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

Catalog Number 3544001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

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: n/a manufacturer¿s reference number: (b)(4).

Event Description

It was reported (via fda medwatch 5088031) that a female patient underwent a breast surgery procedure with mentor memorygel 400cc breast implants and experienced several unexplained sytstemic symptoms including blurry vision, dry eyes, brain fog, loss of memory, choking, eruptions on my face, dry skin, gum decay, hair loss, exhaustion, swollen lymph nodes, migraines, headaches, joint pain, back pain, breast pain, indigestion, insomnia and night sweats.No device issue such as rupture was reported, the root cause of the patient¿s symptoms is unclear.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the right side.

• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-868
• MDR Report Key: 8952863
• MDR Text Key: 159674409
• Report Number: 1645337-2019-18240
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 00081317000907
• UDI-Public: 00081317000907
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2012
• Device Catalogue Number: 3544001
• Device Lot Number: 5750253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2007
• 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): Other