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Medtronic® Infuse Bone Graft

Potentially serious, life-threatening complications when used in the upper/cervical spine

The Medtronic® Infuse 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 Medtronic® Infuse Bone Graft in these areas in some cases to treat neck pain, may experience serious and life-threatening complications.

An investigation is ongoing of:

whether the pre-approval manufacturer researchers withheld important safety data information

if Medtronic® did not adequately warn doctors and patients of the serious and potentially fatal complications, and

if doctors received payment for authoring articles that omitted or downplayed important product safety information, including reports of alleged payment to one doctor of at least $10 million (Forbes)

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
infertility/sterility
bone or other cancer
disability
death

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. As there may be a time limit to file a claim, contact our firm immediately by calling 800-883-2299 or filling out the inquiry form on this page

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 Medtronic® Infuse Bone Graft controversies. See a summary of the issues addressed in this NASS press release.

An investigation of whether researchers withheld important safety data information and if Medtronic® did 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.

While the product has not been recalled, there is a potential class action; do not delay contacting our firm for more details as there may be a time limit to file your claim. Call 800-883-229 or submit the inquiry form on this page

Attorneys who are investigating the Medtronic® Infuse 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.

Related information:

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

Click here to read full attorney disclaimers

Related Media

Use of the Medtronic® Infuse Bone Graft in the upper and cervical spine may cause serious complications.

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