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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH SALINE IMPLANT BREAST IMPLANT

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MENTOR MENTOR SMOOTH SALINE IMPLANT BREAST IMPLANT Back to Search Results
Event Date 07/01/2002
Event Type  Injury  
Event Description

On (b)(6) 2002, pt stated she was implanted with mentor smooth saline breast implants during reconstructive surgery at the age of (b)(6). Immediately after, she suffered from: joint and muscle pain, neuro-cognitive changes, chronic fatigue, hair loss, light sensitivity, and vitiligo. She vomited at least 8 times a day and when she suffered from a cold, it would last 3 months. She states that she went from having an academic diction to having difficulty understanding commonly used words. She was also diagnosed with severe pulmonary hypertension. She also suffered with ambulation difficulties and had the feeling of walking on broken glass. On (b)(6) 2005, she had the implants removed. Upon removal of her implants, all neurological symptoms dissipated. However, fatigue, mild joint pain, infertility, hair loss, and an impaired immune system did remain. The explanted silicone shells of the implants were visibly thinner. There was green mold lodged in the valves, there were two white strings found in the saline and a considerable amount of the saline inside the implants had leaked out. On (b)(6) 2010, pt states that she then went in for additional surgery to remove scar tissue. She said scar capsules were found from her neck to the sides of the ribs. Immediately afterwards, she no longer had any of the symptoms and her pulmonary hypertension was diagnosed as mild. She had undergone antifungal treatment due to a diagnosis of systemic candidiasis at this time; she said that she was completely cured of her pulmonary hypertension. She is hla dr52 positive which, she states, is linked to a severe auto-immune response following the introduction of breast implants. She said that a simple test could have warned her of how her individual immune system would react to the silicone, thus saving her from the toll it took on her immune system, brain, and heart.

 
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Brand NameMENTOR SMOOTH SALINE IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key2750415
Report NumberMW5026941
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 09/18/2012 Patient Sequence Number: 1
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