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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT; BREAST IMPLANTS
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MENTOR SALINE BREAST IMPLANT; BREAST IMPLANTS Back to Search Results
Model Number 1600
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Codes Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Pain (1994); Tinnitus (2103); Depression (2361)
Date of Event 05/27/2002
Type of Reportable Event Serious Injury
Event or Problem Description
I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002.Ever since that surgery, i had left scapular pain.I had lime green nipple discharge on the right side and blood coming out the left breast nipple.I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone.I had a metal taste in my mouth, tinnitus, chronic pain, chronic fatigue, depression, brittle hair and nails with ridges, +ana test, thyroid levels off and left scapular pain so bad i wanted to overdose and die.It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out.All these things are completely gone now that these toxic bags are out.They need to be taken off the market.
 
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Brand Name
SALINE BREAST IMPLANT
Common Device Name
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6607433
Report NumberMW5070137
Device Sequence Number12133386
Product Code FWM
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2002
Device Explanted Year2017
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 05/31/2017
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? Yes
Operator of Device No Information
Device Model Number1600
Device Catalogue Number350-1650
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/31/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Disability;
Patient Age28 YR
Patient Weight64
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