MAUDE Adverse Event Report: BAYER ESSURE

Model Number ESS305

Device Problems Bent (1059); Material Protrusion/Extrusion (2979)

Patient Problems Emotional Changes (1831); Hemorrhage/Bleeding (1888); Pain (1994); Abdominal Cramps (2543); Pregnancy (3193)

Event Date 01/05/2015

Event Type  Injury  

Event Description

I had the essure procedure done (b)(6) 2014.During the procedure one of the coils bent when the doctor inserted it into my right fallopian tube.He redid that coil and all was good.I bled for a month straight and had bad cramps and pains on my right side.I had the confirmation test done (b)(6) 2014 via an ultrasound that showed both coils in place, however the right coil was only 3/4 the way in the tube the other 1/4 was protruding into my uterus.I was told the procedure worked and it was ok to stop using all forms of birth control.(b)(6) 2015 i am 6 days late with a confirmed positive pregnancy test.Now i have no option but to have an abortion because i can't afford another baby which is the reason i had the procedure done to begin with.I don't think the risks of pregnancy, especially ectopic pregnancy, is fully disclosed nor accurate from bayer.Furthermore, bayer should not have immunity from lawsuits when there are women being harmed physically/emotionally/mentally everyday and they just turn their heads.I am emotionally distraught and words can't describe how i feel.I recommend this product be taken off the market.If i could go back i would have just gotten a tubal done and save myself the pain and heartache.Even if i could afford to keep this baby the risks are too major.With the coil protruding into my uterus it would put the fetus at risk and possibly end up with a still born.Someone needs to be responsible for this faulty device that is treated like a walk in the park, easy, painless etc and i assure you what the website said, it's not what i felt during or after the procedure.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4402933
• MDR Text Key: 5431566
• Report Number: MW5040094
• 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
• Type of Report: Initial
• Report Date: 01/05/2015

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?: No
• Device Operator: Other
• Device Model Number: ESS305
• Device Catalogue Number: ESS305
• Device Lot Number: C76446
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 30 YR
• Patient Weight: 53