Missy Clyne Diaz  |  December 15, 2014

Category: Legal News

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Infuse bone graft

Spinal fusion surgery helps form a solid bridge between two vertebrae in order to stop movement in that area of the spine.

A bone graft acts as the foundation for the body to grow new bone and fuse a section of the spine together into one long bone. Bone grafting is possible because bone tissue, unlike most other tissues, has the ability to regenerate completely if provided the space into which to grow.

Medtronic’s Infuse Bone Graft System is used during spinal fusion surgeries to stimulate bone growth. A bio-engineered protein is surgically implanted between the vertebrae. Medtronic developed the Infuse bone graft as an alternative to traditional bone grafting, where cadaver bones or bones from other parts of a patient’s body are harvested.

The U.S. Food and Drug Administration (FDA) approved limited use of Medtronic’s system in 2002, allowing it only to be used in lower spine surgery. However, the company has been accused of marketing their bone protein for unapproved, “off-label” surgeries including the cervical spine and upper back.

The off-label surgeries have reportedly 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.

Medtronic is the world’s largest medical device maker. Doctors have used the Infuse Bone Graft System on more than 1 million patients.

The company faces more than 1,000 lawsuits over its Infuse Bone Graft System. Plaintiffs accuse the company of intentionally concealing dangerous side effects and allege that Medtronic has marketed the Infuse bone graft for the off-label uses, putting thousands of spine surgery patients at risk for dangerous complications.

In 2002 the FDA first approved the Infuse bone graft — used to fill in spaces where bone is needed — to be used in certain spinal procedures. Two years later it was approved for tibia repairs and in 2007 for use in dental procedures. It contains a synthetic protein that makes it ideal for promoting bone growth. It is also approved for facial surgeries and fusing damaged vertebrae in the lower spine.

Believing it carried few side effects, doctors used it in a variety of other procedures in the upper, cervical spine and other areas.

After questions about Infuse’s safety, Medtronic commissioned a $2.5 million review. The findings were detailed in the Annals of Internal Medicine. The two studies collectively looked at 2,000 patients. One study found no difference in overall success rates between Infuse and similar bone grafts when used in lumbar spine fusion, according to a 2013 Bloomberg News report.

But when used in other types of surgery, “Infuse patients had higher, though not always significant, increases in retrograde ejaculation, urogenital problems, bone spurs that can cause nerve pain and wound complications,” according to the Bloomberg News report.

“We couldn’t find a clear advantage in terms of benefits, and when you take into account there could be potential risks that should be more carefully evaluated, it tips the scales toward not using it,” said senior author Mark Helfand, an internal medicine specialist.

The other study found that Infuse patients had better fusion rates after two years, “with more early pain and less later pain,” according to the Bloomberg News report. “Cancer occurred in a small number of people and may have been more common with Infuse.”

In 2008, the FDA issued a Medtronic Infuse warning following multiple reports of life-threatening complications caused by the bone protein. Medtronic allegedly promoted the use of the bone protein in unapproved settings including the upper back and neck regions. Medtronic also allegedly failed to warn patients and doctors about the severity of Infuse bone graft complications when used in the lower back.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, Infuse bone graft lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as nerve damage; excessive bone growth; chronic pain; difficulty breathing, swallowing, and speaking; male sterility and other uro-genital injuries. See if you qualify to take legal action by filling out the short form below.

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