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

Catalog Number	3508001BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Seroma (2069); Impaired Healing (2378)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.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.Reason for device explant and/or reoperation: rupture, seroma, impaired healing.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision surgery with implantation of an 800cc mentor memorygel breast implant prosthesis.Post-operatively, the patient experienced drainage/discharge from the incisional sites of both breasts.During a physical exam with a medical professional, the fluid of the right breast was described as gelatinous drainage while the left was a clear liquid.The right fluid was determined to be serous fluid.As a result, the patient underwent revision of the bilateral breasts for evaluation on (b)(6) 2025.During the exploratory surgery, the patient was discovered to have a ruptured right breast implant with seeping silicone and no problems were observed with the left implant.As a result, the right breast implant was replaced with an 800cc mentor memorygel breast implant without replacement of the left.Wound cultures were taken from both breasts to rule out any impending infections.Culture results indicated there was bacterial growth of the left sample without growth from the right.This report is for the right breast prosthesis.
Additional Manufacturer Narrative
On march 26, 2025, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection, leak testing, and microscopic examination of the device.Visual analysis of the returned device revealed a tear on the anterior view of the breast implant, measuring approximately 1.2 cm.Leak testing was performed, in accordance with mentor procedures, and no additional areas of gel exposure were found.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.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.Some patients may experience a prolonged wound healing time.Delayed wound healing may increase the risk of infection, extrusion and necrosis.Depending on the type of surgery or the incision, wound healing times may vary.Delayed wound healing is a known complication associated with these devices and is referenced in our current product insert data sheet.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.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: 21657651
• Report Number: 1645337-2025-02993
• Device Sequence Number: 7547437
• Product Code: FTR
• UDI-Device Identifier: 00081317000389
• UDI-Public: (01)00081317000389(17)270405(10)9717883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 3508001BC
• Device Lot Number: 9717883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White