Medtronic, Manufacturer Of Infuse, Failed To Disclose Serious Side Effects
January 3rd, 2012
Medtronic, manufacturer of Infuse, failed to disclose serious and potentially life-threatening side effects. Infuse is often used in spinal fusion operations in which spinal vertebrae are fused together to reduce back pain; it is a bioengineered material that spurs bone growth. It as reported that in none of the 13 trials funded by Medtronic were any adverse events disclosed. It has been reported that up to 50 percent of patients who received Infuse suffered side effects including infection, pain, cyst formation and cancer.
The U.S. Food and Drug Administration approved Infuse for only anterior approach lumbar fusion surgery. Many patients have received Infuse in off-label uses in either the lumbar or cervical spine. The FDA has not authorized Infuse in either lateral or posterior approach lumbar fusion surgeries or for use in the cervical spine.
The patient must be informed of off-label or experimental use of a drug or medical devise by a physician prior to surgery and full disclosure of the risk. Many patients who received off-label use of Infuse in their spine were not informed. Specific side effects reported from the off-label use of Infuse:
- Ectopic bone growth or uncontrolled bone growth in the spinal canal
- Ongoing or chronic radiating pain in the legs or arms called radiculopathy or radiculitis
- Sterility, retrograde ejaculation, or other urogenital injuries in male patients
- In cervical spine surgeries: acute neck swelling several days after surgery resulting in death or permanent injury
- Nerve injuries causing chronic pain
If you are a family member were seriously injured after receiving Infuse, Please fill out the Contact Us section below for a confidential case evaluation.
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