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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Inflammation (1932); Nausea (1970); Rash (2033); Vomiting (2144); Anxiety (2328)

Event Date 03/25/2014

Event Type  Injury  

Event Description

I had essure implanted (b)(6) 2014.During implantation, it was obvious that my dr, dr (b)(6) in (b)(6), didn't know what she was doing.She invited 2 sales reps into the room without my consent.They stood over her shoulder and instructed her on how to implant the device.She had trouble getting one in and the rep was telling her, "twist your wrist slightly to the right, no, too far, pull it out slightly then go back in with a slight right angle." so he was instructing her and doing everything he could short of doing it himself.At that time, i felt extremely uncomfortable, even violated because i had an audience without permission with my legs spread open and feet in stirrups on the exam table.I had pain immediately even though i was told it would just be slight cramping.I had severe abdominal pain and was bed ridden for several days.Three weeks later, i was back at the same dr with severe abdominal pain, nausea and vomiting.Her solution was to put me back on birth control to manage my hormones which i've been taking ever since.I asked at that point if i could just get the essure taken out because it was only explanation for my symptoms.She insisted it wasn't the problem even though i never had these symptoms prior.Over the next 9 months, i was in the er five times with the same symptoms - abdominal pain, nausea, vomiting.Each time i was given fluids, anti-nausea and pain medication and sent home.Eventually, i was referred to gi where i had a colonoscopy, endoscopy and swallowed a pill camera, i was told i had inflammation but they could never find a diagnosis.So they put me on meds for depression, anxiety, insomnia, add, and acid reflux and basically said there was nothing they could do.In the year following my essure implantation, i went from being on 2 medications to 11.One year after essure, i gave up on western medicine and found a naturopath.Through major diet changes and supplements i got some quality of life back after spending months in bed but i still wasn't 100%.I would say at my best, i was operating at about 60% of my normal energy.I still had constant nausea and took zofran daily for over 4 years to deal with it as much as possible.In 2017, i started getting unexplained hives and rashes.I saw several drs.In (b)(6) of 2018 my allergist dr (b)(6) in (b)(6), told me i had the beginning stages of an autoimmune disorder but he wasn't sure what it was exactly.At that point, i ordered my medical records and started putting the pieces of the puzzle together.I knew all along that essure was causing my health issues and i realized that the only way i would get better would be to have it removed.I found dr (b)(6) in (b)(6) who has done hundreds of removals.He was the first dr who really listened to me and agreed right away that the essure needed to come out.He said if i didn't have any of these symptoms prior to essure and then they developed it was only logical to assume the connection.Besides abdominal pain and nausea that i already mentioned, here are some of my other symptoms that i developed after essure was implanted: extreme fatigue, new allergies, unexplained hives and rashes, pimples type bumps on my scalp; headaches, loss of sex drive - pain/bleeding with sex, insomnia, brain fog, add, anxiety; keep in mind, i didn't have any of these symptoms before essure except for mild post-partum depression that was treated.Whoever reads this, i'm begging you to do whatever you can to make bayer stop now.They are taking essure off the market but drs are still implanting it and can do so until the end of 2019.I beg you to put a stop to this now, so more women don't have to suffer like i have.Please put women's health above corporate profits.Please.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7922451
• MDR Text Key: 122452775
• Report Number: MW5080222
• 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: 09/28/2018

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 87