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

Catalog Number	SSX-800
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported via account representative reported: ¿it has happened again, the same situation¿ and ¿disfigured and had taken on a different shape.Like someone took a piece of string and put it on the center of the implant and tightened it up, kind of like a double implant or a depressed section of the implant.¿ healthcare professional further reported "shaped differently, disfigured", "malformed", "creases" and "odd shape".Affected side is left.The device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a2, d9, h3, h6.Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: - varied injurie : unable to observe as it is not related to the manufacturing process.- wrinkling: observed.- device appearance: observed deformation on device.As per the investigation procedure, crease 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
Account representative reported: ¿it has happened again, the same situation¿ and ¿disfigured and had taken on a different shape.Like someone took a piece of string and put it on the center of the implant and tightened it up, kind of like a double implant or a depressed section of the implant.¿ this record is for the left side.The device remains implanted.
Additional Manufacturer Narrative
Implant due to aesthetic appearance of the product, the otherwise unnecessary surgery would be considered a serious harm, severity 3.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: device appearance.
Additional Manufacturer Narrative
A review of the device history record has been or will be initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Event or Problem Description
The previously reported events were initially reported from a healthcare professional.Healthcare professional further reported "shaped differently, disfigured", "malformed", "creases" and "odd shape".The device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH 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: 21968654
• Report Number: 9617229-2025-07325
• Device Sequence Number: 8141751
• Product Code: FTR
• UDI-Device Identifier: 10888628033467
• UDI-Public: (01)10888628033467(10)1228622(11)240220(17)290120
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2025

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: 02/20/2024
• Device Catalogue Number: SSX-800
• Device Lot Number: 1228622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 06/05/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/03/2025; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White