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

Catalog Number	SRF-450
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding event, product, or patient details has been requested.No additional information is available at this time.\ \ the event of \"capsular contracture baker grade iv\" is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.\ \ 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.\ \ reason for reoperation: \"capsular contracture baker grade iv\".
Event or Problem Description
Healthcare professional reported \"capsular contracture baker grade iv\" and \"hardening\".The patient was prescribed montelukast and massage therapy.This record is for the right side.Device remains implanted.
Event or Problem Description
Healthcare professional reported \"capsular contracture baker grade iv\" and \"firmness\", later healthcare professional reported \"capsular contracture\".Patient was prescribe \"montelukast\".An implant massage was performed.This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b2, b5, d6b, h6.

• 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: 50859628
• Report Number: 9617229-2026-18040
• Device Sequence Number: 21320506
• Product Code: FTR
• UDI-Device Identifier: 10888628007345
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SRF-450
• Device Lot Number: 1301900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 05/15/2025
• 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: Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 208 LB
• Patient Race: Black Or African American