MAUDE Adverse Event Report: BAYER ESSURE COIL

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Emotional Changes (1831); Death, Intrauterine Fetal (1855); Perforation (2001); Rupture (2208); Malaise (2359); Abdominal Cramps (2543); Fluid Discharge (2686); Pregnancy (3193)

Event Date 06/25/2012

Event Type  Death  

Event Description

Essure coils were scheduled to be inserted in (b)(6) 2012.Urine test at (b)(6) hospital in (b)(6) for pregnancy before procedure were negative.Procedure continued as scheduled.Two weeks later i began to feel ill all the time and i thought maybe i was having a reaction to the coils, so i went back to my doctor to be checked out and found out that i was 6 weeks pregnant.So immediately i asked about the coils and if they would in any way have any type of affect on my pregnancy.I was told by dr.(b)(6) that my coils "would bend out of the way and they would not cause any harm to my pregnancy." i went on about my everyday life with my other 2 children and my husband as if things would be fine.Because that's what a medical professional told me, everything would be fine.I was at 22 weeks when i got up in the morning to go to the restroom.As i climbed over my husband, there was a loud, popping sound, like a balloon.It felt weird in my stomach so i didn't move.After a few seconds i got off the bed and immediately had water trickling down my legs.I panicked and went to the er at (b)(6) and was given a ferning test to see if i was leaking amniotic fluid.Test came back negative.Was sent home.Back again the next day, still leaking, another test, no ferning, sent home.Returned again 2 days later with cramping and fluid loss still, was given an ultrasound and was found to have an amniotic level of 10.Normal is around 14.A cerclage was placed to try and save the pregnancy.An ultrasound 2 days later revealed that my fluid level had dropped to a 4, and that my baby would not survive.Being a catholic hospital they would not remove the cerclage to perform a d&c and that was not what i wanted.I signed out (b)(6) and was admitted to (b)(6) hospital.There the high risk team assessed me and decided to remove the cerclage and let my body do the rest.As i was having a procedure to remove the cerclage, which was one of the most traumatizing things i've ever had to go through in my life, the high risk doctor performing the procedure stopped abruptly and said "what the (profanity) is an essure coil doing in her vaginal tract?" the coil had never implanted in fallopian tube and was floating around inside of my uterus my whole pregnancy.The coil had perforated the amniotic sac causing it to rupture and causing me and my husband to lose our beautiful baby girl daphne.I was too far along to have the pregnancy removed so i had to deliver her on my own.I gave birth to her on (b)(6) 2012.She lived for almost 15 minutes in my and my husband's arms.Since she was too far along to have the procedure, we had to have a funeral for her.I had to bury my baby because of a coil.Because i trusted my doctor to keep me and my baby safe and he didn't.I was never made aware at any time that there were any types of risk involved if i were to become pregnant.And i am assuming that is because bayer did not anticipate the possibility of it happening.Well, it did.And this was the outcome.I now suffer from ptsd because of the traumatizing nature in which this all happened.Bayer should be held responsible for what their product has done.Not just to me, but to all the women who believed and trusted their doctors that this was or is a safe and effective method of birth control.

• Brand Name: ESSURE COIL
• Type of Device: ESSURE COIL
• Manufacturer (Section D): BAYER
• MDR Report Key: 5115605
• MDR Text Key: 27212526
• Report Number: MW5056664
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 1 DA