Medtronic Infuse

An Overview- Medtronic Infuse Complications

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.

Serious Complications

Medtronic has been accused of downplaying serious complications associated with Infuse including:

Cyst formation
Infection
Cancer
Infertility (sterility in men)
Death

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
Death

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.

Contact an Experienced Defective Medical Device Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent our clients efficiently and aggressively.

Your choice does matter. If you or a loved one has suffered serious injuries because of a defective medical device, call the Thomas J. Henry Injury Attorneys immediately. We are available 24/7, nights and weekends.

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