Nancy, others will likely have better answer than I. I think that a device has to pass FDA approval if it is being sold as having a medical use or health benefit. The reverse syringes you use work the same way. Except you have to find a way for the woman to apply suction 24 hours a day (preferably) for a month. This allows the nipple to be stretched while the underlying tissue grows. So the marketing info says. This device is a little "thimble," attached by tubing to a syringe. Margery Wilson, IBCLC