MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL XTRA BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SHPX200
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On april 08, 2026, mentor completed an evaluation on the returned device.Device evaluation: mentor then conducted visual inspection, leak test and microscopic examination of the device.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, in accordance with mentor procedures, and two tears (a,b) were found on the anterior aspect of the implant measuring tear a approximately 0.2 cm and tear b approximately 0.1 cm.No additional areas of gel exposure were found.Microscopic examination was performed on the edges of the ruptures (a, b), and parallel striations were found in the whole area of the tears.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.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.The investigation found the reported event was caused by use error (reasonably foreseeable misuse).Foreseeable misuse is considered in the company¿s risk management documentation.The post-market surveillance (pms) system periodically trends complaint data to detect signals related to product quality, patient safety, and use error.Quality issues that could affect safety are escalated through the quality system and may trigger a trend report when appropriate.Pms reviews and complaints feed into the risk management process; based on current review, no device design, usability, or instructions/training changes are needed.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 09, 2026, the mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Paperwork received with the device indicated that the patient had concerns that her implants were moving and when she laid down, they would fall to the sides.During a physical exam, she was diagnosed with bilateral implant displacement.As a result, the patient underwent the exchange surgery.Furthermore, the right implant was noted to be ruptured when removed.Reason for device explant and/or reoperation: migration.As an event for the contralateral side was indicated, another file was generated to document the event.This report is for the right breast prosthesis.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.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 surgery with implantation of a 200cc mentor memorygel xtra breast implant prosthesis.Post-operatively, the patient was diagnosed with a ruptured right implant by a medical professional.As a result, the patient underwent bilateral exchange with mentor gel implants on (b)(6) 2026.

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 24436082
• Report Number: 1645337-2026-01972
• Device Sequence Number: 10392857
• Product Code: FTR
• UDI-Device Identifier: 00081317025207
• UDI-Public: (01)00081317025207(17)280522(10)9901063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,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 Catalogue Number: SHPX200
• Device Lot Number: 9901063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/08/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/02/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White