MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	TRF-365
Medical Device Problem Codes	Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "white cloud in my breast area" and "extreme density" diagnosed via mammogram.Later, patient reported implant has "popped" and "high blood pressure", "soreness in right arm and breast" and "feeling dizzy and a little off".Later, patient reported "implant exchange due concern with the product" and "tingling in arms and legs, plus blood pressure is sky high".Later, healthcare professional reported "patient's concern with the product" and "rupture".This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: rupture.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: ¿ nipple sensation increase/decrease: unable to observe as it is not related to the manufacturing process.¿ breast pain: unable to observe as it is not related to the manufacturing process.¿ varied injuries: unable to observe as it is not related to the manufacturing process.¿ anxiety - product/ procedure: unable to observe as it is not related to the manufacturing process.¿ rupture: not observed.As per the investigation procedure, creases and deformation were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
There are currently no reportable events against device on record.This record is no longer reportable to the fda and will be un-reported.
Event or Problem Description
The device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.

• 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 ; 8479366324
• MDR Report Key: 22084860
• Report Number: 9617229-2025-08633
• Device Sequence Number: 7885261
• Product Code: FTR
• UDI-Device Identifier: 10888628008311
• UDI-Public: (01)10888628008311(10)2875212(11)160228(17)210128
• 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: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2025

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: 01/28/2021
• Device Catalogue Number: TRF-365
• Device Lot Number: 2875212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 07/17/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 07/01/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2016
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White