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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Arthritis (1723); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Swelling (2091); Rupture (2208); Chronic Obstructive Pulmonary Disease (COPD) (2237); Complaint, Ill-Defined (2331); Arthralgia (2355)
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 Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
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
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 Age65 YR
Patient Weight75
Patient Outcome(s) Life Threatening; Other; Disability;
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