Some of the side effects reported by patients after a Medtronic infuse bone grafts surgery includes: The research study stated that these severe effects were 10 to 50 times higher than the original estimates published by peer-reviewed publications, which were industry-sponsored. It wasn’t until a review was published in 2011 that the adverse side effects of BMP products came to light. Bone Morphogenetic Protein (BMP) products have also been linked to a 43% higher complication rate in comparison to traditional bone grafts. Many clinical studies reveal that infuse can cause inflammation of nearby bones and tissues, which can result in urinary issues and cancer growth among patients. Side Effects of Using the Medtronic Infuse Bone Graft In this regard, numerous Medtronic infuse bone graft lawsuits have been settled, but many cases are still pending today.

The company’s sheer negligence caused injuries and pain to many patients, which is why they have filed lawsuits against Medtronic. The most astonishing fact is that it is alleged that Medtronic hid this information from consumers, and paid off researchers and doctors to promote their products. Infuse bone grafts are also risky and can lead to severe side effects while also increasing the risk of cancer. Millions of people around the globe have undergone infuse bone graft surgeries after it was approved by the FDA. This collagen sponge gets soaked with synthetic proteins and is then injected into the patient’s spine to ease their pain. Collagen Sponge: It is created from cow type 1 collagen, which works as a natural carrier for delivering the rhBMP-2 protein.RhBMP-2: It refers to a genetically engineered type of natural protein (Bone Morphogenetic Protein) that is found in the human body and aids in regulating bone healing and growth.Medtronic’s infuse bone graft includes the following two parts: However, keep in mind the FDA has only approved one spinal surgery method for the infuse bone graft, which is anterior lumbar interbody fusion. The infuse system is, therefore, more effective than these options, especially for patients with degenerative disc disease. Moreover, using a donated bone increases the risk of infection. Using a synthetic bone graft eliminates the need to harvest bone from another part of the patient’s body. Once the fusion procedure is done, it leads to the formation of a solid bone, which helps eliminate irritation of nerves in the patient’s spine and allows them to lead a painless lifestyle. Doctors may even use a donated or synthetic bone. The bone is usually taken from a different part of the patient’s body. For spinal fusion, the individual damaged spinal bones are fused surgically.

An increasing number of individuals experience chronic back pain caused by arthritis or other conditions. Reasons for Infuse Bone Graftingīone grafts are bone substitutes or bone pieces that are used to replace diseased or damaged bones in different parts of the body. Due to the injuries and complications experienced by patients after using an infuse graft, they have filed Infuse Bone Graft lawsuits against Medtronic.

Moreover, the company has also been accused of paying off doctors to use its products and intentionally hiding their side effects, as well as using deceptive strategies for marketing. But, a number of patients are now reporting of severe complications from their use. Therefore, the product was later approved for the treatment of tibial shaft fractures in 2004 and oral-maxillofacial procedures in 2007.Īlthough infuse bone grafts have been utilized in millions of medical procedures around the globe. The FDA approved the use of these infuse bone grafts for spinal fusion in 2002. Infuse bone grafts are concentrated, synthetic proteins used for certain trauma, dental, and spine indications created by Medtronic. These settlements were projected to reach $460 million or more. The company has settled around 4,000 lawsuits and plans to settle thousands of pending cases as well.However, the company was unsuccessful in this strategy since the FDA never approved the product for off-label use Medtronic also attempted to dismiss the lawsuit on the grounds that the FDA had approved the use of Infuse.They have been accused of paying off researchers and doctors to promote their products despite these risks. It is alleged that the company hid the risks of using Infuse bone grafts from the consumers and that it may lead to severe side effects while also increasing the risk of cancer.Lawsuits have been filed against Medtronic due to the injuries and complications experienced by patients after using an infuse graft.