Medtronic® Infuse Bone Graft
Potentially serious, life-threatening complications when used in the upper/cervical spine
The MedtronicInfuse Bone Graft is a genetically engineered product containing a protein that emulates a naturally occurring bone-building protein. Approved in 2002 to treat various spinal injuries and degenerative conditions in the lower back and in 2010 for the lumbar spine, the infusion is designed to strengthen and grow bone.
The product has not been approved for use in the upper spine and cervical areas. Patients who received the MedtronicInfuse Bone Graft in these areas in some cases to treat neck pain, may experience serious and life-threatening complications.
Some of the side effects from use of the product in the upper and cervical spine being reported to the FDA are:
- swelling/edema in the neck and throat
- breathing problems
- trouble speaking
Other potential complications could be:
- infection and bone or tissue degeneration
- cysts and abcesses
- bone or other cancer
While the product is reported to have helped many patients relieve pain and regain function particularly in the approved use in the lower spine, there is mounting concern that the side effects of of use in the upper and cervical spine may cause these serious complications. In an unusual and significant statement on the severity of these complications, The Spine Journal, a publication of the North American Spine Society dedicated the entire June issue of their publication on the MedtronicNASS press release.Infuse Bone Graft controversies. See a summary of the issues addressed in this
An investigation of whether researchers withheld important safety data information and if Medtronicdid not adequately warn doctors and patients of the serious and potentially fatal complications is ongoing. If you or someone you know has had complications after undergoing a Medtronic infuse bone graft in the upper or cervical spine, you have legal options including the possibility of compensation.
Early warning about the product
As early as 2008, the FDA issued "Public Heath Notification: Life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion. The findings of alleged withholding of safety data, payments to doctors, and adequate failure to warn is what could require the manufacturer to provide compensation for injured patients.
Attorneys who are investigating the MedtronicInfuse Bone Graft product include:
Stephen A. Sheller, Esq.
Jamie L. Sheller, Esq.
Brian J. McCormick, Esq.
Claudine Q. Homolash, Esq.
and others at Sheller, P.C.
North American Spine Society, June 28, 2011: The Spine Journal calls for end to "Years of Living Dangerously" in promotion of bone growth factors
Forbes, June 28 2011: Medical journal slams Medtronic over payments to doctors