"If you are suffering pain or any adverse side effects following a Infuse Bone Graft procedure, Gilman Law LLP is here to help."
Naples, FL (PRWEB) January 04, 2012
Gilman Law LLP, a leading national law firm with over 30 years of experience protecting the rights of victims is actively investigating complaints involving off-label use of Medtronic Infuse(R) bone graft. Gilman Law is offering free consultations to victims and their families who allegedly have suffered from complications due to the "off-label" use of a Infuse(R) Bone Graft, including:
- Excessive swelling of the throat and neck
- Difficulty breaking, swallowing, or speaking
- Heightened risk of retrograde ejaculation, which leads to sterilization
- Compression of the airway
- Respiratory depression
- Nerve damage
Medtronic Infuse(R) Bone Graft Procedure
Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. designed and marketed the Infuse(R) Bone Graft device (“Infuse(R)”) for lumbar spine surgery. Infuse(R) is a bio-engineered bone filling material containing a bone morphogenetic protein (“BMP”), and is used as an alternative to grafting a patient’s own bone, typically from the patient’s hip. The purpose of Infuse(R) is to accomplish the same clinical outcomes as grafting a patient’s own bone into these locations but without the difficulties of grafting bone from the hip and other sites, since grafting sites typically have side effects such as pain and long recovery. It uses a genetically engineered protein -rhBMP to help fuse vertebrae in the lower (lumbar) spine in order to treat degenerative disc disease.
Infuse(R) Bone Graft manufactured by Medtronic, Inc. is only approved for a limited surgical procedure, yet Medtronic allegedly illegally promoted it for a number of off-label procedures according to a pending lawsuit filed in the Superior Court of California. Case No.: BC465313
Infuse(R) was approved by the Food and Drug Administration (“FDA”) on July 2, 2002, for use only in the lower region of the spine (at levels L4 through S1) to treat degenerative disc disease, and was approved only for anterior surgeries at L4 through S1. That meant that it was initially approved only to be used by surgeons, when the surgeons placed the cage within the vertebrae in the lumbar region of the back, and only by entrance through the abdomen. On March 9, 2007, the FDA approved the use of Infuse(R) for dental use.
Infuse(R) has never been approved by the FDA for use in other parts of the body or for use in any other type of procedure, and any such uses are “off-label” uses. The Complaint alleges that while physicians may use FDA-approved medical devices in any way they see fit, companies are not permitted to promote off-label uses for their medical devices or to pay doctors inducements or kickbacks to promote the off-label uses or to perform procedures using the devices off-label.
Gilman Law is representing victims who have been harmed in off-label uses of Infuse(R), which is approved by the FDA only for a small section of the spine in the lower, or lumbar region. At least 280 reports of adverse events involving Infuse(R) have been made to the FDA. Approximately 75% of those reports involve off-label use. On July 1, 2008, the FDA issued a Public Health Notification about complications from the off-label use of Infuse(R) in the neck, or cervical, area of the spine. The FDA reported that it had received 38 reports over a four year period through July 1, 2008, of complications from cervical uses of Infuse(R); and, that some reports were of life-threatening and fatal events. Some of the complications were associated with swelling of the neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck, and patients reported difficulty swallowing, breathing and speaking. Several patients required emergency treatment, including tracheotomies and the insertion of feeding tubes. FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion, issued July 1, 2008 (http://www.fda.gov/cdrh/safety/070108-rhbmp.html)
Gilman Law LLP is a leading Defective Medical Device Product Liability law firm and is here to help you receive the best compensation for your injuries. If you or a family member have been injured by an off-label use of the Infuse(R) bone graft procedure, you may have valuable legal rights. For a free evaluation of your case, please visit our website, or CALL TOLL FREE (1-888-252-0048) today.
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