The recent investigations conducted by the
Recent reports have exposed the world’s largest medical device company, Medtronic, of falsifying reports that should have proclaimed the fatal side effects associated with their $800 million dollar a year product. The device is called the Medtronic inFUSE Bone Graft and is used as a “safer” alternative to the typical bone graft. The device itself is a metal cage with a collagen sponge inside that has a liquid bioengineered Bone Morphogenic Protein (BMP) applied to it. The cage is placed in the spine between the vertebrae to help support U.S. Senate finance committee have caused quite the eruption in the medical world.
the spine while the BMP genetically produces new bone. The benefit of Medtronic inFUSE Bone Graft versus typical bone grafts is that instead of having two surgeries, one to extract bone graft from somewhere else in the body (typically the hip), and then place it into the needed spot, the Medtronic inFUSE only requires one surgical procedure and thus eliminates the danger associated with having to have two surgeries.
In 2002, the product was approved by the FDA for an anterior approach to spine fusion, lower back , and when used as approved, the results have been highly effective. Where the problem begins with the Medtronic device, and what Medtronic paid over $200 million to cover-up, is when the device is used in areas other than the FDA approved lower back. The “off-label” use of the device has led to serious side effects, with some even being life-threatening.
The side effects that have resulted from off-label use are uncontrolled bone growth, ectopic bone growth, inflammatory cyst formation, difficulty speaking, difficulty swallowing, male sterility, cancer, and finally, paralysis. As you can see, these are not just minor complications like a rash or hair loss, these are life-changing problems that are the result of Medtronic ignoring their duty to warn in their pursuit of greater profits. The most common misuse of the device is in the neck, where the device is not meant to be placed and as aforementioned, has been shown to grow uncontrollably or abnormally where it then restricts one’s ability to breath and talk, and in some cases, walk.
The FDA caught wind of the deadly side effects linked to the off-label use of the product, and in 2008, issued a warning against such use citing thirty-eight accounts where the Medtronic device was used in places other than the lower back and the results were fatal. That number, however, is only a small portion of the actual ineffectiveness of the product. Other reports contain as many as 280 testimonies of patients who have received the product and experienced adverse effects, with over 75 percent of those due to off-label use.
Off-label use of drug and medical devices is not uncommon, with reportedly one in five prescriptions in the US falling under this category, but it is the obligation of the company to report any discoveries that might adversely affect the alternative use of the product. Such reports were never given by Medtronic, and instead Medtronic paid doctors and analyst to forge fake reports that actually endorsed the off-label use of it.
If you received this form of treatment and are experiencing any of these side effects, then you are entitled to a claim that will compensate you for the injustice unrightfully weighed upon you. An inFUSE Bone graft expert attorney can make sure that this compensation is obtained and that Medtronic pays for their greediness. Even if you have not experienced these side effects, but have received treatment involving the device, then retain such an attorney anyway so that you can become proactive in your case versus reactive.