Doctors and patients need to be aware of a substance used to promote bone growth during spine-repair surgery. Made by Medtronic Inc. “Infuse Bone Graft” has led to complications, largely during the “Off-label” use of the liquid.
The FDA has reportedly received 38 adverse health reports over four years concerning side effects. The Infuse Bone Graft is put in a metallic cage containing a spongy material that is placed between the spinal vertebrae. When the drug is used in surgeries on the cervical spine around the neck, it can lead to swelling of the neck and throat tissue.
For patients that means compression in the airway and someone could have difficulty swallowing, breathing and even speaking.
For some patients the symptoms are so bad that a tracheotomomy has had to be performed to allow the patient to breath. For its part, Medtronic says the rate of complications is low and reports to the FDA of problems are few.
The procedure to repair the spine is not uncommon. Every year, an estimated 500,000 undergo spinal-fusion to repair and stabilize damaged discs. Also used to treat conditions such as scoliosis, which is a curvature of the spine, the infuse bone graft has become a best seller for Medtronic, averaging about $815 million in the year that ended in April.
Remember Medtronic is the same company that had to issue a recall of some of its defibrillators because they were prone to depleted battery power. This is a problem for someone who has undergone heart surgery – you’d like there to be few surgeries and for the pacemakers and defibrillators to last many years.
Medtronic also had to recall a line of defibrillator wires which were known to deliver multiple shocks and in some cases death. The company had to settle more than 2,600 lawsuits concerning battery depletion for about $114 million.
A wise consumer must ask their doctor about their financial relationship with Medtronic. Many who are on the receiving end have written favorably about the off-label use of Infuse on web sites.
Conflicts-of-interest are common and justified within the industry. Doctors are paid for giving seminars, for consulting, for educational meetings – and the end result is often that they push the product.
Congress will soon insist that major drug companies disclose these relationships in the name of “transparency” and many have agreed to begin databases, beginning next year to disclose what they pay and to whom. But it pays to ask now. #
