STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-10472
- Event Type
- Injury
- Date Received
- June 24, 2025
- Report Date
- August 5, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUED E1 (PHONE NUMBER): (B)(6) A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING SYSTEM IDENTIFIED THAT THERE WERE OTHER RECORDS FOR UNITS MANUFACTURED ON LOT NUMBER 2358137: 1933471: CAPSULAR CONTRACTURE. DEVICE RETURNED TO DEVICE ANALYSIS. 1933472: RUPTURE. DEVICE RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WAS ONE ADDITIONAL COMPLAINTS OF RUPTURE FOR THIS LOT NUMBER, THE DEVICE WAS RETURNED, AND AFTER INSPECTION NO WORKMANSHIP WAS DETECTED. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01- 004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE 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 EVENT (A0412 MATERIAL RUPTURE). THE EVENT OF "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN" 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 UNKNOWN AND DEVICE RUPTURE.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED AN OPENING ASSESSED AS FOLD FLAW OPENING. CYST(S): UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, CREASES, 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 "SHELL DISRUPTION, RUPTURE¿, "CAPSULAR CONTRACTURE," BAKER GRADE UNKNOWN AND "SMALL CYST(S)" VIA ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "SHELL DISRUPTION, RUPTURE¿, "CAPSULAR CONTRACTURE," BAKER GRADE UNKNOWN AND "SMALL CYST(S)" VIA ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2063187 | STYLE 115 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2358137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |