Medtronic’s Infuse bone graft, a cutting edge treatment designed to help patients re-grow bone in the spine, has resulted in the medical device maker being sued in more than 1,000 Infuse bone graft lawsuits. These Infuse lawsuits similarly accuse the medical device company of intentionally concealing dangerous Infuse bone graft side effects, including: cancer, male sterility and other uro-genital injuries, nerve damage, excessive bone growth, chronic pain, and difficulty breathing, swallowing, and speaking.

The Infuse bone graft received limited U.S. Food and Drug Administration (FDA) approval in 2002 as a bone graft treatment in lower spine fusion surgery. The Infuse bone graft is essentially a bio-engineered protein that is surgically implanted between the vertebrae to stimulate bone growth during spinal fusion surgeries. Infuse was developed and marketed as a safe and effective alternative to traditional bone grafting, which uses cadaver bones or harvests bones from a patient’s other body parts.

Surgeons have used and continue to use the Infuse bone graft product in a multitude of procedures. In 2004, the Infuse bone graft received FDA approval for tibia repairs, and in 2007 for use in some dental procedures because of Infuse’s synthetic protein that makes it ideal for promoting bone growth. The Infuse bone graft also approved for facial surgeries and fusing damaged vertebrae in the lower spine. However, recent Infuse bone graft studies have indicated that the genetically engineered protein used in the Infuse product could contain a cancer-causing agent.

Medtronic Infuse Bone Graft Side Effects and FDA Warnings

Within the last couple years, Medtronic, the world’s largest medical device maker, has been accused of marketing the bone protein for unapproved, “off-label” uses including injection into the cervical spine and upper back. The off-label surgeries have allegedly resulted in a plethora of complications including: excessive bone growth, paralysis, retrograde ejaculation, back and leg pain, swelling in the neck and throat, numbness, nerve damage, excessive bone growth, airway compression, difficulty breathing, swallowing and speaking, male sterility and other uro-genital injuries, and chronic pain.

In response to these alleged Infuse bone graft complications, the FDA issued a 2008 public health notification warning healthcare providers about life-threatening complications associated with recombinant human bone morphogenetic protein (rhBMP, which is contained in the Infuse Bone Graft) when used in the cervical spine are.

According to the 2008 Infuse Bone Graft warning:

“the FDA has received at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. … Anatomical proximity of the cervical spine to airway structures in the body has contributed to the seriousness of the events reported and the need for emergency medical intervention. The mechanism of action is unknown, and characteristics of patients at increased risk have not been identified.”

Most Infuse bone graft complications occurred between 2 and 14 days after an operation in which the Infuse product was used with only a few negative Infuse events occurring prior to day 2 of post-operation. When an airway complication allegedly caused by the Infuse bone graft occurred, medical intervention was frequently required. Victims of Infuse bone graft side effects reportedly needed several treatments, including respiratory support with intubation, anti-inflammatory medication, tracheotomy and most commonly a second surgery to drain the surgical area.

Because of the dangers and the serious side effects and medical complications associated with the use of the Infuse bone graft system, it is easy to see why Medtronic currently faces over 1,000 Infuse lawsuits in various U.S. federal courts.