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

Catalog Number	N-TRF345
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "implant rupture", "cysts", "small avascular cysts", "fibroadenoma", "fibroadenomatosis", "shallow folds", "integrity of the endoprosthesis impaired in the projection of the inner quadrant", "heliomas", "silicogranulomas", "capsule is unevenly thickened", double circuit of the endoprosthesis, "axillary lymph nodes on the sides are increased" and "axillary lymph node hyperplasia".Later healthcare professional reported "pain", "changes in shape", "density" and "implant rupture".Healthcare professional later reported capsular contracture baker grade ii.This record is for the left side.The device was explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: it is not possible to determine the lot number or catalog number through the photos provided.Visual analysis of the photographs identified: rupture: observed, opening on the device but cannot perform an assessment of the opening as no microscopic analysis can be performed.Capsular contracture: unable to observe since it is not related to the device.No additional observations are performed.No further actions are required since no issue in the manufacturing of the device is observed.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.

• 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: 50667882
• Report Number: 9617229-2026-17041
• Device Sequence Number: 10175043
• Product Code: FTR
• UDI-Device Identifier: 10888628008304
• UDI-Public: (01)10888628008304(17)170827
• 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: 2013
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 08/27/2017
• Device Catalogue Number: N-TRF345
• Device Lot Number: 2335714
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 08/27/2012
• 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