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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS (SILICONE)

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MENTOR BREAST IMPLANTS (SILICONE) Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Asthma (1726); Autoimmune Reaction (1733); Fatigue (1849); Increased Sensitivity (2065); Numbness (2415); Palpitations (2467); Confusion/ Disorientation (2553); Vascular System (Circulation), Impaired (2572)
Event Type  Injury  
Event Description
I had silicone breast implants from mentor in 2013.Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies.
 
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Brand Name
BREAST IMPLANTS (SILICONE)
Type of Device
BREAST IMPLANTS (SILICONE)
Manufacturer (Section D)
MENTOR
MDR Report Key6656739
MDR Text Key78174485
Report NumberMW5070532
Device Sequence Number1
Product Code FTR
Reporter Country CodeCY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/19/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/19/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other;
Patient Age26 YR
Patient Weight50
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