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.
Thanks