Medtronic’s Infuse Bone Graft Study Falsified

Former Walter Reed Army Medical Center surgeon and Medtronic consultant Dr. Timothy Kuklo has come under fire for falsifying studies concerning Medtronic’s Infuse bone graft used in patients with broken legs.
According to the Walter Reed investigation, Kuklo forged other doctors’ signatures whom he claimed were co-authors in a study praising the effectiveness of Infuse. Kuklo has also been accused of inflating the number of patients treated with the Infuse bone graft.
This isn’t the first sign of trouble for the Infuse bone graft. In July, the FDA warned Medtronic of problems associated with off-label use of the graft. When the product was used in cervical spine surgeries, patients reported difficulty breathing, speaking and swallowing. Several patients required further surgeries including tracheotomies and the insertion of feeding tubes.
Medtronic is a leading medical device manufacturer that has run afoul of the FDA before the Infuse bone graft problems. Medtronic’s cardiac defibrillator leads have been found to be defective causing inconsistent electronic pulses to the heart.