Medtronic Bone Growth Agent Linked to Neck Surgery Problems

A new study seems to indicate that the bone growth agent in the Medtronic Infuse bone graft may be linked to life-threatening problems after neck surgery, where it may cause swelling that makes it difficult to breath.

The study, conducted by researchers at Brigham and Women’s Hospital, was published June 30 in The Journal of the American Medical Association, and found that Infuse and other products that use a bioengineered bone growth protein called BMP appear to result in a higher incidence of neck surgery problems when they are used during cervical spinal fusion procedures to correct neck pains.

The study looked at both Infuse, and a Stryker product called OP-1 Putty, which is used in a very limited number of patients where other spinal fusion methods are not an option.

The bone growth proteins were first approved in 2002 for use during lower back fusions. However, some doctors also use the bone graft to treat upper spinal pain, which the study data indicates can lead to an increased risk of complications. In 2006, the two products were used in 25 percent of all spinal fusion surgeries, with Infuse accounting for most of the BMP use.

Use of BMP has become popular because it allows bone to heal faster after surgery. It also tends to require less repeat surgeries, and doctors do not have to harvest the bone from other parts of the body, such as the hip.

The study found that patients who received bioengineered proteins in upper spinal fusion procedures suffered a complication rate of 7 percent; 50 percent higher than those who did not. When used on lower spinal, or lumbar, fusion procedures, there was no increase in complications, however.

Researchers say the rate of complication is probably higher, because the study only looked at patients who suffered complications while still in the hospital recovering from surgery. Many patients likely had complications after they left the hospital that went unreported.

The FDA issued an alert last year advising doctors not use infuse in upper spinal fusion procedures after receiving 38 reports of potentially fatal complications that included swelling of the neck and breathing difficulties. An FDA advisory panel recommended the FDA not approve OP-1 Putty for wider use in late March.

A number of Medtronic Infuse lawsuits have ben filed on behalf of individuals who experienced problems with breathing and swallowing that developed days or weeks following their neck surgery. This can lead to an emergency tracheotomy or death.

In November 2008, the U.S. Department of Justice initiated an investigation into the actions of Medtronic, Inc., and whether they actively promoted and marketed the Infuse bone graft for use in the cervical spine. 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.