MAUDE Adverse Event Report: CONCEPTUS OR BAYER ESSURE

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Abscess (1690); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Tachycardia (2095); Cramp(s) (2193); Dizziness (2194); Depression (2361); Palpitations (2467); Weight Changes (2607)

Event Date 03/29/2012

Event Type  Injury  

Event Description

After pcp failed to run pregnancy test, less than 24 hours later, i experienced a ruptured ectopic pregnancy, lost over 2 liters of blood, coded twice. I had the mirena iud at the time which the surgeons left in place. Two days later, i requested it be removed before my hospital discharge as it had obviously failed. I was terrified, in pain, on many medications and 8 weeks later had the essure coil implanted in my remaining fallopian tube. Recently, i have discovered that per the essure ifu, it is not recommended to have essure placement unilaterally, however, the ob/gyn placed it regardless. Within 3 weeks of having the essure coil placed, i had continued cramping, bleeding, excruciating pain, nausea, weight loss, lower left pelvic pain, dizziness, extreme fatigue. It felt like my body was rejecting the coil and i could pinpoint the exact location of the coil due to the pain. I had to force treatment as several doctors told me it was all in my head, that they had consulted several coworkers as well as the mfr of essure, all of whom stated my symptoms and complaints could in no way be related to their coil. Finally, the ob/gyn performed exploratory surgery to verify the location of the coils - from vaginal entry with camera the coils were unable to be located. The surgeon then had to go in laparoscopically through abdomen, removed the left fallopian tube, and located "foreign object" aka essure coil in my tube. The surgeon performed a hysterectomy. I had never had medical issues prior to these events. The largest part of my medical history was my pregnancy in 2010. Since (b)(6) 2012, i have been to doctor's appointments in excess of 150 times in a 2 year period. My immune system has not been working, dizziness, extreme fatigue, depression, weight gain, abscesses on arms, tachycardia, heart palpitations, migraines are all symptoms and medical problems i have been living with and cannot explain with any other explanation, other than the rupture hemorrhage, essure coil, and it's migration and negligence of the doctors. I have read the recent reviews about the findings that these reported adverse reactions don't impact the fda's position regarding essure. How can the essure product be removed from the ca pre-emptive law as it is not a life saving device and should not be exempt from liability. There are several websites and groups with no hundreds, but thousands of women who all have the same problems, all of which did not begin until essure placement.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): CONCEPTUS OR BAYER
• MDR Report Key: 3580915
• MDR Text Key: 18369197
• Report Number: MW5033878
• 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: 01/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other

Patient Treatment Data

Date Received: 01/13/2014 Patient Sequence Number: 1