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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE IMPLANTS; SALINE BREAST IMPLANTS
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MENTOR SALINE IMPLANTS; SALINE BREAST IMPLANTS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Myalgia (2238); Anxiety (2328); Complaint, Ill-Defined (2331); Impaired Healing (2378); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Lethargy (2560); Weight Changes (2607); No Code Available (3191)
Event Date 01/02/2017
Event Type  Injury  
Event Description
I couldn't pick a date as i have been sick from my mentor saline implants since 2014.And continue to get sick today.I got my implants in 2010.Started showing symptoms in 2012.Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues.Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities.Inflammation, hoarse voice and throat clearing, hair loss, alcohol intolerance, anxiety, fatigue, muscle pain, insomnia.Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel.
 
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Brand Name
SALINE IMPLANTS
Type of Device
SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7181726
MDR Text Key97091121
Report NumberMW5074531
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 01/09/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/10/2018
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
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age42 YR
Patient Weight82
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