STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-19195
- Event Type
- Injury
- Date Received
- November 6, 2025
- Date of Event
- November 26, 2011
- Report Date
- December 31, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- UDI-DI
- 10888628000421
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 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. THREE ADDITIONAL COMPLAINTS WERE NOTED FOR DEVICES STERILIZED UNDER STERILIZATION RUN 110581. 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.
DEVICE EVALUATION: PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ DEFLATION: OBSERVED AN OPENING THROUGH MICROSCOPIC INSPECTION ASSESSED AS UNIDENTIFIED (TEAR) OPENING. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. ¿ CYST(S): UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. ¿ INFECTION (LATE ONSET): UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (CREASES) 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 INFECTION (LATE ONSET) 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: DELFATION, CYST, AND INFECTION (LATE ONSET) FI SUMMARY: 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 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. THREE ADDITIONAL COMPLAINTS WERE NOTED FOR DEVICES STERILIZED UNDER STERILIZATION RUN (B)(4). 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.
PATIENT REPORTED "BREAST INFECTION AND TREATMENT FOR SEBACEOUS CYST". HEALTHCARE PROFESSIONAL LATER REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
PATIENT REPORTED "BREAST INFECTION AND TREATMENT FOR SEBACEOUS CYST". HEALTHCARE PROFESSIONAL LATER REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WAS RETURNED.
PATIENT REPORTED "BREAST INFECTION AND TREATMENT FOR SEBACEOUS CYST". HEALTHCARE PROFESSIONAL LATER REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2085430 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 1554555 | 10888628000421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention |