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

Catalog Number	THPX620
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/31/2025
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: insufficient information.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 620cc mentor memorygel xtra breast implant prosthesis.Post-operatively, the patient underwent a revision surgery on (b)(6) 2025, for an undisclosed reason.However, during the surgery a ruptured right implant was discovered which resulted in bilateral exchange with sientra (non-mentor) implants.There was a 45-minute delay, but no patient harms or consequences were reported as a result.
Additional Manufacturer Narrative
On december 30, 2025, mentor was notified that the patient underwent the surgery as she complained of small breasts and bilateral breast ptosis.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.Reason for device explant and/or reoperation: ptosis manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 26, 2026, the mentor analysis lab received the suspect medical device for evaluation.On february 02, 2026, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted a visual inspection and microscopic examination of the device.Visual analysis of the returned device revealed that the breast implant was found to be ruptured and received in two (2) parts.Microscopic examination was performed, and the cause of the tear could not be identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following things may cause implant to rupture: damage by surgical instruments; stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.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
On february 22, 2026, mentor became aware that part of the device evaluation was inadvertently omitted from the 2nd supplemental report.Corrected data: h11 additional manufacturer narrative: device evaluation: mechanical testing was conducted on complaint samples including tension set to evaluate the residual elongation, joint strength to examine the ability of the shell/patch bond to withstand stress while the shell material adjacent to the bond is elongated, and tensile/elongation to measure the inherent material behavior.All testing results met or exceeded the international standards.Manufacturer¿s reference number: (b)(4).

• 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: 23634305
• Report Number: 1645337-2025-13053
• Device Sequence Number: 10314468
• Product Code: FTR
• UDI-Device Identifier: 00081317025771
• UDI-Public: (01)00081317025771(17)271113(10)9823649
• 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: 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,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: THPX620
• Device Lot Number: 9823649
• 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: 12/30/2025; 01/26/2026; 02/22/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/23/2026; 02/03/2026; 02/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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: 50 YR
• Patient Sex: Female