MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Insufficient Information (3190)

Patient Problems Hair Loss (1877); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Memory Loss/Impairment (1958); Pain (1994); Hot Flashes/Flushes (2153); Cramp(s) (2193); Heavier Menses (2666)

Event Date 06/01/2013

Event Type  Injury  

Event Description

I had essure implanted and a few months after having it implanted, i started having side effects.Since 2013 when it was implanted, i have had continuous problems with new ones arising every year while the old ones persist.These side effects include: uterine infection, excessive bleeding during period (menorrhagia), painful ovulation (mittelschmerz), night sweats, loss of libido, hot flushes, bleeding / spotting after sex, painful periods (dysmenorrhea), painful intercourse (dyspareunia); bleeding between periods (menorrhagia), bacterial vaginosis, cramping, sharp / stabbing pelvic pain, lack of menstrual cycle (amenorrhea); haven't had a period for 6 months, brain fog, pelvic pain and cramping; hair loss and changes vision problems.This list may not include all problems as it is long and i'm going off my memory right now.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7842214
• MDR Text Key: 119216535
• Report Number: MW5079528
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• 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: 08/29/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 59