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Author Topic: Xiaflex denial letter for a second round of shots, anyone else get denied?  (Read 135 times)

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My Dr. attempted to get three more rounds of xiaflex (6 shots) after my first four rounds (8 shots).   Apparently the FDA only approves 8 shots per chunk of plaque.  My plaque has shrank about 40-50% and my upwards curve went from 70 -50 degrees.  The fourth round of shots is where I got the most curvature improvement and shrinkage of the plaque.   Sadly I am stuck with a 50% curve.  I plan to appeal but I don't expect any success. 

According to the FDA you can only get 8 shots per chunk of plaque.  Any additional rounds must be applied to a new chunk of plaque.  See attached letter.

Has anyone else got denied like this?  Your feedback is greatly appreciated.  The battle continues.  Bought a Soma vacuum device today and I already have a Restorex.

51 yo, onset late 2018, painful erections lasted 18 months
70 degree upward bend, 50 degrees after 4 rounds/8shots of xiaflex, post xiaflex still hourglass & major girth/length loss
8 shots of xiaflex ended 5/22
restorex 1hr per day + xiaflex
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