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

Catalog Number 3502251BC

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problems Calcium Deposits/Calcification (1758); Granuloma (1876); Deformity/ Disfigurement (2360)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.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: ptosis, rupture, calcification, granuloma 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).

Event Description

It was reported that a patient who underwent primary breast augmentation with 225cc mentor memorygel breast implants experienced left sided rupture, bilateral ptosis, bilateral benign appearing breast calcifications, left sided granuloma, and right sided breast mass post procedure.These issues were identified through ultrasound and mammography.There was free silicone in the left axillary lymph node.There are two stable breast masses in the right breast that were biopsied in 2021.As a result, bilateral capsulectomy, bilateral mastopexy, explant, and fat grafting was performed on (b)(6) 2024.See 1645337-2024-04255 for contralateral prosthesis report.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Type of Device: 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: 19073804
• MDR Text Key: 339742444
• Report Number: 1645337-2024-04257
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 00081317000259
• UDI-Public: 00081317000259
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Catalogue Number: 3502251BC
• Device Lot Number: 7416898
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female