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

MAUDE Adverse Event Report: DOW CORNING WRIGHT / MENTOR SILICONE BREAST IMPLANT

  • 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
 

DOW CORNING WRIGHT / MENTOR SILICONE BREAST IMPLANT Back to Search Results
Event Date 08/18/2010
Event Type  Injury  
Event Description

This is not a one time event, but this was the beginning of many different health issues i had. I got severe spinning vertigo that lasted 6 years. Along with that were 35 other symptoms. Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down. Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSILICONE BREAST IMPLANT
Type of DeviceSILICONE BREAST IMPLANT
Manufacturer (Section D)
DOW CORNING WRIGHT / MENTOR
MDR Report Key6989846
Report NumberMW5073034
Device Sequence Number2
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/26/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/31/2017 Patient Sequence Number: 1
-
-