A new study links the bone growth agent in the Medtronic Infuse Bone Graft to life-threatening problems after neck surgery, where it may cause swelling that makes it difficult to breath. This can lead to an emergency tracheotomy or death.
The U.S. Department of Justice is investigating the actions of Medtronic, Inc. and their off-label promotion of this product in violation of federal law.
While the Infuse Bone Graft is only approved for use in the lower lumbar spine, it has been widely used off-label in the cervical spine which has been associated with life–threatening problems, such as:
- Difficulty Breathing
- Difficulty Swallowing
- Difficulty Speaking
- Swelling of the Neck
- Compression of Airways
- Nerve Damage
- Death
The close proximity of the cervical spine to the airway has caused a number of serious complications associated with use of the Medtronic Infuse bone graft in the cervical spine or neck fusions.
The FDA issued a warning to healthcare providers in July 2008 highlighting at least 38 reports of cervical spine fusion problems with the bone morphogenetic protein in the Medtronic Infuse. The serious and life-threatening complications caused by airway compression have required a number of patients to receive respiratory support, tracheotomies, insertion of feeding tubes anti-inflammatory medications and additional surgery.
A number of Medtronic Infuse lawsuits have been filed on behalf of individuals who experienced problems with breathing and swallowing that developed days or weeks following their neck surgery.
In November 2008, the U.S. Department of Justice initiated an investigation into the actions of Medtronic, Inc., and whether they actively promoted and marketed the Medtronic Infuse bone graft for use in the cervical spine. While doctors are allowed to use FDA approved medical devices for non-approved purposes, the manufacturer is not allowed to promote or encourage such uses that they have not established as safe and effective.
The Medtronic Infuse bone graft is a man-made liquid bone graft that includes a biologically engineered protein called bone morphogenetic protein (BMP), made by Wyeth.
The bone stimulator is used to encourage bone growth and replace damaged spinal disks by filling the gaps between vertebrae. The Infuse is soaked in a sponge-like material and implanted between spinal vertebrae, enclosed in a metallic cage.
Since it was approved by the FDA in 2002, the Medtronic bone graft has been widely used during spinal fusions and has generated sales of over $3 billion.
Most of the Medtronic Infuse bone stimulator complications have occurred within 2 to 14 days after surgery as the neck swells, compressing the airway and nerves.
According to research previously presented by a group of North Carolina surgeons, the Medtronic Infuse cervical spine complication rate is about 59%, compared with a complication rate of 21% for bone grafts or collagen used in conventional cervical spine fusions.
The new study, conducted by researchers at Brigham and Women’s Hospital, was published June 30 in The The Journal of the American Medical Association and found that Medtronic Infuse and other products use a bioengineered bone growth protein called BMP that appears to be the cause of the higher incidence of neck surgery problems when they are used during cervical spinal fusion procedures to correct neck pains.
The study looked at both Medtronic Infuse, and a Stryker product called OP-1 Putty, which is used in a very limited number of patients where other spinal fusion methods are not an option.
Use of BMP has become popular because it allows bone to heal faster after surgery. It also tends to require less repeat surgeries, and doctors do not have to harvest the bone from other parts of the body, such as the hip.
The study found that patients who received bioengineered proteins in upper spinal fusion procedures suffered a complication rate of 7 percent; 50 percent higher than those who did not. When used on lower spinal, or lumbar, fusion procedures, there was no increase in complications, however.
Researchers say the rate of complication is probably higher, because the study only looked at patients who suffered complications while still in the hospital recovering from surgery. Many patients likely had complications after they left the hospital that went unreported.
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