KCR partner Brooks Cutter has been accepting numerous cases involving patients who were injured by a Medtronic bone graft device known as INFUSE® BMP-2. These patients report that they were not informed about serious and potentially life-threatening complications that could arise when the Medtronic INFUSE® bone graft device is used in spine surgeries.
INFUSE® rhBMP-2 is a "bone morphogenetic protein,” a genetically engineered version of a human protein designed to promote bone growth. 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).
INFUSE® was approved by the U.S. Food and Drug Administration (FDA) in 2002 for anterior approach lumbar fusion, which is one specific type of spine surgery. INFUSE® has not been approved for use in other types of spine surgery, including lateral or posterior approach lumbar fusion surgeries, or cervical spine surgeries (neck surgery).
Patients must consent to the use of a medical device and be informed of all of its risks prior to performing the surgery. If the patient is not informed of the risks and then suffers complications related to the device, the patient can sue the manufacturer for damages related to use of the medical device.
Risks of Injury from Spinal Fusion Surgery Using INFUSE ®
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
INFUSE® Related to Cervical Spine Problems and Neck Surgery Complications
INFUSE® has not been approved by the FDA for use in cervical spinal fusion surgeries. Many neck surgeries using INFUSE ® have had devastating results. In some cases where Medtronic Infuse was implanted in the cervical spine area, the result was severe neck swelling that resulted in permanent injury or death.
Medtronic Lawsuits: Proven Results
KCR attorneys have successfully litigated product liability cases against large pharmaceutical companies, including Medtronic, Inc., one of the world’s largest medical
device manufacturers. Brooks Cutter was appointed by the Federal Court to the Plaintiff's Steering Committee in the Medtronic Sprint Fidelis product liability case, which settled for over $220 million.
Additionally, Brooks Cutter
recently participated in the successful resolution of government fraud claims
brought against Medtronic, Inc, for $23.5 million.
Read more lawsuit results
Contact an experienced product liability attorney
If you or a loved one has undergone spinal fusion surgery using Medtronic INFUSE® BMP-2 and have
experienced problems, contact Brooks Cutter for a free and confidential case evaluation by calling 888-285-3333 or filling out the contact form on this page.