The Medtronic InFuse Bone-Graft is a medical device that is used to help stimulate bone growth in patients who have spinal fusion surgery. Although it is only approved for use in the lower spine, it is frequently used “off-label” in other areas. Unfortunately, when it is used “off-label” in the neck, it can cause life-threatening swelling. Experts have also raised concerns about “off-label” use of Infuse in children.
UPDATE: Studies Find Infuse Is Not Better than Bone Grafts
June 19, 2013 — Medtronic has paid $2.5 million to produce two studies conducted by independent researchers. Both studies have found that Infuse is no better than traditional bone graft surgeries, but may have higher risks (such as cancer). Click here to read more.
October 15, 2012 — Researchers have found that 9.2% of spinal surgeries in children use the Medtronic Infuse or other BMP product from Medtronic. However, the FDA has never approved these products for use in children. Medtronic has never conducted studies to evaluate the safety or effectiveness of these products in children. Researchers are calling on surgeons to stop using the products in children until more studies are conducted. Click here to read more.
What’s the problem?
Medtronic is now facing numerous Off-Label lawsuits, brought against the company for promoting uses of their product that were not approved by the FDA. This is called “off-label” use, and though doctors are legally protected for using products in this way, manufacturers of the products are not legally allowed to promote their products for uses that are not FDA-approved.
The “off-label” use of Medtronic Infuse Bone Graft appears to be quite common. Of the 200 adverse events reported to the FDA, more than 75% of these were for off-label uses — particularly in neck surgeries. Over four years, the FDA received 38 reports of swelling in the neck tissue that constricted a person’s airway. These patients required emergency tracheotomies, feeding tubes, and additional surgery. Some of these people are now filing Medtronic Infuse off label lawsuits.
How does the Medtronic Infuse Bone Graft work?
The Food and Drug Administration has approved the Medtronic Infuse Bone Graft for use in people who have Disk Degenerative Disease, fractures of the tibia, and certain types of dental bone grafting procedures.
Infuse works by creating a “scaffolding” to promote a patient’s own bone growth to heal injuries or degeneration. It contains a type of protein that is naturally found in the body (called “rhBMP-2”). This is placed on a sponge made from cow collagen. Over time, the sponge releases the protein, which promoted bone growth.
The product is not approved for use in the neck, or in any other part of the body. These are considered “off-label” uses. A person who receives the graft in another part of the body may suffer serious injury.
Congressional Investigation, Medtronic Infuse Off-Label Lawsuits, and Suppressed Safety Research
In November 2008, the U.S. Department of Justice began an investigation to discover whether Metronic broke the law in engaging in off-label promotion of the Infuse product.
In addition, there was criticism of the company for suppressing safety information. A clinical trial that Medtronic conducted to determine the safety of the product had to be suddenly halted because volunteers suffered from uncontrolled bone growth. Even so, the company did not announce the results of this study for five years. The company was also criticized for paying the surgeons conducting the study millions of dollars. Some volunteers who suffered uncontrolled bone growth have needed additional surgery to fix the bones. During those five years, the company continued to promote the Infuse Bone Graft as a safe and effective.