MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Asthma (1726); Fatigue (1849); Hair Loss (1877); Headache (1880); Itching Sensation (1943); Pain (1994); Rash (2033); Thrombus (2101); Blurred Vision (2137); Weakness (2145); Dysphasia (2195); Arthralgia (2355); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666)

Event Date 06/11/2019

Event Type  Injury  

Event Description

I was implanted with essure in (b)(6) 2010 after strong endorsement from my dr.She claimed this was the way to go for birth control - safe, effective, simple, no recovery, no incisions, etc.Over the next few years i began having hip / pelvic pain that gradually increased in severity until it was so bad that i had to start seeking the cause and find a solution.Many docs, physical therapy, anti-inflammatory meds daily, numbing injections, myofascial release, pain meds, 2 hip impingement surgeries even, and yet the pain persisted and worsened.Meanwhile other symptoms were building throughout that time: chronic fatigue, muscle pain and weakness (hips, legs, back, neck, arms, hands), joint pain, severe tenderness all around hips and thighs (light touch felt like punching a bruise), vitamin d deficiency, anemia, asthma, excessive weight gain, hair loss, frequent headaches / migraines, insomnia, blurred vision, brain fog, (unable to get verbalize the word that i know and want to use in conversation, just blank), cloudy feeling in my head, unexplained rash with crazy itching.Periods became longer and more intense with very heavy bleeding and large clotting.Upon realizing that the 2 major hip surgeries did not help me and the hip / pelvic / upper thigh pain was rapidly progressing.I visited my ob/gyn in search of answers.I had a total hysterectomy and bilateral salpingectomy, including the removal of the essure devices, in (b)(6) 2019.Immediately upon waking up from surgery, the horrible pain in hips / pelvis / thighs that i had lived with for 5+ years was gone.Without a doubt those devices were the source of my pain and suffering.I feel my body was in a constant inflammatory response to the devices, for which i got immediate relief upon removal at the more localized area of their location.However, after 9 years, my entire body was now involved and trying to tell me something was wrong.Unfortunately, i didn't get them removed in time to stop progression of the rest of the autoimmune symptoms i was experiencing from this reaction to the devices.I'm still suffering from chronic fatigue, muscle pain and weakness throughout my body, daily headaches and basilar migraines, blurred vision and brain fog.I am sometimes unable to do the most basic tasks like stir noodles, cut chicken, depress the top of a hair product or spray bottle or even have enough strength to open a kitchen cabinet.Essure was the worse decision i have ever made.Prior to 2010 and getting these devices, i was a very healthy person.I rarely had need to see a dr for anything other than pre-natal care and labor / delivery.I had no diagnosed illnesses or conditions, took no medications.I was extremely healthy.Everything went downhill after essure.I now take multiple medications, have appts regularly every 4-6 wks, and have seen (and continue to be referred to) different specialists for the symptoms i continue to experience as a result of essure.Do not have the dates and specifics readily available.Doc informed me of severe vitamin d deficiency and iron deficiency for which i was prescribed vitamin d2 and told to take daily iron supplements.Was able to stop the iron the day of my hysterectomy.Continue to take vitamin d.All other labs / bloodwork stays within normal range despite the autoimmune symptoms.Fda safety report id# (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 8965353
• MDR Text Key: 158352153
• Report Number: MW5089575
• 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: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2012
• Device Model Number: ESS305
• Device Lot Number: 678818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 40 YR
• Patient Weight: 95