Infuse Bone Graft consists of two parts: a protein – rhBMP-2 (recombinant human bone morphogenetic protein-2), a genetically engineered version of a protein that regulates bone growth and healing, and a carrier. The carrier is a sponge manufactured from bovine (cow) Type 1 collagen. It releases the protein over time where it is placed, provides a scaffold (framework) for new bone to grow into, and is absorbed and replaced by bone.
There have been a number of cases where patients suffered serious injury or death after receiving Medtronic Infuse.
Infuse Bone Graft eliminates the need for a second surgery to surgically remove (“harvest”) bone from your body for placement at the surgery site. Infuse Bone Graft is surgically placed where new bone growth is needed. It attracts your body’s own bone-building cells to the site and over time, new bone is formed.
Medtronic Infuse is approved by the FDA for the treatment of degenerative disc disease in the lower (lumbar) region of the back and open fractures of the tibia, and it is also approved for use in two dental bone grafting procedures. However, Medtronic Infuse is not approved for use in the part of the spine that supports the neck (cervical surgery), where it may cause unwanted bone growth and inflammation that could prove injurious or even fatal to the patient.
The FDA has received hundreds of Adverse Event Reports concerning patient injury or death after use of Medtronic Infuse, and up to 75% of these reports specifically refer to off-label (unapproved by the FDA) use of Infuse in cervical surgery. Infuse complications that result after cervical surgery are especially dangerous because this part of the spine is in such close proximity to airway structures.
According to the FDA warning, the long list of potential injuries that may occur after use of Medtronic Infuse in neck surgery include:
- Unintended, uncontrolled, or ectopic bone growth
- Inflammatory cysts
- Compression of the airway
- Inflammation in the neck
- Retrograde ejaculation
- Damage to nerves
- Respiratory difficulties
- Difficulty swallowing
- Speech difficulties
The FDA issued a formal warning about off-label use of Medtronic Infuse in cervical surgery in 2008, and again in 2011.
It is not illegal for physicians to use medical products for off-label purposes. It is, however, illegal to advertise off-label use of medical products. There is undisputed evidence that Medtronic exercised gross negligence in promoting Infuse for off-label cervical procedures. Moreover, it is now public knowledge that Medtronic paid a surgeon $800,000 to lie about study results related to off-label use of Infuse, and that they willfully downplayed the risk of serious injury or death when Infuse is used in this capacity.
In fact, the rate of complication for off-label cervical surgery with Infuse reported by the FDA is significantly higher than the rate disclosed by Medtronic and Medtronic-sponsored doctors in published studies. Many patients who have undergone cervical surgery with Infuse were not told that this use of the product was not approved by the FDA, nor were they made explicitly aware of the risks associated with off-label use of Infuse.
As a result of Medtronic’s negligence, patients who suffered injury, or family members who lost a loved one after cervical surgery with Infuse, are eligible to collect compensation for their damages.
Can I file a lawsuit if I have have been injured by Medtronic Infuse?
Possibly. If a manufacturer produces a dangerous or defective product, it can be held responsible to those who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has been harmed by Medtronic Infuse, you should contact your doctor immediately. You may also wish to contact an experienced Medtronic Infuse lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.