The Spine Journal recently reported that complication rates were 10 to 50 times greater than previously reported by doctors who received millions of dollars from Medtronic for downplaying what they knew were serious side effects from Medtronic’s Infuse.
The Infuse bone graft was developed by Medtronic and approved by the Federal Drug Administration (FDA) in 2002 for use in some surgical procedures. Also known as BMP-2, Infuse contains recombinant human Bone Morphogenetic Protein (rhBMP), a genetically engineered version of a natural protein which stimulates bone growth. Surgeons can implant the Infuse bone graft instead of harvesting a bone graft from the patient’s hip or using a cadaver bone.
In 2002 the FDA approved the Infuse Bone Graft for treatment of degenerative disc disease, open fractures on the tibia, sinus augmentation, and some dental procedures. The FDA approval for the use of Infuse in spinal surgery was limited to only anterior approach lumbar fusion surgeries (those done from the front of the body); they did not approve it for lateral or posterior approach lumbar fusion surgeries or for cervical spine surgeries.
The FDA regulates drug and medical device approval, but doctors are free to use them for “off-label” purposes which they deem to be medically appropriate. Medtronic is alleged to have encouraged the off-label use of Infuse in cervical spine surgeries in order to generate additional sales. In July 2008, the FDA issued a warning concerning off-label Medtronic Infuse Bone Graft use, pointing out that there are risks associated with the use of the bone graft on the cervical spine, and specifically stating that “these products are not approved by FDA for this use.”
Estimates are that more than 100,000 spinal fusions are done each year in the United States which utilize bone grafts. Medtronic is the leading supplier of such devices, with 44 percent of the market and sales at one time topping $700 million. For fiscal year 2013, Medtronic reported that sales of BMP-2 had dropped to $468 million.
Several factors have influenced the recent history of Medtronic and Infuse, including a review published in 2011 by the Spine Journal reporting that complication rates from the use of Infuse were 10 to 50 times greater than previously reported by doctors who received millions of dollars from Medtronic for downplaying what they knew were serious side effects.
The U.S. Senate Finance Committee also launched an investigation into reports that doctors with financial ties to Medtronic were aware of serious complications with the product yet failed to reveal them in medical journal articles. Their findings were released in October 2012, namely that there were “questionable ties between the medical technology company and the physician consultants tasked with testing and reviewing Medtronic products” and that they “inaccurately represented InFuse’s risks.”
What are the risks and side effects associated with the use of Infuse?
- Uncontrolled bone formation and the need for additional surgery
- Life-threatening inflammation
- Implant movement
- Cancer risk
- Radiating leg pain
- Bladder retention
- Uro-genital complications that cause sterility in men.
When used off-label for cervical spine surgeries, the Medtronic Infuse bone growth stimulator in the cervical spine has been associated with many other serious problems:
- Difficulty breathing, swallowing or speaking
- Compression of the airway
- Need for respiratory support
- Nerve damage
- Tracheotomies and other additional surgeries
- Insertion of feeding tubes
- Severe neck swelling resulting in death or permanent injury.
Infuse has not been recalled. However, many lawsuits have been filed across the country by patients injured by the product. In August of 2013, one plaintiff received a ruling that although she cannot sue Medtronic simply because doctors used Infuse as an off-label treatment, her claims of injury may proceed because Medtronic actually aggressively promoted the off-label use.
Situations in which Infuse has been used off-label include:
- Cervical spine (neck) surgeries
- Lumbar fusion surgeries done using posterior approach (from the back)
- Lumbar fusion surgeries done using lateral approach (from the side)
- Fusion of more than two vertebrae
- Fusion of vertebrae outside of the L1-S1 range
- Application through methods other than the approved sponge and cage.
If you or someone you love has been injured by an Infuse bone graft, you have a right to seek compensation from the manufacturer. Such damages may include past and future medical expenses, past and future lost earnings and loss of earning capacity, other out-of-pocket expenses, and damages for pain and suffering.
For a free review of your circumstances and to discuss your questions, please contact us online or call: 1-888-348-6787