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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE

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BAYER ESSURE Back to Search Results
Model Number ESS305
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Eye Injury (1845); Fatigue (1849); Headache (1880); Pyrosis/Heartburn (1883); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Swelling (2091); Loss of Vision (2139); Dizziness (2194); Malaise (2359); Depression (2361); Disability (2371); Abdominal Cramps (2543); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)
Event Date 06/28/2012
Event Type  Injury  
Event Description

After two miscarriages within 18 months, i had the essure permanent birth control device implanted in a surgical day care facility under anesthesia on (b)(6) 2012. (reference #(b)(4), lot #919017). I had planned on having a standard tubal ligation to prevent pregnancy. However, i opted for essure after learning about the minimal down time that it offered and my doctor's testimonial of its success. I expressed my concern about nickel being in the device because i have never been able to wear costume jewelry and suspected a nickel allergy. I was told that the nickel warning had been removed from the product because there was such a low amount of it in the device. After a successful and unremarkable essure implantation, i had the expected side effects of pelvic pain and cramping. However, those side effects never went away and many other effects began to surface immediately after implantation. (i had the mandatory hsg dye test 3 months after implantation which showed perfect placement of the essure coils and complete blockage of the tubes. ) i began bleeding (like a menstrual cycle) immediately after implantation and it continued for 3 months straight. I always had a light cycle every 28-30 days like clockwork before essure. In the 16 months post-essure, my periods were heavy with incredible clotting, severe cramps, and occurred every two to three weeks. I could not wear tampons due to pain and clotting. I had constant abdominal pain, cramping, and bloating that never went away for the 16 months that essure was in my body. I looked pregnant, and people commented on it. I had constant excruciating lower back pain, stabbing abdominal pains (alternating sides, very distinct stabbing feeling), severe joint inflammation to the point where i was virtually unable to walk after 15 months, constant fatigue/loss of energy, constant nagging headaches and an increase in the incidence and severity of migraine headaches, the feeling of being stabbed when i sat down and a feeling of tearing when i stood up - all the time, hair loss to the point where i cut my hair extremely short to hide the fact a save my plumbing, an increase in cystic acne, hot flashes, insomnia, mood swings/irritability, metal taste in my mouth, swelling of hands and feet, dental issues where i was losing silver fillings, weight gain, visual acuity declined dramatically within 1 month of essure and requires me to wear glasses all of the time now, occipital neuralgia, forgetfulness/brain fog/cloudiness short-term memory loss/confusion, dizziness with and without nausea, heartburn, and depression from always being sick, feeling lousy, having my health deteriorate, and not being able to do the things that i was always able to do before essure. In (b)(6) 2013, i lost vision in my right eye. I was diagnosed with optic neuritis and multiple sclerosis. It is very unusual to be diagnosed with ms at (b)(6). In (b)(6) 2013, i had a formal nickel allergy test that confirmed a severe nickel allergy. My allergist recommended that the coils be removed immediately. On (b)(6) 2013, i had a laparoscopic assisted vaginal hysterectomy with removal of the fallopian tubes - thus removal of the essure device. In the past 16 months, i have spent an incredible amount of money on sanitary care products, pain medications and prescriptions, doctor and specialist visit co-pays, a (b)(6) insurance co-pay to have surgery to have the product removed, eye glasses, drain cleaners because of my hair loss, and dental care. I feel incredible now 8 weeks after having essure removed! although most of my symptoms have vanished, i am still diagnosed with multiple sclerosis (an inflammatory disease that in my case is suspected to be caused by constant exposure to the pet fibers in the essure device) and loss of visual acuity.

 
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Brand NameESSURE
Type of DeviceESSURE
Manufacturer (Section D)
BAYER
MDR Report Key3542308
MDR Text Key4115281
Report NumberMW5033628
Device Sequence Number1
Product Code HHS
Combination Product (Y/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 12/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/24/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberESS305
Device LOT Number919017

Patient TREATMENT DATA
Date Received: 12/24/2013 Patient Sequence Number: 1
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