A Missouri woman has become the latest to claim off-label use of the defective Medtronic Infuse bone growth product caused her to suffer serious and life-altering injuries.
According to a recent report, Laura Blankenship claims complications caused by the Infuse bone growth product is causing her to suffer persistent neck and back pain. She has filed a lawsuit against Medtronic Inc. in U.S. District Court for the Central District of California.
The woman claims she underwent a surgery to repair back pain and her surgeon used Infuse and the LT-Cage to promote the fusion of vertabrae in her spinal column. Infuse is not approved by the Food and Drug Administration in this indication and therefore use of it is considered off-label.
Blankenship said she was not made aware of the potential risks of complications Infuse with the LT-Cage could cause after her procedure. She now claims that her neck and back pain are worse than prior to her surgery and that Infuse has promoted excessive bone growth around the implanted LT-Cage.
Infuse is only approved in a very limited number of procedures but Medtronic has been implicated in numerous lawsuits for promoting its use for unapproved procedures. It is illegal for a medical device manufacturer to promote one of its products for off-label procedures.
A doctor or surgeon may suggest an off-label treatment but should make patients fully aware of the potential complications or side effects it could cause.