FLORIDA INJURY ATTORNEYS FIGHTING FOR THE RIGHTS OF THOSE WHO ARE SUFFERING FROM COMPLICATIONS DUE TO A MEDTRONIC INFUSE BONE GRAFT
Medtronic Infuse Bone Graft was initially approved by the FDA as an alternate choice for people wanting to avoid grafting bone from the hip. Surgeons use the product while performing their procedures in order to help the bone to grow. Ultimately, the growth of the bone replaces the previously injured section. Medtronic Infuse Bone Graft was only given approval for certain use and had never been given approval to be used in procedures to correct cervical spine injuries.
Medtronic received approval from the Food and Drug Administration in 2002. In doing so, the FDA limited the product for use on procedures involving lower back injuries to the lumbar spine, as well as for a few dental scenarios. The FDA, in particular, gave Medtronic its approval to assist with problems involving degenerative disc disease.
Through genetic engineering, Medtronic created this bone graft product which houses recombinant human Bone Morphogenetic Protein. This protein is a version of the protein that our bodies release naturally. When surgeons apply Bone Morphogenetic Protein to the spine, it helps to start growing bone in the specified regions of the spine. Surgeons are able to gain some control as to where re-growth of the bone will take place.
UNAUTHORIZED / OFF-LABEL USES FOR THE MEDTRONIC INFUSE
Though Medtronic Bone Infuse was granted approval to be used in certain surgical situations, it has been demonstrated that is can drastically cause severe problems when used for off-label purposes. There have been a multitude of accounts where Medtronic Bone Infuse was used for procedures involving upper neck injuries. When Medtronic Bone Infuse is used for cervical spine injuries the risk of dangerous outcomes increases. The main reason that using Medtronic Bone Infuse on the cervical spine creates such a problem is because the genetically manufactured protein that promotes the bone growth has shown possibilities of leaking. It has been indicated by research, that problems arising from the use of Medtronic Infuse have developed in approximately half of the patients who have been treated with the product. Issues with the use of Medtronic Infuse Bone Graft range from continuous pain in the region of surgery, all the way up to death. The reality of such a severe problem becomes even more increasingly concerning when considering the possible effects, including:
- Uncontrolled and/or excessive bone growth
- Nerve Damage
- Chronic radiating pain in the legs or arms
- Respiratory Depression / Compression of the Airway
Consequently, a seemingly “helpful” product has become a nightmare for so many people. Medtronic has been accused of promoting off-label use of its product as a stimulator to doctors; more specifically, with regards to the cervical spine. The encouragement of off-label use from Medtronic to its physicians has created mass sales, clearing the $3 billion dollar mark. To date, around 700,000 units of Infuse Bone Graft have been used in the United States.
Madalon Law understands that when you are considering whether you have a valid claim for damages, it can sometimes be overwhelming. Allow our legal team in Miami and Fort Lauderdale assist you in determining the most effective way to approach the injury you may have sustained as a result of a Medtronic Bone Infuse Graft. Contact us today, so your questions and concerns can be answered.