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

Model Number	120-550
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	06/15/2019
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 event of "capsular contracture, baker grade unknown" 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.
Event or Problem Description
Patient reported right side "huge and hard." patient additionally reported a right side capsular contracture, baker grade unknown.Device remains implanted.
Event or Problem Description
Healthcare professional reported right side rupture and "patient¿s concern with the product".
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: visibility/palpability: unable to observe as it is a medical event not related to the device.Hematoma: unable to observe as it is a medical event not related to the device.Capsular contracture: unable to observe as it is a medical event not related to the device.Rupture: broken observed on posterior side assessed as unidentified (tear)opening (shell thickness was within specification).Anxiety-product/procedure: unable to observe as it is a medical event not related to the device.Additional observations: creases were observed.Brown particles observed in the gel and surface of the shell.Wear abrasion observed.No further actions are required as the device was implanted.
Event or Problem Description
Patient reported right side "huge and hard".Patient later reported capsular contracture, baker grade iv.Healthcare professional then reported exchange from textured to smooth due to the patient's concern and possible rupture.Healthcare professional additionally reported seroma and hematoma.The device has been explanted.
Event or Problem Description
The device has been explanted.
Event or Problem Description
Patient reported right side "huge and hard".Patient later reported capsular contracture, baker grade iv.Healthcare professional then reported exchange from textured to smooth due to the patient's concern and possible rupture.Healthcare professional additionally reported seroma and hematoma.Patient representative later reported "patient alleges that one or more biocell devices caused personal injuries and damages including but not limited to the following: significantly increased risk of developing cancer, emotional distress, including fear and anxiety of developing cancer, accumulation of foreign and adulterated silicone particles in body, including the resulting inflammation, cellular damage, past and future medical expenses, physical pain and suffering from explantation, including permanent scarring and disfigurement." patient has not been diagnosed with bia-alcl.The device has been explanted.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 15237290
• Report Number: 9617229-2022-01509
• Device Sequence Number: 4768814
• Product Code: FTR
• UDI-Device Identifier: 10888628002586
• UDI-Public: 10888628002586
• 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: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/12/2024

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: 02/13/2020
• Device Model Number: 120-550
• Device Catalogue Number: 120-550
• Device Lot Number: 2716360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 05/24/2023; 07/05/2023; 07/23/2024
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/12/2022; 06/13/2023; 07/27/2023; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2015
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 64 KG