Medtronic Is In The News Again
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This time patients and doctors need to be aware of a substance used to promote bone growth during spine-repair surgery. “Infuse Bone Graft” has led to complications, largely during the “Off-label” use of the drug, according to the Wall Street Journal.
The FDA has reportedly received 38 adverse health reports over four years. 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 some patients have had difficulty swallowing, breathing, and even speaking.
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 running out of battery power. Medtronic also had to recall a line of defibrillator wires which delivered multiple shocks and in some cases death. The company had to settle more than 2,600 lawsuits concerning battery depletion for about $114 million.
The company is also known for paying doctors for "consulting" and seminars. Conflicts-of-interest are common and justified within the industry.
Many drug companies have adopted a new "transparency" attitude to disclosing these relationships - but until you can go to an online database and see which doctor has received what - ask your practitioner if he or she is on the receiving end.
You don't want to find out after the fact.