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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANT

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MENTOR MENTOR SALINE BREAST IMPLANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Asthma (1726); Autoimmune Disorder (1732); Cyst(s) (1800); Fungus (1872); Hypersensitivity/Allergic reaction (1907); Hernia (2240); Cognitive Changes (2551); Weight Changes (2607); No Code Available (3191)
Event Date 12/27/2010
Event Type  Injury  
Event Description
I got mentor saline breast implants.Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog.Within a year i developed a hernia, then had another hernia the following year.After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed.I also developed asthma, and allergies to foods that were never an issue before.
 
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Brand Name
MENTOR SALINE BREAST IMPLANT
Type of Device
MENTOR SALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6975780
MDR Text Key90301728
Report NumberMW5072931
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 Patient
Type of Report Initial
Report Date 10/23/2017
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 Received10/25/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Weight76
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