INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-08143
- Event Type
- Injury
- Date Received
- May 18, 2025
- Date of Event
- December 23, 2024
- Report Date
- July 9, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 5060191607148
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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. 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: ¿INTRACAPSULARE RUPTURE AND CAPSULARE CONTRACTURE BAKER GRADE IV." CONT E1 PHONE NUMBER- (B)(6).
DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING INDICATES THAT THERE WERE NO OTHER RECORDS RELATED TO THIS EVENT FOR UNITS MANUFACTURED ON LOT NUMBER 2243013. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01-004-HER1-G02 REVISION 6.0. THE REVIEW OF ALL POTENTIAL TREND EVALUATIONS FOR BREAST IMPLANTS CLOSED DURING THE PAST 12 MONTHS INDICATES THAT NO CONFIRMED COMPLAINT TRENDS HAVE BEEN OBSERVED FOR THE EVENTS A0412 - MATERIAL RUPTURE AND A150202 - MALPOSITION OF DEVICE. CLARIFICATION TO H10: PREVIOUS MEDWATCH DID NOT INCLUDE "DHR TREND SUMMARY". ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6 DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ RUPTURE: OBSERVED, OPENING ASSESSED AS FOLD FLAW OPENING. ¿ MALPOSITION : UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. ¿ CREASE / FOLDING OF IMPLANT: OBSERVED CREASES ON DEVICE. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE, WEAR ABRASION AND NON-PENETRATING NICK WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
HEALTHCARE PROFESSIONAL REPORTED ¿INTRACAPSULARE RUPTURE AND CAPSULARE CONTRACTURE BAKER GRADE IV, BREASTS ARE VERY HARD IN CONSISTENCY, DEFORMED, AND PAINFUL TO THE TOUCH¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED ¿INTRACAPSULARE RUPTURE AND CAPSULARE CONTRACTURE BAKER GRADE IV, BREASTS ARE VERY HARD IN CONSISTENCY, DEFORMED, AND PAINFUL TO THE TOUCH¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED ¿INTRACAPSULARE RUPTURE AND CAPSULARE CONTRACTURE BAKER GRADE IV, BREASTS ARE VERY HARD IN CONSISTENCY, DEFORMED, AND PAINFUL TO THE TOUCH¿. REGULATORY AGENCY REPORTED "INTRACAPSULAR RUPTURE, FOLDS, WAVES, ROTATION, CAPSULAR CONTRACTURE (BAKER GRADE IV)". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2051094 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2243013 | 5060191607148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Required Intervention |