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

Catalog Number	3542757MC
Medical Device Problem Codes	Material Discolored (1170); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Seroma (2069); Deformity/ Disfigurement (2360)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
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: na.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
A female patient who underwent breast surgery with an unknown mentor silicone prosthesis experiences unknown sided silent symmetry post operation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On december 11, 2025, mentor became aware that this complaint has been identified as a duplicate of manufacturer report number: 1645337-2025-12768, and 1645337-2025-13072.This pc will be updated to reflect all of the most current and correct information, and final reporting/documentation of this event will take place on this pc.Per additional information in these pcs, patient right side implant double in size; procedure-breast augmentation primary; patient age at the time of the event 65 years old; patient ethnicity-not hispanic/latino and race-white.Lot number added as 6813564.Serial number updated to (b)(6).The patient developed late onset of seroma and scheduled for removal surgery on (b)(6) 2026.Date of event was on october 3, 2025.The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 6, 2026, mentor became aware that follow up #:2 failed to update the coding.Correction: pc serious injury and pec silent rupture (post-implant) were removed.Pc medical device removal and pec rupture symptomatic (post-implant) were added.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Per additional information received on december 17, 2025, the patient also experienced possible silent rupture and will replace both implants to non-mentor prosthesis.The mri was inconclusive.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
According to additional information received on february 9, 2026, the patient developed a recurrent seroma of the right breast.The seroma was drained and the fluid sent for cytology, which was negative for malignancy.Although a rupture of the right implant was initially reported, this was not confirmed during the bilateral explantation performed on (b)(6) 2026.Both the preoperative and postoperative diagnoses documented only right breast seroma and breast ptosis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Per additional information received on feb26, 2026, the patient also experienced right sided implant site calcification and the implant post -op was cloudy.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: 23560401
• Report Number: 1645337-2025-12679
• Device Sequence Number: 21289452
• Product Code: FTR
• UDI-Device Identifier: 00081317004387
• UDI-Public: (01)00081317004387(11)140328(17)190331(10)6813564
• 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: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 03/31/2019
• Device Catalogue Number: 3542757MC
• Device Lot Number: 6813564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 12/17/2025; 01/06/2026; 02/09/2026; 02/26/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/19/2025; 01/06/2026; 01/26/2026; 02/24/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2014
• 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: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White