The number of spinal fusions has increased 1,500 percent among Medicare patients between 2002 and 2007. According to a report by HealthWorks Collective, this spike is mostly due to a product called Medtronic Infuse. Infuse uses a genetically engineered protein in an effort to stimulate bone growth in the spine. Although the product was marketed as an innovative way to perform spinal fusion surgeries, several research studies suggest that Infuse can cause more pain than it’s worth. Given what we know about Infuse, experts question whether or not these findings will impact Medicare’s coverage of the product.
When Infuse first gained clearance in 2002, it was only approved for anterior lumbar fusions, which are performed through the front of the body. However, surgeons soon began using Infuse in other types of fusions and in the cervical (neck) spine as well. These uses are not approved by the FDA, and are deemed “off-label”. Peer-reviewed studies about the off-label use of Infuse were part of the driving force behind its apparent success, HealthWorks Collective notes. In fact, some 85 percent of Infuse procedures are off-label.
In 2008, the FDA warned that using Infuse off-label in the cervical spine could lead to deadly complications, such as:
- Swelling of neck and throat tissue, resulting in compression of the airway and/or neurological structures in the neck
- Difficulty swallowing, breathing or speaking
- Nerve damage
- Severe dysphagia
Medtronic has been entangled in scandal over Infuse in the past few years. The issue truly came to light in June 2011, when a group of scientists questioned the validity of the off-label Infuse studies. The experts pointed out that the studies were funded by Medtronic and the authors listed had been paid millions in royalties by the company. Thepublication also found that the Medtronic studies failed to mention several side effects linked to Infuse, such as male sterility, increased back and leg pain, infections and cancer.
In response to growing suspicions, Medtronic asked Yale researchers to independently review the data. These reviews, which were published recently in the Annals of Internal Medicine, found that it was not better than a traditional bone graft harvested from a patient’s own hip. Additionally, these researchers found that Infuse could pose many risks. Infuse has been associated with
· Retrograde ejaculation
- Extraneous bone growth.
Medtronic has also been investigated by the Senate Finance Committee, who reported late last year that a number of Medtronic employees had helped write and edit the positive Infuse studies. This so-called “ghostwriting” is considered unethical because it inserts a bias into studies that are used to make decisions about patients’ health.