Multiple lawsuits have been filed against Medtronic Inc. over its Infuse Bone Graft device. Medtronic Inc. is the one of nation’s largest medical technology and service companies.

The Infuse Bone Graft lawsuits claim that Medtronic violated consumer protections laws, and failed to warn the general public and medical community of certain complications associated with using the medical device. Complications associated with Medtronic Infuse Bone Grafts include difficulty breathing, chronic pain, excessive bone growth, nerve damage, male sterility, and death.

The lawsuits also claim that Medtronic aggressively marketed the Infuse Bone Graft for off-label (non-FDA approved) uses.

In 2008, the FDA released a public health notification warning the public that the Infuse Bone Graft hormone rhBMP could result in the swelling of the neck and throat tissue. The warning stated that in some patients the swelling resulted in the compression of patients’ airways or neurological structures.

According to the report, these complications generally occurred two to 14 days after the operation that inserted the Infuse Bone Graft. The swelling side effects around airways often required medical intervention such as intubation, tracheotomy, and anti-inflammatory medication.

Excessive bone growth is another serious complication associated with using Medtronic Infuse Bone Grafts. The Infuse Bone Graft is a medical device that helps patients bodies grow bone.

The device works by creating a delivery system for the protein rhBMP-2, a natural bone growth hormone found in everyone’s body. It is thought that excessive bone growth occurs when small amounts of the growth protein seeps into unintended parts of the body. Symptoms of excessive bone growth include pain, paralysis, leg cramps and spasms.

Another study was recently published by Stanford University linking Medtronic Infuse Bone Grafts to retrograde ejaculation, a condition known to cause sterility in men. Retrograde ejaculation occurs when semen enters the bladder instead of traveling through the penis during orgasm.

According to the study, men who used the Infuse Bone Graft for their anterior lumbar fusion were more likely to develop retrograde ejaculation at a much higher rate. For many of the men the sterility was permanent.

Infuse Bone Graft lawsuits have been filed in both state and federal courts across the nation. Plaintiffs in these lawsuits are generally patients who have suffered from complications like those listed above or by family members who have lost loved ones due to Infuse Bone Graft complications.