MAUDE Adverse Event Report: BAYER HEALTHCARE LLC. ESSURE BIRTH CONTROL IMPLANT; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Dry Eye(s) (1814); Emotional Changes (1831); Fatigue (1849); Incontinence (1928); Nausea (1970); Neuropathy (1983); Pain (1994); Increased Sensitivity (2065); Vomiting (2144); Arthralgia (2355); Reaction (2414); Sweating (2444); Heavier Menses (2666); Constipation (3274)

Event Date 10/01/2009

Event Type  Injury  

Event Description

This all started in 2009 approx 1 1/2 yrs after my essure implant, but has progressively gotten worse.First started with fatigue, and has progressed to small fiber neuropathy, degenerative disk disease in the lumbar and autonomic dysfunction.I don't know if there is enough space to type at all.After the implant my symptoms began around 2009 with severe constipation that required prescription, reactions to metals and joint pains, low sex drive, mood swings, small patches of dry skin on my body.I also had a uncomfortable pain when pressure was applied to my lower abdomen, but not sharp, just uncomfortable.I contributed that to constipation/digestive issues, but i now know it's not.It is uncomfortable to wear certain pants, seatbelt if it is too high across my lower abdomen.It is very uncomfortable.It almost feels like there is something in there.But my pelvic exams come back normal.Shooting, pins and needle type pains in groin area.Carpel tunnel and ulnar tunnel surgery 2010.Hip surgery 2016.In 2012, i was diagnosed with degenerative disk disease and had a back fusion l4-s1.About two yrs later, i noticed i was only sweating on half of my body.Increased joint pain and body achiness.Lower back pain.Stiffness in joints of hips, lower back.Within the past 2-3 yrs (starting 2014-2015).Everything has snowballed.I have been diagnosed with small fiber neuropathy - hypersensitivity to touch, numbness in my legs, lack of being able to feel cold on my skin, lack of feeling vibrations in my feet.I cannot stand to be touched.Not sweating on one side, excessive sweating on the other, hidradenitis suppurativa (a dermatology issue of bumps under the armpit and sometimes groin area), headaches, rib pain, achy pain from waist to upper thighs (i feel like i have the flu, i ache so much), lower back pain, gallbladder issues, anemic, heavy periods, and large clots.I am constantly cold if the temperature is in the 70s.But i cannot tolerate anything in the upper 90's because of the sweating (thyroid is under control with meds, so i was told it is not my thyroid causing this problem.I was told to deal with the cold.Wearing a hoodie last week in my house, (b)(6) in (b)(6).) i cannot drink alcohol any more; if i have more than 2 drinks, i have nausea/vomiting the entire next day.I feel funny when i eat certain foods - i've been told it is a histamine intolerance.All test are normal - no autoimmune, no cancer, not diabetic.I feel like my body is shutting down.I feel like i am in a constant state of dehydration.I drink approx a gallon of water a day.I have water near my bed, in my car; it goes everywhere with me.Dry mouth, dry eyes, dry lips, dry skin (since i don't sweat on one side).Sweat excessively on the other side.Urinary urgency/incontinence, and increased constipation.Pelvic floor dysfunction, facial flushing.Hot areas on my back, pins and needles/numbness in shoulder/back area.I have been drs since june 2017 (neurologist,.Gi doc, endocrinologist, rheumatologist, the obgyn that did the implant, another neurologist, scheduled now for ophthalmologist.Another gyno, endocrinologist and dermatologist.

• Brand Name: ESSURE BIRTH CONTROL IMPLANT
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC.
• MDR Report Key: 7596165
• MDR Text Key: 111091884
• Report Number: MW5077808
• 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: Patient
• Type of Report: Initial
• Report Date: 06/11/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 68