INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-08036
- Event Type
- Injury
- Date Received
- May 9, 2024
- Date of Event
- January 1, 2023
- Report Date
- October 1, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE, SEROMA AND EDEMA WAS RECEIVED ON AUGUST 22, 2024 WITH LOT NUMBER 2854441. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. SEROMA: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. EDEMA: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE DEFORMATION AND PARTICLES WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENTS OF CAPSULAR CONTRACTURE AND SEROMA-LATE ARE PHYSIOLOGICAL COMPLICATIONS 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. THE REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE IV, PERIPROSTHETIC FLUID.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: SEROMA : UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. EDEMA : UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. CAPSULAR CONTRACTURE : UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.
EXPLANTING PHYSICIAN REPORTED RIGHT SIDE SWELLING, CAPSULAR CONTRACTURE, BAKER GRADE IV AND PERIPROSTHETIC FLUID DIAGNOSED VIA ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED WITH A COMPLETE CAPSULECTOMY AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE CAPSULE WAS SENT FOR ANATOMICAL AND HISTOPATHOLOGICAL STUDY WHICH FOUND FIBROSIS IN RELATION TO THE PERIPROSTHETIC CAPSULE AND CD30 NEGATIVE LYMPHOID COMPONENT.
EXPLANTING PHYSICIAN REPORTED RIGHT SIDE SWELLING, CAPSULAR CONTRACTURE, BAKER GRADE IV AND PERIPROSTHETIC FLUID DIAGNOSED VIA ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED WITH A COMPLETE CAPSULECTOMY AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE CAPSULE WAS SENT FOR ANATOMICAL AND HISTOPATHOLOGICAL STUDY WHICH FOUND FIBROSIS IN RELATION TO THE PERIPROSTHETIC CAPSULE AND CD30 NEGATIVE LYMPHOID COMPONENT.
EXPLANTING PHYSICIAN REPORTED RIGHT SIDE SWELLING, CAPSULAR CONTRACTURE, BAKER GRADE IV AND PERIPROSTHETIC FLUID DIAGNOSED VIA ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED WITH A COMPLETE CAPSULECTOMY AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE CAPSULE WAS SENT FOR ANATOMICAL AND HISTOPATHOLOGICAL STUDY WHICH FOUND FIBROSIS IN RELATION TO THE PERIPROSTHETIC CAPSULE AND CD30 NEGATIVE LYMPHOID COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471062 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2854441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | Required Intervention |