MAUDE Adverse Event Report: CONCEPTUS / BAYER HEALTHCARE LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Fatigue (1849); Hair Loss (1877); Itching Sensation (1943); Memory Loss/Impairment (1958); Abdominal Cramps (2543); Heavier Menses (2666); Fibrosis (3167)

Event Date 12/19/2018

Event Type  Injury  

Event Description

I had the essure coils implanted in (b)(6) 2012, and after developing severe abdominal cramps, heavy and prolonged menstrual bleeding/cramps, hair loss, memory problems, profound problems with sexual desire/response/functioning, chronic/severe fatigue, joint pain/problems, widespread rashes and itchiness, easy/slow-healing bruising, and newly brittle nails and teeth, i was finally able to convince a doctor to remove the coils.Prior to having the coils implanted, i was told that the coils were made ¿entirely of titanium¿ as i had informed the doctor that i was very allergic to nickel.The doctor told me that the coils were completely safe, more effective against pregnancy than all other forms of contraceptives including surgical tubal ligation (which i had requested before being told that essure coils were the only option unless i were to have had a cesarean section at the same time, and i was not pregnant), required no recovery time, had no side effects, and had no risks beyond infection from the initial insertion.The removal surgery was wednesday, (b)(6) 2018, and intended to be a paracervical (partial) hysterectomy/bilateral salpingectomy, sparing both the cervix and ovaries.Unfortunately, my uterus was completely misshapen with multiple large fibroids which had also completely destroyed my cervix to the point where it had to be removed as well.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE
• Manufacturer (Section D): CONCEPTUS / BAYER HEALTHCARE LLC
• MDR Report Key: 8199804
• MDR Text Key: 131934062
• Report Number: MW5082636
• 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: 12/21/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 37 YR
• Patient Weight: 102