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I saw in the newspaper that a doctor was sued for "inappropriate use of a bone graft sponge." I have had a spinal fusion and my surgeon used a BMP sponge. What would be an inappropriate use of something like this?
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The safety of bone morphogenetic protein (called BMP) in spinal fusions has been raised and evaluated by the Food and Drug Administration (FDA). BMP is a naturally occurring protein that scientists have discovered can be a replacement for bone grafts. But inappropriate use of this product has resulted in some adverse effects that have only been reported after the fact.
What constitutes "inappropriate" use of BMP? The manufacturers of this product are clear in how it is to be used. Off-label use (in other words, using it for something other than it was meant for) is one inappropriate use. Another is changing the concentration of the BMP. It is usually applied on a collagen sponge. Squeezing the sponge too much or overfilling the sponge are two ways the implant may be used differently than recommended by the manufacturer.
That might not seem like such a terrible offense but the list of adverse effects suffered by patients as a result of using BMP inappropriately is long. Bone resorption, inflammation, leg pain from radiculitis, breathing problems, infection, swelling and fluid collections, too much bone growth or bone growth into the soft tissues, and blood clots are just a few of the complications reported.
Until more is known about the true risks and safety concerns about BMPs, surgeons are advised to be aware of potential problems and discuss them ahead of time with their patients. Using the products according to the manufacturer's directions may help ensure safe and effective use of BMP. Inappropriate and off-label uses should be avoided until safety issues have been resolved.
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*Disclaimer:*The information contained herein is compiled from a variety of sources. It may not be complete or timely. It does not cover all diseases, physical conditions, ailments or treatments. The information should NOT be used in place of visit with your healthcare provider, nor should you disregard the advice of your health care provider because of any information you read in this topic. |
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