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

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Thrombosis (2100); Dizziness (2194); Heavier Menses (2666)

Event Date 10/11/2012

Event Type  Injury  

Event Description

I was implanted with essure in (b)(6) 2008.Diagnosed with rare autoimmune disorder ttp thrombotic thrombocytopenic purpura which is a life threatening disorder upon each episode.I have to date relapsed 4 times on average being a year apart.I was given rituxan in (b)(6) 2015 which kept me in remission for approx 26 months.Relapsed again at the 26 month mark (b)(6) 2017 and given routine treatment and rituxan again.Each episode prior was within a year and high dose prednisone 80 milligrams as well as plasmapheresis.Unfortunately after treatment which lasts about 3 months takes me a year to feel back to any sense of normal.Upon relapse i have been hospitalized for 12 days each time.I have had no other ongoing medical issues prior to this.Only one dvt and kidney stones.My quality of life has diminished.I am in the beginning stages of essure removal and nickle allergy testing to happened as well.Other symptoms include fatigue, light-headedness, gi issues, heavy menstrual cycles with no diagnosis.Lastly, although i was never tested prior to the essure implant, i am allergic to some degree to nickle or similar metals as i cannot wear inexpensive jewelry of any kind; within hours my skin will react.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): CONCEPTUS / BAYER HEALTHCARE LLC
• MDR Report Key: 7805723
• MDR Text Key: 118124532
• Report Number: MW5079312
• 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: 08/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• 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: 37 YR
• Patient Weight: 82