STYLE 68 SALINE FILLED BREAST IMPLANT

Report

Report Number: 9617229-2026-00639
Event Type: Injury
Date Received: January 9, 2026
Date of Event: December 15, 2025
Report Date: April 29, 2026
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FWM
PMA / PMN Number: P990074
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, H6 (EXPLANT DATE NOT PROVIDED).

Additional Manufacturer Narrative · 0

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: DEFLATION.

Additional Manufacturer Narrative · 0

ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D6B.

Additional Manufacturer Narrative · 0

CLARIFICATION TO H10 RELATED REPORT NUMBERS: INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED VIA EMDR MANUFACTURER REPORT NUMBERS 9617229-2026-00474 AND 9617229-2026-00475. ALL INFORMATION HAS BEEN CONSOLIDATED INTO THIS REPORT.

Additional Manufacturer Narrative · 0

"IMPLANT DATE OF 26/MAY/2011 IS BEFORE THE MANUFACTURING** DATE OF BOTH DEVICES..." DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT DEFLATION WAS RECEIVED ON APRIL 06,2026, WITH LOT NUMBER 3252983 . PER THE INVESTIGATION PROCEDURE, THE DEVICE IS ANALYZED THROUGH VISUAL INSPECTION MICROSCOPIC INSPECTION IF OPENINGS ARE OBSERVED AND A WEIGHT VERIFICATION. (IF APPLICABLE).PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ DEFLATION: OBSERVED AND OPENING THROUGH MICROSCOPIC INSPECTION ASSESSED AS ADHESIVE FAILURE. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.