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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SALINE IMPLANTS PROSTHESIS BREAST

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MENTOR SMOOTH SALINE IMPLANTS PROSTHESIS BREAST Back to Search Results
Event Date 02/10/2005
Event Type  Injury  
Event Description

On (b)(6) 2005, i replaced silicone breast implants (which i discovered had capsular contraction in one and the other was ruptured) with mentor smooth saline implants with the assurance that they were "safe". I have suffered numerous health problems that i now attributed to the implants: chronic fatigue, cognitive dysfunction, muscle aches, joint pain and soreness, hair loss, dry skin, eyes, mouth, easy bruising and slow healing of wounds. Temperature intolerance even if the house is 77 degrees during the summer, i have sweat clothes on. My hormones are completely of whack. I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs. Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. Premature aging, vision disturbances, digestive issues. Food intolerance and allergies, smell and chemical sensitivities, persistent infections, throat clearing, chronic inflammation, dizziness, mood swings, emotional instability, anxiety and panic attacks. Depression, diagnosed in 1990 with ms 3 years after original silicone implants.

 
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Brand NameSMOOTH SALINE IMPLANTS
Type of DevicePROSTHESIS BREAST
Manufacturer (Section D)
MENTOR
MDR Report Key6875906
Report NumberMW5072200
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 09/17/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received09/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/18/2017 Patient Sequence Number: 1
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