Severe Complications Reported with Medtronic Infuse
Serious and life-threatening complications have been reported with Medtronic’s Infuse bone graft product. The FDA has been investigating Medtronic for failing to warn doctors and patients of these serious risks. In addition, off-label use of the bone graft on the upper portion of the neck can cause respiration problems so serious that patients are at risk of dying.
UPDATE: MEDTRONIC WROTE AND MANIPULATED JOURNAL ARTICLES FAVORING ITS PRODUCT
In late October 2012, a U.S. Senate investigation revealed that Medtronic employees were involved in writing journal articles that favored its bone graft products. In addition, Medtronic paid $210 million to doctors who wrote favorable journal studies about Infuse back surgery products. Medtronic employees collaborated with doctors on 11 papers published from 2002 to 2009.
Medtronic’s actions violate the trust patients have in their medical care … Patients are at risk when companies distort facts the way Medtronic has,” Senator Max Baucus (D-Mont), in a Senate press release about the findings.
In 2002, the Food and Drug Administration (FDA) approved Medtronic’s bone graft product, “Infuse,” for the treatment of degenerative disc disease in the lower spine. The medical device consists of a metallic cage surrounding a bone graft substitute (rhBMP) that stimulates bone growth to create a fusion between two vertebrae.
FDA WARNING AND FEDERAL INVESTIGATION
By 2008, the FDA had received 38 reports of complications associated with off-label uses of the device by doctors. By 2011, the company was under federal investigation for failing to inform doctors and patients of serious risks associated with the medical device and for illegally promoting it for off-label uses.
Medtronic has been accused of downplaying serious complications associated with Infuse including:
- Cyst formation
- Infertility (sterility in men)
DANGEROUS OFF-LABEL USES
The FDA approved Medtronic’s Infuse for use in lower spine fusion surgeries; yet, a number of surgeons reportedly used the device in cervical spine fusion surgeries. In July 2008, the FDA issued a warning stating that the presence of the bone graft substitute (rhBMP) in the cervical portion of the spine (near the neck) can cause serious complications including:
- Difficulty breathing, swallowing, or speaking
- Compression of the airway
- Respiratory depression
- Nerve damage
INFUSE LAWSUITS FILED
- 2008– A wrongful death lawsuit was filed against Medtronic on behalf of a woman who went into respiratory arrest after a neck surgery that involved the use of the Medtronic Infuse bone graft.
- 2011– A woman filed suit again Medtronic after being implanted with Infuse during a posterior-approach lumbar spine. The unapproved placement of the device led to the development of an ectopic bone growth in her spine, which compressed her nerves and led to chronic and ongoing severe pain.