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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
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes 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)
Date of Event 12/18/1998
Type of Reportable Event Serious Injury
Event or Problem 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 Name
SALINE BREAST IMPLANT
Common Device Name
SALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6975814
Report NumberMW5072937
Device Sequence Number10034954
Product Code FWM
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year1994
Device Explanted Year1998
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/25/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening; Other; Disability;
Patient Age65 YR
Patient Weight75
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