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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
Device Problem Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Capsular Contracture (1761); Dehydration (1807); Dry Eye(s) (1814); Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Inflammation (1932); Pain (1994); Rash (2033); Visual Impairment (2138); Tingling (2171); Dizziness (2194); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Impaired Healing (2378); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)
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 Name
SMOOTH SALINE IMPLANTS
Type of Device
PROSTHESIS BREAST
Manufacturer (Section D)
MENTOR
MDR Report Key6875906
MDR Text Key86830423
Report NumberMW5072200
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 09/17/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/18/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age56 YR
Patient Weight54
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