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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
Device Problem Material Rupture (1546)
Patient Problems Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Pain (1994); Tinnitus (2103); Depression (2361)
Event Date 05/27/2002
Event Type  Injury  
Event 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
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6607433
MDR Text Key76656421
Report NumberMW5070137
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 05/31/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1600
Device Catalogue Number350-1650
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age28 YR
Patient Weight64
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