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

Catalog Number	SRX-650
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	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "unknown rupture".This record is for right side.Device was explanted, replaced and will be returned.
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.Reason for reoperation: rupture.
Event or Problem Description
Healthcare professional reported "unknown rupture".This record is for right side.Device was explanted, replaced and will be returned.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d1, d4, d6(a), g4.
Event or Problem Description
Patient reported that the device was intact.This record is no longer reportable to the fda and will be un-reported.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, h6.
Additional Manufacturer Narrative
Correction to b5 description of event: the previous supplemental medwatch reported the right-side device was intact and this record is no longer reportable to the fda.However, after additional review, it has been identified that the patient was mistaken when reporting the affected side of the rupture.The explanting physician's office confirmed right side rupture after explant surgery occurred and that information remains valid.This medwatch is being submitted to re-report the event of rupture.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Reason for reoperation: rupture.
Event or Problem Description
Healthcare professional reported "unknown rupture" and later confirmed "implant that was ruptured was on [the] right side".Later patient reported rupture diagnosed via ultrasound.This record is for right side.Device was explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: h3, h6.Device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: - rupture: observed a missing piece of shell through microscopic inspection assessed as inconclusive.No further actions are required as it is not related to the manufacturing process.None of the other observations performed during the device analysis non-penetrating nicks are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Healthcare professional reported "unknown rupture" and later confirmed "implant that was ruptured was on [the] right side".Later patient reported rupture diagnosed via ultrasound.This record is for right side.Device was explanted.

• 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: 23973660
• Report Number: 9617229-2026-00267
• Device Sequence Number: 9013083
• Product Code: FTR
• UDI-Device Identifier: 10888628007604
• UDI-Public: 10888628007604
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: SRX-650
• Device Lot Number: 3453320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 03/12/2026; 04/15/2026; 05/11/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/04/2026; 04/02/2026; 05/07/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 57 KG