Medtronic Infuse Bone Graft
The Infuse Bone Graft, manufactured by Medtronic, Inc. was originally approved for the use in lumbar spine procedures, however in recently filed whistleblower and separate individual injury lawsuits the company has been accused of marketing the product for use in the cervical spine (neck) procedures, which is an “off-label” use and not approved by the FDA.
When the Infuse Bone Graft is used in an off-label procedure, it has the potential to cause life threatening injuries, complications and/or deaths.
What You Can Do & How We Can Help
The Schmidt Firm, LLP is currently accepting Medtronic Infuse Bone Graft claims in all 50 states. If you or somebody you know has experienced complications after a procedure in which the Medtronic Infuse Bone Graft product was used, you should contact our law firm immediately for a free case evaluation. Please click here to contact our Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What’s the problem?
The U.S. Food & Drug Administration (FDA) has issued safety warnings, The U.S. Department of Justice (DOJ) has begun a criminal investigation and most recently, Medtronic admitted to paying a surgeon nearly $800,000 who is accused of falsifying the results of a study … all regarding the Medtronic Infuse Bone Graft product.
The Infuse Bone Graft has only been approved by the FDA for use in lower spine-repair surgery to promote bone growth, however Medtronic has been accused of promoting the “off-label” use(s) of the Infuse product to healthcare providers. In three whistleblower lawsuits seeking damages on behalf of the U.S. Government, former Medtronic employees alleged illegal marketing by the company, including inducements paid to doctors to use Infuse and other Medtronic spine products.
Healthcare providers are allowed to use FDA approved drugs, devices and products in an off-label manner when they see fit, however the promotion and/or marketing of off-label use by the manufacturer is illegal.
What is the Infuse Bone Graft?
Infuse is a man-made liquid form of bone morphogenetic protein, or BMP. It is implanted between vertebrae soaked in a sponge-like substance enclosed in a metallic cage. Ideally, BMP causes bone growth that fills in the gap between vertebrae to replace damaged disks.
Off-Label Use & Promotion
The Wall Street Journal reported that “a number of patients say they have been harmed in off-label uses of Infuse, which is approved by the FDA only for a small section of the spine in the lower, lumbar region. At least 280 reports of side effects involving Infuse have been made to the FDA. About three-quarters of those reports involve off-label use. In July, the agency issued a safety alert about complications from the off-label use of Infuse in the neck, or cervical, area of the spine.”
Symptoms of Medtronic Infuse Bone Graft Complications
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:
- swelling of the neck
- difficulty swallowing, breathing and speaking
- Compression of the Airway
- Respiratory Depression
- Nerve damage
- Death
Several patients that were recipients of the Medtronic Infuse Bone Graft in off-label procedures required emergency treatment, including tracheotomies and the insertion of feeding tubes.
Do I Have a Medtronic Infuse Bone Graft Lawsuit?
Again, if you or somebody you know has experienced complications after a procedure in which the Medtronic Infuse Bone Graft product was used, you should contact our law firm immediately for a free case evaluation. Please click here to contact our Medical Device Litigation Group, use the form below or call toll free 24 hours a day at (866) 920-0753.
Free Case Evaluation
