A report declared Medtronic’s Infuse Bone Graft partially responsible for a patient’s life-threatening vascular injury which occurred during spinal surgery.

According to the 2013 report by a neurosurgeon published by the National Institutes for Health, the Infuse Bone Graft contributed to fibrosis (the formation of excess fibrous connective tissue) and scarring which caused the patient’s iliac vein to adhere to an area of the patient’s spine.

The report advises spinal surgeons to add inflammatory fibrosis to the list of reported complications to be aware of when dealing with Infuse Bone Grafts.

Infuse Bone Graft is a medical device used to aid bone re-growth, particularly in the spine. The device uses RhBMP-2, a synthetic protein to promote the re-growth of bone. Every year, over 100,000 patients undergoing spinal fusion surgery receive an Infuse Bone Graft.

Infuse Bone Graft side effects include difficulty breathing, speaking, and swallowing, excessive bone growth, nerve damage, chronic pain, male sterility, other urogenital injuries, and death.

FDA Warns Against Off-label Uses

Infuse Bone Graft is manufactured by Medtronic Inc., the nation’s largest medical device manufacturer. In 2002, the U.S. Food and Drug Administration (FDA) approved Medtronic’s Infuse Bone Graft for anterior approach lumbar fusions, which are performed through the front of the body.

Over the years Infuse Bone Graft has been approved for two other forms of dental surgery. Although some doctors use the device for off-label purposes chances of complications greatly increase with off-label use.

Off-label use refers to any use not approved by the FDA. While it is not illegal for doctors to use medical devices for off-label purposes, it is illegal for device manufacturers to market or promote a device for any off-label use.

Regardless, patients should be informed if they are undergoing an off-label procedure. The FDA has issued a warning that using Infuse Bone Graft for off-label uses may lead to life threatening complications.

Controversy arose in June 2011 when a group of spine experts published a study in Spine Journal, denouncing research funded by Medtronic.

The researchers claimed that the studies funded by Medtronic failed to accurately report on the side effects associated with Infuse Bone Grafts. According to the researchers, complications actually occurred in 10 percent to 50 percent of the patients who received the Infuse Bone Graft during trials conducted between 2000 and 2010. These percentages varied from what was initially reported in the Medtronic-funded reports.

The review also pointed fingers at the financial relationship between Medtronic and the original doctors involved in the studies. In a separate investigation the government declared that the studies performed were biased. The government noted employees of Medtronic assisted in writing and editing 11 of the 13 original trial reports. While this is not illegal it is highly frowned upon in the scientific community.

Medtronic Infuse Bone Graft Lawsuits

Thousands of Infuse Bone Graft lawsuits have been brought against Medtronic within the last few years. Along with patients, investors in Medtronic are also suing the company.

The investors claim that by manipulating the data from the initial studies, Medtronic was involved in a scheme to defraud its investors.

Many of the Infuse Bone Graft lawsuits brought by patients against the company include claims for intentional concealment of dangerous side effects. Infuse Bone Graft lawsuits may help many patients recover compensation for the serious side effects they experienced from using an Infuse Bone Graft device.