Lieff Cabraser Heimann & Bernstein, LLP

Medtronic Infuse (BMP-2) Bone Graft and Infuse Lawsuits March 2012 Update 

Infuse is the trade name for bone morphogenetic protein or BMP-2, which promots bone growth. The BMP-2 is placed inside a small cage and then implanted in the patient.

Manufactured by Medtronic, the nation’s largest maker of medical devices, over 100,000 U.S. patients in the U.S. annually undergoing spinal fusion surgery receive Infuse. Many of these patients received Infuse in either the lumbar or cervical spine, areas of the spine where Infuse has not been approved for surgery.

Infuse Approved for Limited Back Surgery

The U.S. Food and Drug Administration approved Infuse in 2002 for one specific type of spine surgery - anterior approach lumbar fusion.

The FDA did not approve the use of Infuse in either lateral or posterior approach lumbar fusion surgeries. Nor has the FDA approved Infuse for use in the cervical spine (the portion of the spine that runs from the shoulders to the head).

Infuse Side Effects and Infuse Bone Graft Injuries

When any medical device, including Infuse, is used by a physician in an off-label use, the patient must be informed of this off-label or experimental use, and the risks of such use must be fully disclosed to the patient prior to the surgery, so that the patient may make an informed decision as to whether or not he or she wishes to consent to the off-label use.

Many patients who have received off-label use of Infuse in their spine were not informed of the off-label nature of the surgery, and were not told of the risk of serious complications linked to Infuse.

The reported side effects from the off-label use of Infuse include:

• ongoing or chronic radiating pain in the legs or arms (i.e., radiculopathy or radiculitis);
• sterility, retrograde ejaculation, or other urogenital injuries in male patients;
• ectopic bone growth or uncontrolled bone growth in the spinal canal;
• nerve injuries causing chronic pain; and
• in cervical spine surgeries: acute severe neck swelling several days after surgery resulting in death or permanent injury.

Serious Infuse Side Effects Allegedly Not Disclosed

The Spine Journal, an international medical journal, last year criticized research by other experts that supported the widespread use of Infuse as “biased and corrupted research.”

The Journal reported that in none of 13 studies funded by Medtronic were any Infuse adverse events disclosed. Data provided to U.S. regulators and other publications, however, showed that up to 50 percent of the patients who received Infuse may have suffered side effects, including infection, pain, cyst formation, and infertility in men, the reviewers said. 

Medtronic Infuse Lawsuit | Infuse Lawyer | Infuse Attorney

Updated March 6, 2012: Patients represented by Lieff Cabraser  allege in Infuse lawsuits that Medtronic failed to disclose serious and potentially life-threatening complications from Infuse when used in off-label surgeries.

Please also read our Answers to Frequently Asked Questions for Infuse patients and on Infuse Medtronic Lawsuits.

In an earlier Infuse litigation, we represented the family of a patient that received Infuse BMP-2 and died from complications allegedly caused by Infuse. We obtained a confidential settlement for the family.

Contact Lieff Cabraser

Lieff Cabraser represents patients nationwide seriously injured after receiving the Medtronic Infuse bone device. Please click here to contact an attorney at Lieff Cabraser for a free case evaluation. Or call us toll-free at 1-800-541-7358 and ask to speak to Medtronic Infuse injury attorney Kent L. Klaudt.

Our Medtronic Infuse lawyers handle all patient inquiries with the strictest confidentiality and sensitivity. There is no charge or obligation for our review of your claim.

Trademark Notice

Infuse is the registered trademark of Medtronic, Inc. The use of this trademark is solely for product identification purposes.  Lieff Cabraser is in no way affliated with Medtronic.