MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PLUS PROFIL; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3502300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
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 prosthesis deflation.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.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation procedure with a mentor smooth round moderate plus profile 300cc saline breast prosthesis that deflated post implantation.Deflation of the patient¿s left breast prosthesis was reported.As a result, the patient underwent explantation on (b)(6) 2025.
Additional Manufacturer Narrative
On 16-dec-2025, mentor received additional information about the event.It was initially reported that it was the patient¿s left breast prosthesis that spontaneously deflated.New information received states that it is actually the right breast prosthesis that deflated.Block d has been updated with information (lot number, serial number, udi) about the correct suspect medical device (right breast implant).On 29-dec-2025, mentor completed the investigation on the patient¿s received right breast prosthesis.Device evaluation summary: according to the information received, the patient experienced deflation in the breast implant.The product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.Visual analysis of the returned device revealed that the breast implant had a crease/fold on the posterior view.In addition, a tear was found within the crease/fold, measuring approximately 0.1 cm.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in a deflation in a later time.Breast implants may also simply wear out over time.The contralateral device was also received (lot number 7465157).The patient did not report any issue with this device.Therefore, no further analysis of the contralateral device is required.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria, and that normal wear may have caused the observed defect.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 08-dec-2025, the mentor failure analysis lab received the device for evaluation.On 11-dec-2025, mentor received additional information about the event.The patient had both breast prostheses explanted and they were replaced with mentor smooth round moderate profile 175cc saline breast prostheses.On 14-dec-2025, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the breast implant.The product was returned to mentor for evaluation.Mentor then conducted visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned device determined that the breast implant had a crease/fold on the posterior view.Leak testing was performed, in accordance with mentor procedures, and revealed two tears (a and b) on the anterior view, measuring approximately 0.2 cm both tears.In addition, no other leak sites were detected during the analysis.Microscopic examination was performed on the edges of the ruptures (a and b), and parallel striations were found in the whole area of the tears a and b.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Based on the information currently available, microscopic examination of the returned product indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures.The contralateral device was also received (lot number 7433572).The patient did not report any issue with this device.Therefore, no further analysis of the contralateral device is required.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.H6 investigation findings c22: cosmetic defect (the crease/fold on the posterior view).Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PLUS PROFIL
• 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: 23638115
• Report Number: 1645337-2025-13062
• Device Sequence Number: 9249593
• Product Code: FWM
• UDI-Device Identifier: 00081317001393
• UDI-Public: (01)00081317001393(17)210212(10)7433572
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2021
• Device Catalogue Number: 3502300
• Device Lot Number: 7433572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 12/16/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/15/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2017
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White