The Medtronic Infuse Bone Graft was approved by the FDA for use in lower spine repair surgeries. The Infuse Bone Graft was used to help promote bone growth. Allegedly, the manufacturer of this medical product did not warn or inform medical professionals or patients that use of the Medtronic Infuse Bone Graft in unapproved medical procedures such as cervical spine surgeries could lead to serious potential medical problems. As of September of 2008, about 680,000 units of Infuse Bone Grafts had been used in the United States, according to Medtronic.
Patients that have used the Infuse Bone Graft in unapproved or off-label medical procedures may be at risk for complications. The FDA notes that most Medtronic Infuse complications occurred between two and 14 days following surgery. Reportedly, complications from the Medtronic Infuse Bone Graft have included:
- Respiratory Depression
- Erectile Dysfunction
- Uncontrolled Bone Growth
- Severe Inflammatory Reaction
- Impaired Mobility
In July 2008, the FDA issued a warning concerning off-label Medtronic Infuse Bone Graft use, stating that risks were associated with the use of the bone graft on the cervical spine. The agency’s warning stated,” that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”
If you or a loved one has suffered from any of these Medtronic Infuse Bone Graft complications after undergoing a procedure such as cervical spine surgery or other procedure for which use of the Medtronic Infuse Bone Graft was not approved, you may be entitled to compensation. For a free case evaluation please contact the Law Offices of Michael A. DeMayo, L.L.P.