INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2021-57640
- Event Type
- Injury
- Date Received
- November 29, 2021
- Date of Event
- January 1, 2019
- Report Date
- November 17, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191607285
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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.
PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: NO OBSERVED. ¿ FEVER : UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. ¿ LYMPHEDEMA : : 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. ¿ PAIN : UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. ¿ SEROMA -LATE : UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. ¿ MALPOSITION : 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. ADDITIONAL OBSERVATIONS: ¿ BLACK PARTICLES OBSERVED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED. CLARIFICATION TO D.9. RETURNED TO MFG ON: THE DEVICE HAS NOT BEEN RETURNED. SEE PHOTO ANALYSIS IN H.10.
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 SEROMA-LATE AND LYMPHEDEMA ARE A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: RUPTURE, LYMPHEDEMA, AND SEROMA-LATE.
PATIENT REPORTED LEFT SIDE "FEVER", "LYMPHEDEMA, SWELLING, PAIN, DISCOMFORT, ENCAPSULATION" AND RUPTURE. DEVICE REMAINS IMPLANTED. HEALTHCARE PROFESSIONAL THEN REPORTED LEFT SIDE "PERI-IMPLANT FLUID INCREASE," "¿IMPLANT ROTATED," "ASYMMETRY OF THE BREASTS," "DISCRETE ENHANCEMENT OF THE FUNDUS" AND "LYMPH NODES OF USUAL APPEARANCE IN AXILLARY REGIONS," AND "CAPSULAR CONTRACTURE."
DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED LEFT SIDE "FEVER", "LYMPHEDEMA, SWELLING, PAIN, DISCOMFORT, ENCAPSULATION" AND RUPTURE. DEVICE REMAINS IMPLANTED. HEALTHCARE PROFESSIONAL THEN REPORTED LEFT SIDE "PERI-IMPLANT FLUID INCREASE," "¿IMPLANT ROTATED," "ASYMMETRY OF THE BREASTS," "DISCRETE ENHANCEMENT OF THE FUNDUS" AND "LYMPH NODES OF USUAL APPEARANCE IN AXILLARY REGIONS," AND "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
A PATIENT REPORTED ¿FEVER", "LYMPHEDEMA, SWELLING, PAIN, DISCOMFORT, ENCAPSULATION", ¿IMPLANT ROTATED, WITH INCREASED PERI-IMPLANT FLUID CAUSING INCREASED BREAST VOLUME¿ AND ¿RUPTURE". DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1785377 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2358699 | 05060191607285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention | TORAGESIC |