Missy Clyne Diaz  |  November 26, 2014

Category: Legal News

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spine xrayTwo independent reviews have concluded that Medtronic’s Infuse Bone Graft, intended to speed bone healing following spinal surgery, works no better than a traditional graft and may increase the risk of cancer, among other side effects.

Study results published in the Annals of Internal Medicine carry a mixed message about the risks and benefits of the Medtronic Infuse system. Though Infuse is less invasive than a traditional bone graft, which can require a separate surgery, cancer rates and other potential risks are cause for concern.

“I remain concerned that products like these are approved with too little study before they reach the market and too little afterward,” Harlan Krumholz, a Yale University professor who headed  the project, told Bloomberg News in an interview after the study findings were first published. “There is a tremendous amount of uncertainty about the benefit it provides and how safe it is.”

Medtronic, the world’s largest medical device maker, is facing over 1,000 Infuse side effects lawsuits accusing the company of intentionally concealing dangerous side effects, such as male sterility and other uro-genital injuries, nerve damage, excessive bone growth, chronic pain, and difficulty breathing, swallowing, and speaking.

Further, according to the lawsuits, Medtronic has marketed the Infuse Bone Graft for 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 to promote 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 the $2.5 million review whose findings were detailed in the Annals of Internal Medicine. Doctors have used the Infuse Bone Graft on more than one million patients.

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.

But when used in other types of surgery many Infuse patients suffered an increase in side effects.

“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,” senior study author and internal medicine specialist Mark Helfand told Bloomberg.

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

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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