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

Model Number ESS305

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2015

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 02-mar-2022.This spontaneous case was reported by a consumer and describes the occurrence of metal poisoning ('nickel and tin poisoning'), abdominal discomfort ('heaviness in the lower abdomen, feelings of abdominal inflammation'), headache ('headaches'), adenomyosis ('diffuse adenomyosis') and pruritus genital ('itchy genitals') in a (b)(6) female patient who had essure (batch no.C68117) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right insert in loop" (seriousness criterion intervention required) on 23-jul-2015.On (b)(6) 2015, the patient had essure inserted.On (b)(6)2015, the patient experienced metal poisoning, abdominal discomfort, headache, pruritus genital, nasal pruritus ("itchy nose"), eye pruritus ("itchy eyes"), tinnitus ("tinnitus"), tendonitis ("regular tendonitis"), musculoskeletal pain ("muscle and joint pain"), fatigue ("increased fatigue"), middle insomnia ("sleep disorders with nocturnal awakenings"), aphasia ("loss of words, difficulty reading and comprehending reading"), amnesia ("memory loss/ forgetfulness"), cystitis ("recurrent cystitis"), dry skin ("dry skin"), tooth fracture ("broken teeth"), tooth abscess ("tooth abscesses resistant to antibiotics") and disturbance in attention ("attention disorder in the professional environment"), 3 months after insertion of essure.On an unknown date, the patient experienced adenomyosis, anger ("excessive anger"), depression ("depression") and cognitive disorder ("persistent cognitive disorders (distractibility and planning disorder demonstrated by memory test)").The patient was treated with surgery (vaginal hysterectomy with bilateral salpingectomy in (b)(6) 2020).Essure was removed on (b)(6) 2020.At the time of the report, the metal poisoning, headache, adenomyosis, tinnitus, musculoskeletal pain, fatigue, aphasia, amnesia, disturbance in attention, anger, depression and cognitive disorder had not resolved, the abdominal discomfort, pruritus genital, nasal pruritus, eye pruritus, tendonitis, cystitis, dry skin, tooth fracture and tooth abscess outcome was unknown and the middle insomnia was resolving.The reporter provided no causality assessment for abdominal discomfort, adenomyosis, amnesia, anger, aphasia, cognitive disorder, cystitis, depression, disturbance in attention, dry skin, eye pruritus, fatigue, headache, metal poisoning, middle insomnia, musculoskeletal pain, nasal pruritus, pruritus genital, tendonitis, tinnitus, tooth abscess and tooth fracture with essure.The reporter commented: patient¿s current status: feels much better since removal.Chronic fatigue, depression and persistent cognitive disorders (distractibility and planning disorder demonstrated by memory test (b)(6)2021) after removal, on sick leave since (b)(6) 2021.From (b)(6) 2018 to (b)(6) 2020: sick leave due to burn-out syndrome.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).Blood test - on (b)(6) 2020: chromium (inductively coupled plasma mass spectrometry [icp-ms]): <0.50 g/l (biological interpretation values from the general adult population blood chromium < 1.26 g/l).Nickel (icp-ms): 1.3 g/l (biological interpretation values from the general adult population plasma nickel < 1.3 g/l).Tin (icp-ms): 0.10 g/l (biological interpretation values from the general adult population plasma tin < 0.70 g/l).Neurological examination - in (b)(6) 2021: memory test: persistent cognitive disorders: distractibility and planning disorder demonstrated.Scan - in (b)(6) 2016: brain scan: nothing abnormal detected; on an unknown date: pelvic scan (no results provided).X-ray - on (b)(6) 2020: radiograph of removed tubes: looped coil on right side, non-linear coil on left side.A technical investigation will be conducted, including a batch review and review of complaint records and records of non-conformance's data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4) on (b)(6) 2022.The most recent information was received on (b)(6) 2022.This spontaneous case was reported by a consumer and describes the occurrence of metal poisoning ('nickel and tin poisoning'), abdominal discomfort ('heaviness in the lower abdomen, feelings of abdominal inflammation'), headache ('headaches'), adenomyosis ('diffuse adenomyosis') and pruritus genital ('itchy genitals') in a 42-year-old female patient who had essure (batch no.C68117) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right insert in loop" (seriousness criterion intervention required) on (b)(6) 2015.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced metal poisoning, abdominal discomfort, headache, pruritus genital, nasal pruritus ("itchy nose"), eye pruritus ("itchy eyes"), tinnitus ("tinnitus"), tendonitis ("regular tendonitis"), musculoskeletal pain ("muscle and joint pain"), fatigue ("increased fatigue"), middle insomnia ("sleep disorders with nocturnal awakenings"), aphasia ("loss of words, difficulty reading and comprehending reading"), amnesia ("memory loss/ forgetfulness"), cystitis ("recurrent cystitis"), dry skin ("dry skin"), tooth fracture ("broken teeth"), tooth abscess ("tooth abscesses resistant to antibiotics") and disturbance in attention ("attention disorder in the professional environment"), 3 months after insertion of essure.On an unknown date, the patient experienced adenomyosis, anger ("excessive anger"), depression ("depression") and cognitive disorder ("persistent cognitive disorders (distractibility and planning disorder demonstrated by memory test)").The patient was treated with surgery (vaginal hysterectomy with bilateral salpingectomy in (b)(6) 2020).Essure was removed on (b)(6) 2020.At the time of the report, the metal poisoning, headache, adenomyosis, tinnitus, musculoskeletal pain, fatigue, aphasia, amnesia, disturbance in attention, anger, depression and cognitive disorder had not resolved, the abdominal discomfort, pruritus genital, nasal pruritus, eye pruritus, tendonitis, cystitis, dry skin, tooth fracture and tooth abscess outcome was unknown and the middle insomnia was resolving.The reporter provided no causality assessment for abdominal discomfort, adenomyosis, amnesia, anger, aphasia, cognitive disorder, cystitis, depression, disturbance in attention, dry skin, eye pruritus, fatigue, headache, metal poisoning, middle insomnia, musculoskeletal pain, nasal pruritus, pruritus genital, tendonitis, tinnitus, tooth abscess and tooth fracture with essure.The reporter commented: patient¿s current status: feels much better since removal.Chronic fatigue, depression and persistent cognitive disorders (distractibility and planning disorder demonstrated by memory test (b)(6) 2021) after removal, on sick leave since (b)(6) 2021.From (b)(6) 2018 to (b)(6) 2020: sick leave due to burn-out syndrome.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 68 kgs.Blood test - on (b)(6) 2020: chromium (inductively coupled plasma mass spectrometry [icp-ms]): <0.50 g/l (biological interpretation values from the general adult population blood chromium < 1.26 g/l).Nickel (icp-ms): 1.3 g/l (biological interpretation values from the general adult population plasma nickel < 1.3 g/l).Tin (icp-ms): 0.10 g/l (biological interpretation values from the general adult population plasma tin < 0.70 g/l).Neurological examination - in july 2021: memory test: persistent cognitive disorders: distractibility and planning disorder demonstrated.Scan - in june 2016: brain scan: nothing abnormal detected; on an unknown date: pelvic scan (no results provided).X-ray - on (b)(6) 2020: radiograph of removed tubes: looped coil on right side, non-linear coil on left side.Lot number: c68117 production date 2014-06-17 expiration date 2017-06-30 quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2022: quality safety evaluation of ptc a technical investigation was conducted, including a batch review and review of complaint records and records of non-conformance's data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

The below report was received by health authority ansm (reference number: (b)(4).On 02-mar-2022.The most recent information was received on 28-mar-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of metal poisoning ("nickel and tin poisoning"), abdominal discomfort ("heaviness in the lower abdomen, feelings of abdominal inflammation"), headache ("headaches"), adenomyosis ("diffuse adenomyosis") and pruritus genital ("itchy genitals") in a 42 year-old female patient who had essure inserted (lot no.C68117).Additional non-serious events are detailed below.Product or product use issues identified: device shape alteration ("right insert in loop" on (b)(6) 2015).There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, 91 days after essure insertion, she experienced metal poisoning, abdominal discomfort, headache, pruritus genital, nasal pruritus ("itchy nose"), eye pruritus ("itchy eyes"), tinnitus ("tinnitus"), tendonitis ("regular tendonitis"), arthralgia ("muscle and joint pain"), fatigue ("increased fatigue"), middle insomnia ("sleep disorders with nocturnal awakenings"), aphasia ("loss of words, difficulty reading and comprehending reading"), amnesia ("memory loss/ forgetfulness"), cystitis ("recurrent cystitis"), dry skin ("dry skin"), tooth fracture ("broken teeth"), tooth abscess ("tooth abscesses resistant to antibiotics") and disturbance in attention ("attention disorder in the professional environment").Essure was removed on (b)(6) 2020.On unknown date she experienced adenomyosis, anger ("excessive anger"), depression ("depression"), cognitive disorder ("persistent cognitive disorders (distractibility and planning disorder demonstrated by memory test)"), myalgia ("muscle pain problems too"), paraesthesia ("tingling in my hands") and tooth disorder ("problems with my teeth").The patient was treated with surgery (vaginal hysterectomy with bilateral salpingectomy in (b)(6) 2020).At the time of the report, the middle insomnia was resolving and the metal poisoning, headache, adenomyosis, tinnitus, arthralgia, fatigue, aphasia, amnesia, disturbance in attention, anger, depression and cognitive disorder had not resolved.The outcomes for abdominal discomfort, pruritus genital, nasal pruritus, eye pruritus, tendonitis, cystitis, dry skin, tooth fracture, tooth abscess, myalgia, paraesthesia and tooth disorder were unknown.No causality assessment was received for essure with regard to metal poisoning, abdominal discomfort, tendonitis, fatigue, aphasia, disturbance in attention, arthralgia, amnesia, headache, tinnitus, eye pruritus, nasal pruritus, pruritus genital, dry skin, middle insomnia, cystitis, tooth fracture, tooth abscess, anger, depression, cognitive disorder, adenomyosis, myalgia, paraesthesia or tooth disorder.The reporter commented: patient¿s current status: feels much better since removal.Chronic fatigue, depression and persistent cognitive disorders (distractibility and planning disorder demonstrated by memory test (b)(6) 2021) after removal, on sick leave since (b)(6) 2021.From (b)(6) 2018 to (b)(6) 2020: sick leave due to burn-out syndrome.I felt like an 80-year-old grandmother.The doctors were in denial, saying that it was age, that it¿s normal, that at age 44 it was menopause.But i felt that it wasn¿t normal.I searched alone, the doctors told me i was in a state of depression.When we talk to doctors about our implants, it's not taken into account.In any case, there¿s no examination in this respect and it¿s a shame.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 68 kg.[blood test] on (b)(6) 2020: chromium (inductively coupled plasma mass spectrometry [icp-ms]): <0.50 g/l (biological interpretation values from the general adult population blood chromium < 1.26 g/l).Nickel (icp-ms): 1.3 g/l (biological interpretation values from the general adult population plasma nickel < 1.3 g/l).Tin (icp-ms): 0.10 g/l (biological interpretation values from the general adult population plasma tin < 0.70 g/l) [neurological examination] in (b)(6) 2021: memory test: persistent cognitive disorders: distractibility and planning disorder demonstrated [scan] in (b)(6) 2016: brain scan: nothing abnormal detected; (date unknown): pelvic scan (no results provided) [x-ray] on (b)(6) 2020: radiograph of removed tubes: looped coil on right side, non-linear coil on left side lot number: c68117.Production date 2014-06-17.Expiration date 2017-06-30.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 28-mar-2024: upon receipt of new follow up it was confirmed that argus cases (b)(4) are duplicate of each other therefore case (b)(4) marked for deletion.All source documents, references , events (myalgia, tinnitus, & tooth disorder) , reporters are transferred to retention case (legacy device number (b)(4)).A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, this 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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 13677958
• MDR Text Key: 286667318
• Report Number: 2951250-2022-00196
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C68117
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2022
• Date Device Manufactured: 06/17/2014
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 68 KG