MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SRX-545
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade iii".This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Lab analysis: based on the product analysis performed, the assessments of the complaint codes are: ¿ capsular contracture: unable to observe as it is not related to the manufacturing process.A workmanship was observed not related to the complaint for a split in patch event.A further investigation is requested.As per the investigation procedure, deformation and crease were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.Further investigation: the review of the documentation associated to the manufacturing process indicates that all devices involved in this work order were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.According to the device analysis performed in the laboratory was observed split (ss) in patch area.The event of capsular contracture was unable to observe, and the workmanship has not relation to reported complaint.Therefore, the reported event was not confirmed.A review of the current risk documents pfmea-silicone filled bi and sizer assy rev.8.0 was performed, and the event of split in patch is a known event, for which current process controls and inspections are established to reduce the incidence of this defect.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with split in patch will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade iii".This record is for the right side.The device was explanted, replaced and returned.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
Device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 22792335
• Report Number: 9617229-2025-13708
• Device Sequence Number: 12959171
• Product Code: FTR
• UDI-Device Identifier: 10888628007567
• UDI-Public: (01)10888628007567(10)3475461(11)201117(17)251017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2025
• Device Catalogue Number: SRX-545
• Device Lot Number: 3475461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 10/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/07/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 79 KG