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

Catalog Number	3543001
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Breast Cancer (1759); Seroma (2069)
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: late-onset seroma, breast cancer.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
"[safety_note]"impacted product number:(b)(4)|product name:sx mpp gel 300cc|notes: it was reported that a female patient who underwent breast reconstruction revision surgery with mentor sx mpp gel 300cc gel breast implants on (b)(6) 2015 experienced a right-sided late-onset seroma.Per the information provided, the patient believes they are experiencing a late seroma on the right side, accompanied by a change in the shape of their breast.Per the event description, "it's on the same side of her breast cancer".Patient scheduled for removal on (b)(6) 2025.No further details were provided.Should more information become available, this note will be updated and the case will be reassessed.
Additional Manufacturer Narrative
Per additional information received on april 9, 2026, the patient also experienced right sided rupture and decided to do the replacements in another date.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 13, 2026, mentor became aware that follow up#1 failed to report that the rupture was symptomatic.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Per additional information received on june 30, 2026, the patient underwent bilateral replacement with unspecified mentor implants on (b)(6)2026.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 20518226
• Report Number: 1645337-2024-12438
• Device Sequence Number: 15656161
• Product Code: FTR
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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: 12/05/2019
• Device Catalogue Number: 3543001
• Device Lot Number: 6885378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 04/09/2026; 04/13/2026; 06/30/2026
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 04/10/2026; 04/14/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2014
• 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: Required Intervention
• Patient Sex: Female