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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Fatigue (1849); Fever (1858); High Blood Pressure/ Hypertension (1908); Menstrual Irregularities (1959); Pain (1994); Perforation (2001); Tachycardia (2095); Discomfort (2330); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Vitamin Deficiency (4497); Unspecified Kidney or Urinary Problem (4503); Swelling/ Edema (4577)

Event Date 03/22/2014

Event Type  Injury  

Event Description

I was implanted with the essure device in (b)(6) 2012.About 2 years later i noticed my periods getting heavier and much more painful.As time went on i became more and more fatigued, and i was also suffering from severe gastrointestinal pain and discomfort.My abdomen became very bloated over time to where strangers and friends thought i was pregnant (which i wasn't).I had anemia that my doctors and i couldn't resolve and a vitamin d deficiency.I had to have unnecessary tests done including and endoscopy and colonoscopy in 2018.I also had the get depo shots which proved unsuccessful and pelvic pt which was completely demeaning.I was finally scheduled for a hysterectomy on (b)(6) 2019 at the age of (b)(6) to get these demon coils out.Leading up to surgery i was having extreme pain on my lower right side of my pelvis and given no pain meds to help get me through till surgery.It's because very difficult to walk, sleep and basically live my everyday life.When i finally had my hysterectomy, it turns out the right sided coil perforated and left one was beginning to as well.I then had to spend 5 nights on the hospital due to increased blood pressure and heart rate and my bladder refused to work for the first 2-3 days.I had surgery on a tuesday and was not released till saturday afternoon.I had to have a blood transfusion while i was there.Not even a day and a half later on monday i woke up with a 103 degree fever and was dead, lifted to the hospital for another 5 days.I am still trifling at times to get back to normal nearly a year and a half later.This product was horrible and should never been approved by the fda.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: 11018992
• MDR Text Key: 222059915
• Report Number: MW5098389
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

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: 12/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 98