Description of Event or Problem · 1
I'M A REPRODUCTIVE ENDOCRINOLOGIST AND MY OFFICE IS LOCATED DOWN THE STREET FROM MIRA'S OFFICE IN (B)(6). I'M WRITING TODAY TO EXPRESS MY DEEP CONCERNS WITH THE MIRA PRODUCTS THEY CLAIM TO BE FDA APPROVED. MIRA HAS A LINE OF PRODUCTS LISTED ON THEIR SITE THAT CLAIM TO MONITOR THE HEALTH OF A PREGNANCY BY TRACKING PDG AND HCG HORMONES IN URINE. THESE PRODUCTS ARE MARKETED FOR WOMEN TO USE AT HOME AND WITHOUT A DOCTOR. THESE DEVICES ALSO CLAIM TO HELP DETECT EARLY SIGNS OF MISCARRIAGE. THIS IS VERY, VERY DANGEROUS. ONE OF MY PATIENTS CAME INTO MY OFFICE AND WAS USING THE PDG (PROGESTERONE) WANDS TO MONITOR HER PREGNANCY. SHE WAS HAVING PAIN, BUT SINCE HER MIRA TOLD HER THAT PROGESTERONE LEVELS WERE HIGH, SHE DID NOT WORRY ABOUT THE PAIN UNTIL IT WAS ALMOST TOO LATE. TURNS OUT IT WAS AN ECTOPIC PREGNANCY AND MIRA ALMOST CAUSED A LIFE-THREATENING CONDITION FOR THIS PATENT. IT IS NOT SAFE TO ALLOW WOMEN TO MONITOR THE HEALTH OF THEIR PREGNANCIES, THIS SHOULD ALWAYS BE UNDER THE CARE OF A DOCTOR. THE FDA APPROVE HAS NOT APPROVED THIS DEVICE FOR HOME USE WITH THE CLAIMS FOR MONITORING PREGNANCY. IT IS NOT SAFE FOR WOMEN TO DO AT HOME WITHOUT A DOCTOR AND IT IS VERY DANGEROUS FOR MIRA TO MAKE THESE DAMAGING CLAIMS. DEVICES LIKE THESE CAN NOT REPLACE MEDICAL CARE LIKE THEY CLAIM. PLEASE INVESTIGATE THEM BEFORE THEY CAUSE MORE HARM TO WOMEN AND THEIR UNBORN BABIES.