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

Model Number	FM-410310
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); Swollen Lymph Nodes/Glands (4432)
Date of Event	10/15/2018
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 reported events 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.Reason for reoperation: capsular contracture baker grade unknown, exchange from textured to smooth implants due to the concerns with the product.
Event or Problem Description
Patient reported left capsular contracture and exchange from textured to smooth implants due to the concerns with the product.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b6, h6.
Event or Problem Description
Physician later reported rupture.Device remains implanted.
Event or Problem Description
Patient reported left implant protrudes toward shoulder blade which they think may be a possible capsular contracture and exchange from textured to smooth implants due to the concerns with the product.Patient representative reported the following: manufacturing defect, failure to warn, design defect, negligence and consumer fraud against a textured implant device.Healthcare provider reported rupture.Healthcare provider provided mri which noted rupture and "findings: breast retropectoral implant.Breast intracapsular rupture.Other: axillary enlarged lymph nodes measuring up to 12 mm short axis containing silicone are likely reactive." a mammogram was also noted that showed rupture.Healthcare provider provided an operative report which noted "capsular contracture baker grade iv and rupture.The implant was noted to be grossly ruptured with extensive silicone and implant material leakage." the device has been explanted.
Additional Manufacturer Narrative
The event of "lymphadenopathy" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Patient reported left implant "protrudes toward shoulder blade", which they think may be a possible capsular contracture [baker grade unknown], and exchange from textured to smooth implants due to the concerns with the product.Patient representative reported the following: manufacturing defect, failure to warn, design defect, negligence and consumer fraud against a textured implant device.Healthcare professional reported left side findings via mammogram and mri: "breast intracapsular rupture" and "axillary enlarged lymph nodes measuring up to 12 mm short axis containing silicone are likely reactive." healthcare professional later reported left side capsular contracture baker grade iv confirmed during surgery, "implant was noted to be grossly ruptured with extensive silicone and implant material leakage".The device has been explanted.
Additional Manufacturer Narrative
Clarification to d9 returned to mfg on: device has not been returned.Photos of the explanted device have been analyzed.Continued h.6.Health effect - impact code: f2201 - biopsy.The events of "capsular contracture" and "lymphadenopathy" are physiological complications and analysis of the device generally does not assist abbvie in determining a probable cause for these events.Reason for reoperation: rupture; capsular contracture baker grade iv; "axillary enlarged lymph nodes measuring up to 12 mm short axis containing silicone are likely reactive".Photo analysis: visual analysis of the photographs identified: rupture: observed, opening on the device but cannot perform an assessment of the opening as no microscopic analysis can be performed.Anxiety - product/ procedure: unable to observe as it is a medical event that is not related to the device.Unable to observe as it is a medical event that is not related to the device.Lymphadenopathy: unable to observe as it is a medical event that is not related to the device.Capsular contracture: unable to observe as it is a medical event that is not related to the device.Silicone migration: unable to observe as it is a medical event that is not related to the device.No further actions are required since no issue in the manufacturing of the device is observed.Additional, changed, and/or corrected data: b1, b5, b6, b7, g2, h6, h11.

• 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 10477234
• Report Number: 9617229-2020-13586
• Device Sequence Number: 2991422
• Product Code: FTR
• UDI-Device Identifier: 10888628002845
• UDI-Public: 10888628002845
• Combination Product (Y/N): N
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/14/2025

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: 02/04/2020
• Device Model Number: FM-410310
• Device Catalogue Number: FM-410310
• Device Lot Number: 2711129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 06/12/2024; 03/10/2025; 03/13/2025
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 06/25/2024; 03/12/2025; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• 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: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic