INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-16937
- Event Type
- Injury
- Date Received
- October 6, 2025
- Date of Event
- July 29, 2025
- Report Date
- January 8, 2026
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, H6.
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON NOVEMBER 20, 2025, WITH LOT NUMBER 1193201. 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: ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. A WORKMANSHIP WAS OBSERVED THROUGH VISUAL INSPECTION NOT RELATED TO THE COMPLAINT FOR A SPLIT IN PATCH EVENT. A FURTHER INVESTIGATION IS REQUESTED. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (CREASES AND DEFORMATION) ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE III/IV.
FURTHER INVESTIGATION: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES INVOLVED IN THIS WORK ORDER WERE RELEASED IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. ADDITIONALLY, NO ER/ NCR(S) WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED WITH THIS LOT AND THE COMPLAINT. ACCORDING TO THE DEVICE ANALYSIS PERFORMED IN THE LABORATORY WAS OBSERVED A SPLIT IN PATCH AREA, IT IS OUT OF SPECIFICATION PER QA 199.04 (SS). THE EVENT OF CAPSULAR CONTRACTURE WAS UNABLE TO OBSERVED, AND THE WORKMANSHIP HAS NOT RELATION TO REPORTED COMPLAINT. THEREFORE, THE REPORTED EVENT WAS NOT CONFIRMED. A REVIEW OF THE CURRENT RISK DOCUMENTS PFMEA-SILICONE FILLED BI AND SIZER ASSEMBLY, SMOOTH REV. 3.0 WAS PERFORMED, AND THE EVENT OF SPLIT IN PATCH IS A KNOWN EVENT, FOR WHICH CURRENT PROCESS CONTROLS AND INSPECTIONS ARE ESTABLISHED TO REDUCE THE INCIDENCE OF THIS DEFECT. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH SPLIT IN PATCH WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.
LATER HEALTHCARE PROFESSIONAL REPORTED "CLASS IV CAPSULAR CONTRACTURE" CAPSULECTOMY PERFORMED. DEVICE HAS BEEN EXPLANTED AND REPLACED.
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". LATER HEALTHCARE PROFESSIONAL REPORTED "CLASS IV CAPSULAR CONTRACTURE" THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED, REPLACED AND IT WAS RETURNED.
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". LATER HEALTHCARE PROFESSIONAL REPORTED "CLASS IV CAPSULAR CONTRACTURE" THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED, REPLACED AND IT WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2342498 | INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1193201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Female | Required Intervention |