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 surgery 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 include but are not limited to back and leg pain, cyst formation, disc space collapse, infection, retrograde ejaculation, implant displacement, and malignancy.
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.
Furthermore, OrthoSpineNews is reporting that, “Medtronic says Infuse has been implanted in more than 500,000 patients by more than 2,300 surgeons. Its sales amount to several hundred million dollars a year.”
If you or a loved one has been implanted with Infuse and has experienced complications please fill out a contact form or call the Branch Law Firm to speak with an attorney or one of our knowledgeable support staff to help you.