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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 Insufficient Information (3190)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415); Confusion/ Disorientation (2553); Patient Problem/Medical Problem (2688)
Event Date 07/20/2008
Event Type  Injury  
Event Description
I got mentor saline breast implants and right after stated having symptoms resembling ms joint pain, confusion, numbness, brain fog, hormone issues resulting in hysterectomy at (b)(6).One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity.Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away.I still struggle with gut issues and joint pain.I have had years of extensive testing done.Both functional med and regular doc over (b)(6) dollars worth.
 
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Brand Name
SALINE BREAST IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6345452
MDR Text Key67990109
Report NumberMW5067958
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/16/2017
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? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/16/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
BERBERINE; OREGANO; OTC MEDS: MAGNESIUM CITRATE; RX MEDS: SUPPLEMENTS ONLY NO MEDICATIONS.; VITAMIN C; VITAMIN D
Patient Outcome(s) Required Intervention; Disability;
Patient Age32 YR
Patient Weight56
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