Infuse Bone Graft Complications Hid by Medtronic Researchers

Allegedly, Medtronic, the nation’s largest medical device manufacturer, may have hidden serious side effects of its popular bone growth product Infuse (rhBMP-2). The Spine Journal, the nation’s leading spine periodical, dedicated its entire June issue to challenging previous research on Infuse by doctors reportedly on Medtronic’s payroll. Additionally, two U.S. Senators recently demanded that Medtronic hand over all documents pertaining to possible negative complications from Infuse. The authors of the recent report called the previous research “biased and corrupted” and said that patients are seriously harmed when “special interests permeate medical research.”

15 of the researchers who took part in the studies reportedly received $62 million from Medtronic over a 10-year period.

Infuse is a bioengineered morphogenetic protein (BMP) that spurs bone growth. It is approved by the FDA for use in lower back surgeries and oral procedures, but it has also been used extensively by doctors in unapproved procedures, including neck surgeries. These uses have been reported to cause serious side effects such as trouble swallowing or breathing, increased back or leg pain, inflammatory reactions, male infertility, cancer, osteolysis, cyst formation, infection, implant dislodgement, and other life-threatening complications. Medtronic had $15.9 billion in sales and $3.1 billion in profit last year, with Infuse pulling in $900 million alone.

Infuse was approved by the Food and Drug Administration (FDA) in 2002. Despite an FDA mandate that certain perceived risks be included on the Infuse label, researchers connected with Medtronic stressed in thirteen separate publications that Infuse led to no serious complications. In fact, the recent report by The Spine Journal found that those 13 original industry-sponsored studies reported 10 to 50 times fewer complications with Infuse than were found in the original FDA summaries or other documents. Many are worried that special interests seriously influenced the previous reports, especially considering that 15 of the researchers who took part in the studies reportedly received $62 million from Medtronic over a 10-year period. Forbes has predicted that the recent reports on Infuse could lead to a significant reduction in sales, a review by the FDA and the Justice Department, emergence of Medtronic Infuse lawsuits, and maybe even the potential sale of the Memphis business.

If you or a loved one has had a surgery involving the use of Infuse and has experienced any of the aforementioned complications, you may be eligible to receive compensation for lost wages, medical bills, and pain and suffering. Contact a knowledgeable Medtronic Infuse lawyer through the free case review form on the right to find out if you have legal recourse.