History of the INFUSE Bone Graft
A bone graft is used to replace a damaged piece of bone in the body. The INFUSE bone grafts from Medtronic contain human bone morphogenetic proteins. They are used during a spinal fusion procedure. The Medtronic INFUSE bone grafts received approval by the U.S. Food and Drug Administration in 2002. INFUSE is used in over 100,000 spinal fusion operations in the United States every year. The product bring in about $900 million in sales every year. The bone graft composition is infused in individuals to alleviate pain.
Side Effects & Complications of INFUSE Bone Grafts
There are some risks in using Medtronic INFUSE bone grafts. A person who uses these bone grafts may be subject to infection or urinary problems. Individuals who have used INFUSE bone grafts also suffer from male sterility, as well as bone and nerve injury. There is also an increased cancer risk for people who use INFUSE bone grafts. Patients have reported infection issues after using INFUSE bone grafts. There have been allegations that Medtronic, the manufacturer of INFUSE, has been paying doctors so that they will use their products with patients. The manufacturer has also been accused of hiding the potential side effects of INFUSE. There have been concerns that Medtronic is also using deceptive marketing practices to communicate with consumers.
Legal Issues with Medtronic INFUSE Bone Grafts
In 2011, an editorial was published in The Spine Journal. This editorial revealed that Medtronic research studies failed to adequately disclose the side effects of using rhBMP-2. This is a synthetic protein component of the bone graft system. There was high compensation offered to researchers who completed these studies, being anywhere from $1 million to $23 million a year. There were also extensive incentives provided to doctors who agreed to use INFUSE grafts. Doctors were given luxury trips to hot vacation spots, and they were also included in royalty agreements.
Complications Arising from INFUSE Bone Grafts
Patients who have used INFUSE bone grafts have reported very serious illnesses and injuries as a result of this use. First, patients have experienced inflammatory reactions after using INFUSE bone grafts. They have also experienced severe back and leg pain as a result of using INFUSE bone grafts. Radiculitis, a pain that spreads through the nerve system, has also been reported as a side effect that patients have suffered. Implant displacement and retrograde ejaculation have been two of the other side effects that patients have experienced as a result of using INFUSE. Some of the more serious complications include cancer and male sterility. Individuals have suffered from various forms of cancer that may be linked to INFUSE. Osteolysis and ectopic bone formation are two of the other serious complications arising after the use of INFUSE. The most tragic instances in which people use INFUSE result in their deaths.
Medtronic INFUSE Bone Graft Lawsuits
If you or a loved one has suffered from complications as a result of using INFUSE, then you may be eligible to file a lawsuit. An attorney may be able to help you settle a lawsuit outside of court. You may be able to recover damages for the medical expenses that you face as a result of using INFUSE. You may also be able to receive damages for any pain and suffering or emotional distress that you have experienced as a result of using INFUSE bone grafts. An attorney can review your claims in an initial consultation meeting. You can schedule a free initial consultation today to begin the process of moving forward in filing your Medtronic INFUSE lawsuit.