MEDTRONIC Infuse Bone Graft
Medtronic Infuse Bone Graft may cause 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.
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 800-883-2299 or submit the inquiry form on this page.
- January 2015: The FDA recommends against routine use of these products in patients under age 18 because their safety and effectiveness has not been reviewed or approved for use in this population.
- An investigation is ongoing about 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)
WHAT ARE THE FDA WARNINGS?
The FDA recommends against routine use of these products in patients under age 18 because their safety and effectiveness has not been reviewed or approved for use in this population. The FDA considers bone graft substitutes containing recombinant proteins or synthetic peptides high-risk (Class III) medical devices. Reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling, have increased the FDA’s concern. FDA Safety Communication
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 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.
WHAT ARE THE SIDE EFFECTS THAT MAY LEAD TO SERIOUS 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 asbcesses
- bone or other cancer
LINKS & RESOURCES
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
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 LIMITED TIME TO FILE A CLAIM, CONTACT OUR FIRM IMMEDIATELY BY CALLING 800-883-2299 OR BY FILLING OUT A CONFIDENTIAL FORM BELOW.