Lawsuit Filed Over Medtronic Infuse BMP Complications

According to a new lawsuit filed against Medtronic and a local hospital, complications from a Medtronic Infuse BMP bone graft procedure have have left a Kentucky woman permanently disabled following “off-label” use of the device for a type of spinal surgery that was never approved by the FDA as a safe or effective application. 

The complaint was filed on May 10 by Crystal Stevens in Jefferson County Circuit Court in Kentucky, alleging that Medtronic actively and illegally promoted their Infuse bone graft, which can cause uncontrolled bone growth that may damage spinal nerves.

Medtronic Infuse features an absorbable collagen sponge that is treated with a genetically engineered bone morphogenetic protein, referred to as BMP, to stimulate bone growth and fuse vertebrae when used during bone graft procedures.

For spinal surgery, the Medtronic Infuse BMP has only been approved by the FDA for use during single-level anterior lumbar fusions, where the spine is approached from the front. However, the device has been widely used “off-label” for other types of spine surgery, including cervical fusions and posterior lumbar fusion.

Off-label use of Medtronic Infuse BMP has been linked to reports of serious and potentially life-threatening complications, including inflammatory reactions, airway compression when used in the cervical spine, nerve damage and other problems.

If the Infuse BMP leaks out of the small cage it is placed in, unwanted bone growth may result.

Stevens’ lawsuit claims that she underwent spinal surgery in 2006 and the bone growth caused by the Infuse migrated out of the cage and caused her to suffer nerve damage. As a result, she now has severe pain that requires her to spend most of her time lying flat on her back and her husband’s help is needed to perform simple tasks, such as tying her shoes.

In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving reports of fatal complications caused by swelling of the neck and breathing difficulties.  A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse during a cervical spine surgery.

The U.S. Department of Justice initiated an investigation into the actions of Medtronic that same year, investigating whether the manufacturer illegally promoted and marketed the Infuse bone graft for uses that were never approved by the FDA.  While doctors are allowed to use FDA approved medical devices for non-approved purposes, the manufacturer is not allowed to promote or encourage such uses that they have not established as safe and effective.

Last year, concerns also emerged that side effects of the Medtronic Infuse bone graft may increase the risk of cancer or sterility in men.

Stevens joins a growing number of people throughout the United States who have filed a Medtronic Infuse BMP lawsuit after experiencing complications associated with unwanted bone growth. The complaints involve similar allegations that Medtronic failed to adequately research the BMP bone graft or warn doctors about the risks associated with off-label use of the product.