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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Dizziness (2194); Urinary Frequency (2275); Confusion/ Disorientation (2553); Abdominal Distention (2601); Swelling/ Edema (4577)

Event Date 04/09/2014

Event Type  Injury  

Event Description

Fitted with essure (b)(6) 2014 since then have a long list of side effects detailed below, have had many visits over the years to gp and specialists, no diagnosis eventually after researching my symptoms i came across a support site for over 1400 women i (b)(6) suffering my symptoms, i have made my gp aware they are not educated to these symptoms being related, i am now having to travel to (b)(6) and pay privately for removal as i can no longer cope with the daily pain and how it is affecting my mental health.A list of my symptoms: severe bloating from flat stomach to 5 months pregnant, severe headaches and neck, and jaw pain.Joint pain all over.Shooting pains from feet up legs.Leg and feet swelling.Sharp stabbing pains in abdomen varies in length and position.Dull persistent ache in pelvis.Frequent need to urinate.Uncomfortable full feeling.Dizzy episodes with white flickers.Forgetfulness, fatigue; my gynaecologist in england agrees that the essure device has caused all the above symptoms and advised removal is the only option; this is scheduled for (b)(6) 2022.Fda safety report id #:(b)(4).

Event Description

Fitted with essure (b)(6) 2014 since then have a long list of side effects detailed below, have had many visits over the years to gp and specialists, no diagnosis eventually after researching my symptoms i came across a support site for over 1400 women i (b)(6) suffering my symptoms, i have made my gp aware they are not educated to these symptoms being related, i am now having to travel to (b)(6) and pay privately for removal as i can no longer cope with the daily pain and how it is affecting my mental health.A list of my symptoms: severe bloating from flat stomach to 5 months pregnant, severe headaches and neck, and jaw pain.Joint pain all over.Shooting pains from feet up legs.Leg and feet swelling.Sharp stabbing pains in abdomen varies in length and position.Dull persistent ache in pelvis.Frequent need to urinate.Uncomfortable full feeling.Dizzy episodes with white flickers.Forgetfulness, fatigue; my gynaecologist in england agrees that the essure device has caused all the above symptoms and advised removal is the only option; this is scheduled for (b)(6) 2022.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: 13584420
• MDR Text Key: 286134785
• Report Number: MW5107633
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: IBUPROFEN
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 31 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White