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

Catalog Number	SSF-365
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "ruptured", "implant rupture", "implant intact", "patient taken to or to replace ruptured implant.Upon opening incision implant was intact".Per operative report "baker iii capsular contracture" and "it was removed without difficulty and found to be entirely intact.There was a small amount of serous fluid in the pocket that drained spontaneously" and "an anterior capsulotomies was also carried out" and "the original, intact implant was replaced into the existing spaces without difficulty".This record is for right side.Device remains implanted.Device will not be returned.
Additional Manufacturer Narrative
E1.Zip code: (b)(6).A review of the device history record has been completed.No deviations or non-conformances noted.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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, improper or incorrect procedure or method.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5 d6b h6 clarification to initial medwatch h6: disregard a2303 improper or incorrect procedure or method, this will be unreported as it is not a serious event.
Event or Problem Description
The device has been explanted and will not be returned.

• 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: 23966158
• Report Number: 9617229-2026-00194
• Device Sequence Number: 13053685
• Product Code: FTR
• UDI-Device Identifier: 10888628033146
• UDI-Public: (01)10888628033146(10)3631204(11)220809(17)270709
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Catalogue Number: SSF-365
• Device Lot Number: 3631204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/22/2026
• Date Device Manufactured: 08/09/2022
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 50 KG