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

Lot Number C35242

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Autoimmune Reaction (1733); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Inflammation (1932); Nausea (1970); Pain (1994); Weakness (2145); Cramp(s) (2193); Palpitations (2467); Weight Changes (2607); Heavier Menses (2666)

Event Date 02/18/2015

Event Type  Injury  

Event Description

I had essure placed on (b)(6) 2015 and began to have what i thought were random issues shortly after, getting more and more serious as time went on.I now believe these are adverse reactions to essure.I began to have extremely painful, heavy periods, where i would go through an entire box of 22 overnight pads in a day per period shortly after having essure placed.I began having severe abdominal pain and cramping even when not on my period.My hair began to fall out, my skin on my fingers and arm began to peel.I had extreme mood swings, painful intercourse which caused damage to my marriage, auto-immune symptoms including becoming neutropenic that required a week long hospital stay in (b)(6) 2017, rapid weight gain, inflammatory issues through-out my whole body, heart palpitations, constant nausea and digestive issues, weak and physically exhausted all the time.I suffered loss of organs when i had a hysterectomy with bilateral salpingectomy (b)(6) 2018 to remove the devices.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: 8735235
• MDR Text Key: 149474473
• Report Number: MW5087614
• 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: 06/21/2019

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
• Device Lot Number: C35242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 31 YR
• Patient Weight: 136