What is Infuse Bone Graft?
Medtronic Inc. manufactures the Infuse Bone Graft, a medical device that is used to fuse vertebrae after spinal surgery. The device consists of an absorbable sponge made from cow collagen that is soaked in a genetically-engineered bone-growth protein (rhBMP-2). It is marketed as an alternative to traditional bone grafting techniques, which involve harvesting bone from other areas of a patient’s body (usually the hip) or cadavers.
What is the problem?
The Infuse Bone Graft controversy erupted in June 2011, when The Spine Journal devoted an entire issue to report that researches who were paid millions of dollars in royalties and “consulting fees” produced studies showing that Infuse was superior to traditional bone grafts. Over the course of a decade, Medtronic secretly wrote or co-authored at least 13 studies for medical journals that systematically failed to reveal serious complications. Doctors received a median of at least $12-16 million per study — and in each study, the conflicts of interest were never reported.
Medtronic Infuse Lawsuits
Soon afterward, the Justice Department launched an investigation and Medtronic was hit with a number of class actions and individual lawsuits. Many Infuse Bone Graft lawsuits have been filed by individuals who are seeking compensation for their pain and suffering, medical expenses, disability, lost income, and more.
In October 2012, the U.S. Senate Finance Committee concluded a year-long investigation, finding that Medtronic paid 13 physicians about $210 million, and the company was “heavily involved in drafting, editing, and shaping the content of medical journal articles authored by the physician consultants.”
FDA Warning for Infuse Bone Graft
The U.S. Food and Drug Administration (FDA) approved the Medtronic Infuse Bone Graft in 2002 for spinal fusion surgery in the lumbar spine (lower-back) in adults with Degenerative Disc Disease. However, within a few years, more than 80% of its use was “off-label” — for uses that were never evaluated or approved by the FDA.
Unfortunately, there is a significantly increased risk of side effects when Infuse is used “off-label” for cervical spine surgeries, lateral approach, or posterior approach spinal procedures. For example, when Infuse is used in spinal surgeries on the lower back performed from the front of the body (anterior), up to 25% of male patients will have a complication called retrograde ejaculation.
In 2008, the FDA published a Safety Communication for life-threatening complications that can occur when Infuse is used in cervical spine fusion in a patient’s neck. The FDA received at least 38 reports involving swelling of neck and throat tissue, which resulted in compression of the airway and/or nerves in the neck. Some patients had problems breathing, swallowing, or speaking. Most complications occurred between 2-14 days post-operatively.
Medtronic Infuse Bone Graft Side Effects
- Chronic pain
- Excessive bone growth
- Nerve damage
- Swelling in the neck
- Retrograde ejaculation
- Inflammatory reactions
- Radiating leg pain
- Male sterility
- And more
Do I have an Infuse Bone Graft Class Action Lawsuit?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Infuse Bone Graft lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Infuse Bone Graft Lawsuit Evaluation: Again, if you or a loved one was injured by the Infuse Bone Graft, you should contact our law firm immediately. You may be entitled to compensation by joining an Infuse Bone Graft class action lawsuit or by filing an Infuse Bone Graft lawsuit, and we can help.