Replacement Lawyers: Omni Life Apex ARC Hip Replacement Lawyers OMNI Life Science’s ARC hip Replacement has a  chromium and cobalt ball connecting to a titanium stem, is a metal-on-metal design. This hip replacement is l...

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Stryker Hip Replacement Lawsuit Update, Stryker Hip Replacement Lawyers

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog, Stryker Hip Replacement, Stryker Hip Replacement Lawyer

Stryker has recently recalled it’s Rejuvinate Hip replacement and ABG II Hip Stems due to the number of failed components causing complications. In June 2012, Stryker initiated a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems. “While modular-neck hip stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, we decided to voluntarily recall these modular-neck hip systems due to the potential for fretting and corrosion at the modular-neck junction which may result in ALTR (adverse local tissue reactions), as well as possible pain and/or swelling at or around the hip.” Since that date we have had  100’s of calls from people with a failed hip replacement.

The DePuy Hip Replacement Helpline announces The Stryker Hip Replacement Helpline. The mission of the new Stryker Hip Replacement Helpline is to locate all people with a failed Stryker who have required revision surgery or have been told they need revision surgery and help them file a Stryker Hip Replacement lawsuit.

New Jersey Stryker Lawsuit Update

The New Jersey Supreme Court has ruled that all cases in the state should and will be consolidated into a “multicounty litigation” in Bergen County Superior Court before Judge Brian R. Martinotti.

Stryker Hip Replacement Helpline  lawyers are filing lawsuits for injury from the newly recalled Stryker Rejuvinate Hip Replacement and ABG II Modular Stems.

A number of  patients with failed metal component  hip replacements have chosen  to file a Stryker hip replacement lawsuit after experiencing serious complications linked to the devices, and a consolidation of a number of lawsuits has taken place.

If you have been injured by a Stryker Rejuvinate Hip replacement recall  or the ABG II Modular Stems  we want to hear from you and  connect you to a  lawyer to review your medical records to see if you have a claim against Stryker for your failed hip replacement.

 

Biomet Hip Replacement MDL Update, Biomet Hip Replacement Lawyers

Written by lisaspitzer on . Posted in Biomet Hip Replacement Helpline, Depuy Hip Replacement News, Stryker Hip Replacement

DePuy Hip Replacement Helpline lawyers are  accepting faulty Biomet hip replacement clients for litigation. If you or a loved one has a faulty Biomet hip replacemant conta the Biomet Hip Replacement Helpline for  a free case evaluation.

 Biomet Magnum Hip Lawyers Appointed to Leadership Roles in MDL

Posted: 17 Dec 2012 08:17 AM PST

More than two dozen lawyers have been appointed to serve in various leadership positions in the federal multidistrict litigation (MDL) established for all Biomet M2A Magnum hip lawsuits filed in the federal court system.

These attorneys will take various actions throughout the litigation that will benefit all plaintiffs who filed a product liability lawsuit after experiencing problems with the Biomet metal-on-metal hip replacement system.

On October 2, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all product liability lawsuits filed against Biomet in federal courts throughout the country that involve the M2A Magnum metal hip implant will be centralized for pretrial proceedings before U.S. District Judge Robert L. Miller, Jr. in the Northern District of Indiana.

Centralizing the litigation is designed to reduce duplicative discovery in dozens of cases, avoiding conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and Courts.

In an order (PDF) issued on December 5, Judge Miller established the organizational structure of the Plaintiffs’ Steering Committee (PSC) in the Biomet MDL, appointing 22 different attorneys to serve in various roles throughout the consolidated proceedings.

The Biomet Magnum hip lawyers selected for the PSC will conduct pretrial discovery that applies to multiple cases, examine witnesses and introduce evidence on behalf of all plaintiffs at hearings and perform other tasks during pretrial proceedings that may apply to all cases in the MDL.

Judge Miller appointed Thomas R. Anapol and W. Mark Lanier to serve as Co-Lead Counsel, with Robert T. Dassow and Frederick R. Hovde appointed to serve as Liason Counsel. In addition, another six lawyers were designated to serve on the Executive Committee of the PSC.

Biotmet is another to the long list of faulty hip replacements which includes Stryker Rejuvinate, DePuy hip replacement.and Zimmer.Stryker hip replacement and ABG II modular-neck hip stems; DePuy, Inc., Smith and Nephew, plc. Biomet Inc., and Zimmer Holdings, Inc

 

 

Toning Shoes Causing Hip Fractures, Skechers Sneakers Lawyers Filing Lawsuits

Written by lisaspitzer on . Posted in Skechers Tone Ups Hip fracture Injury lawyer, Toning Shoes Lawsuits

Toning shoes cause Hip fractures and Hip replacements are no laughing matter. With sneakers causing hip fractures and hip replacements being recalled what are we to do? Lawsuits galore for malfunctioning devices that wreck havoc on seniors. Beware and call for an injury lawyer now.

By ELISABETH LEAMY (@elisabethleamy)
Feb. 16, 2011

A new lawsuit alleges that Skecher's Shape-up shoes can cause serious injuries.

An Ohio woman is suing the company after developing stress fractures in both hips — which she blames on the shoes.

Skecher's Shape-ups have a distinctive round sole. They are marketed as toning shoes, the fastest-growing segment of the athletic shoe market.

Toning shoes are meant to help you get in shape as you walk or work. But at least one person says rather than helping them, the shoes hurt them.

Holly Ward, 38, says her routine involves physical therapy and she now has pins in her hips because of injuries she says were caused by wearing Sketcher's Shape-ups.

"The extended use of these shoes has injured me catastrophically," Ward told "Good Morning America."

Shape-ups are advertised as helping you get in shape and helping reduce pain. Kim Kardashian and former NFL quarterback Joe Montana have appeared in commercials for Shape-ups.

Ward says she wore the shoes during her work as a waitress and while on walks and developed severe pain after five months. According to her lawsuit, she had fractures in both hips near where they meet the thigh bones even though she has the healthy bone density of a young woman.
 

"The femoral bone is the strongest bone in the human body and I fractured not one but two of them without being in a car crash or any traumatic incident," she said.

Skechers and its critics do agree on one thing: Shape-ups shoes change the way you walk.

A Skechers training video advises wearers to "step forward with the middle section of your heel hitting the ground first. Roll forward onto the ball of your foot and push off with your toes."

Company Says Millions Wear Shape-Ups Without Problems

The company calls its shoes revolutionary. Ward's lawyer calls them dangerous.

"We do not know of any testing or safety studies that Skechers did to determine safety," said Ronald Johnson, Ward's attorney. "If they're going to invent a whole new way for a human being to walk, the very first thing they should do is studies to make sure that's not going to harm their customers."

Ward says the potential gain is not worth the potential risk.

ABC spoke to half a dozen orthopedists and most were skeptical that shoes alone could cause stress fractures.

Skechers told ABC that "since this lawsuit is brand new, we have not had an opportunity to review Ms. Ward's allegations … millions of people wear Shape-ups without experiencing what Ms. Ward alleges."

Sketcher sneaker lawyers are accepting sketcher sneaker injury claims for:

Foot Injuries including:
Stress Fractures, Fallen Arches, Hammer Toe, Turf Toe, Inflammation of the Forefoot, Plantar Fasciitis, and Joint Displacement.

Leg Injuries including
Strains and Sprains, Fractures, Dislocation, Joint Injuries, Shin Splints, Tendonitis, and Nerve Damage.

Head Injuries including:
Coma, Concussion, Hematomas, Brain Damage, Hemorrhage, Skull Fracture, Contusions and Blood Clots.

    Broken Hip,
    Broken Ankle,
    Broken Leg,
    Knee Injury,
    Trimalleolar Ankle Fracture,
    Muscle Strains,
    Torn Ligaments,
    Dislocated Hip,
    Ruptured Achilles Tendon,
 

 

Stryker Helpline Launches National Campaign To Locate Seniors With Recalled Stryker

Written by lisaspitzer on . Posted in Stryker Hip Replacement

Learn About Your Stryker Hip Replacement

Many seniors have fallen victim to the new Stryker hip replacement recall. This is not metal on metal but, Metal stems and components but, has shown the same rate of complications and metal toxicity factors. Seniors must see a doctor immediately and contact our Stryker helpline for a lawyer. Revision surgery for seniors includes months of rehabilitation. Our concern for our seniors with these faulty hip replacements has lead to a massive outreach campaign to contact all seniors with this implant and their families and children to be alerted to the potential need for revision surgery and to learn about the current Stryker lawsuits.
IN July of  2012 Stryker Orthopaedics recalled the Rejuvenate Modular Hip System and ABG II Modular-neck stems due to risk of wear and  corrosion resulting in the need for additional  revision surgery.

Stryker Implant Failure is Hurting Many Seniors

We urge seniors to contact the Stryker Implant Helpline asap to get information regarding  the  early failure of the device  and the need for revision surgery

  •     Wear and corrosion at the modular-neck junction
  •     Osteolysis or bone dissolution
  •     Joint loosening and dislocation
  •     Excessive metal debris leading to metal  toxicity
  •     Inflammation of tissues
  •     Death of tissues
  •     Pain
  •     Allergic responses
  •     Broken device
  •     Adverse Local Tissue Reaction

 

 

 

Stryker Lawsuit Updates, Stryker Lawyers Propose Consolidation

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

Current news and updates regarding the Stryker Hip Replacement

Consolidation Of Lawsuits Against Stryker Are In the Works
The Logic Behind The Consolidation

Lawsuits have been filed against Stryker Orthopaedics over its defective hip implants.  Cases are under consideration for consolidation New Jersey.The  The proposal is to move for an MDL or consolidation in Bergen County Superior Court in Hackensack, N.J., Honorable Brian Martinotti, who is the judge presiding over that court, has experience overseeing Depuy ASR hip implant lawsuits.

At issue are Stryker’s Rejuvenate and ABG II modular-neck hip stems, which were marketed as a way for orthopaedic surgeons to give patients a better fit with their hip implants because they can be customized using various parts. The Rejuvenate hip offers surgeons six stems and 16 necks, and the ABG II has 10 necks and 16 stems that work together.
Metal-on-Metal Problems

The problem, however, is that the neck and stem parts have all-metal conjunctions, Stryker stated, which are to blame for complications similar to those seen in DePuy hip implant patients. Stryker patients are experiencing painful, early failure of their devices because the metal parts are grinding against each other and wearing out. Most hip implants have an average life of 15 years, but the Rejuvenate and ABG II modular-neck hip stems are failing after just months, by some reports. All-metal hip implants also have been associated with metallosis, or the poisoning of the bloodstream.

Stryker recalled the Rejuvenate and ABG II on July 6, 2012. The Rejuvenate had only been on the market since February 2009.

If you have a failed Stryker Implant contact the helpline today.

Stryker Hip Replacement Outreach Campaign Launched To Locate People Injured By The Stryker Recall

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Stryker has recalled their Rejuvenate and metal stem hip replacements for problems and complications. The Strkyer recall is new but, we expect thousands to be injured and need painful revision surgery. The new metal component hip replacement appears to have the same problems as the metal on metal DePuy including chromium and cobalt toxcity.

A campaign is now being launched to locate victims of the Stryker recall who have the:

 

  •     Stryker® Rejuvenate Modular Primary Hip System,
  •     Stryker® Rejuvenate Total hip System,
  •     Modular-Neck Stems,

The first round of the Stryker recall outreach  is projected reach the following cities

  • New York, N.Y.,
  • Los Angeles, Calif.,
  • Chicago, Ill.,
  • Houston, Tex.,
  • Philadelphia, Pa,.
  • Phoenix, Ariz,.
  • San Antonio, Tex.,
  • San Diego, Calif.,
  • Dallas, Tex.,
  • San Jose, Calif.,

Second  Stryker recall Outreach Campaign

  • Jacksonville, Fla.,
  • Indianapolis, Ind.,
  • San Francisco, Calif.,
  • Austin, Tex.,
  • Columbus, Ohio,
  • Fort Worth, Tex.,
  • Charlotte, N.C.,
  • Detroit, Mich.,
  • El Paso, Tex.,
  • Memphis, Tenn.,

Third round of the Stryker recall outreach campaign

  • Baltimore, Md.,
  • Boston, Mass.,
  • Seattle, Wash.,
  • Washington, DC,
  • Nashville,
  • Denver, Colo.,
  • Louisville,
  • Milwaukee, Wis.,
  • Portland, Ore.,
  • Las Vegas, Nev.,

Additional Stryker Lawsuits  Outreach

  • Oklahoma City, Okla,
  • Albuquerque, N.M.,
  • Tucson, Ariz.,
  • Fresno, Calif.,
  • Sacramento, Calif.,
  • Long Beach, Calif.,
  • Kansas City, Mo.,
  • Mesa, Ariz.,
  • Virginia Beach, Va.,
  • Atlanta, Ga.,
  • Colorado Springs, Colo.,
  • Omaha, Nebr.,
  • Raleigh, N.C.,
  • Miami, Fla.,
  • Cleveland, Ohio,
  • Tulsa, Okla.,
  • Oakland, Calif,.
  • Minneapolis, Minn.,
  • Wichita, Kans.,
  • Arlington,,

J & J Payoff for DePuy Hip Replacement Lawsuits, DePuy Hip Recall Lawyers

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

Hip replacement helpline lawyers are filing lawsuits for people with failed hip replacements. The first group of payoffs has commenced.

Johnson & Johnson (JNJ), which faces about 8,000 lawsuits over hip implants it recalled in 2010, agreed to pay about $600,000 to resolve three cases in the first settlements of the litigation, people familiar with the accords said.

Officials of J&J’s DePuy unit agreed earlier this month to settle Nevada residents’ suits over the company’s ASR hip implants, two people familiar with the agreement said. The company will pay about $200,000 a case to resolve the suits before they were scheduled to go to trial later this year, the people said. They spoke on condition of anonymity because they weren’t authorized to speak publicly about the accords.

J&J officials were able to negotiate settlements “at the low end of what the company should have expected” to pay, Eric Gordon, a business professor at the University of Michigan who follows the pharmaceutical industry, said in a telephone interview yesterday. “J&J should have expected to pay in the $200,000-to-$500,000 range per case.”

J&J’s DePuy unit recalled its 93,000 ASR hips worldwide in 2010, including 37,000 in the U.S., saying more than 12 percent of the devices failed within five years. Lawsuits in federal and state courts describe patients in pain and immobilized by joint dislocations, infections and bone fractures.
Metal Debris

Patients suing J&J, based in New Brunswick, New Jersey, claim metal debris from the hips, made from a cobalt and chromium alloy, causes tissue death around the joint and may increase metal ions in the bloodstream to harmful levels.

Bill Price, a spokesman for J&J, declined in a phone interview yesterday to comment on the settlements.

J&J faces more than 8,000 cases alleging the ASR hips are defective, according to court filings. U.S. District Judge David Katz in Toledo, Ohio, is overseeing about 6,000 federal suits that have been consolidated for pretrial evidence gathering. The drugmaker also is defending itself in more than 2,000 cases filed in courts in California, Maryland, Nevada and other states.

The first settlements involve cases filed in state court in Las Vegas, the people familiar with the accords said. Claims by Annelise Rundle, Martha Bender and Katherine Guy had been consolidated and set for trial Dec. 3, according to court documents.
Three Women

Rundle, 74, Bender, 69, and Guy, 60, all had ASR hip replacements done by the same surgeon during the past six years, court filings in Las Vegas show. All three later had the artificial hips removed after experiencing pain and other side effects, according to the filings.

Tests on Rundle showed she had health problems associated with metal filings from her hip, her lawyers said in the filings. In Bender’s case, doctors discovered evidence of bone damage from the device, lawyers said.

“Each of these plaintiffs has incurred a painful and debilitating hip-revision surgery as a result of the failure of their DePuy ASR Hip,” their lawyers said in a December filing.

J&J lawyer’s countered in court filings that the hips didn’t cause Rundle and the other women to develop life- threatening illnesses.

Medical records turned over by Rundle’s doctors, for example, showed she was “generally healthy with no major medical problems,” the company’s lawyers said in a Jan. 17 court filing in Las Vegas challenging the women’s request for an early trial date.

Brian Franciskato, a Kansas City, Missouri-based lawyer for the three women, declined in a telephone interview today to comment on the settlement.
$800 Million

The company said in January that it spent about $800 million on the recall during the past two years. It wouldn’t estimate its product-liability costs.

J&J faces a state-court trial in Prince George’s County, Maryland, in January involving three hip-replacement recipients, according to court filings. Those cases would be the first to go to trial if they aren’t settled.

The first federal trial of claims over the devices is expected in March or April, lawyers involved in the consolidated cases said earlier this year.

The University of Michigan’s Gordon contends it may cost the drugmaker as much as $2 billion to resolve all litigation over DePuy’s ASR hips.
‘Giant Number’

“They’re looking at a giant number before it’s done because there are a giant number of cases,” Gordon said. The biggest benefit to J&J out the Nevada settlements is that the drugmaker has “anchored settlement expectations at the low end of the range,” he said.

J&J’s rose 8 cents to $67.78 in New York Stock Exchange composite trading. The company’s 4.95 percent bonds, due to mature in May 2033, fell $1.23, or 1 percent, to $121 after news of the hip settlements was announced.

The consolidated Nevada cases are Rundle v. DePuy Orthopaedics Inc., A-11-636272, Clark County District Court (Las Vegas).

The federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net; David Voreacos in Newark at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Andrew Dunn at adunn8@bloomberg.net

 

Stryker Hip Replacement Helpline, Stryker Recall Lawyers

Written by lisaspitzer on . Posted in Stories and Sharing

A Stryker Hip Replacement Helpline has been launched for victims of the latest Stryker voluntary recall of the Stryker ABG II modular-neck stem used for total hip replacement surgery and the Stryker Rejuvinate modular-neck stem hip implant. The  Stryker hip implants have been recalled due to the fact that they could fret or corrode, harming body tissue and causing pain or swelling.

Complications and Injuries that are noted include:

  •     Severe inflammatory reactions
  •     Pain in the groin
  •     Need for additional medical care and revision surgeries
  •     Breakdown of muscles, tendons and other soft tissues in and around the hip joint
  •     Loss of surrounding bone
  •     Loss of mobility

The Stryker Rejuvenate side effects  appear to be similiar to the  Metal on Metal Hip Replacements that have caused a landslide of lawsuits against DePuy Orthopedics.
While other types of hip implants such as those made by Johnson & Johnson and DePuy Orthopaedics Inc. involve a metal ball rubbing against a metal socket, the Stryker Rejuvenate products involve a metal neck inside a metal stem. It appears that lawyers are beginning to build cases against Stryker as a part of the complete metal on metal hip replacement lawsuits. Stryker does run the risk of metal toxicity as chromium and cobalt poisoning may occur.

Anyone experiencing side effects from these Stryker products is advised to call the Stryker Hip Replacement Helpline for a Stryker Hip Replacement lawyer.

 

Stryker states that the rate of complications arising from the recalled devices was "extremely low." The company based its recall decision on information collected since the products hit the market, saying it "may be predictive of a trend." It instructed patients implanted with the devices to contact their surgeon.

If you or a loved one has been injured by a Stryker Rejuvenate product  a Stryker Hip replacement Lawyer contact the Stryker Hip Replacement Helpline for a

Hip replacement lawyer.

Stryker Hip Implant Recalls, Stryker Hip Replacement Lawyers

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Hip replacement lawyers are accepting clients for the The Stryker ABG II modular-neck stem used for total hip replacement surgery and
The Stryker Rejuvinate modular-neck stem hip implant. Stryker recalled both of these products on July 4, 2012 because the metal of the neck and stem can corrode, releasing toxic metal ions that can damage tissue and bones around the hip implant.  This can cause severe pain, inflammation, metal poisoning (metallosis from chromium and cobalt), tissue death (necrosis), bone damage, pseudotumers, gait issues, and other serious problems. Revision surgery (to remove and replace the recalled Stryker hip product) may be required.

Hip Replacement Lawyers and the DePuy Hip Replacement Helpline has launched a special division and helpline for victims of a failed Stryker hip implant.

Styker Orthopaedics has announced a recall of the ABG II modular-neck stem hip implant. Metal-on-metal parts of the device can corrode, shed toxic nano-particles into the body, and cause severe pain, inflammation, metal poisoning (metallosis), pseudotumors, and more
What You Can Do & How a Stryker ABG II Hip Implant Lawsuit Can Help

The Stryker ABG II modular-neck stem

The Stryker ABG II modular-neck stem is a new type of multi-piece hip replacement system. When it was approved, the company claimed that its many interchangeable parts made it ideal for matching each patient’s unique biomechanics.
Although the Stryker ABG II is technically a plastic-on-ceramic hip implant, the device has a unique neck/stem junction that is a metal-on-metal design. Like other metal-on-metal hip implants (including the DePuy ASR, which was recalled in 2010), the Stryker ABG II was fast-tracked through the FDA’s approval process via the 510(k) system. The FDA allows manufacturers to avoid conducting long-term safety studies of new devices so long as they are “substantially similar” to existing devices
Stryker ABG II Recall

Stryker first warned orthopedic surgeons about the risks of the ABG II hip implant in an Urgent Field Safety Notice that was sent in May 2012. The warning advised doctors to be aware of the following severe side effects associated with the ABG II hip implant:

  •     Excessive corrosion at the neck joint, which could shed toxic nano-particles into the patient’s body
  •     Pain, inflammation, tissue damage, and swelling caused by toxic metal nano-particles
  •     Allergic reaction, especially in patients with metal sensitivity
  •     Osteolysis (dissolving bone loss) caused by metal nano-particles

Complications

  •     Chronic pain in the hip joint
  •     Inflammation, swelling
  •     Less walking ability, changes in gait
  •     Metallosis (metal poisoning)
  •     Corrosion of the hip implant
  •     Tissue damage or death (necrosis)
  •     Bone loss in the hip
  •     Pseudotumors

The Stryker Rejuvenate hip implant

Stryker Rejuvenate Recall
In July 2012, Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck stems from the market. The products were recalled due to reports of fretting and corrosion. According to some reports, the FDA received two adverse events linked to the recalled devices, including one in which the device was removed.

On May 28, 2012, Health Canada announced that Stryker Rejuvenate was being recalled so the instructions for use could be updated. The recall affected only Rejuvenate devices sold in Canada and was based on a reported rate of less than one percent for revisions associated with the Rejuvenate. So far, no such Stryker recall has been announced in the US.

Call the Stryker hip implant helpline for a Stryker hip replacement Lawyer Today

Medtronic Infuse Bone Graft Helpline, Infuse Bone Graft Lawyers

Written by lisaspitzer on . Posted in Stories and Sharing

 

Medtronic Infuse Bone Graft lawyers, Medtronic Infuse Bone Graft Helpline

DePuy Hip replacement helpline all Orthopedic related  dangerous device updates

Written by Injury Lawyer

 

 

May 16, 2012

. Posted in Accident Injury lawyer

Injury Lawyers  announce launch of Medtronic Infuse Bone Graft Lawsuit  Division and Medtronic Infuse Bone Graft Helpline
to educate individuals and families harmed by  off-label bone graft procedures and to help them understand the complications and how to pursue legal action with a Metronic Infuse Bone Graft Lawyer.

Medtronic faces an increasing number of product liability and personal injury lawsuit. Most recently, a Louisiana man, filed a lawsuit alleging that the company’s Infuse bone graft caused unwanted bone growth along his spinal cord, which worsened his back pain following a lumbar fusion.

The plaintiff, Martin Gavin alleges that Medtronic concealed information about the risk of complications from the Medtronic Infuse bone graft.

What is Medtronic Infuse?

Infuse, also known as bone morphogenetic protein-2, is a powerful bioengineered agent used in spinal fusion surgery. The product stimulates bone growth and eliminates the need to harvest a small amount of a patient's own bone to create a fusion between two vertebrae. As a result, it is highly popular with spine surgeons.

FDA Approved Infuse for limited use

The FDA approved Infuse in 2002 for use during anterior lumbar fusion surgeries. But as a result of slick and pressured marketing, it has been widely used off-label for a number of other types of spinal surgery, which have been found to increase the risk of severe adverse side effects.

Plaintiffs allege that they were never told that the Infuse was only approved for single-level anterior lumbar fusion, and had ever been adequately tested or approved for the type of spine surgery they underwent.

Medtronic Infuse Off Label Use

Off-label use of the Medtronic Infuse bone graft during procedures other than single-level anterior lumbar fusion have been linked to the growth of bone in those areas, leading to swelling and nerve damage.

FDA 2008 Warning

The FDA issued an alert in 2008, advising doctors not to use the Medtronic Infuse in neck or cervical spinal fusion procedures. The FDA had received numerous adverse event reports, involving potentially fatal complications that included swelling of the neck and respiratory difficulties.

U.S. Department of Justice investigation

The U.S. Department of Justice initiated an investigation focusing on the actions of Medtronic in 2008. The U.S DOJ was particularly interested in investigating whether Medtronic illegally promoted and marketed the Infuse bone graft for uses that were never approved by the FDA.

Other Medtronic Infuse Side Effects

Last year, concerns also emerged that the Medtronic Infuse bone graft may increase the risk of cancer. There have also been concerns that med treated with Medtronic Infuse may face a risk of sterility.

Shareholders said Infuse sales and Medtronic's share price fell after the company revealed that the U.S. Department of Justice was probing off-label marketing and the U.S. Senate began its own inquiry.

he Infuse Bone Graft is  manufactured by Medtronic. The infuse Bone Graft is a  biologically-engineered protein (known as rhBMP-2) that is used to promote bone growth and replace damaged spinal discs. It is used in conjunction with a metallic cage implant (LT-Cage Device) that works to stabilize the spine as the new bone grows. Infuse Bone Graft is designed to reduce the pain and complications that are associated with treating degenerative disc disease (DDD) by eliminating the second surgery that is typically required to remove bone from a patient’s hip for transplantation to the spine for repair.

FDA Alerts on the Infuse Bone Graft

The FDA put special emphasis on the fact ”that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”

The FDA stated that they had received at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. Severe dysphagia following cervical spine fusion using rhBMP products has also been reported in the literature.

The Infuse Bone graft has been Approved for

DDD occurs when a spinal disc deteriorates to the point of causing back pain, a diagnosis that must be confirmed by history and x-rays. Spinal fusion is a surgical method used to treat DDD and involves removing the damaged disc and replacing it with bone graft that will fuse – or join – the two adjacent vertebrae together in order to stabilize the spine. Infuse Bone Graft is used in over 100,000 U.S. spinal fusion surgeries each year.

Infuse Bone Graft is currently approved by the U.S. Food and Drug Administration (FDA) for use in anterior spinal fusion of the lumbar spine, as well as for the repair of open tibial shaft fractures and two minor dental procedures.

                                                                 Infuse Bone Graft should not be used  for

  • Women who are pregnant or who suspect pregnancy
  • Individuals with infections near the area of the surgical incision
  • Individuals who have had a tumor removed from the area of the implantation site
  • Individuals who currently have tumors in or near the area of the implantation site
  • Individuals whose bones have not stopped growing
  • Individuals who are sensitive to titanium, titanium alloy, bovine (cow) Type I collagen or rhBMP-2.

The Infuse Bone graft is being Used for off label not FDA approved Use

The FDA originally approved Infuse Bone Graft in 2002 but as with many drugs and devices, off-label use of Infuse Bone Graft was permitted once the device received FDA approval. The practice of using a drug or device off-label is permitted if physicians believe it will benefit their patients and if they fully advise their patients of the risks associated with the off-label use. In July of 2008, the U.S. Food and Drug Administration issued a warning to healthcare providers about reported life-threatening complications associated with the off-label use of Infuse Bone Graft for cervical (neck) spinal fusions. This warning was issued in response to 38 reports of complications received by the FDA between 2004 and 2008. These complications include neck and throat swelling leading to airway compression, swallowing and breathing difficulties, as well as problems with speech. In the warning, the FDA noted that “the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”

Infuse Bone Graft lawyers are Filing lawsuits for complications from the infuse bone graft

The Medtronic Infuse Bone Graft has been linked to life-threatening complications in patients who were given Medtronic off-label. Medtronic bone graft complications include swelling of the airways, which can cause difficulty breathing, speaking and swallowing. Medtronic Infuse has also been linked to retrograde ejaculation which can lead to male sterility. A number of Medtronic lawsuits allege the manufacturer illegally promoted the Medtronic bone product for off-label uses.

Speak to  a Medtronic Bone Graft Lawyer

If you or someone you know has experienced complications after being treated with a Medtronic bone growth product call the medtronic Bone graft helpline today. Our lawyers   are  currently reviewing  Medtronic lawsuits nationwide.