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

Catalog Number	SCM-520
Medical Device Problem Codes	Gel Leak (1267); Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number 9617229-2023-17607.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 unknown, rupture.A review of the device history record has been completed.No deviations or non-conformance's noted.
Event or Problem Description
Patient reported rupture and leaking confirmed via sonogram.Later, healthcare professional reported capsular contracture baker grade unknown.This record is for right side.The device was explanted.
Additional Manufacturer Narrative
The right side device was found intact upon explant, hence unreporting the previously reported rupture.The event of seroma is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Lab analysis: based on the product analysis performed, the assessments of the complaints are: capsular contracture: unable to observe as it is not related to the manufacturing process.Seroma-late: unable to observe as it is not related to the manufacturing process.As per the investigation procedures, observed three openings and creases were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.Additional, changed, and/or corrected data: a6, b5, b6, d9, h3, h6.
Event or Problem Description
Healthcare professional further reported "large seroma", "nodule".The device has been explanted and replaced.Observations during surgery "hole on patch side".The right side device was found intact upon explant, hence unreporting the previously reported rupture.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6 device evaluation: based on the product analysis performed, the assessments of the complaints are: capsular contracture: unable to observe as it is not related to the manufacturing process.Seroma-late: unable to observe as it is not related to the manufacturing process.Gel bleed: not observed since the shell barrier can be observed through microscopic inspection.As per the investigation procedures, observed three openings and creases were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
Patient reported rupture and leaking confirmed via sonogram.Later, healthcare professional reported device intact, capsular contracture baker grade unknown, "nodule" and "large seroma".This record is for right side.The device was 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: 22073551
• Report Number: 9617229-2025-08547
• Device Sequence Number: 8702072
• Product Code: FTR
• UDI-Device Identifier: 10888628029958
• UDI-Public: (01)10888628029958(10)3267862(11)181018(17)230918
• 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: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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: 09/18/2023
• Device Catalogue Number: SCM-520
• Device Lot Number: 3267862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 07/15/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/08/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2018
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White