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

Model Number ESS305

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Emotional Changes (1831); Hair Loss (1877); Menstrual Irregularities (1959); Pain (1994); Swelling (2091); Depression (2361)

Event Date 01/01/2016

Event Type  Injury  

Event Description

Essure caused debilitating pain, hair loss, painful sex, severe swelling in abdomen, sporadic periods and mental health issues.I started bringing these issues to my gyn (b)(6) 2016 (implanted (b)(6) 2015.) after multiple tests including hsg imaging, regular x-rays, pelvic ultrasounds, full hysterectomy was performed (b)(6) 2019.The right coil had migrated out of my fallopian tube and into my uterus and was embedded into the muscle of it.I've had to have cervix, both tubes, and uterus removed due to the essure devices.My surgeon has pictures of the embedded device as well as the pathology reports, i can provide once i physically receive them, if needed.Since essure implantation, i have had to take two antidepressants for both depression and pain associated with the essure 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: 9540627
• MDR Text Key: 173945628
• Report Number: MW5092004
• 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: 12/31/2019

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 Model Number: ESS305
• Device Lot Number: C18708
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 98