Robert J. Boumis  |  March 27, 2015

Category: Legal News

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Infuse bone graftIn January of this year, the U.S. Food and Drug Administration (FDA) issued new a new Safety Communication to health care professionals, reminding them that the Infuse Bone Graft System is not designed or intended for use in children under the age of 18. The Safety Communication reported that serious Infuse side effects could occur if the Infuse Bone Graft System was used in younger patients.

Infuse Bone Graft Allegations

The Infuse Bone Graft System is a bio-engineered gel designed to encourage bone growth. It is intended and approved for several facial, dental, and spinal surgeries. In the spine, Infuse is only approved for spinal fusion surgery in the lower back. During an Infuse bone graft spinal fusion procedure, adjacent vertebrae are joined together to strengthen them after the discs of the spine fail.

The makers of the Infuse Bone Graft System have found themselves facing hundreds of Infuse lawsuits, which similarly allege that the Infuse Bone Graft System can cause serious Infuse complications. Many Infuse lawsuits claim that the bioengineered gel component of Infuse can encourage uncontrolled bone overgrowth. In the delicate tissues of the spine, uncontrolled bone overgrowth can allegedly cause a host of painful, serious complications, and may require surgical correction to reverse the Infuse side effects.

Infuse lawsuits also allege Medtronic, the makers of the Infuse Bone Graft System, illegally marketed their bone graft product far beyond its FDA approval. Under U.S. law, doctors can use a drug or medical device for purposes beyond its FDA approval, an act called “off-label” usage of the medical device. However, medical companies are strictly forbidden from marketing their wares for off-label use. Some plaintiffs allege that Medtronic engaged in a clandestine campaign of illegal, off-label marketing for their Infuse product.

Additionally, Medtronic allegedly paid doctors and medical researchers to publish favorable papers and give presentations on the benefits of using the Infuse Bone Graft System in off-label surgical procedures. Infuse bone graft lawsuits further claim Medtronic may have gone as far as to encourage researchers funded by the company to downplay risks liked to the Infuse, or to not mention Medtronic funding in conflict-of-interest statements.

FDA Infuse Safety Warning

The FDA’s Safety Communication was published to remind physicians that the Infuse Bone Graft System was not designed for use in children under 18, as the Infuse Bone Graft System was not tested on children and growing and developing bone could react unpredictably to the bio-engineered gel. The government agency encourages surgeons to only consider the Infuse Bone Graft System for children if all other options have been completely exhausted.

Additionally, the FDA statement mentions concerns that the Infuse Bone Graft System may not work normally due to the small size of children compared to the adults the bone graft product was tested on. Instead, the FDA recommends a procedure called autograft or allograft (which uses donor bone from either elsewhere in the body or bone tissue from another person) to perform the type of procedures that the Infuse Bone Graft System is usually used for.

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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