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

Catalog Number	SRLP-265
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture" confirmed via mammogram/ultrasound.This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
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 system identified that there were other records for units manufactured on lot number 3596117 : 2731848: no complaint against the device.Device not returned to device analysis.(b)(6): capsular contracture (a010102 - device appears to trigger rejection, e2303 - capsular contracture).Device returned to device analysis.The search criteria of these queries are mentioned on qpp07-01-004-her1-g02 (v6.0).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.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.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5; d6b; h6.
Event or Problem Description
Healthcare professional reported left side rupture, pain, fat necrosis nodules within breasts, and capsular contracture, baker grade i.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side rupture, capsular contracture, baker grade i (with pain) and necrotic nodules.The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6 device evaluation: based on the product analysis performed, the assessments of the complaint codes are: ¿ rupture: observed an opening assessed as surgical damage.A piece of missing shell assessed as inconclusive.¿ lump/nodule: unable to observe as it is not related to the manufacturing process.¿ capsular contracture: unable to observe as it is not related to the manufacturing process.No additional observations performed on the device.No further actions are required.

• 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: 22412069
• Report Number: 9617229-2025-11141
• Device Sequence Number: 8352903
• Product Code: FTR
• UDI-Device Identifier: 10888628006881
• UDI-Public: (01)10888628006881(10)3596117(11)220307(17)270207
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SRLP-265
• Device Lot Number: 3596117
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/14/2025; 08/25/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/06/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White