MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abdominal Distention (2601)

Event Date 01/01/2012

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of abdominal distension ('abdominal distention') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Medical conditions: no tests were performed before essure insertion.No stab-like pain in my right iliac fossa, referred to the lumbosacral region before the essure removal.In (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced procedural pain ("very painful after insertion"), malaise ("perpetuating chronic malaise starting after insertion") and complication of device insertion ("complication of device insertion").In 2012, the patient experienced abdominal distension (seriousness criterion intervention required), dyspepsia ("digestive problems, diagnosis functional dyspepsia"), flatulence ("excessive amounts of gas, diagnosis meteorism"), asthenia ("asthenia") and muscular weakness ("muscle weakness").On (b)(6) 2017, the patient experienced abdominal pain lower ("stab-like pain in my right iliac fossa after essure removal"), back pain ("referred to the lumbosacral region after essure removal"), abdominal adhesions ("adherences caused by the surgery") and complication of device removal ("complication of device removal").On an unknown date, the patient experienced mental disorder ("psychological problems") and stress ("stress").The patient was treated with amitriptyline hydrochloride (triptizol), pregabalin (lyrica), physical therapy (myofascial release therapy and myofascial release therapy, 20 rehabilitation sessions + 4 poyet method sessions) and surgery (removal of fallopian tubes with essure coils).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal distension, procedural pain, malaise, dyspepsia, flatulence, asthenia, muscular weakness and complication of device insertion outcome was unknown and the abdominal pain lower, back pain, abdominal adhesions, mental disorder, stress and complication of device removal had not resolved.The reporter considered abdominal adhesions, abdominal distension, abdominal pain lower, asthenia, back pain, complication of device insertion, complication of device removal, dyspepsia, flatulence, malaise, mental disorder, muscular weakness, procedural pain and stress to be related to essure.The reporter commented: essure insertion: my pain score was noted as very painful.It is stated in the progression notes that i had to be assisted for quite a while due to generalised malaise.Between 2012 and 2016, symptoms turning me into a completely sedentary person.Several tests done, for gluten and lactose intolerance among others, since the treatments i was on for gas were not working, which led to the diagnosis of meteorism and functional dyspepsia.After essure removal with removal of both fallopian tubes, and after taking the necessary postoperative bed rest, i noticed that upon standing up and moving i would feel a stab-like pain in my right iliac fossa, referred to the lumbosacral region, i did not suffer such pain before the removal surgery.This pain remained throughout the entirety of 2017, with no improvement even under pharmacological treatment (lyrica and triptizol) and 20 rehabilitation sessions + 4 poyet method sessions.Every treatment i use comes from private institutions, as well as radiology testing, such as magnetic resonance, computed tomography (ct) scans, and x-rays.Despite all this, i still feel pain to this day.Currently, i am waiting for an appointment at the pain unit for the diagnosis of chronic pain.I am undergoing myofascial release therapy (fascial release in the body due to adherences caused by the surgery).Everything mentioned also caused me financial damages, since i had to get private health insurance, as well as psychological problems due to my limited capacities throughout these past years and the stress of physical changes caused by abdominal distension.Diagnostic results (normal ranges are provided in parenthesis if available): investigation - on an unknown date: several tests done, for gluten and lactose intolerance: diagnosis of meteorism and functional dyspepsia.Lactose tolerance test - on an unknown date: meteorism and functional dyspepsia.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of abdominal distension ('abdominal distention') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Medical conditions: no tests were performed before essure insertion.No stab-like pain in my right iliac fossa, referred to the lumbosacral region before the essure removal.In (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced procedural pain ("very painful after insertion"), malaise ("perpetuating chronic malaise starting after insertion") and complication of device insertion ("complication of device insertion").In 2012, the patient experienced abdominal distension (seriousness criterion intervention required), dyspepsia ("digestive problems, diagnosis functional dyspepsia"), flatulence ("excessive amounts of gas, diagnosis meteorism"), asthenia ("asthenia") and muscular weakness ("muscle weakness").On (b)(6) 2017, the patient experienced abdominal pain lower ("stab-like pain in my right iliac fossa after essure removal"), back pain ("referred to the lumbosacral region after essure removal"), postoperative adhesion ("adherences caused by the surgery") and complication of device removal ("complication of device removal").On an unknown date, the patient experienced mental disorder ("psychological problems") and stress ("stress").The patient was treated with amitriptyline hydrochloride (tryptizol), pregabalin (lyrica), physical therapy (myofascial release therapy and myofascial release therapy, 20 rehabilitation sessions + 4 poyet method sessions) and surgery (removal of fallopian tubes with essure coils).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal distension, procedural pain, malaise, dyspepsia, flatulence, asthenia, muscular weakness and complication of device insertion outcome was unknown and the abdominal pain lower, back pain, postoperative adhesion, mental disorder, stress and complication of device removal had not resolved.The reporter considered abdominal distension, abdominal pain lower, asthenia, back pain, complication of device insertion, complication of device removal, dyspepsia, flatulence, malaise, mental disorder, muscular weakness, postoperative adhesion, procedural pain and stress to be related to essure.The reporter commented: essure insertion: my pain score was noted as very painful.It is stated in the progression notes that i had to be assisted for quite a while due to generalised malaise.Between 2012 and 2016, symptoms turning me into a completely sedentary person.Several tests done, for gluten and lactose intolerance among others, since the treatments i was on for gas were not working, which led to the diagnosis of meteorism and functional dyspepsia.After essure removal with removal of both fallopian tubes, and after taking the necessary postoperative bed rest, i noticed that upon standing up and moving i would feel a stab-like pain in my right iliac fossa, referred to the lumbosacral region, i did not suffer such pain before the removal surgery.This pain remained throughout the entirety of 2017, with no improvement even under pharmacological treatment (lyrica and tryptizol) and 20 rehabilitation sessions + 4 poyet method sessions.Every treatment i use comes from private institutions, as well as radiology testing, such as magnetic resonance, computed tomography (ct) scans, and x-rays.Despite all this, i still feel pain to this day.Currently, i am waiting for an appointment at the pain unit for the diagnosis of chronic pain.I am undergoing myofascial release therapy (fascial release in the body due to adherences caused by the surgery).Everything mentioned also caused me financial damages, since i had to get private health insurance, as well as psychological problems due to my limited capacities throughout these past years and the stress of physical changes caused by abdominal distension.Diagnostic results (normal ranges are provided in parenthesis if available): investigation - on an unknown date: several tests done, for gluten and lactose intolerance: diagnosis of meteorism and functional dyspepsia.Lactose tolerance test - on an unknown date: meteorism and functional dyspepsia.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 16-jun-2021: quality safety evaluation of ptc based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 11907266
• MDR Text Key: 266062729
• Report Number: 2951250-2021-02492
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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: Health Professional
• Device Model Number: ESS305
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 05/31/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention