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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Fever (1858); Headache (1880); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Pain (1994); Vomiting (2144); Anxiety (2328)

Event Date 06/11/2015

Event Type  Injury  

Event Description

I had the essure implants put in on (b)(6) 2015.The procedure itself was the most painful, excruciating and inhuman incident i've ever gone through.I went into my dr's office to discuss having a tubal ligation only.She really pushed essure on us as the only option.She told us there were no reported side effects.That the devices are 99.85% effective, migrate in less than.001% of people.She reassured us this could be the fasted, easiest and best decision we could make.This was by far the worst decision of my life.I've suffered chronic pelvic pains since implantation accompanied by excessive bleeding, large clots, fatigue, nausea and vomiting.On (b)(6) 2015, i was hospitalized with severe bleeding, pain, fever and vomiting.I had a lot of scars completed and tests run.The drs were unfamiliar with essure and not very helpful.Everyone wanted to prescribe narcotics to help but nothing helped.In one scan you could see that my coil from my right tube had already fallen into my uterus.The pain and bleeding was from this essure actually working its way out of my body.It was awful.I honestly thought i was going to die.In (b)(6) of 2016, i started having the most severe migraines of my life.My first migraine bout lasted 6 full weeks.I saw 4 different drs in this time trying to find relief to no avail.Over the next few months i had more bad days than good.I had test after test and nothing was found.No reasons behind my migraines.The only thing that had changed in my life was the essure.In (b)(6) of 2016, i was diagnosed with chronic migraine.I've taken multiple meds trying to get relief but have not been my normal self since.I now get 35 botox injections every 12 weeks in my face and neck and take 2 injections of aimovig every 4 weeks.These things do help my migraines not be as severe but they're still here.I have serious memory loss.I lost about half the vision in one eye within 6 months of the migraines started.I've not been able to drive in 3 years because my depth perception has gotten so bad.Since the essure was implanted, i suffer from anxiety like i never could've imagined.I can't go for a walk because my anxiety is so intense that i shake and panic.I get lost very easily because the anxiety seems to take over my ability to think.I've had to take a leave from work.I'm an insurance agent and i can't discuss legally binding info with clients when i'm unable to trust my own thoughts.I can't always pull thoughts forward to complete sentences and often can't answer questions.I have to write everything down and double check everything i say.I can't do my job that way.I have no stamina.I can't play with my kids.I can't be the person i've fought so hard to become.Essure has stolen 4 years of my life and it's not okay.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: 8658089
• MDR Text Key: 146837334
• Report Number: MW5087020
• 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: 05/28/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 91