• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number 359-1660
Device Problem Insufficient Information (3190)
Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Tinnitus (2103); Anxiety (2328); Skin Inflammation (2443); No Code Available (3191)
Event Date 10/31/2014
Event Type  Injury  
Event Description
In 2005, i had mentor smooth saline implants placed above the muscle.In (b)(6) 2009, i had a rupture of the left breast implant and (b)(6) 2009 had both replaced with mentor smooth saline moderate profile.Starting in (b)(6) 2014, i started having alopecia areata.I was treated by several different dermatologist with steroids im as well as into the bald patches on my head.There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014.This included all body hair (underarms, pubic, legs) as well as any head hair.(scalp, eye brows, eye lashes, nasal hair, facial peach fuzz).I have been to a multitude of doctors, none of which have been able to treat the problem.It was bought to my attention by my new functional medicine doctor that i could be having an autoimmune response to the implants.On (b)(6) 2017, i had the mentor implants removed and no implant replacement.Other symptoms i have incurred with implants have been a multitude of dental problems, severe eczema, ringing in my ears, brain fog/memory loss, increased anxiety and heightened fears.I also tested positive for lyme disease.Adrenal fatigue.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key6940466
MDR Text Key89248070
Report NumberMW5072707
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 10/09/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number359-1660
Device Catalogue NumberSTYLE:1600
Device Lot Number5912239/RIGHT
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Weight68