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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE

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BAYER ESSURE Back to Search Results
Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Miscarriage (1962); Pain (1994); Thyroid Problems (2102); Dizziness (2194); Anxiety (2328); Discomfort (2330); Arthralgia (2355); Weight Changes (2607); Heavier Menses (2666); Pregnancy (3193)
Event Date 07/01/2014
Event Type  Injury  
Event Description
(b)(4).I began having pelvic pain the day of implantation.I realized this was normal or expected so just took it easy.Unfortunately this pain never subsided.I had terrible lower back pain but also had a newborn baby so for the longest time i contributed symptoms to that.I also began experiencing joint pain, noticeable when i'd carry the baby up to bed.I began having gallbladder issues about 2 months after implantation so the pain and discomfort from that added to the pelvic pain and back pain was difficult to just do daily life.I had an ultrasound and an mri which determined i had sludge so i started a strict diet.I lost 15 pounds.I began to have severe fatigue, dizziness, constant fogginess and was so tired at times i was scared i would just pass out.I went to a doctor desperate for answers.They performed blood tests checking for thyroid issues, my a1c, hormone issues, liver functioning, etc and all was normal except my vitamin d level was low.I was devastated to have no answers! my periods returned about 10 months after implantation and were so heavy i had to wear a tampon and pad.I had huge clots and felt even more tired then usual.My periods would last around 10 days, twice the length before implantation.I have always dealt with mild hypoglycemia but after implantation, i began dealing with low blood sugars several times a day no matter what i ate.In (b)(6) i had a uti that would not go away.On my second round of antibiotics, i ended up having a panic attack.I was driving with two of our boys and it just so happens my blood sugar dropped, my gallbladder attacked and i felt as if i was going to pass out.I went to urgent care and after 3 hours the attack subsided.Unfortunately i have now had to deal with anxiety over having another attack.It is exhausting.My life is honestly largely stress free, no worries, problems, i have a lot of support, no depression issues, i am just stuck with fear of another attack.It is a physical response that is very difficult to control.I had an hsg done 3 months after implantation which showed correct placement, a blocked left tube, and a small opening still in the right tube.I was told to give it another 3 months and repeat the hsg.Unfortunately by that time i was in so much pain and my anxiety was terrible when it came to medical procedures, add in our insurance refusing to pay for a second hsg and i couldn't have it done.My husband and i used protection during sex but sex was so painful it was rare.We found out i was pregnant on (b)(6), the baby was perfectly placed in the middle of the uterus, my numbers were great, and there was a strong heartbeat.We did ultrasounds a week apart and the baby grew exactly on target.I had another uti that required a second round of antibiotics.I started to bleed but thought it was just uti related, it was not.We went in at 10 weeks on (b)(6) and the baby no longer had a heartbeat.It was determined i needed a dnc so the next day we went in for the procedure.The doctor knew at this point i wanted the coils removed so she attempted to remove them during the dnc.The right coil fragmented and the left was not visible so we knew at this point a hysterectomy was going to be necessary.Over the next week's my symptoms became much worse, in my opinion because the fibers were now scattered all around my uterus.The pain on my left side was terrible and my gallbladder made it to where i wasn't able to eat much of anything.Surgery was scheduled for (b)(6) to remove the gallbladder as well as a vaginal hysterectomy, leaving the ovaries.My ob found a large spot of endometriosis on my left side as well as a coil that had migrated up my tube and was as close to perforated as is possible.It was poking my abdominal wall and she said if left much longer it would have embedded in my abdomen.This brings me up to today.I almost immediately felt relief which was incredible considering i just had major surgery.The dizziness, fatigue, brain fog, joint pain was just gone.All of the pelvic pain related to the essure is gone, all i am dealing with is surgical pain.I am only (b)(6) years old and chose the essure because it was presented as a non surgical option with rare side effects.This has been the most difficult year and a half of my life and my family has all suffered as well.I was perfectly healthy before implantation.I know the coils are to blame for it all and feel like i can now live again with them out.This product must be removed from the market.The risks and side affects are severe and in no way worth continued implantations.I fully believe the women who seem to have no issues with it either don't know yet to contribute symptoms to essure or will all eventually be negatively affected.I plead with you to get this off of the market.I realize the amount of money involved and in my opinion corruption within bayer, but ending the suffering of so many women is worth more.I ask that you ban the essure.
 
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Brand Name
ESSURE
Manufacturer (Section D)
BAYER
MDR Report Key5440171
MDR Text Key38295805
Report NumberMW5060171
Device Sequence Number0
Product Code HHS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/16/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age34.000 YR
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