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

Catalog Number	SCF-650
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side ¿tightness, lump, implant sits high, feels abnormal, capsulectomy, can feel other things¿ diagnosed via mammogram and "exchange".Healthcare professional later reported "capsular contracture baker grade iii, hardness and pain" diagnosed via sonogram.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ crease / folding of implant: observed creases on device.¿ capsular contracture: unable to observe since it is a medical event and is not related to the device.As per the investigation procedure, deformation and wear abrasion were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Additional Manufacturer Narrative
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, lump/nodule, visibility/palpability.
Event or Problem Description
Patient reported left side ¿tightness, lump, implant sits high, feels abnormal, capsulectomy, can feel other things¿ diagnosed via mammogram and "exchange".Healthcare professional later reported "capsular contracture baker grade iii, hardness and pain" diagnosed via sonogram.Device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH COHESIVE 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: 23127223
• Report Number: 9617229-2025-16127
• Device Sequence Number: 20660723
• Product Code: FTR
• UDI-Device Identifier: 10888628030183
• UDI-Public: (01)10888628030183(10)3448097(11)200702(17)250602
• 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: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2025
• Device Catalogue Number: SCF-650
• Device Lot Number: 3448097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2020
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American