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

Catalog Number	SMHB435
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with implantation of a 435cc mentor memorygel boost breast implant prosthesis.Post-operatively, the patient was diagnosed with a bottomed out left breast implant and a high riding right breast by a medical professional.As a result, the patient underwent bilateral breast implant surgery for left-sided capsulorrhaphy and right-sided mastopexy on (b)(6) 2024.The left breast implant was removed and replaced with a 435cc mentor memorygel boost breast implant and the right breast implant was removed and reinserted.Additionally, during the surgery, a ruptured left breast implant was discovered.There were no reported procedural delays or patient consequences due to discovery.This report is for the left breast prosthesis.
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.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.Reason for device explant and/or reoperation: device migration.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 20, 2025, the mentor analysis lab received the suspect medical device for evaluation.On february 26, 2025, mentor completed an evaluation on the returned device.Mentor then conducted visual inspection and microscopic examination of the device.Visual analysis of the returned sample determined that the breast implant was found to be ruptured and received in two parts.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the anterior view, measuring less than 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Implant displacement/migration 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 BOOST 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: 21106859
• Report Number: 1645337-2025-00248
• Device Sequence Number: 8136592
• Product Code: FTR
• UDI-Device Identifier: 10081317031113
• UDI-Public: (01)10081317031113(17)290503(10)9988945
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 2024
• 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: SMHB435
• Device Lot Number: 9988945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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: 19 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White