MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542655
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Breast Cancer (1759); Deformity/ Disfigurement (2360)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female who underwent a breast augmentation revision with a mentor siltex round moderate profile, 350cc saline prosthesis experienced left-sided deflation and breast pain post procedure.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.[safety_note] impacted product number: ip-01779567|product name: sal siltex rnd diap pkg 350cc|notes: it was reported that a female patient who underwent breast augmentation revision surgery with mentor sal siltex rnd diap pkg 350cc gel breast implants was diagnosed with breast cancer.Per the additional information received on 03-jan-2025, the patient reported being diagnosed with breast cancer.The right breast implant was replaced, but the left implant was not due to ongoing cancer treatment.The right breast implant was removed on (b)(6)2024.The new replacement on right is cat:3505375bc sn (b)(6), she went from saline to gel.This report relates to the right side.No further information was provided at the time of this review.Should more information become available, this note will be updated and the case will be reassessed.
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: breast cancer.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Per the additional information received on 10-jan-2025.Summary of the information provided: ¿confirmed patient did have surgery on (b)(6) 2024 to remove both implants and replace the right side.Patient has not replaced left side yet as she was going through treatment on the left side for her cancer¿.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The initial report mistakenly included incorrect dates for both the "date of awareness" and the "submission due date." the correct "date of awareness" is january 3, 2025, which sets the "submission due date" to february 2, 2025.Therefore, the initial report is not late based on these corrected dates.
Additional Manufacturer Narrative
Per correct codification, pc breast cancer was removed from the right side (b)(6) and pc anisomastia was added.The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 21114490
• Report Number: 1645337-2025-00317
• Device Sequence Number: 7436317
• Product Code: FWM
• UDI-Device Identifier: 00081317001805
• UDI-Public: (01)00081317001805(11)040612(17)080611(10)553945
• Combination Product (Y/N): N
• Initial Reporter Country: PR
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 06/11/2008
• Device Catalogue Number: 3542655
• Device Lot Number: 5539450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 01/10/2025; 01/21/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/13/2025; 01/16/2025; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2004
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Female