![]() The reoperation rate of 18.2% in the current study was larger than that reported in most of these studies.įuture cost-benefit analyses comparing INFUSE to less-expensive bone graft expanders are warranted for both “on-label” and “off-label” use. In particular, these studies have suggested that INFUSE leads to higher rates of hematomas/seromas, neurological deficits, soft-tissue swelling, ectopic bone formation, and vertebral osteolysis. Of note, the average cost of INFUSE was $26,752 per operation, while the average range of costs for alternative bone graft supplements (e.g., demineralized bone matrix and Beta TriCalcium Phosphate ) per operation would range from $2,672 to $4,000 (with overhead).Īlthough we cannot directly link the requirement for second spinal operations to the use of INFUSE in this study, other studies have done so. In fact, only seven (4%) of 177 cases were performed “on label” for ALIF alone, at a cost of $296,419. Infuse Bone Graft, also known as Bone Morphogenetic Protein-2 (rhBMP-2), is proven and medically necessary for the enhancement of bone healing and/or. Although INFUSE is only “marketed” by the company for “on-label” use, we found at our institution that 170 (96%) of 177 cases were performed “off-label” at a cost of $4,547,822. Some people naturally have adequate bone density to be able to sustain the screws and supports that are. ![]() Bone density is very important to the structure and success of dental implants. We offer a free consultation so you can discuss your case with a member of our experienced legal team.We examined the use of INFUSE to perform spinal fusions in one institution during 1 year. Infuse Bone Graft is a bone morphogenetic protein (BMP) graft which stimulates the growth of bone in places, such as the jaw, that have little bone density. To learn more about your options, contact one of our California product liability lawyers online or call toll free (415) 981-7210. If you are one of the many patients to suffer side effects after having back surgery, it’s important that you understand your legal rights. Contact Us to Learn About Your Legal Rights When it Comes to Defective Medical Devices Clinical trials were stopped after only 34 surgeries had taken place. Serious Infuse Bone Graft Complications Inflammatory reactions Back and leg pain Radiculitis (pain that spreads through the spinal nerves) Implant displacement Retrograde ejaculation (occurs when semen enters the bladder) Male sterility Cancer Infection Osteolysis (degeneration of bone tissue). In 1999, a Medtronic-sponsored clinical trial of posterior lumbar interbody fusion indicated that bone was forming in the wrong place in 70 percent of the patients participating in the study. Why Is INFUSE Bone Graft Used Only For This One Type Of Surgery?Įarly testing of other types of surgical procedures showed the potential for serious medical complications. If our defective medical device attorney believes you may have a case, we will obtain a medical review of your records to determine if you are eligible to bring a defective product claim for injuries from an INFUSE bone graft. Our firm has a long track record of successful financial recovery for injured people in California, Nevada and across the U.S.Ĭontact us online today – your consultation is free. The San Francisco law firm of Walkup, Melodia, Kelly & Schoenberger represents people who have been injured by defective medical devices and dangerous drugs. If you are experiencing pain or have other side effects from your INFUSE bone graft, we can help. Numerous patients who have received an INFUSE bone graft are now experiencing serious side effects and have become injured due to the graft. Likewise, the FDA has not approved INFUSE for spinal surgery involving the upper back and neck (the cervical spine). Infuse Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound. Even so, Doctors have inadvisably used InFUSE in procedures not approved (off-label) by the FDA. This procedure minimizes injury to the back muscles and nerves.
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