Medtronic Bone Infuse Graft
Medtronic Infuse Bone Graft was originally approved by the FDA for use in lower back surgery and some dental bone procedures. However, the device has been used for treatment in the neck area which has resulted in serious and potentially fatal side effects for many of the unfortunate people subjected to this unapproved process.
Serious and potentially fatal side effects
The side effects of Medtronic infuse bone graft are serious and can range from neck swelling to more severe injuries such as male infertility as documented in a study published by Stanford University surgeon Dr. Carragee. No matter what injuries you have experienced, you may be eligible for a free case review.
FDA has received at least 280 reports of serious complications
Many of the adverse event reports submitted to the FDA were for off label uses. Subsequently, the U.S. Justice Department began investigating Medtronic for the illegal advertisement of the Medtronic Infuse Bone Graft.
Almost 2 of every 3 uses were off-label
The National Center for Biotechnology Information, which is part of the US Government’s National Institutes of Health reported that nearly 2 out of every 3 uses of the Medtronic Infuse Bone Graft were off label uses such as fusing the bones in the upper part of the back and neck. These off-label uses resulted in numerous bodily injuries.
Some common injuries include:
- Difficulty breathing
- Difficulty speaking
- Ectopic/uncontrolled bone growth near or at surgery site
- Chronic pain in arms or legs
- Retrograde ejaculation or ur-genital injury
- Nerve injury causing pain
- Acute/severe neck swelling more than 3 days post surgery
- Other permanent injury