INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-19265
- Event Type
- Injury
- Date Received
- November 7, 2025
- Date of Event
- February 1, 2019
- Report Date
- May 25, 2026
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1. PHONE NUMBER CONTINUED: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE, BREAST PAIN.
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE, BREAST PAIN AND INFLAMMATION/IRRITATION WAS RECEIVED ON (B)(6) 2026 WITH LOT NUMBER 3182224. PER THE INVESTIGATION PROCEDURE, THE DEVICE IS ANALYZED THROUGH VISUAL INSPECTION MICROSCOPIC INSPECTION IF OPENINGS ARE OBSERVED AND A WEIGHT VERIFICATION. PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ RUPTURE: OBSERVED AN OPENING THROUGH MICROSCOPIC INSPECTION ASSESSED AS FOLD FLAW OPENING. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. ¿ BREAST PAIN: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. ¿ INFLAMMATION/IRRITATION: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (NON-PENETRATING NICKS) ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS.
THE EVENT OF INFLAMMATION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, B3, B6, D6A, H6.
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "BREAST PAIN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
HEALTHCARE PROFESSIONAL THROUGH REGULATORY AGENCY REPORTED "RUPTURE" AND "BREAST PAIN". LATER HEALTHCARE PROFESSIONAL REPORTED "INFLAMMATION OF LEFT CAVITY DUE TO IMPLANT¿S RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
HEALTHCARE PROFESSIONAL THROUGH REGULATORY AGENCY REPORTED "RUPTURE" AND "BREAST PAIN". LATER HEALTHCARE PROFESSIONAL REPORTED "INFLAMMATION OF LEFT CAVITY DUE TO IMPLANT¿S RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "BREAST PAIN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267917 | INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 3182224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |