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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
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Hypersensitivity/Allergic reaction (1907); Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415); Confusion/ Disorientation (2553); Patient Problem/Medical Problem (2688)
Date of Event 07/20/2008
Type of Reportable Event Serious Injury
Event or Problem 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
Common Device Name
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6345452
Report NumberMW5067958
Device Sequence Number9976803
Product Code FWM
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2015
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/16/2017
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
BERBERINE; OREGANO; OTC MEDS: MAGNESIUM CITRATE; RX MEDS: SUPPLEMENTS ONLY NO MEDICATIONS.; VITAMIN C; VITAMIN D
Outcome Attributed to Adverse Event Required Intervention; Disability;
Patient Age32 YR
Patient Weight56
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