Medtronic Information Center: __________________ Problems with Medtronic Infuse Bone Growth Product Medtronic Infuse and Serious Issues Medtronic Infuse - Bone Graft Lawsuit Infuse Bone Graft Medtronic Bone Graft Lawsuit Medtronic Bone Graft Death Lawsuit FDA Warning on Medtronic Off-Label Use Cancer Concerns Raised by New Study on Medtronic Infuse Bone Graft

Medtronic is the maker of a Medical Product known as Infuse. Infuse is a bioengineered material that spurs bone growth. It is often used in spinal fusion operations, a procedure in which spinal vertebrae are fused together to reduce back pain. Manufactured by Medtronic, each year over 100,000 U.S. patients undergoing spinal fusion surgery receive Infuse. 

The FDA originally approved Infuse for only one specific type of spine surgery - anterior approach lumbar fusion.

This product known as Infuse was not approved by FDA for and still is not approved for use in either lateral or posterior approach lumbar fusion surgeries and Infuse has never been approved by FDA for use in the cervical spine or neck.

Despite this fact, many patients have received Infuse in off-label uses in either the lumbar or cervical spine.  Contact our Office if the Infuse product was implanted or installed in your neck or your lateral or posterior spine.

When any drug or medical device, such as 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/or were not told of the potential risks of serious and permanent injuries related to such experimental use of this product.

In lawsuits filed against Medtronic, patients have alleged that they were injured and Medtronic failed to disclose serious and potentially life-threatening side effects with Infuse. We represented the family of a patient that received Infuse and died from complications allegedly caused by Infuse. We obtained a confidential settlement for the family.

Specific Injuries Being Investigated

• 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 Not Disclosed - 2011 Update

On June 28, 2011, The Spine Journal, a medical journal, criticized research by other experts that supported the widespread use of Infuse as “biased and corrupted research.” The articles in The Spine Journal charge that studies in support of Infuse were authored by researchers with financial ties to Medtronic and vastly understated Infuse side effects and risks by saying there were none.  

Specifically, it was reported that in none of the 13 trials involving 780 patients funded by Medtronic any adverse events from the product were disclosed. Data provided to U.S. regulators and other publications, however, showed that up to 50 percent of patients suffered side effects, including infection, pain, cyst formation and cancer, and infertility in men, the reviewers said.

Legal Rights of the Injured

The law allows for persons who have been seriously injured by a medical product to file a claim – call our Office for more information. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against medical companies for dangerous and undisclosed side effects and injuries include:

• Physical pain and suffering, mental anguish and physical impairment;
• Medical expenses, past and future; and
• Loss of earnings and/or earning capacity.

In the case of a patient's death, the family of the victim may file a wrongful death action and seek damages. 

Call our Offices day or night for more information at 1-800-862-1260.

TRADEMARK NOTICE: Sprint Fidelis is a trademark of Medtronic Corporation.

The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Medtronic Corporation. The use of this mark is solely for informational and product identification purposes.

Other Medtronic recall information:

The following model numbers of the Sprint Fidelis family of defibrillator leads have been recalled:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949

To determine if you have a recalled Sprint Fidelis lead, check your patient ID or wallet card. If in any of the rows under the column marked Model #, you see one of the following four sets of numbers, 6949, 6948, 6931, or 6930, then you have the recalled heart lead. These numbers may be shown at the beginning of a longer set of numbers and letters on your ID card.

The U.S. Food & Drug Administration (FDA) is recommending that patients who have had the Sprint Fidelis lead implanted should contact their physician immediately, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.

If you or a loved one has been injured by the Medtronic Sprint Fidelis lead, contact us immediately. You may be entitled to compensation. Call the Law offices of Carabin and Shaw, P.C. for a free consultation at 1-800-862-1260.