In 2002 the Federal Drug Administration (FDA) approved the marketing and sale of Medtronic Infuse. Infuse is also referred to as bone morphogenetic protein-2 (rhBMP-2) and was used in spinal surgeries to grow bone and help fuse vertebrae.
In an early clinical trial it was found that 70% of the subjects developed unwanted bone growth. The bone overgrowth causes painful impingement on nerve roots and a second surgery is needed to correct the problem.
More recently, The Spine Journal reports that, “…investigations shows actual patient risk is 10-50 times more than reported in original industry sponsored studies.” Adverse events includes but are not limited to abnormal bone growth, severe pain, burning sensation, severe numbness and tingling, cyst formation, neck swelling, respiratory problems, cyst formation, and cancer.
Medtronic is now the subject of a U.S. Senate panel probe that will investigate reports that doctors with financial ties to the medical device company were aware of serious complications with a lucrative spine surgery product yet failed to reveal those problems in medical journal articles.
If you or a loved one has been implanted with Infuse and have experienced complications, please fill out a contact form or call Funk & Associates and a knowledgeable attorney will be glad to advise you of your rights.
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