Medtronic INFUSE® Bone Grafts are used for patients who need bones restored or reinforced. For patients with back problems, the Medtronic INFUSE + LT-Cage®1 is used to help fuse the spine when other treatments such as exercise and medicines no longer relieve a patient's problems with pain or stability.2 While the Medtronic INFUSE Bone Graft procedure has been approved for specific types of lower back and dental surgeries, its application in cervical spine surgeries goes against product labeling. The Food and Drug Administration (FDA) has discovered that certain applications of the Medtronic INFUSE Bone Graft, both off-label and on-label, can cause life threatening complications.3
Medtronic infuse bone graft side effects and complications
FDA warnings about the misuse of and serious complications arising from the Medtronic Bone INFUSE Graft first surfaced in 2008. At the time, government investigations found that some of the major problems with the Medtronic Bone INFUSE Graft were not being reported.4 Some of these Medtronic INFUSE bone complications and side effects5 include:
- Sexual dysfunction
- Gastrointestinal problems
- Problems swallowing, breathing, and speaking
- Neck and throat swelling
- Abnormal bone growth
- Implant failure
- Bowel and Bladder dysfunction
- Nerve damage
Many complications require emergency action for patients, including procedures for feeding tubes or tracheotomies.6 In some cases, patients may require additional surgeries.
Suspicion prompts federal investigation
By 2011, Medtronic was profiting $900 million each year for its Bone INFUSE Graft.7 Available study data at the time reported no side effects. However, it was later learned that study researchers were paid considerable sums of money to offer favorable reports of the product. Although no Medtronic INFUSE Bone Graft studies reported adverse events, the FDA began to recieve reports of several such instances. This contradiciton of data of drew attention and resulted in a federal investigation.
Back surgeries are becoming more common as a means of treating back problems. Millions of Americans have some type of back surgery each year, and the procedures cost tens of thousands of dollars.8 However, where the procedures are supposed to improve quality of life, the Medtronic INFUSE Bone Graft system has caused more harm than good in many cases.
If you or a loved one has suffered serious complications as a result of the Medtronic INFUSE Bone Graft, you may have a right to recover from your damages. Experienced personal injury and product liability lawyers may be able to help you protect your rights and ensure that you recieve a fair recovery.