MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	MM-410185
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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/will be requested.No additional information is available at this time.Reason for reoperation: rupture; capsular contracture, baker grade iii.
Event or Problem Description
Healthcare professional reported right side rupture and capsular contracture, baker grade iii.The device has been explanted and replaced.
Event or Problem Description
Previous medwatch submission noted rupture.Upon further information, abbvie has determined that the event of rupture did not occur.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture : observed, opening assessed as unidentified (tear) opening.Shell thickness was within specification).Capsular contracture : unable to observe since it is a medical event and is not related to the device.No additional observation.No further actions are required as no issues with the manufacturing process are observed.
Event or Problem Description
Healthcare professional reported "rupture and capsular contracture".Healthcare professional later reported "grade 3".Healthcare professional later reported accident.This record is for the right side.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported event of rupture, silicone migration, pain, anxiety - product/ procedure, inflammation/irritation, varied injuries and capsular contracture was received on (b)(6) 2024, with lot number 2642830.Based on the device analysis grid, the assessments of the complaint are: ¿ rupture and silicone migration: observed, opening assessed as unidentified (tear) opening.Shell thickness was within specification).¿ capsular contracture : unable to observe since it is a medical event and is not related to the device.¿ pain: unable to observe since it is a medical event and is not related to the device.¿ anxiety - product/ procedure: unable to observe since it is a medical event and is not related to the device.¿ inflammation/irritation: unable to observe since it is a medical event and is not related to the device.¿ varied injuries: unable to observe since it is a medical event and is not related to the device.No additional observation.No further actions are required as no issues with the manufacturing process are observed.
Event or Problem Description
Egal affairs later reported "plaintiff alleges that one or more biocell devices caused personal injuries and damages including but not limited to the following: increased risk of bia-alcl, emotional distress including fear and anxiety of developing cancer, accumulation of foreign and adulterated silicone particles in their bodies, including the resulting inflammation, cellular damage, and subcellular damage, past and future medical expenses, physical pain and suffering from explantation".

• Brand Name: STYLE 410 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: 19180707
• Report Number: 9617229-2024-07181
• Device Sequence Number: 17949859
• Product Code: FTR
• UDI-Device Identifier: 10888628003590
• UDI-Public: 10888628003590
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/02/2024

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: 07/18/2019
• Device Catalogue Number: MM-410185
• Device Lot Number: 2642830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 06/11/2024; 11/08/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/07/2024; 07/02/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2014
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Hispanic
• Patient Race: White