Medtronic Infuse Bone Graft
The Medtronic Infuse Bone Graft is a medical device used during spinal surgery to stimulate bone growth and replace damaged discs in the spine. The FDA only approved the Medtronic Infuse Bone Graft for anterior lumbar fusions. An anterior lumbar fusion requires the surgeon to make an incision through the abdomen in the front of the body. However, Medtronic marketed the Infuse Bone Graft for other procedures that were not approved by the FDA. The Infuse Bone Graft has been used by doctors for posterior lumbar fusions, where the surgeon enters from the back, and for cervical or neck fusions. These are "off-label uses" and are not approved by the FDA.
The Infuse Bone Graft contains bioengineered bone protein that is called recombinant human Bone Morphogenetic Protein (BMP) which stimulates bone growth. This material is inserted into a cage that is implanted into the spine. Unfortunately, severe complications from the Infuse Bone Graft can occur. In some situations, there is an overgrowth of bone that affects nerves or the spinal cord. Some of the adverse symptoms are:
- Uncontrolled bone growth
- Difficulty swallowing
- Difficulty breathing or speaking
- Male sterility or retrograde ejaculation
- Nerve injuries
- Spinal cord injuries
- Certain types of cancer
- Compression of the airway
- Respiratory depression
Some individuals who have received the Medtronic Infuse Bone Graft have required feeding tubes, anti-inflammatory medications, tracheotomies, and additional, corrective surgeries.
The FDA Warned Medtronic
On July 1, 2008, the FDA issued a public health notification [click here to read the warning] alerting healthcare practitioners of life-threatening complications associated with BMP when used in the cervical spine. The FDA received 38 reports of complications for patients with the Infuse Bone Graft used in the neck or cervical spine.
The Wall Street Journal has reported that Medtronic paid approximately $800,000 to a surgeon who was accused of fabricating a study that reported positive results in support of the Infuse Bone Graft. The United States Congress is beginning an investigation into the Medtronic Infuse Bone Graft. Lawsuits have been filed against Medtronic alleging injury from the Infuse Bone Graft.
At Bohrer Brady LLC, our lawyers are committed to protecting the rights and interests of people who are injured by a defective medical device. If you or someone you love has suffered an injury as a result of the Medtronic Infuse Bone Graft, contact our offices today for a free, confidential consultation.
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