Medtronic Infuse Lawsuit | Medtronic Infuse Bone Graft Lawsuits
Medtronic Infuse Lawsuit | Medtronic Infuse Bone Graft Lawsuits | Lawyers, Attorney, Lawsuits | Side Effects: Acute Severe Swelling, Severe Neck Swelling, Difficulty Swallowing, Difficulty Breathing, Difficulty Speaking, Speech Impaired, Uncontrolled Bone Growth, Ectopic Bone Growth, Nerve Injuries, Severe Chronic Pain, Radiating Leg Pain, Radiating Arm Pain, Neuritis, Radiculopathy, Radiculitis
Medtronic Inc.’s Infuse Bone Graft product, a synthetic liquid form of bone morphogenetic protein (BMP) that is used in spinal surgeries, has been associated with serious and life-threatening side effects, especially when used in off-label procedures. Since coming on the market in 2002, Infuse Bone Graft has been implanted in more than 100,000 patients nationwide. Remarkably, over 75% of those Infuse procedures have hot been approved by the U.S. Food & Drug Administration (FDA), and Medtronic has been investigated for illegally promoting off-label use of Infuse.
Recipients of Medtronic Infuse may be entitled to file a personal injury lawsuit if they suffered from any Infuse side effects, that may include:
- Increased cancer risk, especially pancreatic, breast and prostate cancers
- Respiratory failure
- Uncontrolled bone growth
- Nerve damage
- Erectile dysfunction
- Male Sterility
- Angioedema (swelling of the neck and throat, which can cause fatal suffocation)
- Bone dissolution
- Worsened back and radiating leg pain
If you or someone you love suffered a serious injury following spinal surgery with Infuse, legal advice from an attorney experienced with Infuse injury lawsuits should be sought immediately. Wright Schulte LLP, a nationwide law firm focused on obtaining justice for the people, represents the victims of defective medical devices, including Medtronic Infuse Bone Graft. If Medtronic Infuse caused you or a loved one to experience tremendous pain and suffering, we urge you to contact Wright Schulte LLP for a free, no obligation lawsuit evaluation today.
Medtronic Infuse Side Effects
Medtronic Infuse was developed as an alternative to traditional bone grafting, which involves painful bone-harvesting from other areas of the body. The product consists of a sponge which is soaked with a liquid form of BMP. The sponge is inserted into the LT-CAGE, a thimble-sized, cage-like device. The cage is then implanted between spinal vertebrae, where the BMP stimulates bone growth, while the sponge eventually dissolves.
When the FDA approved Infuse, it was only cleared for use in the lower-spine (lumbar) region following spinal surgery. However, it is known that more than 75% of Infuse uses involve off-label procedures. In some cases, patients injured by Infuse were not informed that the procedure they were subjected to was off-label, and were not told of the risk of serious complications linked to Infuse. In 2008, the FDA warned that Infuse had caused serious and potentially life-threatening problems when used off-label in cervical spine (neck) surgeries. In some instances, the uncontrolled bone growth caused by Infuse in off-label procedures forced patients to undergo additional surgery to remove excess bone. Some Infuse victims have required emergency insertion of a feeding tube or tracheotomy.
In the summer of 2011, The Spine Journal published a study that was highly critical of the research Medtronic used to garner FDA approval of Infuse. The report asserted that of 13 Infuse clinical trials funded by Medtronic, all failed to publically disclose adverse events, including infection, pain, cyst formation, and male infertility. Data provided to U.S. regulators and other publications, however, showed that up to 50 percent of the patients who received Infuse may have suffered such side effects.
In November 2011, a study presented at the North American Spine Society indicated that a higher-dose formulation of Infuse, known as Amplify, had been linked to a significantly higher number of cancers than were found among those who received a traditional bone graft. Patients who were implanted with the higher dose BMP product were 2.5 times more likely to develop cancer – including breast cancer, pancreatic cancer and prostate cancer – within the next year than those who were not implanted with the bone growth product, according to the study’s findings. At three years, the risk climbed fivefold. While Amplify was never approved by the FDA because of its cancer association, the author of the study noted that Infuse is often used in similar-sized doses when it is administered in off-label procedures.
Medtronic Infuse Lawsuit Evaluations
The attorneys of Wright Schulte LLP work every day to preserve the rights of personal injury victims, one case and one client at a time. If you or someone you love was injured by Medtronic Infuse Bone Graft, and you’re looking for a personal injury law firm that will guarantee the caring, personalized and loyal representation you deserve, please do not hesitate to contact Wright Schulte LLP today. For a free, no obligation legal evaluation of your case, simply fill out the online form on the right, or give Wright Schulte LLP a call, toll-free, at 1-800-555-5555.