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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Pain (1994); Vertigo (2134); Arthralgia (2355); Palpitations (2467); Confusion/ Disorientation (2553)

Event Date 03/01/2014

Event Type  Injury  

Event Description

In (b)(6) of 2008 i was implanted with essure device as sold by bayer.Since 2014 i have had worsened symptoms including but not limited to excessive, abnormal dysfunctional bleeding; heavy bleeding, large blood clots and bleeding outside of my menstrual period.I bleed for 2 weeks every 2 weeks.Last year i had a uterine polyp removed.In the last year and half i have had worsened joint pain in my neck, mid back and low back.I have hip pain, severe abdominal pain where the coils are located, sharp pains that radiate around my back.I have had teeth break and had to have them pulled.I have hair loss, brain fog, forgetfulness, fatigue, vertigo and heart palpitations.I am unable to afford the surgery required to have the coils removed and therefore continue to struggle with the pain and suffering this device has caused.I did not have any of these issues prior to being implanted.This device was falsely advertised as safe and affective.It has been anything but.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: 8935294
• MDR Text Key: 155792625
• Report Number: MW5089323
• 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: 08/23/2019

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 35 YR