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

Catalog Number	N-TRM360
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
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: "ruptured" and "capsular fibrosis".
Event or Problem Description
Patient reported a "ruptured" and "capsular fibrosis".This record is for the left side.The device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.3., d.6a., d.6b., h.6.
Event or Problem Description
Patient reported a "ruptured" and "capsular fibrosis".Later through medical report healthcare professional reported "implant inversion", "double capsule formation" and confirmed "capsular fibrosis iii".This record is for the left side.The device was explanted.
Event or Problem Description
Patient reported a "ruptured" and "capsular fibrosis".Later through medical report healthcare professional reported "implant inversion", "double capsule formation" and confirmed "capsular fibrosis iii".This record is for the left side.The device was explanted.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported events of capsular contracture and double capsule was received on jun 22, 2026, with lot number 2501919.Per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification.Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: - capsular contracture: unable to observe through visual inspection as it is a physiological phenomenon.-double capsule: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (observed broken device, missing piece of shell, creases and wear abrasion) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.Additional, changed, and/or corrected data: d.9., h.2., h.3., h.6.

• Brand Name: Inspira Textured 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: 24608233
• Report Number: 9617229-2026-04680
• Device Sequence Number: 10334130
• 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: 2014
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2026

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: 09/13/2018
• Device Catalogue Number: N-TRM360
• Device Lot Number: 2501919
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 07/02/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/18/2026; 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2013
• 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: 40 YR
• Patient Sex: Female