INFUSE® rhBMP-2 is a “bone morphogenetic protein,” a genetically engineered version of a human protein designed to promote bone growth, created by one of the largest medical device companies in the world, Medtronic, Inc. When combined with an absorbable collagen sponge and placed inside a small LT-CAGE® fusion device, the bone graft is implanted into the spine, eliminating the need for an additional surgery to harvest pieces of bone from the patient’s hip (autograft).
Every year, INFUSE® is used in over 100,000 U.S. spinal fusion surgeries. It is often implanted in types of surgery that have not been approved by the FDA. Additionally, many of the patients who received INFUSE® through unapproved uses were not informed that it was used in an off-label manner or that it carried a risk for serious complications.
Many patients who have received INFUSE® in have reported the following complications:
radiculopathy or radiculitis: persistent radiating pain in the legs or arms
ectopic bone growth: excessive growth of bone in the spinal canal
nerve injuries that cause chronic pain
in male patients: sterility, retrograde ejaculation, or other urogenital injuries
neck swelling after cervical spine surgery