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

Catalog Number	3501635
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted with two 250cc mentor smooth round moderate profile saline breast prostheses experienced bilateral device migrations and breast implant illness symptoms post-operatively.As a result, the patient underwent explantation on (b)(6) 2026.
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: generalized illness, device migration.H6 health effect, clinical code e2402: generalized illness.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).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, the customer thought it was bii and removal only, the implants were not ruptured but flipped upside down md does not believe alcl.The product was returned to mentor for evaluation.Mentor then conducted visual inspection and microscopic examination of the returned device.Visual analysis of the returned device, determined that the breast implant was found to have a tear on the anterior view, measuring approximately 1.6 cm.In addition this tear was found to be marked with a marker by the customer which matches the information received.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.This findings match the information provided by the customer.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.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).Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Implant displacement/migration is a known complication associated with these devices and is referenced in our current product insert data sheet.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH 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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 24619246
• Report Number: 1645337-2026-02937
• Device Sequence Number: 13155557
• Product Code: FWM
• UDI-Device Identifier: 00081317001225
• UDI-Public: (01)00081317001225(17)140731(10)6009431
• 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: 2010
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 07/31/2014
• Device Catalogue Number: 3501635
• Device Lot Number: 6009431
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2010
• 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: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White