Medtronic Infuse Bone Graft Lawsuits
Last Updated: November 2008 • 6 Comments
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Off-label use of the Medtronic Infuse Bone Graft in the cervical spine has been associated with a number of serious and life-threatening complications. The U.S. Department of Justice is investigating the actions of Medtronic, Inc. and their off-label promotion of this product in violation of federal law.
MEDTRONIC INFUSE LAWSUIT STATUS: Potential legal claims are being investigated and reviewed for individuals who experienced cervical spine fusion problems involving the device.
>>REVIEW A POTENTIAL MEDTRONIC INFUSE BONE STIMULATOR LAWSUIT WITH A LAWYER<<
MANUFACTURER: Medtronic, Inc.
OVERVIEW: The Medtronic Infuse bone graft is a man-made liquid bone graft that includes a biologically engineered protein called bone morphogenetic protein (BMP), made by Wyeth.
The bone stimulator is used to encourage bone growth and replace damaged spinal disks by filling the gaps between vertebrae. The Infuse is soaked in a sponge-like material and implanted between spinal vertebrae, enclosed in a metallic cage.
Since it was approved by the FDA in 2002, the Medtronic bone graft has been widely used during spinal fusions and has generated sales of over $3 billion.
While the Infuse bone graft is only approved for use in the lower lumber spine, it has been widely used off-label in the cervical spine which has been associated with life–threatening problems, such as:
- Difficulty Breathing
- Difficulty Swallowing
- Difficulty Speaking
- Swelling of the Neck
- Compression of Airways
- Nerve Damage
- Death
MEDTRONIC INFUSE CERVICAL SPINE FUSION SIDE EFFECTS: The close proximity of the cervical spine to the airway has caused a number of serious complications associated with use of the Medtronic Infuse bone graft in the cervical spine or neck fusions.
According to recent research presented by a group of North Carolina surgeons, the Medtronic Infuse cervical spine complication rate is about 59%, compared with a complication rate of 21% for bone grafts or collagen used in conventional cervical spine fusions.
The FDA issued a warning to healthcare providers in July 2008 highlighting at least 38 reports of cervical spine fusion problems with the bone morphogenetic protein in the Medtronic Infuse. The serious and life-threatening complications caused by airway compression have required a number of patients to receive respiratory support, tracheotomies, insertion of feeding tubes anti-inflammatory medications and additional surgery.
Most of the Medtronic Infuse bone stimulator complications have occurred within 2 to 14 days after surgery as the neck swells, compressing the airway and nerves.
JUSTICE DEPARTMENT MEDTRONIC INFUSE INVESTIGATION: On November 19, 2008, Medtronic disclosed that the Justice Department is probing their Infuse bone graft marketing and promotion to doctors and actions taken by the company that encouraged off-label use that has not been approved or determined to be safe by the FDA.
Pingback by Justice Department Probing Medtronic Infuse Bone Graft Off-Label Promotion : AboutLawsuits.com on 21 November 2008:
[...] Medtronic Infuse bone graft is a synthetic liquid spinal implant that helps bone growth. It includes a bioengineered protein [...]
Pingback by Medtronic Bone Graft Lawsuit Filed Over Neck Surgery Use : AboutLawsuits.com on 4 December 2008:
[...] California woman who went into respiratory arrest after a neck surgery that involved the use of the Medtronic Infuse bone graft. The lawsuit alleges that Medtronic is responsible for her death because they promoted the bone [...]
Pingback by Medtronic Class Action Lawsuit Filed Over Infuse Bone Graft Problems : AboutLawsuits.com on 12 December 2008:
[...] alleging that the company made false and misleading statements that failed to disclose their Infuse Bone Graft problems and the extent to which sales of the bone stimulator were dependent on “off-label” uses [...]
Pingback by Medtronic Infuse Bone Graft Death Will Be Reported to FDA Following Lawsuit : AboutLawsuits.com on 16 December 2008:
[...] The Wall Street Journal reports that Medtronic, Inc. is notifying the FDA about the August death of Shirley Nisbet, whose family filed a wrongful death lawsuit against the medical device manufacturer earlier this month alleging that fatal complications following her cervical spine fusion were caused by the Medtronic Infuse Bone Graft. [...]
Pingback by Medtronic Infuse Bone Substitute Used Off-Label 17% of Time : AboutLawsuits.com on 12 January 2009:
[...] from the Cleveland Clinic have suggested that nearly 1 in 5 surgeries in which the Medtronic Infuse bone substitute is implanted involve off-label use, for which the bone graft is not approved. Off-label use of the [...]
Pingback by Infuse Bone Replacement Graft Lawsuit Filed Against Medtronic : AboutLawsuits.com on 16 January 2009:
[...] Medtronic Infuse lawsuit has been filed as a result of complications allegedly caused by the use of Medtronic’s bone [...]