MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problems Cyst(s) (1800); Emotional Changes (1831); Headache (1880); Pain (1994); Weight Changes (2607); Heavier Menses (2666)

Event Date 01/24/2014

Event Type  Injury  

Event Description

Had essure implanted, have constant pain, heavy bleeding.I was told i was too heavy to have hysterectomy so i had a gastric sleeve.Lost over 100 lbs and still have all the adverse symptoms.I have even gone to emergency room for bleeding that would not stop.Headaches, mood swings, bleeding, pain, cysts on ovaries, i had to have xray and found that one coil is missing, i will have a hysterectomy in the summer to remove everything.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 3690869
• MDR Text Key: 4291109
• Report Number: MW5035033
• 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: 03/13/2014

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 104