UFE- UTERINE FIBROID EMBOLIZATION
Received Jun 26, 2025 · Event occurred Feb 27, 2024
Report MW5172067 · MDR key 22348879
Device
Generic name
Agents, Embolic, For Treatment Of Uterine Fibroids
Manufacturer
UnknownProduct problems
- Defective Device
Patient
49 YR · Female
- Hemorrhage/Blood Loss/Bleeding
- Menstrual Irregularities
- Embolism/Embolus
- Hemorrhage/Blood Loss/Bleeding
- Menstrual Irregularities
- Embolism/Embolus
Narrative
Description of Event or Problem
I HAD UTERINE FIBROID EMBOLIZATION DONE. (UFE) I HAD DYE PUT INTO MY UTERINE ARTERIES BECAUSE I HAD FIBROIDS. I WAS TOLD THAT MY UTERUS WAS TOO BIG FOR A LAPAROSCOPIC HYSTERECTOMY AND THAT IF I CHOSE TO GET A HYSTERECTOMY, I'D HAVE A CUT ON MY ABDOMEN. THE UFE DIDN'T WORK. IT JUST FLUSHED THROUGH MY ARTERIES AND MADE THE SYMPTOMS WORSE. (SERIOUS, HEAVY BLEEDING AND CRAMPS) I HAD TO TAKE A PILL TO STOP THE BLOOD FLOW. I GOT A SECOND OPINION. THAT DOCTOR TOLD ME THAT I WAS A GOOD CANDIDATE FOR A LAPAROSCOPIC HYSTERECTOMY. I HAD THAT DONE (B)(6) 2024. SO BASICALLY, I FEEL THAT THE UFE PROCEDURE IS INEFFECTIVE. I WAS TOLD THAT I WAS A GOOD CANDIDATE FOR IT AND FOR THE SIZE OF MY UTERUS, THEY SHOULD HAVE TOLD ME OTHERWISE. THEY KNEW THE SIZE OF MY UTERUS BECAUSE I WAS REQUIRED TO GET AN MRI UPFRONT. THEY BLEW THE RESULTS UP ON A HUGE SCREEN. UFE BILLED MY INSURANCE OVER $54,000; JUST FOR ME TO TURN AROUND AND HAVE THE SURGERY ANYWAY IN THE SAME YEAR. UN-ACCEPTABLE. UFE CAUSED ME SO MANY ISSUES. I GOT NO HELP THIS IS WHY I'M FILING A COMPLAINT TO SEE IF THIS PROCEDURE SHOULD BE ON THE MARKET. HOW DOES THE FDA KNOW IF SOMETHING DIDN'T HAVE GREAT RESULTS; UNLESS SOMEONE LIKE ME MAKES YOU AWARE. THIS WAS A MEDICAL PROCEDURE THAT I FEEL IS INEFFECTIVE; UFE.