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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

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MENTOR SALINE BREAST IMPLANT Back to Search Results
Event Date 12/18/1998
Event Type  Injury  
Event Description

I had a saline breast implant rupture (b)(6). On (b)(6) i had neck fusion. Woke up systemically ill and in widespread body pain. Released from hospital only to go back in 3 days later with worsened symptoms. I was near death and couldn't figure out what happened. Bedridden 9 years and on narcotics for pain. Doctors were baffled because lab testing was normal for some time. Then, my ana, c-reactive protein and other tests were elevated. Years later i was diagnosed with copd and for 6 years. It resolved with detoxing and i have residual lung scarring but no asthma or copd. I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. I was on biologic drugs several years without any relief of joint pain or swelling. I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellon's, ulcerative colitis and neuropathy.

 
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Brand NameSALINE BREAST IMPLANT
Type of DeviceSALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6975814
Report NumberMW5072937
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 10/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
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: 10/25/2017 Patient Sequence Number: 1
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