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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Menstrual Irregularities (1959); Menorrhagia (4508)

Event Type  Injury  

Event Description

This spontaneous case was reported by a healthcare professional and describes the occurrence of heavy menstrual bleeding ("menorrhagia with changes every hour") and dysmenorrhoea ("intense dysmenorrhea categorised as vas (visual analogue scale) 7-8") in a 47 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of appendectomy (by laparoscopy) and caesarean section.Concurrent conditions were listed as drug intolerance (to primperan), extrasystoles (in the process of investigation) and insulin resistance (not requiring treatment).On (b)(6) 2016, the patient had essure inserted.In 2019 she experienced dyspareunia ("post-coital pain for about 4 years, ballistic dyspareunia of recent onset").On unknown date she experienced heavy menstrual bleeding (seriousness criterion intervention required), dysmenorrhoea (seriousness criterion medically important), premenstrual pain ("pre-menstrual pain"), ovulation pain ("intense and prolonged ovulation pain"), tinnitus ("bilateral tinnitus"), asthenia ("major asthenia"), arthralgia ("arthralgias"), sinusitis ("sinusitis") and myalgia ("myalgias").The patient was treated with surgery (essure removal with a cornuectomy by laparoscopy).Essure was removed on (b)(6) 2023.No causality assessment was received for essure with regard to heavy menstrual bleeding, tinnitus, ovulation pain, asthenia, dysmenorrhoea, premenstrual pain, dyspareunia, arthralgia or sinusitis.The reporter commented: essure removal was performed at patient's request.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 healthcare professional and describes the occurrence of heavy menstrual bleeding ("menorrhagia with changes every hour") and dysmenorrhoea ("intense dysmenorrhea categorised as vas (visual analogue scale) 7-8") in a 47 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of appendectomy (by laparoscopy) and caesarean section.Concurrent conditions were listed as drug intolerance (to primperan), extrasystoles (in the process of investigation) and insulin resistance (not requiring treatment).On (b)(6)2016, the patient had essure inserted.In 2019 she experienced dyspareunia ("post-coital pain for about 4 years, ballistic dyspareunia of recent onset").Essure was removed on (b)(6)2023.On unknown date she experienced heavy menstrual bleeding (seriousness criterion intervention required), dysmenorrhoea (seriousness criterion medically important), premenstrual pain ("pre-menstrual pain"), ovulation pain ("intense and prolonged ovulation pain"), tinnitus ("bilateral tinnitus"), asthenia ("major asthenia"), arthralgia ("arthralgias"), sinusitis ("sinusitis") and myalgia ("myalgias").The patient was treated with surgery (essure removal with a cornuectomy by laparoscopy).No causality assessment was received for essure with regard to heavy menstrual bleeding, tinnitus, ovulation pain, asthenia, dysmenorrhoea, premenstrual pain, dyspareunia, arthralgia, sinusitis or myalgia.The reporter commented: essure removal was performed at patient's request.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 20-feb-2024: 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.

Manufacturer Narrative

This spontaneous case was reported by a healthcare professional and describes the occurrence of heavy menstrual bleeding ("menorrhagia with changes every hour") and dysmenorrhoea ("intense dysmenorrhea categorised as vas (visual analogue scale) 7-8") in a 47 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of appendectomy (by laparoscopy) and caesarean section.Concurrent conditions were listed as drug intolerance (to primperan), extrasystoles (in the process of investigation) and insulin resistance (not requiring treatment).On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2019 she experienced dyspareunia ("post-coital pain for about 4 years, ballistic dyspareunia of recent onset").Essure was removed on (b)(6) 2023.On unknown date she experienced heavy menstrual bleeding (seriousness criterion intervention required), dysmenorrhoea (seriousness criterion medically important), premenstrual pain ("pre-menstrual pain"), ovulation pain ("intense and prolonged ovulation pain"), tinnitus ("bilateral tinnitus"), asthenia ("major asthenia"), arthralgia ("arthralgias"), sinusitis ("sinusitis") and myalgia ("myalgias").The patient was treated with surgery (essure removal with a cornuectomy by laparoscopy).No causality assessment was received for essure with regard to heavy menstrual bleeding, tinnitus, ovulation pain, asthenia, dysmenorrhoea, premenstrual pain, dyspareunia, arthralgia, sinusitis or myalgia.The reporter commented: essure removal was performed at patient's request.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 23-feb-2024: upon receiving a new follow-up information, it was confirmed that cases 2024a025590 & 2023a140049 are duplicates of each other therefore case 2024a025590 needs to be marked for deletion.All source documents, references , source documents are transferred to retention case.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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18738066
• MDR Text Key: 335739880
• Report Number: 2951250-2024-00136
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female