Infuse Bone Graft Problem – December 2013 Update
The Infuse bone graft consists of bioengineered liquid bone protein that encourages bone growth housed in a small container or cage that is implanted into the spine. Infuse is a registered trademark of, and is manufactured by, Medtronic, Inc., the nation’s largest maker of medical devices. An estimated 100,000 patients in the U.S. undergoing spinal fusion surgery annually are implanted with Infuse. In late November 2012, Medtronic, Inc. filed a motion to dismiss a whistleblower lawsuit alleging the medical device manufacturer used a spine surgeon, who was being paid by the company, as an editor of a medical journal to promote its Infuse Bone growth device.
In 2002, the Food and Drug Administration (“FDA”) approved Infuse for solely one type of spine surgery – anterior approach lumbar fusion. Infuse was not approved (and still is not approved) for other types of spine surgeries, such as lateral or posterior approach lumbar fusion surgeries. Likewise, the FDA has not approved Infuse for surgery on the neck or cervical spine (the portion of the spine that runs from the shoulders to the head).
Despite its limited authorized use, many patients have received Infuse in off-label uses during surgery on the lumbar or cervical spine. When any drug or medical device, such as Infuse, is used by a physician in an off-label use, the surgeon must fully disclose to the patient of the risks of the off-label use prior to the surgery, so that the patient may make an informed decision as to whether or not he or she wishes to proceed with the surgery.
Infuse Side Effects and Complications Not Disclosed
Last year, The Spine Journal, a medical journal, devoted an entire issue to reviewing earlier Infuse studies, which it characterized as “biased or corrupted research” that had been conducted by physicians with financial ties to Medtronic.
In none of the 13 trials funded by Medtronic involving over 700 patients, The Spine Journal reported, were adverse events from Infuse disclosed. Data provided to U.S. regulators and other publications, however, showed that up to 50 percent of patients implanted with Infuse suffered complications and side effects, including ectopic bone growth, uncontrolled bone growth, inflammatory cyst formation, and cancer, and infertility in men.
Please read our Answers to Frequently Asked Questions about Infuse for detailed information on Infuse problems and your legal rights.
Contact Lieff Cabraser
Lieff Cabraser represents patients across America who were seriously injured as a result of faulty medical devices and products. Learn more about Medtronic Infuse lawsuits.
We have specific experience with Infuse cases, and have successfully litigated against Medtronic in other cases involving serious injuries. Please click here to contact an attorney at Lieff Cabraser for a free case evaluation. Or call us toll-free at 1-888-315-6092 and ask to speak to attorney Kent L. Klaudt.
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