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

Lot Number B40015

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Fatigue (1849); Headache (1880); Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Pain (1994); Rash (2033); Myalgia (2238); Arthralgia (2355); Heavier Menses (2666)

Event Date 12/03/2017

Event Type  Injury  

Event Description

Get the essure and suffered from heavy menstrual cycles, resulting in severe anemia then having iron infusions.High blood pressure, migraines, joint and muscle pain.Swelling and stiffness of joints.Rashes, chronic back and pelvic pain, extreme fatigue, breast pain, stomach pain and burning, heartburn, acid reflux, inflamed esophagus just to name a few.Last diagnosis are polycystic ovarian disease, and fibroids.My cycle never lightened up after years of suffering and then i had to endure an endometrial ablation in march which i'm told should not have been done to someone with the essure device, but after 3 months my cycle has started again.This all began after getting the essure device in 2013.I now have to get a total hysterectomy on tuesday (b)(6) 2018.I was never aware of the materials of essure and these possible inside effects and now i have to pay thousands to have them removed.I have to worry about them being removed correctly, intact so that i am not left with pet fibers of fragments of metal inside of me.I have 3 sons and a husband to live for who are now concerned for my life.This is not fair to the thousands of women who have endured the same issues and worse such as autoimmune diseases they have to now live with for the rest of their lives.Essure should be recalled and bayer should be the ones paying for the removals of this deadly device and reimbursing those who have had to pay for it themselves.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAOL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 600 bayer blvd.; whippany NJ 07981
• MDR Report Key: 7805199
• MDR Text Key: 117979942
• Report Number: MW5079274
• 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: 08/05/2018

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: Health Professional
• Device Expiration Date: 11/14/2015
• Device Lot Number: B40015
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2018
• 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: 38 YR
• Patient Weight: 67