INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-03788
- Event Type
- Injury
- Date Received
- March 5, 2024
- Date of Event
- January 1, 2021
- Report Date
- March 28, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE, BAKER GRADE III/IV.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5, B.6, H.6. THE EVENT OF SEROMA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.
CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH #1. AWARE DATE SHOULD HAVE BEEN LISTED AS 02/JUL/2024.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ WRINKLING OF THE SKIN: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ SEROMA: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ DEVICE WRINKLING: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ CYST: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ CREASE / FOLDING OF IMPLANT: NOT OBSERVED ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ ANXIETY - PRODUCT/ PROCEDURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED. THE EVENT OF SEROMA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.
PATIENT REPORTED LEFT SIDE PAIN, UPTURNED PROSTHESIS, GRADE III OR IV CAPSULAR CONTRACTURE AND "RECALL." THE DEVICE REMAINS IMPLANTED.
PATIENT REPORTED LEFT SIDE PAIN, UPTURNED PROSTHESIS, GRADE III OR IV CAPSULAR CONTRACTURE AND "RECALL." THE DEVICE REMAINS IMPLANTED.
PATIENT REPORTED PAIN, HARDENED BREASTS, TWO FINGERS GAVE WAY, CAPSULAR CONTRACTURE III OR IV." HEALTHCARE PROFESSIONAL LATER REPORTED THICKENING AND ENHANCEMENT OF THE FIBROUS CAPSULE, RADIAL FOLDS, FLUID ADJACENT TO THE IMPLANT, BREAST DEFORMITY, AND RIPPLING. HEALTHCARE PROFESSIONAL LATER REPORTED SIMPLE CYST MEASURING 0.3 CM IN THE 'QSM' OF THE LEFT BREAST NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED PAIN, HARDENED BREASTS, TWO FINGERS GAVE WAY, CAPSULAR CONTRACTURE III OR IV." HEALTHCARE PROFESSIONAL LATER REPORTED THICKENING AND ENHANCEMENT OF THE FIBROUS CAPSULE, RADIAL FOLDS, FLUID ADJACENT TO THE IMPLANT, BREAST DEFORMITY, AND RIPPLING. HEALTHCARE PROFESSIONAL LATER REPORTED SIMPLE CYST MEASURING 0.3 CM IN THE 'QSM' OF THE LEFT BREAST NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1670061 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2794316 | ||
| 354160 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2794316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Required Intervention |