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

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Vomiting (2144); Palpitations (2467); Weight Changes (2607)

Event Date 11/29/2008

Event Type  Injury  

Event Description

Your scale doesn't go back far enough.I was implanted with essure in 2004 and have had a steady stream of problems since including back problems, autoimmune diagnosis, nerve damage, hair loss, nickel allergy and stabbing headaches diagnosed; heart palpitations and weight gain.I have now had to have a hysterectomy to remove the essure, only learning about it when i had this horrific metal taste in my mouth and violent throwing up.Found the connection to all my problems while researching the symptoms.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8094984
• MDR Text Key: 128250479
• Report Number: MW5081536
• 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: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 47 YR
• Patient Weight: 70