MAUDE Adverse Event Report: BAYER ESSURE

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

Patient Problems Emotional Changes (1831); Hair Loss (1877); Headache (1880); Nausea (1970); Disability (2371); Numbness (2415); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Test Result (2695)

Event Date 04/10/2013

Event Type  Injury  

Event Description

(b)(4).I originally signed a tubal ligation paper after i had my 6th child in (b)(6) 2012.My tubal ligation date was set for (b)(6) 2013.Once i arrived at the hospital and was ready to be put to sleep the dr.Came in and explained that he would be doing the essure process.I had no time to research this product nor did i know what it was.I was trusting that my dr.Was doing a tubal ligation.After about 20 days of having essure in me, i began to lose an abundance of hair, was cramping out of control, bleeding so bad i had to go to the dr.He of course just said that my hormones were probably out of whack and that it should subside itself.I then gained about 60 pounds over the course of the next 4 months.I was referred by my pcp to seek a surgical procedure because i was "overweight".I did not! for the last 2 years i began to have horrible migraines that made me nauseous and unable to even function daily with my children.I have lost all urge to have sex with my partner.I had began to have really bad cramping like labor contractions during menstruation, my left arm continues to go numb a random times, and i constantly forget what i was doing or need constant reminders.I finally had enough and cried out to my pcp who then ordered a pelvic ultrasound, then i took those results to my obgyn that did implantation.He scheduled for me to have the flat panel xrays where we found out that one of my coils (left essure) had migrated and is nowhere to be found.I also had pelvic ct scan, abdominal ct scan, and still nowhere to be found.

Event Description

(b)(4).I had to had an exploratory laparotomy on (b)(6) 2015 to have my both my tubes and right essure device removed and the surgeon still could not find the left essure device.I have had to take time off work without pay and have had to have everyone take care of me.No woman should have to live their life like this! i have to go the rest of my life not knowing if i have still the other essure device in me somewhere embedded in an organ.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4901653
• MDR Text Key: 6066620
• Report Number: MW5043772
• 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: 07/09/2015

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: 07/09/2015
• Patient Sequence Number: 1
• Patient Age: 32.000 YR