INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-12951
- Event Type
- Injury
- Date Received
- July 31, 2025
- Date of Event
- April 22, 2025
- Report Date
- October 24, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 5060191606561
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- 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 INDICATES THAT THERE WERE NO OTHER RECORDS RELATED TO THIS EVENT FOR UNITS MANUFACTURED ON LOT NUMBER 2180539. THE SEARCH CRITERIA FOR THESE QUERIES ARE MENTIONED IN QPP07-01-004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE AND REVISION 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 AND A010402 MIGRATION. THE EVENT OF "GRANULOMA" 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: DEVICE RUPTURE AND GRANULOMA.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D.9, H.3, H.6. DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: RUPTURE AND SILICONE MIGRATION: OBSERVED BROKEN DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING. LYMPHADENOPATHY: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. GRANULOMA: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, CREASES AND WEAR ABRASION WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B3; H6
HEALTHCARE PROFESSIONAL REPORTED "COMPLETE RUPTURE OF THE PROSTHESIS", "PRESENCE OF AXILLARY AND MAMMARY SILICONOMA INTERNAL", "LOW LOCATED AXILLARY GANGLION APPEARS A LITTLE MORE HYPERTROPHIED, SILICONOMA RUPTURE ", "GEL EXTRAVASATION", "GRANULOMA OF THE TYPE SILICONOMA" AND "PAIN". EVENTS CONFIRMED VIA ULTRASOAUND AND MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
HEALTHCARE PROFESSIONAL REPORTED "COMPLETE RUPTURE OF THE PROSTHESIS", "PRESENCE OF AXILLARY AND MAMMARY SILICONOMA INTERNAL", "LOW LOCATED AXILLARY GANGLION APPEARS A LITTLE MORE HYPERTROPHIED, SILICONOMA RUPTURE ", "GEL EXTRAVASATION", "GRANULOMA OF THE TYPE SILICONOMA" AND "PAIN". EVENTS CONFIRMED VIA ULTRASOAUND AND MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
HEALTHCARE PROFESSIONAL REPORTED "COMPLETE RUPTURE OF THE PROSTHESIS", "PRESENCE OF AXILLARY AND MAMMARY SILICONOMA INTERNAL", "LOW LOCATED AXILLARY GANGLION APPEARS A LITTLE MORE HYPERTROPHIED, SILICONOMA RUPTURE ", "GEL EXTRAVASATION", "GRANULOMA OF THE TYPE SILICONOMA" AND "PAIN". EVENTS CONFIRMED VIA ULTRASOAUND AND MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165686 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2180539 | 5060191606561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Required Intervention |