MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Inspira Smooth Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	SRL-230
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called to report "rupture" and "encapsulation, the baker grade is unknown".Later the healthcare professional reported the patient is "asymptomatic" and "possible rupture" per ct scan of abdomen.This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
Clarification to b3 date of event: partial date of january 2026 as the patient reported symptom onset "last month", relative to on 17/feb/2026.A review of the device history record has been completed.No deviations or non-conformance's noted.The event of "capsular contracture" is a physiological complication and analysis of the device generally does not assist abbvie 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: rupture; capsular contracture, baker grade unknown.
Event or Problem Description
Patient called to report "rupture" and "encapsulation, the baker grade is unknown".Later the healthcare professional reported the patient is "asymptomatic" and "possible rupture" per ct scan of abdomen.This record is for the left side.The device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h.6.

• 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 ; +1(847)936-6324
• MDR Report Key: 24553102
• Report Number: 9617229-2026-04299
• Device Sequence Number: 9377719
• Product Code: FTR
• 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: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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 Expiration Date: 05/15/2022
• Device Catalogue Number: SRL-230
• Device Lot Number: 3069211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 06/15/2017
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 135 LB
• Patient Race: White