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

Catalog Number	3503330
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Cyst(s) (1800); Deformity/ Disfigurement (2360)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On november 19, 2025, the mentor analysis lab received the suspect medical device for evaluation.On december 03, 2025, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted a visual inspection, leak testing, and microscopic examination of the device.Visual analysis of the returned device revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, in accordance with mentor procedures, and it identified a tear and an area of missing material on the anterior view, measuring approximately 0.1 cm, and 0.1 cm x 0.1 cm, respectively.In addition, no other leaks sites were identified during the analysis.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Also, the microscopic examination was performed on the edges of the missing material, no parallel striations were found in an area of the missing material.Based on the information currently available, the microscopic examination of the tear and the visual evaluation of the missing material, indicates that the implant could have been damaged by an instrument during implantation.The product insert data sheet cautions to not allow cautery devices or instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, drain trocar, cannulas, or scissors to contact the device during the implantation or other surgical procedures.A breast cyst is a fluid-filled sac within the breast.One breast can have one or more breast cysts.They are often described as round or oval lumps with distinct edges.Breast cysts are usually and typically do not require treatment, but they can be drained using fine needle aspiration if the cyst is large or uncomfortable.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.Manufacturer¿s reference number: (b)(4).
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: rupture.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).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with implantation of a 330cc mentor smooth round high profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated right implant using mammogram imaging.Multiple stable bilateral oil cysts were identified on the imaging report as well.As a result, the patient underwent bilateral exchange with mentor gel implants on (b)(6) 2025.This report is for the right breast prosthesis.

• Brand Name: MENTOR SMOOTH ROUND HIGH 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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 23393768
• Report Number: 1645337-2025-11982
• Device Sequence Number: 21340722
• Product Code: FWM
• UDI-Device Identifier: 00081317001645
• UDI-Public: (01)00081317001645(17)180831(10)6855318
• Combination Product (Y/N): N
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 3503330
• Device Lot Number: 6855318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2014
• 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: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American