What is the Medtronic Fuse?
Unlike the typical bone graft used to replace or repair bone breaks or fractures, Medtronic bone grafts are meant to stimulate bone growth by delivering a growth stimulating protein to the bone site. The human Bone Morphogenetic Protein is a genetically engineered version of a naturally-occurring protein initiating bone growth inside the body. This design theoretically permits surgeons to control where bone re-growth occurs.
How Can Medtronic Fuse Harm You?
In July 2008, the FDA issued a warning for off-label Medtronic Infuse Bone Graft use, stating “the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”
Specifically, have been reports of cervical spine grafts resulting in difficulty swallowing, breathing and speaking caused by “compression of the airway and/or neurological structures in the neck.” These patients have required tracheotomies, anti-inflammatory medications, feeding tubes and second surgeries.
How Can We Help?
Attorneys at the Madeksho Law Firm, PLLC will shoulder the burden of taking on the medical device and product industry on behalf of our clients just like it has taken on corporate wrongdoers for over 40 years. There is no reason to hesitate invoking your right to a medical device made safe by adequate warning, adequate research or adequate design. If a medical device carries risks; at least the manufacturer should be honest about it and share whatever those risks are. Call us today and we will explain your legal rights and how we can help. If you choose Madeksho Law Firm, PLLC for legal advice, we will do our duty to keep you informed and protected in a professional, compassionate manner.