Problems with the Medtronic Infuse bone graft medical device

As Laura Miller writes for Becker’s Orthopedic, Spine & Pain Management Review, “off-label” use of the Infuse bone graft medical device has caused serious complications in patients who underwent certain types of back surgery – leading some in the industry to make charges that Medtronic has a defective product on its hands, at least when it comes to off-label use.

Off-label use is the use of a device for which it hasn’t been approved by the Food and Drug Administration.

In the case of Infuse, charges have been made against Medtronic that it pushed significant off-label use of its device, knowing that the device did not produce good outcomes when it was used in surgeries for which it was never approved.

Infuse, however, has been shown to work very well in the type of back surgery for which it had been approved by the FDA: As Miller reports, Dr. Andrew Hecht of Mount Sinai Medical Center says, “I think everyone would agree that Infuse is a very important tool for surgeons to have in a clinical setting. We are figuring out what the right dosage is and what the carriers are in each part of the spine to prevent complications.”

Source: Becker’s Orthopedic, Spine & Pain Management Review, “Where Infuse Stands: 6 Points on the Controversial Spinal Fusion Product,” by Laura Miller, 10/25/11