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 Problem Pain (1994)

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)) on 19-mar-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain during ovulation period") in a female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2016, the patient had essure inserted.Essure was removed on (b)(6) 2020.On unknown date she experienced pelvic pain (seriousness criterion intervention required), toothache ("toothaches 48 hours before my period starts which turn into dental abscesses from time to time"), tooth abscess ("dental abscess"), dysgeusia ("metallic taste in my mouth"), fatigue ("severe fatigue"), amnesia ("loss of memory"), disturbance in attention ("concentration difficulties"), aphasia ("aphasia"), arthralgia ("joint pain"), sciatica ("sciatica/ cruralgia"), tendonitis ("elbow tendonitis"), neck pain ("neck pain"), blindness ("vision loss"), dry eye ("dry eyes"), chalazion ("chalazions in both eyes"), ear pruritus ("severe itching in my ears"), heavy menstrual bleeding ("very heavy menstrual periods"), feeling cold ("chilliness"), hyperhidrosis ("increased sweating"), breast calcifications ("zonectomy of the left breast on microcalcifications") and keratitis ("keratitis in my right eye") and underwent tooth extraction ("major dental problems with extraction of 5 teeth (soon a 6th)").The patient was treated with surgery (bilateral salpingectomy with removal of essure devices and zonectomy).At the time of the report, the tooth extraction, toothache, tooth abscess, fatigue, amnesia, disturbance in attention, aphasia, arthralgia, sciatica and tendonitis had not resolved.The outcomes for pelvic pain, dysgeusia, neck pain, blindness, dry eye, chalazion, ear pruritus, heavy menstrual bleeding, feeling cold, hyperhidrosis, breast calcifications and keratitis were unknown.No causality assessment was received for essure with regard to tooth extraction, toothache, tooth abscess, dysgeusia, fatigue, amnesia, disturbance in attention, aphasia, arthralgia, sciatica, tendonitis, neck pain, blindness, dry eye, chalazion, ear pruritus, pelvic pain, heavy menstrual bleeding, feeling cold, hyperhidrosis, breast calcifications or keratitis.The reporter commented: period of occurrence: april 2017.Major dental work with implant placement and ongoing treatment of periodontics.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 64 kg.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

The below report was received by health authority ansm (reference number: (b)(4) on 19-mar-2024.The most recent information was received on 27-mar-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of ovulation pain ("pelvic pain during ovulation period") in a female patient who had essure inserted for permanent contraceptive tubal implant.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2016, the patient had essure inserted.Essure was removed on (b)(6) 2020.On unknown date she experienced ovulation pain (seriousness criterion intervention required), toothache ("toothaches 48 hours before my period starts which turn into dental abscesses from time to time"), tooth abscess ("dental abscess"), dysgeusia ("metallic taste in my mouth"), fatigue ("severe fatigue"), amnesia ("loss of memory"), disturbance in attention ("concentration difficulties"), aphasia ("aphasia"), arthralgia ("joint pain"), sciatica ("sciatica/ cruralgia"), tendonitis ("elbow tendonitis"), neck pain ("neck pain"), blindness ("vision loss"), dry eye ("dry eyes"), chalazion ("chalazions in both eyes"), ear pruritus ("severe itching in my ears"), heavy menstrual bleeding ("very heavy menstrual periods"), feeling cold ("chilliness"), hyperhidrosis ("increased sweating"), breast calcifications ("zonectomy of the left breast on microcalcifications") and keratitis ("keratitis in my right eye") and underwent tooth extraction ("major dental problems with extraction of 5 teeth (soon a 6th)").The patient was treated with surgery (bilateral salpingectomy with removal of essure devices and zonectomy).At the time of the report, the tooth extraction, toothache, tooth abscess, fatigue, amnesia, disturbance in attention, aphasia, arthralgia, sciatica and tendonitis had not resolved.The outcomes for ovulation pain, dysgeusia, neck pain, blindness, dry eye, chalazion, ear pruritus, heavy menstrual bleeding, feeling cold, hyperhidrosis, breast calcifications and keratitis were unknown.No causality assessment was received for essure with regard to tooth extraction, toothache, tooth abscess, dysgeusia, fatigue, amnesia, disturbance in attention, aphasia, arthralgia, sciatica, tendonitis, neck pain, blindness, dry eye, chalazion, ear pruritus, ovulation pain, heavy menstrual bleeding, feeling cold, hyperhidrosis, breast calcifications or keratitis.The reporter commented: period of occurrence: on (b)(6) 2017.Major dental work with implant placement and ongoing treatment of periodontics.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 64 kg.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: 27-mar-2024: quality safety evaluation of product technical complaint.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: 18967707
• MDR Text Key: 338472446
• Report Number: 2951250-2024-00210
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 03/27/2024
• 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
• Patient Sex: Female
• Patient Weight: 64 KG