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GranuFlo Recall, GranuFlo Lawyers

Written by lisaspitzer on . Posted in Class MDL Class Action News

 GranuFlo recall announced causing sudden heart attacks and death. GranuFlo lawyers filing lawsuits.

FDA Issues GranuFlo Recall
Elise Kramer | September 13th, 2012 | Posted in GranuFlo Lawsuits, Injury Lawsuit News

The Food and Drug Administration issued a recall of the dialysis products GranuFlo and NaturaLyte on the 29th of March, 2012, after a memo from drug maker Fresenius Medical Care was leaked to the public. These products are used during hemodialysis in order to remove toxins from the bloodstream of a patient whose kidneys are not functioning properly; however, GranuFlo and NaturaLyte have been linked to an increased risk of heart attack and sudden death. A number of patients who have experienced these side effects or whose loved ones have experienced them have filed suit against the drug manufacturer in the hopes of gaining compensation for the injuries.
Dangerous side effects linked to products

GranuFlo and NaturaLyte are similar products which were both designed to reduce the build-up of acid in the blood and to utilize bicarbonate in order to neutralize acids. However, these products are different from their competitors in that they use greater concentrations of bicarbonate, which can lead to serious health issues especially if doctors miscalculate the proper and safe dosage. Fatal overdoses, which can cause sudden death, and heart attacks are the most serious side effects of this product.

Fresenius Medical Care published an internal memo on the 4th of November, 2011, regarding risks associated with their product. A reported 941 patients had suffered heart attacks linked to the use of these products, and the memo detailed these “troubling findings”. Medical staff were informed that the problem needed to be “addressed urgently.” However, no contact was made with the Food and Drug Administration about these concerns, and no public warning was issued to patients at risk for GranuFlo related side effects. The memo was leaked to the Food and Drug Administration, which prompted a recall of the products.
Recall leads to individual lawsuits

Patients alerted to the recall suddenly may have been able to connect adverse health events that they had experienced to the use of GranuFlo, and many have hired GranuFlo attorneys in an effort to seek compensation that could help cover injury-related costs they have accumulated.

Stryker Hip Replacement Lawsuits, Stryker Lawyers

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Arizona Multidistrict Litigation Lawyers, Arkansas Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Class MDL Class Action News, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Delaware Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Iowa Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Kentucky Multidistrict Litigation Lawyers, Louisiana Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Mississippi Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Hampshire Multidistrict Litigation Lawyers, New Jersey Multidistrict Litigation Lawyers, New Mexico Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, Ohio Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, Product Recall News, Rhode Island Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, South Dakota Multidistrict Litigation Lawyers, Tennessee Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers, Utah Multidistrict Litigation Lawyers, Vermont Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers, Washington Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers, Wisconsin Multidistrict Litigation Lawyers, Wyoming Multidistrict Litigation Lawyers

The lawsuits are beginning for the Stryker Rejuvenate Hip Replacemants. This is another failed implant just like the DePuy Hip Replacement. Both are metal component or metal on metal. If you have a faile Stryker Hip Replacment you must see a doctor as they have been recalled. Contact our Stryker Hip Replacement lawyers immediately. The news regarding the Stryker hip replacement is out. Stryker is faced with mounting lawsuits

New Jersey Stryker Hip Replacement Claims

many new nationwide  lawsuits were filed in New Jersey Superior Court, claiming that each of the plaintiffs received a Stryker Rejuvenate hip replacement, involving a modular femoral neck stem designed to allow the surgeon to customize the length of the component.

The lawsuits claim that the Stryker  design defects caused the hip replacements to loosen and move out of position, requiring people to undergo revision surgery.

What is The  Problem with Stryker Rejuvenate?

The Stryker Rejuvenate consists of a metal neck that fits inside of a metal stem to allow the implant to be customized for certain aspects of a patient’s anatomy and hip biomechanics.

In July 2012, a Stryker Rejuvenate recall was issued for the modular-neck hip stem components, due to a risk of corrosion at the modular neck junction. The design has been associated with metallosis problems where metal debris may be released into the body as the metal parts grind against each other, leading to hip pain, swelling, local tissue reactions and early failure of the entire hip replacement.

Stryker Lawyers Filing Stryker Rejuvenate Lawsuits

These lawsuits claim that  Stryker is liable for negligent design and manufacturing of the Stryker Rejuvenate system. Stryker has confirmed that the modular neck stem suffered from loosening, corrosion and fretting, similar to problems seen with metal-on-metal hip replacement systems.

The Stryker Hip Replacements Cause:

  • pseudotumors, tissue necrosis,
  • muscle loss,
  • bone loss around the implants,
  • metal poisoning or metallosis.

Coloplast Vaginal Mesh Lawyers, Coloplast Vaginal Mesh Lawsuits

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Arkansas Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Class MDL Class Action News, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Delaware Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Iowa Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Michigan Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Hampshire Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, Ohio Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers, Utah Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers

As the lawsuits keep mounting up a new vaginal mesh manufacturer has been added. It seems as if there is no end to companies that have jumped on the golden mesh band wagon. Over 300,000 women have been implanted with vaginal mesh devices. Despite the warnings, and T.V lawyer ads,  doctors are still putting mesh in to this date. It never ceases to amaze me to see doctors sugggesting a brand new mesh over the old failed one. The vaginal mesh MDL lawyers are now filing lawsuits for a new mesh manufacturer that has been added to the West Virginia MDL, Coloplast. See the vaginal mesh news update below:

 Coloplast Vaginal Mesh  Products  Have Been Named in Mesh Lawsuits
According to their website, Coloplast develops products and services “to make life easier for people with deeply personal and private medical conditions.” The company has a special focus on surgical urology, developing surgical devices for both men and women. For women, Coloplast markets products to treat pelvic organ prolapse and to control urinary incontinence.
The August 6 order by the JPML centralized 13 Coloplast pelvic mesh lawsuits into West Virginia. All plaintiffs allege that the company’s products caused serious injuries. The products at issue in these lawsuits, Novasilk, Exair, Suspend, and Axis, are used to treat pelvic organ prolapse by supporting weakened pelvic muscles.
Consolidation into one court helps conserve resources, increase efficiency, and reduce the risk of duplicative discovery or conflicting rulings from other courts. Each lawsuit retains its individual nature, however, and will be returned to its original court for trial after pre-trial proceedings are complete.

This is part of the huge multi district litigations being filed by vaginal mesh lawyers for 1000's of women nationwide.

Vaginal Mesh Lawsuit MdL’s, Vaginal Mesh Lawyers

Written by lisaspitzer on . Posted in Arizona Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Class MDL Class Action News, Connecticut Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Iowa Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Jersey Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers

The vaginal mesh lawsuits may well be one of the largest ligigations of a hrmful device hurting women we have seen to date.

If is currently thought that over 300,000 women are implanted with various vaginal mesh devices for uterus, bladder and bowel prolapse as well as urinary incontinence. The mesh has caused very serious complications and the numbers of filings continue to grow.

Transvaginal mesh side effects are so common, in fact, that hundreds of lawsuits have been filed by women seeking compensation for their pain and suffering, medical bills, and lost wages due to vaginal mesh complications. The number of vaginal mesh lawsuits being filed is so large that five MDLs have been created to quickly and effectively deal with them. Four vaginal mesh MDLs have been centralized in the U.S. District Court for the Southern District of West Virginia, while a fifth MDL has been created in the U.S. District Court for the Middle District of Georgia.

There are a number of vaginal mesh MDL's currently

Vaginal mesh lawyers representing Plaintiffs argue that even with five vaginal mesh lawsuit MDLs, there is still a need to create a sixth MDL. Federal judges will meet later this month to hear oral arguments regarding whether a new vaginal mesh lawsuit MDL should be created in West Virginia, where U.S. District Judge Joseph R. Goodwin is overseeing five transvaginal mesh MDLs.

Discovery to begin for vaginal mesh lawsuits

Unsurprisingly, discovery is the process of “discovering” information or evidence to support a case. For the vaginal mesh multidistrict litigation, the pretrial discovery process will include interrogatories (fact-finding questionnaires), depositions, and the collection of other paperwork and information to support the plaintiffs’ cases. Judge Goodwin’s issuance of this order is an important step to moving forward with the MDL’s, as it signals the next step toward the first transvaginal mesh lawsuit trials.

The multi district litigation department of Class Action Lawyer Network has authorized an expanded division to continue to help women file vaginal mesh lawsuits for the pain and suffering they have undegone from these failed mesh devices.

This division is headed up by a female medical social worker who is is felt is best equipped to deal with women in crisis from the vaginal mesh. Women need support as well as help finding a doctor and is felt this is best handled by our social work team.

For nationwide mesh lawsuit representation contact us today.

 

 

TransVaginal Mesh Lawsuit, Transvaginal Mesh Lawyers

Written by lisaspitzer on . Posted in California Multidistrict Litigation Lawyers, Class MDL Class Action News, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Michigan Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, New Jersey Multidistrict Litigation Lawyers, New Mexico Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers

 A Transvaginal mesh  is a surgical implant which is used to treat POP ( pelvic organ prolapse ) and stress urinary incontinence (SUI) in women.   These medical problems are a result of a weakened pelvic floor  due to age, childbirth, hysterectomy, or menopause.
Because of the agressive  sales job done by these medical device manufactures, vaginal mesh repair became very common and now over 300,000 women have a mesh implant.

The doctor used a surgical mesh to help reinforce the vaginal wall and to provide an additional supporting mesh structure  to organs like the bladder, bowel or uterus  However, it became apparent after several years after this product was used, many women began to experience complications like pain, infection, bleeding, mesh erosion. lower back pain, increased bowel and urinary problems and the inability to have sexual intercourse due to the severe pain. Many complications have resulted form these mesh implants and they all appear to be similiar no matter waht mesh product has been implanted thru the vaginaa:
    •    Mesh erosion through vaginal wall, bladder or bowel
    •    Infection that does not go away
         Organ perforation
    •    Pain like a knife
    •    Urinary incontinence is back
    •    Recurrence of prolapse
    •    Bladder, bowel or vessel perforation
    •    Vaginal scarring
    •    Pain during sexual intercourse
    •    Other problems that led to a significant decrease in patient quality of life due 
to discomfort and pain.
Now, after receiving over 3000 complaints from women who suffered serious injuries caused by polypropylene transvaginal device/mesh, the FDA issued a very detailed and comprehensive statement to warn doctors that they should consider no longer using mesh to treat their patients.  Just recently Johnson and Johnson removed 4 Gynecare products form the market and did a label change on the fitth. 

If you or a loved one is suffering due to a vaginal mesh implant call us now. We will file a vaginal mesh lawsuit for you and help you locate a doctor.

Lawyers Sueing for Malfunctioning Metronic Infuse Bone Graft

Written by lisaspitzer on . Posted in Class MDL Class Action News

Class Action Lawyer Network Infuse Bone Graft lawyers are reviewing cases for lawsuits agsainst the manufacturer of the Infuse Bone Graft for malfunction and debilitating and disabling injury.

What are the Complications and Symptom of Malfunction?

The FDA issued a safety alert regarding the complications from the off-label use of Infuse in the neck, or cervical area of the spine. These complications, which can be life threatening, include:

  •     Angioedema (swelling of the neck and throat, which can cause fatal suffocation),
  •     Cancer,
  •     Male sterility,
  •     Chronic pain that radiates into the arms and legs,
  •     Respiratory depression,
  •     Nerve damage,
  •     Death

If you or a loved one has been implanted with the infuse bone graft see a ohysician immediately and contact us for a case review, You may be eligible to particapte in a lawsuit against the manufacturer for off label use and:

Cancer – skin (melanoma), thyroid, breast, prostate, lymphoma, pancreatic, ovarian, stomach, leukemia, laryngeal and lung cancers.
Sexual Side Effects – including sterility and uro-genital injuries and other sexual complications in males.
Uncontrolled Bone Growth – INFUSE has been linked to ectopic or uncontrolled bone growth in patients at or near the surgical site (one study said that 75% of INFUSE patients experienced this complication).
Swelling of the Neck or Throat – including trouble swallowing, breathing, and talking.
Nerve Injuries – including chronic and severe radiating pain in the arms or legs (such as radiculitis, radiopathy or neuritis).

and wrongful death of a loved one. Speak to our Infuse Bone Graft lawyer helpline today.

Mirena IUD Having Severe Complications in Women, Perforated Uterus

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Arizona Multidistrict Litigation Lawyers, Arkansas Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Class MDL Class Action News, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Kentucky Multidistrict Litigation Lawyers, Louisiana Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Medical Device Lawsuits, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Mirena IUD Lawyers, Mississippi Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, NYC Class Action Lawyers, Ohio Multidistrict Litigation Lawyers, Rhode Island Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, Tennessee Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers

Criteria for the Mirena lawsuit is a perforated Uterus.

The lawyers of Class Action Lawyer Network are reviewing cases for  perforated Uterus from the Mirnena IUD and gathering facts for the formation of a Mult district litigation action. Women implanted with the Mirena IUD are having serious side effects. The most serious is e gravitation of the IUD to a nearby organ causing it to become embedded in the Uterus or other organ. Organ perforation is another hazard of this gravitation. This is the only criteria right now for the Mirena lawsuits.

Lawyers are seeking all women with organ perforation from the Mirena IUD to submit theor medical records and documentation to be reviewed for a Mirena IUD lawsuit against the Mirena manufacturer.

Serious Side Effects of The Mirena IUD

The numbers of women are starting to grow who have had Mirena implanted and are experiencing serious and even debilitating or life-threatening side-effects. The device has been migrating from its original position after being inserted, perforating the uterus or embedding itself in the uterus. In both instances, a doctor must locate and surgically remove the device. Mirena also migrates outside the uterine cavity and cause adhesions or scarring that can lead to infertility. Depending on the damage caused, you may require a complete hysterectomy, and more serious complications could result in death. You must be aware of any and all changes when you have this device and see an emergency physician immediately if you are experiencing any symptoms.

Be Alerted to the following side effects:

  •     Abscesses
  •     Embedment in the uterus
  •     Erosion of adjacent areas such as the vagina
  •     Infertility
  •     Inflammation of the membrane that lines the abdominal cavity and internal organs (Peritonitis)
  •     Intestinal perforations or obstruction
  •     Pelvic Inflammatory Disease
  •     Perforation of the uterus

Contact us for a Mirena IUD case review.

Stryker Voluntary Recall of Hip Replacement, Stryker Lawyers Take Notice

Written by lisaspitzer on . Posted in Class MDL Class Action News

The Stryker ABG II modular-neck stem used for total hip replacement surgery and The Stryker Rejuvinate modular-neck stem hip implant lawyers filing lawsuits for Stryker Hip Replacement recall.

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.

In July 2012, Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular Hip System. The recall includes both Stryker’s Rejuvenate Modular and ABG II modular-neck hip stems.
Risks

Stryker initiated this voluntary recall due to potential risk associated with modular-neck stems.
 

  •     Fretting and/or corrosion at the modular-neck junction,
  •     Pain and/or swelling.
  •     Need For Revision Surgery
  •     Joint loosening/dislocation
  •     Device wear and tear, such as corrosion and fretting
  •     Excessive metal debris leading to metal ion generation
  •     Inflammation of tissue
  •     Hypersensitivity/allergic response
  •     Broken devices
     

All recipients of these two hip replacements must see their doctor immediately and retain a Stryker Hip replacement lawyer. Do not wait. It is only a matter of time before a new Mutli District Litigation for the Stryker hip Implant becomes T,V news. Lawyers are accepting cases for both of these implants. Contact Class Action Lawyer Network Stryker Hip replacement lawyers today.

Stryker Rejuvenate Hip Implant Lawyers,

Written by lisaspitzer on . Posted in Class MDL Class Action News

Stryker Rejuvenate Hip Implant lawyers accepting cases for stryker Hip replacement
The Stryker Rejuvenate hip replacement device has been linked to an increased risk of metallosis. Although the Stryker Rejuvenate is not a metal-on-metal hip device, it has metal-on-metal components, which are believed to be responsible for the development of metallosis in some patients. According to reports, the Stryker Rejuvenate hip implant device is linked to a high early failure rate, resulting in some patients having revision surgery to replace their hip replacement device. Lawyers are now qccepting cases for the failure of the Syryker Rejuvenate Hip replacement.

Call the new  Stryker Orthopedics Rejuvenate Hip replacement Helplineand speak to a Hip Replacement Lawyer.
Stryker Rejuvenate Hip Implant

The Stryker Rejuvenate hip implant is different from other hip replacement devices in the news recently because it is not a metal-on-metal hip replacement device. Instead, the Rejuvenate hip replacement device, which uses a ceramic component, was meant as an alternative to the metal-on-metal devices. It was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better, which was supposed to result in longer-lasting hip replacement devices that offered a better range of motion.

Some patients reportedly developed metallosis after having the Stryker Rejuvenate hip device implanted. Although it was initially believed that such a condition was not possible—because the Stryker Rejuvenate does not have a metal-on-metal ball and socket design—the Stryker hip device has a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose.

Stryker has responded to concerns about the Rejuvenate failure rate by alleging patients did not properly undergo rehabilitation following surgery, or by blaming doctors' implantation techniques. In a Product Correction Bulletin (04/25/12), Stryker officials noted, "Factors such as diabetes and infection may play a role in potential corrosion of an implant as these conditions may affect the pH of the tissue surrounding the implant."

Metallosis is an adverse tissue reaction to heavy metals in the body. It can cause pain, limited mobility, failure of the hip joint, pseudo-tumors, dissolution of the bone, DNA changes and chromosomal aberrations. Patients who have had their Stryker Rejuvenate hip implant device fail may have undergone revision surgery. Typically, hip implants are expected to last 15 to 20 years. In some cases, the Stryker Rejuvenate hips are failing in less than five years. It seems we once again have a failed hip replacement. If you or a loved one has a failed Stryker hip implant or Cobalt or Chromium poisoning call the Stryker Rejuvente Hip Replacement Helpline  today.

Metronic Infuse Bone Graft Lawyers, Infuse Bone Graft Lawsuits

Written by lisaspitzer on . Posted in Class MDL Class Action News

Lawyers for the victims of the Metronic Infuse Bone Graft are filing lawsuits for victims of off label use of the bone graft.Medtronic Infuse Bone Graft lawsuits  are increasing as more victims come forward
 

Infuse is a bio-engineered bone graft device that is marketed by Medtronic for lumbar surgery. It is intended as a substitute for the traditional surgical procedure involving the taking of a bone graft from the patients hip. The advantage of this product is that no surgery is needed to remove bone from the patient's hip reducing pain and shortening recovery times. However, the introduction of foreign material into the body creates other risks.

The lawsuits allege that Medtronic failed to reveal side effects which Medtronic knew were likely in order to increase sales of the product. These side effects include uncontrolled bone growth called ectopic bone growth that resulted in failures of many surgeries. The active fusion ingredient in the Infuse product is rhBMP-2. The letters BMP stand for Bone Morphogenetic Protein. This ingredient is designed to stimulate bone growth in the spine so that the vertebra will fuse together to relieve back pain.

Injured back surgery patients allege that Medtronic understated the risk of uncontrolled bone growth, inflamatory reactions, retrograde ejaculation, urinary retention, bone reabsorption, implant displacement, sterility, and cancer.

The lawsuits also allege that Medtronic illegally marketed the Infuse product "off-label". Off label marketing means that the company promoted the product for medical uses for which it was not approved by the FDA. Off label use of drugs and medical devices is permissable by medical professionals and can be beneficial to patients but a pharmaceutical drug or device manufacturer is prohibited by the FDA regulations from promoting or marketing products for uses that were not approved by the FDA.

The primary off label use of the products allegedly promoted by Medtronic was for posterior lumbar fusion surgery. Infuse was only approved by the FDA for anterior approach lumbar fusions. This means that Infuse was approved for for spine surgeries with a surgical approach through the abdomen or the front of a person rather than a surgical approach to the spine through the back. It is alleged that Medtronic paid highly respected surgeons it calls "opinion leaders" to influence surgeons to increase off label use of Infuse in posterior spine surgical procedures.

It appears that the Medtronic Infuse bone graft marketing campaign may be yet another incident of a medical device company putting its profits over people.

 

 

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