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	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Depression (2361)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient representative reported "replace breast prostheses due to the recall", "pain", "capsular contracture baker grade iii".Patient's representative later reported "swelling", "circumscribed oval hypoechoic nodule at the junction of the lateral quadrants of the left breast at 3 o'clock" which is not device related.Later patient representative reported "contracture of the prosthesis, as well as folding of the elastomer against the implant", "breast pain, which was accompanied by deformity of the prosthesis and local inflammation", "learned that there was a link between the implanted silicone and a rare type of cancer", "insecurity, panic, fibromyalgia which is not device related, and depression".This record is for the left side.Device has been explanted.
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number 9617229-2020-08735.A review of the device history record has been completed.No deviations or non-conformances noted.The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: capsular contracture baker grade iii, depression.This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.

• 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: 50059734
• Report Number: 9617229-2026-14276
• Device Sequence Number: 10687366
• Product Code: FTR
• UDI-Device Identifier: 10888628034105
• UDI-Public: (01)10888628034105(17)171121
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 11/21/2017
• Device Catalogue Number: N-TSF295
• Device Lot Number: 2377164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 11/21/2012
• 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: 22 YR
• Patient Sex: Female