MAUDE Adverse Event Report: MENTOR SILTEX AND SMOOTH-SURFACE LOW-BLEED GEL-FILLED MAMMARY PROSTHESES SILICONE; BREAST IMPLANT

Catalog Number 3507500BC

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

Patient Problems Fatigue (1849); Hearing Impairment (1881); Pain (1994); Swelling (2091); Visual Impairment (2138); Myalgia (2238); Sore Throat (2396); Neck Pain (2433); Confusion/ Disorientation (2553)

Event Date 01/12/2016

Event Type  Injury  

Event Description

I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002.In the past few years i have been suffering from extreme pain in my right breast.Sometimes can't even have a bra touch it.I have been having vision problems, extreme fatigue, muscle pain, back and neck pain, hearing problems, foggy brain, stomach and intestinal issues, sore throat and can't swallow, swelling in joints and distorted looking breasts.

• Brand Name: SILTEX AND SMOOTH-SURFACE LOW-BLEED GEL-FILLED MAMMARY PROSTHESES SILICONE
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6618491
• MDR Text Key: 76974073
• Report Number: MW5070211
• Device Sequence Number: 1
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/14/2012
• Device Catalogue Number: 3507500BC
• Device Lot Number: 234455
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 64