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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SM ROUND MOD PLUS PROFILE SALINE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
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MENTOR SM ROUND MOD PLUS PROFILE SALINE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Lot Number 5770513
Device Problems Leak/Splash (1354); Material Rupture (1546)
Patient Problems Rheumatoid Arthritis (1724); Bacterial Infection (1735); Bruise/Contusion (1754); Chest Pain (1776); Connective Tissue Disease (1786); Dehydration (1807); Dry Eye(s) (1814); Fatigue (1849); Fever (1858); Gastritis (1874); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Liver Damage/Dysfunction (1954); Lupus (1956); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Raynauds Phenomenon (2034); Renal Failure (2041); Respiratory Distress (2045); Scleroderma (2062); Sjogren's Syndrome (2073); Skin Discoloration (2074); Swelling (2091); Toxins In Children (2098); Thyroid Problems (2102); Tinnitus (2103); Toxic Shock Syndrome (2108); Vertigo (2134); Visual Impairment (2138); Weakness (2145); Burning Sensation (2146); Tingling (2171); Myalgia (2238); Viral Infection (2248); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Arthralgia (2355); Impaired Healing (2378); Numbness (2415); Fungal Infection (2419); Sweating (2444); Choking (2464); Palpitations (2467); Sleep Dysfunction (2517); Abdominal Cramps (2543); Cognitive Changes (2551); Weight Changes (2607); Fibrosis (3167); Anaplastic Large Cell Lymphoma (3264)
Event Date 05/25/2015
Event Type  Injury  
Event Description
Mentor saline breast implants ruptured and began to leak causing illness, infection, and pain.There was no accident or impact to cause the implants to leak.My symptoms: fatigue or chronic fatigue cognitive dysfunction (brain fog, difficulty concentrating, memory loss), muscle pain and weakness, joint pain, hair loss, dry skin and hair.Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms.Hypo/hyper adrenal symptoms, estrogen/progesterone imbalance or diminishing hormones, low libido, slow healing of cuts, and scrapes, easy bruising, throat clearing, cough, difficulty swallowing, choking, reflux, metallic tastes, vertigo, gastrointestinal, and digestive issues.Fevers, night sweats, intolerant to heat/cold, new and persistent bacterial and viral infections, slow clearing of common colds and flus, fungal infections, yeast infections, candida, sinus infections, skin rashes, ear ringing, sudden food intolerance and allergies, headaches, slow muscle recovery after activity, heart palpitations changes in normal heart rate or heart pain, sore and aching joints of shoulders, hips, backbone, hands and feet swollen and tender lymph nodes in breast area.Underarm, throat, neck, groin bouts of dehydration for no reason.Frequent urination, numbness/tingling sensations in upper and lower limbs, cold and discolored limbs, hands and feet, general chest discomfort, shortness of breath, pain and/or burning sensation around implant and/or underarm, liver and kidney dysfunction, cramping, toxic shock symptoms, anxiety, depression and panic attacks, leaky gut, ibs and sibo symptoms of or diagnosis of fibromyalgia, symptoms of or diagnosis of lyme disease, symptoms of or diagnosis of auto-immune diseases such as; raynaud's syndrome.Hashimoto's thyroiditis, rheumatoid arthritis, scleroderma, lupus, sjogren's syndrome, nonspecific connective tissue disease, multiple sclerosis, symptoms of or diagnosis or bia-alcl lymphoma.The implants were 5 y/o when my son was born.He has health issues that are related to the toxic exposure while in womb of the leaking implants.
 
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Brand Name
SM ROUND MOD PLUS PROFILE SALINE
Type of Device
PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR
MDR Report Key6677493
MDR Text Key78721415
Report NumberMW5070713
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/28/2017
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? Yes
Device Operator No Information
Device Lot Number5770513
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/28/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Required Intervention; Disability;
Patient Age30 YR
Patient Weight68
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