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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

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MENTOR SALINE BREAST IMPLANTS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Muscle Weakness (1967); Respiratory Distress (2045); Visual Impairment (2138); Tingling (2171); Anxiety (2328); Arthralgia (2355); Numbness (2415); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Event Date 08/01/2007
Event Type  Injury  
Event Description
I was actually sick from 2008 - 2015 from mentor saline breast implants.My symptoms started two weeks after getting them.Extreme anxiety, numbness tingling, severe joint pain, brain fog, memory loss, confusion, vision problems, major food allergies, difficulty walking, malabsorption, breathing issues, muscle atrophy, hormonal issues.I had a full hysterectomy six months after getting the implants.
 
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Brand Name
SALINE BREAST IMPLANTS
Type of Device
SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6857635
MDR Text Key85924185
Report NumberMW5072099
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 09/09/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age41 YR
Patient Weight56
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