Medtronic’s Infuse bone graft device has been used for a number of off-label uses, many of which has caused irreversible damage to patients. Some of them have even contracted cancer from the device.
However, the FDA has approved three new uses for the device, but only if the devices are made out of plastic, not titanium. Medtronic presented enough evidence to the FDA to prove to them that these formerly off-label uses are safe.
Infuse was originally designed for spinal fusion surgery. They contain a synthetic human protein that causes bones to grow after surgery. The biological component was placed inside a titanium cage inside of the vertebrae. This would cause the bone to grow around the implant. Now Medtronic can market devices that use PEEK instead of titanium. PEEK is a common medical device plastic.
Using the plastic device, surgeons can use the new devices on two of five bones in the lower back using approaches from the front or the sides of the body. Infuse cannot be used for spine surgeries that approach from the back, and the FDA says it may cause life-threatening complications if used in the neck.
Medtronic has been fighting over 6,000 actual and threatened lawsuits over the device. Around 3,900 cases were settled according to securities filings. The device has also been taken off the market in Europe.
If you’ve been implanted with a Medtronic Infuse device, you may be eligible for compensation. John Foy is an experienced Medtronic Infuse liability lawyer. For more information about how you can receive compensation, you must call him at the number on this page.