Medtronic Infuse Bone Grafts have been implicated with causing serious side effects in people who have been treated with the device. The graft is used in surgery as an alternative to using a patient’s own bone, usually resulting in less surgery and improved recovery time. Infuse Bone Graft was initially approved by the FDA for certain procedures involving the lower back and some dental procedures. Unfortunately for consumers, it appears that Medtronic may have promoted unapproved “off-label” uses of their product that can result in serious injury to patients, some of which may be life threatening.
What is Infuse Bone Graft?
The Medtronic Infuse Bone graft is a new type of bone graft device that uses a naturally occurring protein as well as a carrier to deliver the protein. The protein used is an engineered version of human bone morphogenetic protein-2 (rhBMP-2) that the body produces naturally to help regulate the how bones grow and heal. The natural carrier is made from bovine collagen that both releases the protein over time and provides a framework onto which the new bone grows, ultimately being replaced by the bone.
Infuse Bone Graft Side Effects
Although the Medtronic Infuse Bone Graft was only approved by the FDA for a few specific uses, Medtronic and its representatives allegedly encouraged off-label use to treat other, non-approved conditions. When used for these off-label uses, Infuse Bone Graft has been linked to serious complications, some of which may require additional surgery. Some of the side effects associated with Infuse Bone Graft include:
- Abnormal or excessive bone growth
- Failure of the bones to fuse
- Difficulty breathing
- Tissue damage
- Allergic reaction to the implant
- Pain and discomfort
- Damage to the spine or nerves
- Sexual dysfunction
- Retrograde ejaculation
- Inflammatory reaction
Medtronic Infuse Bone Graft Lawsuits
Due to the fact that Medtronic allegedly failed to disclose the potential risks of its Infuse Bone Graft to the medical community and patients, people who have been developed complications may be entitled to significant compensation. A person who has been injured by a bone graft procedure could potentially recover for medical expenses, pain and suffering, lost wages, loss of consortium, or other damages. The law firm of Makarem & Associates is currently evaluating potential cases to determine whether people could have a claim for injuries caused by Infuse Bone Graft.
Contact Makarem & Associates For a Consultation
Makarem & Associates is a civil litigation law firm committed to representing the injured. Working together with The Lanier Law Firm, we provide individualized representation to each client and are committed to obtaining the best possible result in each case we handle. Ron Makarem is a seasoned product liability attorney, who recently achieved a $1.5 million settlement for a prominent Olympic athlete injured in a product liability case. To schedule a free initial consultation, contact us today at (310) 312-0299 or via email at [email protected].