MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Fatigue (1849); Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Disability (2371); Abdominal Cramps (2543); Vaso-Vagal Response (2661); Intermenstrual Bleeding (2665)

Event Date 04/06/2015

Event Type  Injury  

Event Description

(b)(4).I was advised by ob/gyn that essure would be the best option for permanent birth control for me.I was informed it was fast/easy, virtually painless, and permanent.It was none of these, in my case.The procedure was horrific.Nearly 3 hours of constant contracting and pain.It took nearly 2 hours to get left coil inserted.The right coil went quicker, at just around 10 minutes.After procedure, i experienced a vagel response, unable to move any of my joints, and could not breathe.About 30 minutes later i was able to sit up and get dressed.I was exhausted and still cramping.I was not given the depo shot until the following week.3 weeks after implant, i started bleeding and experiencing pain/pressure in my right side.I called nurse who said it's possibly from depo shot.After another 2 weeks of bleeding (fresh bright red blood) i called and demanded to be seen.I went in on (b)(6) to discuss my symptoms.Implant doc said he was concerned due to the way the procedure itself went.That he consulted with his partner and they planned to schedule a 3d ultrasound for following week.However, 2 days later, on (b)(6), i used the restroom and as i pulled out my tampon, i see a huge blood clot with one of the coils attached.I was unable to reach my ob, so visited er to make sure i wasn't bleeding internally.They did us and vag us, determined i was not bleeding internally, however, could not confirm the location of remaining coil.I called ob on monday morning, ((b)(6)) and explained situation.He was obviously concerned due to the whole procedure and offered to perform removal surgery "at no cost".I opted for 2nd opinion from another doctor, as my confidence in implant doc was diminished.New doctor advised my uterus was prolapsed, as well, and advised lavh surgery would be required to remove remaining coil and solve prolapsed uterus.Surgery was (b)(6) 2015, 63 days after implant of essure coils.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4960074
• MDR Text Key: 6035408
• Report Number: MW5044963
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/20/2015

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 38.000 YR