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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR CORP. MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SILICONE GEL
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MENTOR CORP. MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SILICONE GEL Back to Search Results
Catalog Number 350-3751BC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Fatigue (1849); Gastritis (1874); Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Increased Sensitivity (2065); Skin Irritation (2076); Swelling (2091); Tinnitus (2103); Dizziness (2194); Pressure Sores (2326); Anxiety (2328); Complaint, Ill-Defined (2331); Sore Throat (2396); Sleep Dysfunction (2517); Weight Changes (2607); No Code Available (3191)
Event Date 02/13/2014
Event Type  Injury  
Event Description
A plastic surgeon implanted me with mentor memory gel silicone breast implants.I started becoming ill after a few months.I have many chronic illnesses that i never had before including: pain in my breasts, joints, bones, arthritis, migraine headaches and dizziness, aversion to smells and taste, dry skin, canker sores in mouth, throat and swallowing problems, chronic fatigue, memory problems, gerd, insomnia, ear ringing, restless leg syndrome, forgetfulness, anxiety and panic attacks, swelling, inflammation all over body, weight gain in upper extremities.
 
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Brand Name
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SILICONE GEL
Type of Device
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SILICONE GEL
Manufacturer (Section D)
MENTOR CORP.
MDR Report Key6237879
MDR Text Key64509996
Report NumberMW5067157
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/06/2017
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
Device Catalogue Number350-3751BC
Device Lot Number6783952
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/06/2017
Type of Device Usage N
Patient Sequence Number1
Treatment
CYMBALTA; MINERAL REPLACEMENT SUPPLEMENTS; MOTRIN 800 MG; OTC MEDS: ALEVE; RX MEDS: MOBIC ; ZANTAC
Patient Outcome(s) Disability;
Patient Age54 YR
Patient Weight61
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