MAUDE Adverse Event Report: BAYER ESSURE

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Fatigue (1849); Headache (1880); Pyrosis/Heartburn (1883); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Skin Irritation (2076); Tinnitus (2103); Vomiting (2144); Burning Sensation (2146); Hot Flashes/Flushes (2153); Tingling (2171); Twitching (2172); Cramp(s) (2193); Dizziness (2194); Discharge (2225); Urinary Frequency (2275); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Numbness (2415); Fungal Infection (2419); Shaking/Tremors (2515); Cognitive Changes (2551); Abdominal Distention (2601); Heavier Menses (2666)

Event Date 01/12/2010

Event Type  Injury  

Event Description

Essure permanent birth control method was implanted.Since that time i have had mysterious illnesses and am constantly sick.I have been to many specialists to see what the problem was and no treatments ever work.I have spent (b)(6) on specialists, thousands on medications, treatments and a cpap machine, and (b)(6) on supplements, even having surgery for one issue.Nothing ever works for more than a few months, if it works at all.I found that many people were having issues related to this implant.I have many of the symptoms listed.I have the following: cramping, abnormal menses, discharge, hot flashes, excessive bleeding during period (menorrhagia), night sweats, loss of libido, hot flashes, bleeding/spotting after sex, early menopause symptoms, incontinence, long menstrual cycles (polymenorrhea), yeast infection (candida), urgent/frequent urination, itching, burning, stinging, stabbing of vaginal entrance, breast pain/tenderness, abdominal spasms / twitching fluttering, all over body aches/pain, gastrointestinal nausea, vomiting, gas, constipation, diarrhea, severe bloating, heartburn, bowel issues, headaches or migraines, dizziness, tingling sensations, brain shocks, brain fog - cloudiness, forgetfulness, anxiety / panic attacks, mood swings, depression (sadness/suicidal thoughts), ringing in ears (pulsatile tinnitus), diminished brain function (brain fog, confusion, cloudiness, forgetfulness, short term memory loss), numbness/tingling in extremities (hands/feet), sensation of burning, stinging, ticking or pricking of skin (paresthesia), tremors/shakiness, chronic fatigue syndrome, allergies/sensitives, chemical and food sensitivities, metal allergies (nickel), heightened allergies / allergic reactions, food allergies, gluten sensitivity, skin irritation/itching.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 7221298
• MDR Text Key: 98353103
• Report Number: MW5074868
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

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
• Device Model Number: ESS305
• Device Lot Number: 675112
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMBEREN FOR MENOPAUSE RELIEF; AMEN DAILY HEALTH BRAIN AND BODY POWER; ATTENTION SUPPORT; DULERA; ESSURE; FOCUS AND ENERGY; PLEXUS BIO CLEANSE; PRO BIOTICS; SLIM; TUMERIC; VENTOLIN
• Patient Outcome(s): Required Intervention
• Patient Weight: 79