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

Catalog Number	SRM-275
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture, capsular contracture baker grade unknown".Healthcare professional later reported "breast hypomastia; ptosis; capsule contraction; implant bottoming out".This record is for the right side.The device was explanted.Patient was prescribed a capsulectomy.
Event or Problem Description
Healthcare professional reported "rupture, capsular contracture baker grade unknown".Healthcare professional later reported "breast hypomastia; ptosis; capsule contraction; implant bottoming out".This record is for the right side.The device was explanted.Patient was prescribed a capsulectomy.
Additional Manufacturer Narrative
Reason for reoperation: rupture, capsular contracture baker grade unknown and migration clarification for b3: this is a partial date of event for the reported "jun 2026".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 event of "capsular contracture baker grade unknown" is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h6.Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.

• 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: 50763400
• Report Number: 9617229-2026-17532
• Device Sequence Number: 9396155
• Product Code: FTR
• UDI-Device Identifier: 10888628007062
• UDI-Public: (01)10888628007062(17)220423
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 04/23/2022
• Device Catalogue Number: SRM-275
• Device Lot Number: 3058620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/27/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 05/23/2017
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 116 LB
• Patient Race: White