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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

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MENTOR BREAST IMPLANTS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Hair Loss (1877); Incontinence (1928); Pain (1994); Rash (2033); Weakness (2145); Myalgia (2238); Arthralgia (2355); Palpitations (2467)
Event Date 01/01/2000
Event Type  Injury  
Event Description
Breast implant illness.I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999.I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses.Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses.I'm going in this month for toxins testing.My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe.
 
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Brand Name
BREAST IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6604639
MDR Text Key76537027
Report NumberMW5070126
Device Sequence Number2
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/27/2017
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 No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/27/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age45 YR
Patient Weight64
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