In 2002, the FDA approved Medtronic’s Infuse Bone Graft for use in the lumbar spine and for some oral and dental procedures. Medtronic’s product was also approved for treatment of degenerative disc disease and open fractures on the tibia, as well as treatment of localized alveolar ridge augmentation and in sinus augmentation. It was not, however, approved for use in cervical spine treatment.
According to Complaints, Medtronic allegedly encouraged physicians to use the Infuse product off-label in the cervical spine, subsequently boosting sales and causing a number of serious medical complications. This had led to numerous lawsuits across the country and has landed Medtronic in serious legal trouble.
If you or a loved one have received a Medtronic Infuse Bone Graft for an off-label use and have suffered illness or injury because of it, you may be eligible to file a claim.
Complications with Medtronic Infuse Bone Graft Cervical Spine Use
As noted by the FDA, most Medtronic Infuse complications begin two to fourteen days after surgery. Complications can require the need for respiratory support, insertion of feeding tubes, anti-inflammatory medications, tracheotomies and additional surgeries.
Use of the Medtronic Infuse bone growth stimulator in the cervical spine has been associated with many problems, including:
- Nerve damage
- Respiratory depression
- Compression of the airway
- Difficulty breathing, swallowing or speaking
Medtronic Infuse Bone Graft Investigation
In June 2011, the U.S. Senate Finance Committee launched an investigation of surgeons who were paid consultants for Medtronic. The Committee announced that those surgeons may have failed to report complications with the Infuse Bone Graft that were discovered during clinical trials. Swelling of the neck and throat, abnormal bone growth and sterility were among those complications.
In July 2011, a number of articles were published regarding risks associated with Medtronic’s Infuse Bone Graft. These articles include:
- Medtronic’s failure to report that many of the authors who promoted its product had financial ties to the company;
- Medtronic’s failure to disclose the side effects from its clinical trials;
- That Infuse Bone Graft can cause severe problems with nerves and the spinal cord;
- And that off-label use of Infuse Bone Graft can lead to serious side effects.
National Medtronic Lawsuit Attorneys
If you or someone you love has suffered a major medical complication because of Medtronic’s off-label use of Infuse bone graft, it is important to know that you are not alone. The litigation process will require a competent and aggressive attorney to secure your rights and get you the compensation you deserve. To learn more about filing a Medtronic lawsuit call the experienced Medtronic lawsuit lawyers at Phillips Law Firm today. Call us at 1-800-708-6000. Our national Medtronic lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation.