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

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problems Fatigue (1849); Hair Loss (1877); Failure of Implant (1924); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Visual Impairment (2138); Tingling (2171); Arthralgia (2355); Numbness (2415); Cognitive Changes (2551); Intermenstrual Bleeding (2665)

Event Date 07/10/2007

Event Type  Injury  

Event Description

I was implanted with essure coils.Within a month of implantation, i started noticing significant changes in my body.Odd hair growth, fatigue, hair loss, and very painful ovulation.The implanting dr brushed off my symptoms by saying i was getting old.I was (b)(6).I had never had these symptoms before.Three months later, i had the f/u hsg scan performed.There was leakage of the dye on the right side.Six months post implantation, i had another hsg scan.The right coil had "fallen out of the tube and was imbedded in the soft tissue of my uterus".As the years go on, my symptoms worsen and new ones appear.Fatigue, brain fog, trouble concentrating, serious memory issues, muscle and joint aches, massive hair loss, cysts, fibroids, rashes, odd hair growth, painful ovulation, painful intercourse, post coital bleeding, spotting throughout the month, changes in menses, cystic acne, back acne, lower abdominal pain constantly, lower back pain, sharp jabbing pains on the right side, numbness, tingling, and more.It took me years and many trips to the dr, before i realized what was causing the problems.I had a total hysterectomy leaving ovaries at age (b)(6) to have the devices removed.I am currently 10 days post op.I less than 24 hrs, my cystic acne calmed, acne disappeared, my clarity of thought slightly improved, my lower back pain is gone, and even my vision seems slightly better.The right coil was not even in my tube or uterus, but imbedded in my abdominal wall.I pray that every day more symptoms will resolve.I believe that the adverse side effects of this device must be recognized.Thank you.Fda safety report id#: (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 9197164
• MDR Text Key: 162796453
• Report Number: MW5090411
• 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: 10/12/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 66