MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC. ESSURE; TRANSCERVICAL CONTRACEPTIVE

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

Patient Problems Anemia (1706); Hot Flashes/Flushes (2153); Cramp(s) (2193); Depression (2361); Heavier Menses (2666)

Event Date 02/18/2016

Event Type  Injury  

Event Description

I had the essure implanted as a permanent birth control and i have problems with my period.My period is pretty heavy to the point that i became anemic, cramping, restless, headaches, hot flashes and depression.I had no idea it was the essure until doctors did all kinds of tests and no evidence of a problem.Then my suspicions were confirmed when i realized that many other women that had the essure were having the same problems.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC.
• MDR Report Key: 7780299
• MDR Text Key: 117253186
• Report Number: MW5079110
• 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: 08/11/2018

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 63