Lawsuits are being filed against Medtronic related to the improper use of their Infuse Bone Graft. The lawsuits allege that the Medtronic Infuse Bone Graft was being promoted and used for reasons not approved by the FDA, resulting in life-threating medical complications for the victims. If you or a loved one has undergone a surgery where a Medtronic Infuse Bone Graft was used, our legal team is standing by to help determine if you are entitled to reimbursement for your medical complications. Call us today for a FREE LEGAL CONSULTATION at 855-55-BAD-DRUG.
What is the Medtronic Infuse Bone Graft?
In its most basic sense, bone grafting is a surgical procedure where missing bone is replaced in order to allow the human body to repair itself. The space caused from a bone fracture or other gap may require a ‘filler’ to bridge the gap and allow the bone to regenerate or heal completely. Often this ‘filler’ is simply bone fragments taken (grafted) from elsewhere in the patients own body and placed into the gap to act as a bridge or scaffold. Human bones will then use this scaffold and regenerate the bone, absorbing the tiny fragments placed in the gap and healing completely.
In certain procedures, such as lumbar and cervical spinal fusion surgeries (a.k.a disc replacement surgeries), a large amount of material may be needed in order to fill a large space created between vertebrae/bone. Any bone graft is a painful procedure because it requires going into a non injured part of the body and scrapping bone away for use in the area of the gap. The more bone that is needed to fill the gap requires a more intensive and painful graft from another part of the healthy body. If a safe synthetic (fake) material could be designed for use in place of real bone to fill these spaces, the pain associated with grafting would be eliminated.
A new medical device industry has appeared that is making a large profit selling substitute materials for use in these exact situations. The Medtronic Infuse Bone Graft is one such synthetic substitute marketed as an alternative to the grafting of healthy bone in certain procedures. The Medtronic Infuse Bone Graft is an absorbable collagen sponge used during surgery to help initiate bone growth. The sponge contains a genetically engineered recombinant human bone morphogenetic protein (rhBMP) that helps surgeons try to control where the bone growth will occur. While this sounds like an amazing alternative, patients are reporting life-threating complications as a result of the products use. Investigations have also begun into the fraudulent sales practices by Medtronic and the intentional concealment of known dangerous side effects.
Has The FDA Approved The Medtronic Infuse Bone Graft?
In 2002, the United States Food and Drug Administration (FDA) approved the Medtronic Infuse Bone Graft for use in the lower back and only with ALIF surgery. The FDA approval resulted in an estimated one hundred thousand spinal fusions per year that used the device, resulting in sales of $900,000,000 in 2011 alone for Medtronic.
Despite the restricted approval by the FDA, Medtronic lawsuits allege that the company promoted and encouraged the products use in thoracic fusion, cervical fusion, posterior lumbar visions and other multi-level fusion procedures. These unapproved uses are commonly referred to as “off-label” uses. The Infuse Bone Graft lawsuits allege that Medtronic encouraged doctors to perform off-label uses which resulted in more than 3 billion dollars of sales for Medtronic.
Complications From Medtronic Infuse Bone Graft
The life-threating complications associated with the unapproved use of the Medtronic Infuse Bone Graft in the cervical spine are typically reported between 2 and 14 days after surgery. These complications may include:
- Inflammatory Reactions
- Implant Displacement / Failure
- Nerve Damage
- Male Sterility
- Degeneration of Bone Tissue (Osteolysis)
- Back and Leg Pain
- Respiratory Depression Requiring Respiratory Support
- Compression and Restriction of the Airway
- Difficulty Breathing, Speaking or Swallowing Requiring Feeding Tubes
- Unwanted Bone in the Spinal Canal
- The Need for Additional Surgeries such as Tracheotomies
FDA Warnings For Medtronic Infuse Bone Graft
After receiving hundreds of negative reports associated with the Infuse Bone Grafts, many of which required a second surgery to correct, the FDA issued a Public Health Notification to medical providers regarding the complications associated with the product’s unapproved use in cervical spinal fusions.
In June of 2011, an investigation was announced by the US Senate Finance Committee that targeted surgeons who were paid by Medtronic and failed to report complications associated with the Infuse Bone Graft. In July of 2011, The Spine Journal published its findings regarding the Medtronic Infuse Bone Graft risks, which included:
- A failure by the company to truthfully report its clinical trial side effects;
- A failure by the company to disclose financial conflicts of interest from authors and researches;
- A failure by Medtronic to disclose the severe side effects of off-label use of the product, including the severe problems to nerves and spinal cords.
Medtronic was so blatant in their deception that they had Dr. Scott Boden, M.D., tell an FDA advisory committee that FDA should not bother focusing their discussion on the off-label use of Medtronic Infuse Bone Graft. At the time this was done, Dr. Boden was allegedly receiving more than $100,000 a year from Medtronic. It truly goes to show that these companies can purchase whatever opinion they desire from the highest levels of the medical community.
Medtronic Lawsuits and Lawyers for Infuse Bone Graft
As the lawsuits continue to pile up against Medtronic by victims of the improper use of the Infuse Bone Graft, former employees have also filed suit alleging the company improperly paid medical professionals to use the product in unapproved procedures. Medtronic is also facing wrongful death lawsuits by family members of those allegedly killed through the unapproved use of the Infuse Bone Graft. Victims have also alleged that the complications from the Medtronic Infuse Bone Graft has resulted in a lifetime of disability.
If you or a loved one has been the victim of complications from the Medtronic Infuse Bone Graft after a cervical fusion or disc replacement surgery, contact a lawyer for Infuse Bone Graft immediately to discuss your case. Time limits apply which may prevent you from receiving reimbursement for your harms and losses caused by the unapproved use of the Medtronic Infuse Bone Graft. We can be reached for a FREE CONSULTATIONS by calling 855-55-BAD-DRUG, 24 hours a day, 7 days a week. There is NO FEE UNLESS WE WIN YOUR CASE.