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Woman Sues Medtronic Over Uncontrolled Bone Growth After Infuse Spine Surgery

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Jennifer English of Lake Worth, Florida, has filed a personal injury lawsuit in U.S. District Court for the Southern District of Florida, against Medtronic, Inc alleging the Infuse Bone Graft used in a posterior-approach lumbar spine surgery has caused her to develop uncontrolled bone growth in her spine, which is compressing nerves and causing chronic severe pain.

The Infuse Bone Graft device was not approved by the FDA for the type of surgery English had. “The complaint alleges that Medtronic fraudulently misrepresented the risks and benefits of Infuse and improperly promoted and marketed Infuse for non-FDA approved uses,” stated English’s attorney. “When Infuse is implanted in off-label surgeries, medical research shows that it can cause uncontrolled bone growth into or around the spinal cord, often leading to intractable pain and difficult and dangerous revision surgeries to remove unwanted bone.”

Infuse is used in spinal fusion operations to spur bone growth, however the FDA has approved Infuse for only anterior approach lumbar fusion surgeries. Nearly 100,000 patients receive Infuse in the US each year.

The Spine Journal criticized research, which encouraged the widespread off-label use of Infuse. The articles published in the June 28 edition of the medical journal charged that the prior studies in support of Infuse were authored by researchers with significant financial ties to Medtronic, and that this prior research vastly understated or failed to disclose Infuse’s side effects and risks.
 disclaimer: This article: Woman Sues Medtronic Over Uncontrolled Bone Growth After Infuse Spine Surgery was posted on Tuesday, September 20th, 2011 at 8:13 pm at and is filed under Medical Device Lawsuits.

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