MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 120 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	120-500
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	03/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The events of seroma-late and capsular contracture are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: seroma-late, capsular contracture baker grade unknown.
Event or Problem Description
Patient reported "breast swollen, tender and painful", "fluid around breasts" and "exchange of textured devices due to product concern".Patient later reported "fluid with stuff in there" via ultrasound/mammogram.Patient later reported "large amount of fluid outside of device, sharp chest pain, swollen, and tender".Patient later reported "tight, swollen and tender", "filled up again after testing" and "feeling pain and nausea during procedure" via ultrasound.Patient later reported "mild chronic inflammatory cells", "chronic inflammatory cells are comprised predominantly of small mature lymphocytes without significant morphologic abnormality" and "low grade lesion" via cytology testing.Healthcare professional later reported and confirmed "fluid collection around implants" and "capsular contracture baker grade unknown" this record is for the right side.Device remains implanted.
Event or Problem Description
Healthcare professional later confirmed "fluid around breasts", "exchange of textured devices due to product concern", "large amount of fluid outside of device, sharp chest pain, swollen, and tender", "tight, swollen and tender".This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b6, d6b, h6.
Event or Problem Description
Patient reported right side "breast swollen, tender and painful", "fluid around breasts" and "exchange of textured devices due to product concern".Patient later reported "fluid with stuff in there" via ultrasound/mammogram.Patient later reported "large amount of fluid outside of device, sharp chest pain, swollen, and tender".Patient later reported "tight, swollen and tender", "filled up again after testing" and "feeling pain and nausea during procedure" via ultrasound.Patient later reported "mild chronic inflammatory cells", "chronic inflammatory cells are comprised predominantly of small mature lymphocytes without significant morphologic abnormality" and "low grade lesion" via cytology testing.Healthcare professional later reported and confirmed "fluid collection around implants" and "capsular contracture baker grade unknown".Healthcare professional later confirmed "fluid around breasts", "exchange of textured devices due to product concern", "large amount of fluid outside of device, sharp chest pain, swollen, and tender", "tight, swollen and tender".Device has been explanted and not replaced.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: ¿ anxiety - product/ procedure: unable to observe as it is not related to the manufacturing process.¿ chest pain: unable to observe as it is not related to the manufacturing process.¿ pain: unable to observe as it is not related to the manufacturing process.¿ capsular contracture: unable to observe as it is not related to the manufacturing process.¿ nausea: 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 procedure, opening, creases, wear abrasion were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• Brand Name: STYLE 120 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: 21779578
• Report Number: 9617229-2025-05566
• Device Sequence Number: 12740101
• Product Code: FTR
• UDI-Device Identifier: 10888628002579
• UDI-Public: (01)10888628002579(10)2802704(11)150908(17)200808
• 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: 2016
• 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): 08/11/2025

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: 08/08/2020
• Device Catalogue Number: 120-500
• Device Lot Number: 2802704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 07/18/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/12/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2015
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White