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

Catalog Number	3544425
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast augmentation surgery with implantation of a 425cc mentor memorygel breast implant prosthesis.Post-operatively, the patient reported experiencing pain and swelling of the right breast with a leaking right implant.Magnetic resonance imaging was conducted and results indicated fluid accumulation in the right armpit/pectoralis area.A consultation with a medical professional has yet to be conducted.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Follow-ups are pending.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: the patient has not undergone explantation or reoperation at this time.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
On november 19, 2025, mentor was notified that the patient was scheduled for implant removal/revision in december.Date of explantation: (b)(6) 2025.Reason for device explant and/or reoperation: rupture, local reaction 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 28, 2026, mentor was provided with the following information: date of event: (b)(6) 2025.Date of explantation: (b)(6) 2025.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 03, 2026, the mentor analysis lab received the suspect medical device for evaluation.On march 10, 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 have a tear on the junction between the shell and patch of the posterior view.In addition, the breast implant was received in two (2) parts and the patch was completely separated.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 is more likely to occur the longer the implant is implanted.The following may cause implant to rupture: 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.Swelling is a temporary normal post-operative condition.Depending on presentation, delayed swelling may require additional work-up by the surgeon.Swelling is a known complication associated with these devices and is referenced in our current product insert data sheet.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL 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: 23416669
• Report Number: 1645337-2025-12105
• Device Sequence Number: 8956735
• Product Code: FTR
• UDI-Device Identifier: 00081317001096
• UDI-Public: (01)00081317001096(17)140520(10)5911391
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• 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 Expiration Date: 05/20/2014
• Device Catalogue Number: 3544425
• Device Lot Number: 5911391
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 01/28/2026; 03/03/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/05/2025; 02/13/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2009
• 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; Other
• Patient Age: 40 YR
• Patient Sex: Female