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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS
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MENTOR SILICONE BREAST IMPLANTS Back to Search Results
Lot Number 5728780
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Swelling (2091); Visual Impairment (2138); Vomiting (2144); Complaint, Ill-Defined (2331); Sore Throat (2396); Skin Inflammation (2443); Weight Changes (2607); No Code Available (3191)
Date of Event 10/01/2015
Type of Reportable Event Serious Injury
Event or Problem Description
Hair was falling out, constantly getting sick with sinus issues - cold, cough, infections, strep, sore throat, brain fog, tired, low libido.Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin.Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain.Have had multiple visits to the ent and walk in clinic.Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto.My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness - 1 side.Going to dermatologist in a week to check extreme perioral dermatitis.Smooth mpp gel mammary prosthesis.
 
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Brand Name
SILICONE BREAST IMPLANTS
Common Device Name
SILICONE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6940484
Report NumberMW5072708
Device Sequence Number16569215
Product Code FTR
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 10/09/2017
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
Operator of Device No Information
Device Lot Number5728780
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/11/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Disability;
Patient Weight74
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