Patients Need To Be Aware of Medtronic Infuse Use In The Neck
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Medtronic is facing more trouble over its Infuse Bone Graft.
A Texas woman is reportedly preparing a lawsuit blaming off-label use of Infuse for injuries she suffered after cervical spine surgery. Mary Selke claims that bone formed in her neck and it made it difficult for her to breathe and swallow resulting in more surgery, this time of an emergency nature.
Her physician will also reportedly provide testimony that Medtronic promoted use of the product off-label directly to physicians.
Each year, an estimated half million people undergo spinal surgery to repair and stabilize the spine after experiencing damaged discs or to remedy the condition of scoliosis.
“Infuse Bone Graft” is a biologically engineered liquid that is used to promote bone growth in spine-repair surgery. It’s become a best seller for Medtronic Inc. of Minneapolis, estimated to have brought in $815 million in the fiscal year that ended April 2008, according to the Wall Street Journal.
Infuse is not approved to be used in the neck, but doctors are free to use a medical device off-label at their own discretion.
The family of Shirley Nisbet sued after the California woman died in August 2008. Nisbet had spinal-fusion surgery using Infuse in her neck. After her surgery, the suit says, Ms. Nisbet went into respiratory arrest and a coma and was kept alive by artificial means until she died. That off-label use is being investigated by the U.S. Department of Justice.
Medtronic is supposed to report adverse events to the agency, but a spokesman for the Kaiser Hospital in California, where Ms. Nisbet had her surgery, said it did not report the death to Medtronic because it didn’t consider the product to be the cause of death.
The Minneapolis Firefighters’ Relief Association also filed a class-action shareholder lawsuit against Medtronic in December alleging that the company kept secret that most of its revenue came from off-label use of Infuse and that the device as causing complications.
Litigation may be the only way we get a true picture of the damage done by aggressive marketing to physicians of the off-label use of Infuse.
Meanwhile, it is up to patients to be aware of the serious complications that follow Medtronic’s Infuse, used off-label, in spine surgery in the neck. #