FDA Adverse Event Malfunction Summary report: N

MENTOR SMOOTH ROUND MODERATE PROFILE

MDR report key: 23037004 · Received September 12, 2025

Report

Report Number
23037004
Event Type
Malfunction
Date Received
September 12, 2025
Date of Event
August 20, 2025
Report Date
August 28, 2025
Manufacturer
MENTOR TEXAS LP
Product Code
FWM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT REPORTED RIGHT BREAST IMPLANT DEFLATION WHICH OCCURRED SPONTANEOUSLY WHILE AT HOME 2 WEEKS AGO. PER CHART, BILATERAL BREAST IMPLANTS WERE PLACED [DATE REDACTED] - APPROXIMATELY 4 YEARS AGO. RIGHT BREAST IMPLANT FILLED TO 285CC, LEFT BREAST IMPLANT FILLED TO 275CC. DUAL PLANE. PT IS SCHEDULED TO HAVE BOTH IMPLANTS REPLACED ON [DATE REDACTED] - IN APPROXIMATELY 1 WEEK. NOTE FROM [DATE REDACTED]: "THIS IS A PRE OP VISIT. SHE IS SCHEDULED FOR SURGERY ON [DATE REDACTED]. SHE HAS ELECTED TO REMOVE HER DEFLATED RIGHT SALINE BREAST IMPLANT AND INTACT LEFT SIDE SALINE IMPLANT AND REPLACE BOTH WITH NEW SILICONE GEL IMPLANTS. SHE UNDERSTANDS THERE IS AN ADDITIONAL CHARGE TO CHANGE FROM THE SALINE TO SILICONE FROM THE COMPANY MENTOR. WE PROVIDED HER WITH THE MENTOR CHECKLIST OF POSSIBLE RISKS WITH BREAST IMPLANTS. I ALSO REVIEWED WITH [REDACTED] THE FDA'S RECOMMENDATION FOR SCREENING FOR SILENT RUPTURE OF SILICONE BREAST IMPLANTS BEGINNING AT 5 TO 6 YEARS FOLLOWING IMPLANTATION AND THEREAFTER EVERY 2 TO 3 YEARS FOR THE LIFE OF THE IMPLANT. WE DISCUSSED THE PARTICULAR RISKS WITH THIS SURGERY INCLUDING BUT NOT LIMITED TO BLEEDING, INFECTION, UNFAVORABLE SCARS, POSSIBLE DELAYED HEALING POSSIBLE SENSATION CHANGES POSSIBLE NEED FOR OTHER PROCEDURES AS WELL AS RISKS ASSOCIATED WITH GENERAL ANESTHESIA. SHE NOTED THAT SHE DID HAVE A BAD SKIN REACTION TO DERMABOND WITH HER MINI ABDOMINOPLASTY REQUIRING STEROIDS AND THEREFORE WE WILL NOT PLAN TO USE ANY SKIN GLUE AND WILL MINIMIZE THE USE OF ADHESIVE POSSIBLY WE WILL USE STERI-STRIPS WHICH SHE DID NOT HAVE A PROBLEM WITH IN THE PAST FOR HER PRIOR AUGMENTATION. I DID ANSWER ALL OF HER QUESTIONS TODAY TO HER STATED SATISFACTION. [REDACTED] ALSO WAS PRESENTED WITH THE MENTOR EXTENDED WARRANTY."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2304511 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS LP 3501640

Patients

Seq Age Sex Outcome Treatment
1 41 YR Female