MIRADRY SYSTEM
Received Mar 25, 2024 · Event occurred Mar 6, 2024
Report MW5153138 · MDR key 18978281
Device
Generic name
Instrument For Treatment Of Hyperhidrosis
Manufacturer
Miradry, Inc.Patient
40 YR · Female
- Pain
- Unspecified Reproductive System or Breast Problem
- Subcutaneous Nodule
- Swelling/ Edema
- Pain
- Unspecified Reproductive System or Breast Problem
- Subcutaneous Nodule
- Swelling/ Edema
Narrative
Description of Event or Problem
PLEASE INVESTIGATE THE CORRELATION BETWEEN WOMEN WHO HAVE MIRADRY AND THE SIDE EFFECT OF PAINFUL LUMPS/MIGRATED BREAST TISSUE TO THE AXILLA (UNDERARM AREA). AFTER MY DERMATOLOGIST PERFORMED THE MIRADRY PROCEDURE TO TREAT HYPERHIDROSIS, I DEVELOPED PAINFUL, SWOLLEN LUMPS IN MY UNDERARMS THAT PERSISTED FOR OVER 1 YEAR POST-PROCEDURE. IT WAS BELIEVED THESE WERE SWOLLEN SWEAT GLANDS OR TRAPPED FLUID. MIRADRY CLAIMED THESE LUMPED WOULD RESOLVE THEMSELVES; HOWEVER, THEY DID NOT, REQUIRING MY DERMATOLOGIST TO ATTEMPT CORTISONE INJECTIONS, WHICH STILL DID NOT HELP. MY DERMATOLOGIST SENT ME TO MY PCP WHO ORDERED AN ULTRASOUND OF THE AXILLA, ALONG WITH A DIAGNOSTIC 3D MAMMOGRAM, ORDERED BY MY GYN. FOLLOWING THESE IMAGES, A BIOPSY SHOWED THAT THE LUMPS WERE ACTUALLY BREAST TISSUE THAT HAD MIGRATED. I WILL NOW REQUIRE SURGERY TO REMOVE THE EXCESS TISSUE. THIS SIDE EFFECT HAS BEEN VERY PAINFUL AND FRUSTRATING, SIENTRA INC.