Someone is Finally Listening to Sculptra Damage

The FDA provided me with some of the redacted information.  There were over 700 scuptra product technical complaints received by Sanofi during a two year period prior to obtaining the FDA cosmetic use approval.  Sanofi reported zero of those events to the FDA as is required by law.  With their multinational staff and multi level review they were confuse about what was reportable.  Had they reported adverse events as required many of us may not have been harmed.  If you look at the FDA maude database for adverse event reporting, Sanofi has a "new decision tree" for determining if something is reportable.  Since the beginning of 2010 there have been about 40 new reports of "serious adverse events" using this new decision logic.  This Sculptra Damage did not need to happen to us. If you were harmed by this dangerous and unpredictable product to to www.sculptradamage.com there is information on how to report your situation to both the manufacturer and the FDA.