Medtronic® devices have been widely used off-label during spine fusion surgery, which has been associated with a high rate of serious and potentially fatal complications.
The Medtronic Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. According to the company, the device provides a scaffolding where new bone can grow. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.
Medtronic Infuse Bone Graft FDA Warning
In July 2008, the FDA warned the Infuse Bone Graft had caused serious problems when it was used off-label in cervical spine fusion surgeries. The agency said it received 38 reports over four years of side effects – mainly swelling of neck and throat tissue – which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing, and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
Most complications occurred between 2 and 14 days post-operatively with only a few events occurring prior to day 2. When airway complications occurred, medical intervention was frequently necessary. Treatments included respiratory support with intubation, anti-inflammatory medication, tracheotomy and most commonly second surgeries to drain the surgical site.
FDA Warns Against Recombinant Bone Graft Use in Patients Under 18
Jan. 21, 2015 – FDA issued a warning today stating that bone grafts containing recombinant proteins or synthetic peptides should not be used on patients under the age of 18 because their bones may still be growing and the products may cause serious injuries. Reports of excess bone growth, fluid accumulation, inhibited bone healing and swelling have been reported in children treated with bone graft substitutes. Click here to learn more.