Medtronic Infuse Bone Graft
What is an Infuse Bone Graft?
The Medtronic Infuse Bone Graft was originally approved by the FDA for the use in lumbar spine surgeries. Infuse is a liquid form of bone morphogenetic protein, also known as BMP. It is inserted between vertebrae and is supposed to promote bone growth that fills in the gap between vertebrae to replace damaged or removed disks. However, based on a recently filed lawsuits, it was discovered that Medtronic had been accused of marketing the bone graft for use in the cervical spine surgeries and other neck procedures. Such uses are considered “off-label,” and are not approved by the FDA. When Medtronic’s Infuse Bone Graft is used for these off-label uses it has been alleged to cause serious and sometimes catastrophic Injuries.
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Our law firm is currently accepting Medtronic Infuse Bone Graft claims nationwide. If you or somebody you know has experienced complications from a surgery where the Medtronic Infuse Bone Graft product was used, you should contact our law firm immediately for a free case evaluation. Contact an Infuse Bone Graft Lawyer by email or call 24 hours a day at (973) 228-0391.
The Medtronic Infuse Bone Graft has been the subject of FDA safety warnings and U.S. Department of Justice criminal investigations. As a result of the scrutiny, recently Medtronic admitted to paying approximately $800,000 to a doctor who is accused of falsifying the results of a study regarding the Infuse product.
The Infuse Bone Graft has only been approved by the FDA for use in lumbar spine procedures to spur bone growth. Despite this limited approval, Medtronic has been accused of promoting “off-label” uses of the Infuse product to healthcare providers. In multiple whistleblower lawsuits former Medtronic employees alleged illegal marketing by the company, including payments to surgeons to recommend and use Infuse and other Medtronic spine products. Doctors are permitted to use FDA approved products for off-label uses, but it is illegal to market or promote an off-label use.
In a recent article, The Wall Street Journal reported that “a number of patients say they have been harmed in off-label uses of Infuse, which is approved by the FDA only for a small section of the spine in the lower, lumbar region. At least 280 reports of side effects involving Infuse have been made to the FDA. About three-quarters of those reports involve off-label use. In July, the agency issued a safety alert about complications from the off-label use of Infuse in the neck, or cervical, area of the spine.”
Medtronic Infuse Bone Graft Complications
The FDA issued a safety alert regarding the complications caused by using Infuse in cervical spine procedures. These serious complications include:
- Airway restriction
- Swallowing and speaking problems
- Swelling of the neck
- Respiratory issues
- Nerve damage
Several patients that were recipients of the Medtronic Infuse Bone Graft in cervical spine surgeries required life-saving medical treatment due to complications.
Contact a New Jersey Medtronic Infuse Bone Graft Lawyer
The attorneys at Mazie Slater Katz & Freeman, LLC are reviewing Infuse Bone Graft claims and lawsuits. If you or a loved one has suffered complications from a surgery where Infuse was utlized it is important that you contact a New Jersey Infuse Bone Graft Lawyer today for a free consultation. All lawsuits are being pursued under a contingency fee, which means that there are no fees unless a recovery is obtained.
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