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

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Nausea (1970); Rash (2033); Myalgia (2238); Toxicity (2333); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 01/01/2007

Event Type  Injury  

Event Description

Essure implanted in 2007.The next eleven years would be filled with an array of symptoms and health issues that, until recently.I was unaware were related to the essure product.I have dealt with the onset of fibromyalgia and chronic fatigue symptoms, and deal with an almost constant brain fog that often mimics short terms memory loss.I have had an array of immunological symptoms - such as ongoing rashes covering my arms and breast, which are believed to be related to the nickel in the product.I have had needlessly heavy and irregular periods - they are only getting worse with age, even passing clots the size of a fifty cents piece (which at (b)(6), is the exact opposite of what i have come to expect).I deal with nausea on a daily basis.I also suffer from constant pelvic pain, and back pain that makes it painful to stand for any period of time.Bloating and weight gain, which i cannot, no matter the circumstances, seem to lose.I intend to have a complete hysterectomy in the coming months, something i had hoped to avoid initially with the essure implants.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7738986
• MDR Text Key: 115781714
• Report Number: MW5078727
• 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: 07/28/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 134