While advancements in medical technology have allowed doctors today to piece human bones back together using synthetic proteins, this new technology comes at a risk. According to the U.S. Food and Drug Administration (FDA), the use of human Bone Morphogenetic Protein (rhBMP) when implanted in the cervical spine can lead to life-threatening complications.
One such product that has been recalled by the FDA is the InFUSE bone graft system. These devices have been used to treat more than 500,000 patients. InFUSE works by stabilizing the space between bones in the spine and neck while new tissue grows to fill in the space. Some of these patients were implanted with the devices even though they did not suffer from a condition treated with the product is approved for. This is called off-label use.
The company that manufactures InFUSE bone graft systems was recently ordered to pay a settlement of $85 million for illegally marketing the product for off-label procedures. The lawsuit claimed that the manufacturer marketed the off-label uses to doctors. The investor group claims that when the illegal marketing practices came to light, those stocks crashed and they lost money.
Nearly 40 complaints have been filed with the FDA in connection to problems with the InFUSE bone graft system. The Connecticut Defective Product Lawyers with Carter Mario Law Firm would suggest discussing these dangers with your doctor carefully before undergoing a procedure using these products.