EMSCULPT

Description of Event or Problem

I USED AN EMSCULPT DEVICE PER PROTOCOL AND SUBSEQUENTLY DEVELOPED OVARIAN FAILURE AND MENOPAUSE AT THE AGE OF (B)(6) YR OLD DUE TO THE HIGH INTENSITY ELECTROMAGNETIC WAVES USED BY THIS MACHINE. I HAD A FULLY FUNCTIONING NORMAL CYCLES AND SUDDENLY DEVELOPED MENOPAUSAL STAMP YIN'S. I PURSUED MUCH TESTING TO EVALUATE IF THERE WAS AN ORGANIC CAUSE FOR THIS OVARIAN FAILURE BUT ALL TESTING WAS NORMAL AND MY ONLY EXPOSURE WAS TO THIS DEVICE. I AM THIN AND THE DEVICE WAS DIRECTLY ON MY OVARIES. I HAVE ALLOW SINCE FOUND MANY STUDIES THAT REPORT OVARIAN INJURY AND FAILURE AND RATS AFTER HIGH INTENSITY ELECTROMAGNETIC WAVES; PELVIC ULTRASOUND. FDA SAFETY REPORT ID# (B)(4).