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

Model Number	3542615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 60-year-old caucasian female patient underwent a breast augmentation surgery with 150cc mentor siltex round moderate profile saline breast implants.Post-operatively, the patient experienced a deflation of her right breast prosthesis as well as ptosis of the left breast, which was confirmed during a physical exam.The patient also reported experiencing flu and dehydration following the deflation of her implant.As a result, the patient underwent removal and replacement with unspecified 150cc mentor saline breast implants on (b)(6) 2023.This report is for the left implant.Refer to manufacturing report number 1645337-2022-15514 for the contralateral event.
Additional Manufacturer Narrative
The device was returned to mentor for evaluation.Mentor completed a visual inspection of the returned device.Device evaluation summary: during visual evaluation no apparent damage or visual anomalies were observed on the returned device.Some breast ptosis is a normal component of the mature breast.Ptosis becomes undesirable when the breast parenchyma predominates below the areola, droops considerably below the inframammary fold and the nipple points downward.Augmentation alone, without consideration of the ptosis can produce a less than desirable cosmetic result known as a "rock in sock" deformity or an increased ptotic appearance.Ptosis is a known complication associated with these devices and is referenced in our current product insert data sheet.At the present time, there is no sufficient evidence to show an association between breast implants and generalized illness (assessing the risks of breast implants and fda¿s vision for the national breast implant registry).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.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: 16364798
• Report Number: 1645337-2023-01609
• Device Sequence Number: 20718695
• Product Code: FWM
• UDI-Device Identifier: 00081317001720
• UDI-Public: 00081317001720
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 06/30/2017
• Device Model Number: 3542615
• Device Catalogue Number: 3542615
• Device Lot Number: 6727937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2013
• 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: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White