According to a Medtronic Infuse Study Published in The Spine Journal in July 2011, Medtronic-Paid Researchers Downplayed Serious Infuse Side Effects, Including Cancer, Ectopic Bone Growth, Retrograde Ejaculation, Male Sterility, Infections, Bone Dissolution and Worsened Back and Leg pain.
The nationwide law firm of Wright & Schulte LLC is investigating injures allegedly resulting from the use of Medtronic Inc.’s Infuse Bone Graft, a genetically engineered material (recombinant human Bone Morphogenetic Protein-2 or rhBMP-2) that is approved for use in anterior approach lumbar fusion spinal surgery. According to Medtronic’s own numbers, since its approval, Infuse Bone Graft has been used in 500,000 patients and by more than 2,300 surgeons. However, recent reports indicate that 85% of Infuse use involves procedures for which it was never approved. www.medicalnewstoday.com
In 2008, the U.S. Food & Drug Administration (FDA) issued a Public Health Notification to warn of “life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion.” The FDA cautioned that the “the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by the FDA for this use.” According to the alert, off-label use of Infuse in cervical spine surgeries had resulted in the following complications:
- Swelling of neck and throat tissue
- Compression of the airway
- Compression neurological structures in the neck
- Difficulty swallowing, breathing or speaking
- Severe dysphagia
In July 2011, The Spine Journal published a disturbing analysis of 13 Medtronic-funded clinical trials for Infuse. The analysis found that the studies failed to report serious complications, including cancer, retrograde ejaculation, sterility in men, infections, bone dissolution and worsened back and leg pain, in patients treated with the product. According to the report, many of the clinical investigators involved in the trials had substantial financial ties to Medtronic, raising the specter that the studies may have been tainted by conflicts of interest.
A study presented in November 2011 at the North American Spine Society raised further alarm, when it revealed that high doses of rhBMP were associated with an increased risk of cancer, including pancreatic, breast and prostate cancers. Infuse is often administered at higher-than recommended doses when used off-label, raising concerns that patients who underwent unapproved Infuse procedures may now face higher cancer risks.
Wright & Schulte LLC offers free lawsuit evaluations to victims of alleged Medtronic Infuse injuries. Please visit www.yourlegalhelp.com, or call toll-FREE 1-800-399-0795 to learn more about your options for legal recourse.
About Wright & Schulte LLC
Wright & Schulte LLC, a personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged, and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free case evaluations are available through www.yourlegalhelp.com, or call 1-800-399-0795.
Wright & Schulte LLC 865 S. Dixie Dr. Vandalia, Ohio 45377 1-800-399-0795