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My 13 year old daughter was diagnosed with Chiari Malformation and consequently had a decompression surgery. Following the surgery she had a rough recovery and it turned out that a hole had formed in the dural patch that was installed in her dura mater. Once determined, she quickly had another surgery to repair the hole. Through the process we befriended the family in the neighboring ICU unit and learned that their son had the exact same surgery and the exact same problem, resulting in the exact same curative surgery to repair the hole in his patch. In speaking with the surgeon we learned that the holes were created from a reaction in which an adhesive (Adherus developed by Hyperbranch) that was used during the surgery essentially ate a hole through the bovian patch that was installed. Has anyone else experienced a hole in their dural patch? Or, has anyone experienced leaking through the patch that could have been caused by a sealant?
I have reported the incident to the FDA. They acknowledged receipt of the complaint, but I am not aware of an outcome.
If you are scheduled for surgery please make sure you inquire into the use of the Adherus adhesive.
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