MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682)

Patient Problems Deposits (1809); Headache (1880); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Pain (1994); Scarring (2061); Hot Flashes/Flushes (2153); Arthralgia (2355); Inadequate Pain Relief (2388); Sweating (2444)

Event Date 05/24/2010

Event Type  Injury  

Event Description

I had essure implanted in (b)(6) 2010.From the day of insertion i had severe pelvic pain.I was assured by my doctor that this pain would go away and everything would be better after a few weeks.Unfortunately the pain never went away.The pelvic pain got worse and i begun bleeding heavily again, despite having the endometrial ablation done.In (b)(6) 2011 i ended up having a hysterectomy (removal of uterus and cervix) to hopefully control the bleeding and the pain.The bleeding stopped but the pain did not lessen any.I have had many gynecological appointments for the pain as well as all over itching (pruritus), severe lower back pain, constant headaches, night sweats, night terrors, hot flashes, and joint pain.I am a (b)(6) mother and i have not been able to live my life in the manner i was able to before having essure implanted.I have had numerous emergency department visits all resulting in inconclusive answers.I have also developed kidney stones since having essure implanted, something i never had to deal with before.In (b)(6) 2014 i finally found a doctor who was willing to listen to me about my concerns with essure and he ordered an x-ray to check placement.The x-ray showed one essure coil on the left side and what appeared to be a surgical clip on the left side.However, there was no essure coil present on the right side of the x-ray.In (b)(6) 2014, my gynecologist agreed to remove my tubes and look for the right essure coil.After removing much scar tissue believed to be caused by the inflammation from essure, he still could not locate the right coil.It is believed that it was either expelled and i did not notice it or that it has migrated into my intestines or colon.While essure was implanted my ana titers were four times higher than they should have been and i am now being tested for sle and mixed connective tissue disease.No one in my immediate family has this.Sle is caused by inflammation in the body and it is my belief that having essure implanted for so long has caused me to be at risk for autoimmune disorders because of the constant inflammation essure causes.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 3705290
• MDR Text Key: 4264173
• Report Number: MW5035253
• 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: 03/15/2014

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: 03/27/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31.000 YR