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

Catalog Number	MF-410335
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called to report, right side rupture.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: rupture.
Event or Problem Description
Patient called to report right side rupture.Device was explanted.Later, hcp reported called to report right side replacement from textured to smooth due to the patients concern of the product.Later, hcp reported double capsule and patient deformity.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d.9, h.3, h.6.Device evaluation: based on the device analysis grid, the assessments of the complaint are: exposure: unable to observe as it is not related to the manufacturing process.Anxiety-product/procedure: unable to observe as it is not related to the manufacturing process.Rupture: not observed.Visibility/palpability: unable to observe as it is not related to the manufacturing process.Double capsule: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, deformation was 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
Device has been explanted and replaced.
Event or Problem Description
Patient reported right side rupture via mri.Healthcare professional later reported "biocell recall." healthcare professional additionally reported "textured" and "hole, non-specific." device has been explanted, replaced, and discarded.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a5, b1, b5, b6, d4, d6b, e1, g2, h4, h6.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d4, h4.
Event or Problem Description
Patient called to report right side rupture.Later, hcp reported called to report right side replacement from textured to smooth due to the patients concern of the product.Later, hcp reported double capsule and patient deformity.Device was explanted.

• 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: 19535747
• Report Number: 9617229-2024-15118
• Device Sequence Number: 17748564
• Product Code: FTR
• UDI-Device Identifier: 10888628003460
• UDI-Public: (01)10888628003460(10)2729419(11)150416(17)200316
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/06/2025

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: 06/15/2020
• Device Catalogue Number: MF-410335
• Device Lot Number: 2729419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 02/05/2025; 03/26/2025; 04/29/2025; 07/14/2025
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 02/26/2025; 04/17/2025; 05/20/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2015
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: American Indian Or Alaskan Native