FDA Adverse Event Injury Summary report: N

INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

MDR report key: 20131612 · Received September 3, 2024

Report

Report Number: 9617229-2024-20012
Event Type: Injury
Date Received: September 3, 2024
Date of Event: January 31, 2025
Report Date: May 21, 2025
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FTR
PMA / PMN Number: P020056
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE III/IV.

Additional Manufacturer Narrative · 0

CLARIFICATION TO B5 DESCRIPTION OF EVENT AND H6 ADVERSE EVENT PROBLEM IN THE PREVIOUS MEDWATCHES: SUPPLEMENTAL MEDWATCH #1 UN-REPORTED THE EVENT OF RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV DUE TO THE HEALTHCARE PROFESSIONAL CLARIFYING THEIR INITIAL REPORT AND STATING "PATIENT IS NOT EXPERIENCING ANY ISSUES". HEALTHCARE PROFESSIONAL LATER REPORTED A CLINIC VISIT FROM THE PATIENT ON (B)(6) 2025, AND SUPPLEMENTAL MEDWATCH #2 WAS SUBMITTED TO REPORT THE NEW DIAGNOSIS OF RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. 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. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE III. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A6, B3, B5, B6, B7, D6B, E1, H6, H11.

Additional Manufacturer Narrative · 0

ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, B6, B7, H6.

Additional Manufacturer Narrative · 0

ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6 DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, CREASES, DEFORMATION AND WEAR ABRASION WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.