STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-19534
- Event Type
- Injury
- Date Received
- November 12, 2025
- Date of Event
- October 22, 2025
- Report Date
- December 11, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 10888628001466
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF "UNSPECIFIED INFECTION" 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: UNSPECIFIED INFECTION.
FURTHER INVESTIGATION RESULTS: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT UNITS INVOLVED IN THIS WORK ORDER WERE MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS RELATED TO THE REPORTED EVENT. SEAL STRENGTH INSPECTION WAS SUCCESSFULLY COMPLETED AND RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE, AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. ONE ADDITIONAL COMPLAINT WAS NOTED FOR DEVICES STERILIZED UNDER STERILIZATION RUN 112840. HOWEVER, IT IS UNLIKELY THAT THE EVENTS RELATED TO THE REPORTED INFECTION ARE ASSOCIATED WITH THE STERILIZATION METHODS UTILIZED. THE TERMINAL STERILIZATION CYCLE USED BY ABBVIE WAS DEVELOPED AND VALIDATED TO ACHIEVE A HIGH LEVEL OF STERILITY ASSURANCE. THE STERILIZATION CYCLE HAS BEEN VALIDATED TO ENSURE THAT THE CHANCE OF A NON-STERILE DEVICE IS LESS THAN ONE IN A MILLION. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH INFECTION WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED WITH THE MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT, AND NO ER/ NCR(S) WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED WITH THIS LOT AND THE COMPLAINT, NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 25/APR/2014.
PATIENT REPORTED "INFECTION". LATER PATIENT REPORTED "PAIN AND SORENESS LOCATED "BY THE RIBCAGE" AND SHORTNESS OF BREATHE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
PATIENT REPORTED "INFECTION". LATER PATIENT REPORTED "PAIN AND SORENESS LOCATED "BY THE RIBCAGE" AND SHORTNESS OF BREATHE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2501889 | STYLE 15 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1643096 | 10888628001466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |