Medtronic Infuse Bone Graft Problems Lead to Drop In Sales: Report

Amid mounting lawsuits and problems with the Medtronic Infuse BMP, the medical device manufacturer has reported a drop in sales for the once promising bone grafting product.

Medtronic saw a 26% drop in second-quarter earnings overall, and a five percent decline in its spinal division, which the company attributed to recent issues surrounding the Infuse bone morphogenetic protein (BMP), which is an alternative to traditional spinal fusion procedures, where bone is harvested from a different part of the body or from cadavers.

The company’s earnings also got hit by a $235 million litigation charge following a patent lawsuit loss to Edwards Lifesciences Corp linked to heart valves.

Financial experts point to a Senate Finance Committee report in October, which revealed that Medtronic had unseemly and questionable influence over a number of studies that purported to show few side effects linked to Infuse. However, in some cases, Medtronic officials appear to have edited out damaging information before the reports were published, and in other instances the scientists involved were paid consultants of Medtronic who were told to downplay negative data.

Later independent studies revealed a number of serious side effects and complications with Medtronic Infuse BMP use, including a risk of inflammatory reactions, nerve damage and other problems caused by excessive bone growth around the spine.

Lawsuits and Concerns Over Medtronic Infuse BMP

Medtronic Infuse was introduced in 2002, and has been aggressively promoted by the manufacturer.

Although the FDA only approved the Medtronic Infuse for limited spinal procedures in adults, involving a single-level anterior lumbar interbody fusion (ALIF), where the spine is approached from the front, the Medtronic Infuse has been widely used “off-label” for other types of spine fusion surgery.

In 2008, the FDA issued an alert about the risks associated with such unapproved uses of Medtronic Infuse, after receiving a number of reports involving serious complications and deaths, often involving use in the cervical spine where the bone growth problems may impact the airway.

Off-label use of Medtronic Infuse BMP has been linked to an increased risk of severe and painful complications caused by ectopic bone growth around the spine. 

In recent months, a growing number of individuals throughout the United States have filed a Medtronic Infuse lawsuit alleging the manufacturer failed to adequately warn about the risk of problems with the bone graft device. Complaints also allege the company illegally promoted Infuse for uses not approved by the FDA.

Medtronic has allegedly promoted the use of Infuse by providing false and misleading statements and paying “opinion leaders” to encourage uses beyond what was approved by the FDA.  As a result, some estimates suggest that as much as 85% of all sales for Medtronic Infuse were for such off-label uses.