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

Catalog Number	SRX-560
Medical Device Problem Codes	Material Rupture (1546); Malposition of Device (2616); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient representative reported possible rupture confirmed by ultrasound.This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.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.
Event or Problem Description
It has been determined that the event of rupture did not occur.Therefore, this record is no longer reportable to the fda and will be unreported.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, h.6.
Event or Problem Description
Patient's spouse reported right side "possible rupture" diagnosed via ultrasound.Healthcare professional later reported "despite ultrasound read of [right side] implant rupture, they were intact but flipped", "likely this was a fold issue", "defect in the implant even if there was no frank rupture", "implant malposition", "robust crease noted on medial quadrant", "0 holes observed", "bottoming out", and "high riding nipples".Device has been explanted and replaced.
Additional Manufacturer Narrative
Clarification to h6 adverse event problem: supplemental medwatch #1 un-reported this record after healthcare professional reported "0 holes observed" on the explanted right side device.This record is now reportable again due to the report of implants being found "flipped", captured as a150202 malposition of device.Reason for reoperation: suspected rupture; implants found "intact but flipped" during surgery device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ changes in sleep habits: unable to observe as it is not related to the manufacturing process.¿ crease/folding of implant: observed creases on the device.¿ flipping: observed creases on the device.As per the investigation procedure, deformation were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• 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: 22108805
• Report Number: 9617229-2025-08851
• Device Sequence Number: 7275764
• Product Code: FTR
• UDI-Device Identifier: 10888628007574
• UDI-Public: (01)10888628007574(10)1252389(11)240708(17)290608
• 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: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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 Catalogue Number: SRX-560
• Device Lot Number: 1252389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 08/12/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/22/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White