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

Catalog Number	N-TSF295
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	08/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's representative reported left side "palpable nodule in axillary extension." determined as not device related, "breast with predominantly heterogeneous tissue pattern, with morphostructural changes related to previous mammoplasty." "small cysts sparse in the breast, measuring up to 0.9 cm."(which is not device related) "accessory axillary breast, corresponding to the palpable nodule reported by the patient." "the first for prosthesis explanting, a block explant of the capsule as there was fluid leakage in the patient's body", "it was informed that the prostheses caused the patient suffering.It was informed that the addiction of the product has brought you incalculable losses and may bring even greater and irreversible." "it was reported that it is like a "time bomb" "[as reported]" that could at any moment burst."in the case of the patient, it literally burst." "[as reported]".It was informed that the prosthesis shows clear signs of product defect" " since it presents intense pain and constant swelling,".The device remains implanted.
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number: 9617229-2022-19399.The event of seroma 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: seroma.

• 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: 50189010
• Report Number: 9617229-2026-14937
• Device Sequence Number: 10008129
• Product Code: FTR
• UDI-Device Identifier: 10888628034105
• UDI-Public: (01)10888628034105(17)190414
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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 Expiration Date: 04/14/2019
• Device Catalogue Number: N-TSF295
• Device Lot Number: 2586596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/09/2026
• Supplement Report FDA Received Date: 09/07/2026
• Date Device Manufactured: 04/14/2014
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 118 LB