Serious Complications for Infuse Bone Graft Patients

 Posted on August 26, 2014 in Defective Medical Devices

The Infuse Bone Graft, manufactured by Medtronic, is one medical device that has come under fire in recent years for Medtronic's failure to appropriately warn patients of associated risks. According to Medtronic, the device consists of two parts. One part is a protein found in all human bodies. The other is the device itself—the delivery carrier. The protein found in the device is associated with bone growth and healing. Medtronic notes that the Infuse Bone Graft eliminates the need for a second bone surgery to remove a part of a bone for fusion with another. Clinical trials show that when the Infuse Bone Graft was surgically placed where bone growth was needed, it only grew bone in the site of placement, not in other parts of the body. This device is used most for spinal-repair surgery.

However, The Wall Street Journal reports that the device is linked to life-threatening complications for dozens of patients. Yet many of the complications, states The Wall Street Journal, “occurred during 'off label' uses,” when doctors were using the devices for unapproved purposes. The Food and Drug Administration (FDA) warned surgeons of risks when the device was used on the spine near the neck. “The agency said it received 38 reports over four years of side effects,” which were mostly swelling of the neck and throat tissue. This resulted in patients reporting difficulty breathing, speaking and swallowing. Some ended up requiring “tracheotomies and the insertion of feeding tubes, as well as second surgeries,” notes The Wall Street Journal.

The FDA warning regarding the Bone Grafts was specific to neck surgeries, though many spine surgeons were using the product as well. Doctors who are paid by Medtronic to use the devices are not under the same restrictions that the manufacturer is to deny promotion of implantation of the device for off-label use.

Infuse Bone Grafts were a best seller for Medtronic when the reports surfaced, and were estimated to have sales accounting for $85 million. Regardless, this was not Medtronic's first brush with faulty devices. In 2005, the manufacturer recalled defibrillators and defibrillator wires.

If you or someone you know has been affected by an Infuse Bone Graft device, the most important step is to seek the counsel of a personal injury attorney. Contact an Arlington Heights defective medical device attorney today to discuss your case.