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The most common side effect seen in the off-label use of Infuse® Bone Graft is swelling and constriction of the airway and troubles swallowing. The off-label use that increases these complications is surgery of the cervical spine. These symptoms are most likely to develop two to fourteen days after the procedure is done. While patients can be treated by medical professionals, there are instances when a severe second procedure or surgery is necessary. This could include a tracheotomy or inserting a tube down the throat to allow proper breathing or feeding.
The risk of airway constriction, trouble breathing and/or speaking is higher when an off-label procedure is performed. The potential risks listed on the Food and Drug Administration label for Infuse® Bone Graft are for approved surgeries. However, doctors and surgeons have performed thousands of off-label procedures using the product. It is estimated that 85% of the procedures that utilize Infuse® Bone Graft are off-label. The most common off-label procedure conducted by doctors is surgery of the cervical spine, which is the neck. Most patients undergoing an off-label procedure such as cervical spine surgery are usually unaware of the potential side effects.
In July 2008, the Food and Drug Administration released a warning to surgeons and the general public regarding the use of Infuse® Bone Graft in cervical spine procedures. They had received 38 reports of complications over a four year time period. These studies showed patient data that had to seek emergency medical attention because of restriction of the airway and neurological complications in the throat area. The FDA has also advised medical practitioners to exercise other options other than Infuse® Bone Graft when performing cervical spine surgery.
If any of the following symptoms appear in a patient that has had cervical spine surgery with Infuse® Bone Graft, seek immediate medical attention: neck and/or tongue swelling, trouble speaking, swelling of the neck or chest area, trouble swallowing or trouble breathing. It is critical not to delay if any of these symptoms arise, especially two to 14 days post-surgery. This postoperative time period is when these complications are mostly likely to occur.
If you or someone you know suffered painful injuries after being implanted with a Medtronic Infuse Bone Graft device, you may have valuable legal rights. We’re here to answer any questions you may have. For a free case review, please fill out our online form or call our office at 727-397-9198.