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

Model Number ESS305

Device Problems Biocompatibility (2886); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 03/16/2023

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("medical device removal") in a 42 year-old female patient who had essure inserted (lot no.D35379) for female sterilisation.The patient had a medical history of irregular periods, abdominal pain and pyelonephritis on (b)(6) 2022, flank pain and depression in 2017, nickel allergy, fibromyalgia, iliac fossa pain, fatigue, pain menstrual and heavy periods (her periods have been horrible with flooding the bed and clots and a lot of pllitt) in 2016 and headache, uti and coitus painful.Previously administered products included: mirena, oral contraceptive nos and depo provera.Past adverse reactions to the above products included: pregnancy with contraceptive device with mirena.As concurrent condition the report mentioned back pain since (b)(6) 2022.On (b)(6) 2015, the patient had essure inserted.On 16(b)(6) 2023, 2712 days after essure insertion, she underwent medical device removal (seriousness criterion intervention required) which required surgery (bilateral salpingectomy).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: procedure note:4 coils in left and 3 coils in right.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound pelvis] on (b)(6) 2016: total endometrial thickness= 10mm both implants seen from outer edge of myometrium right ovary within normal limits left ovary contains a 2.8cm simple cyst appearance of correct placement of essure implants.Batch no d35379 , production date 2014-12-05, expiration date2017-12-28.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 04-aug-2023: medical record received.Case became serious incident.Event injury nos is replaced with event medical device removal.New reporter added.Historical drugs, conditions added.Lab data updated.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pain; including chronic pain") in a 42 year-old female patient who had essure inserted (lot no.D35379) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of irregular periods, abdominal pain and pyelonephritis in 2022, flank pain and depression in 2017, nickel allergy, fibromyalgia, iliac fossa pain, fatigue, pain menstrual and heavy periods (her periods nave been horrible with flooding the bed and clots and a lot of pllitt) in 2016 and headache, uti and coitus painful.Previously administered products included: mirena, oral contraceptive nos and depo provera.Past adverse reactions to the above products included: pregnancy with contraceptive device with mirena.As concurrent condition the report mentioned back pain since 2022.On (b)(6) 2015, the patient had essure inserted.Essure was removed on (b)(6) 2023.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergic or hypersensitivty reaction"), dyspareunia ("dyspareunia") and mental disorder ("psychological issues").The patient was treated with surgery (bilateral salpingectomy).The reporter considered dyspareunia, genital haemorrhage, hypersensitivity, mental disorder and pelvic pain to be related to essure administration.The reporter commented: procedure note:4 coils in left and 3 coils in right.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound pelvis] on (b)(6) 2016: total endometrial thickness= 10mm both implants seen from outer edge of myometrium right ovary within normal limits left ovary contains a 2.8cm simple cyst appearance of correct placement of essure implants.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 21-aug-2023: quality safety evaluation of ptc.21-aug-2023: ha number added.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pain; including chronic pai") in a 42 year-old female patient who had essure inserted (lot no.D35379) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of irregular periods, abdominal pain and pyelonephritis in 2022, flank pain and depression in 2017, nickel allergy, fibromyalgia, iliac fossa pain, fatigue, pain menstrual and heavy periods (her periods nave been horrible with flooding the bed and clots and a lot of pllitt) in 2016 and headache, uti and coitus painful.Previously administered products included: mirena, oral contraceptive nos and depo provera.Past adverse reactions to the above products included: pregnancy with contraceptive device with mirena.As concurrent condition the report mentioned back pain since 2022.On (b)(6) 2015, the patient had essure inserted.Essure was removed on (b)(6) 2023.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergic or hypersensitivty reaction"), dyspareunia ("dyspareunia") and mental disorder ("psychological issues").The patient was treated with surgery (bilateral salpingectomy).The reporter considered dyspareunia, genital haemorrhage, hypersensitivity, mental disorder and pelvic pain to be related to essure administration.The reporter commented: procedure note:4 coils in left and 3 coils in right.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound pelvis] on (b)(6) 2016: total endometrial thickness= 10mm both implants seen from outer edge of myometrium right ovary within normal limits left ovary contains a 2.8cm simple cyst appearance of correct placement of essure implants batch nod35379 production date 2014-12-05, expiration date 2017-12-28.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 04-aug-2023: summons received.Event medical device removal is replaced with pelvic pain female.New events genital bleeding, allergic reaction, dyspareunia & psychological issues added.New reporter added.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain; including chronic pain") in a 42 year-old female patient who had essure inserted (lot no.D35379) for permanent contraceptive tubal implant.Additional non-serious events are detailed below.Co-suspect products included dihydrocodeine and diazepam.The patient had a medical history of irregular periods, abdominal pain and pyelonephritis in 2022, flank pain and depression in 2017, nickel allergy, fibromyalgia, iliac fossa pain, fatigue, pain menstrual and heavy periods (her periods nave been horrible with flooding the bed and clots and a lot of pllitt) in 2016 and urinary tract infection, fibromyalgia, chronic fatigue, pregnancy termination, headache, uti and coitus painful.Previously administered products included: mirena, oral contraceptive nos and depo provera.Past adverse reactions to the above products included: pregnancy with contraceptive device with mirena.As concurrent condition the report mentioned back pain since 2022.Concomitant products included metformin from (b)(6) 2016 to (b)(6) 2016, pregabalin from (b)(6) 2016 to (b)(6) 2016, propranolol from (b)(6) 2016 to (b)(6) 2016 and sertraline from (b)(6) 2016 to (b)(6) 2016.On (b)(6) 2015, the patient had essure inserted.From (b)(6) 2016 to (b)(6) 2017 the patient received dihydrocodeine 30 mg at an unspecified frequency.From (b)(6) 2016 to (b)(6) 2016 the patient received diazepam 2 mg at an unspecified frequency.Essure was removed on (b)(6) 2023.On unknown dates she experienced pelvic pain (seriousness criterion intervention required), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergic or hypersensitivty reaction"), dyspareunia ("dyspareunia"), mental disorder ("psychological issues"), dysuria ("dysuria"), fatigue ("fatigue"), vision blurred ("blurred vision") and chest pain ("chest pain").The patient was treated with surgery (bilateral salpingectomy).The reporter considered chest pain, dyspareunia, dysuria, fatigue, genital haemorrhage, hypersensitivity, mental disorder, pelvic pain and vision blurred to be related to essure administration.The reporter commented: procedure note:4 coils in left and 3 coils in right.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2016: not reported.[ultrasound pelvis] on (b)(6) 2016: total endometrial thickness= 10mm both implants seen from outer edge of myometrium right ovary within normal limits left ovary contains a 2.8cm simple cyst appearance of correct placement of essure implants.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: dysuria, fatigue, blurred vision, chest pain.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 01-dec-2023: event added: dysuria, fatigue, blurred vision, chest pain.Sertraline, propranolol 160mg, pregabalin 225mg, metformin 500mg tablets, dihydrocodeine 30mg, diazepam 2 concomitant added.Reporters, medical history, lab data, patient information added.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain; including chronic pain") in a 42 year-old female patient who had essure inserted (lot no.D35379) for permanent contraceptive tubal implant.Additional non-serious events are detailed below.Co-suspect products included dihydrocodeine and diazepam.The patient had a medical history of irregular periods, abdominal pain and pyelonephritis in 2022, flank pain and depression in 2017, nickel allergy, fibromyalgia, iliac fossa pain, fatigue, pain menstrual and heavy periods (her periods nave been horrible with flooding the bed and clots and a lot of pllitt) in 2016 and urinary tract infection, fibromyalgia, chronic fatigue, pregnancy termination, headache, uti and coitus painful.Previously administered products included: mirena, oral contraceptive nos and depo provera.Past adverse reactions to the above products included: pregnancy with contraceptive device with mirena.As concurrent condition the report mentioned back pain since 2022.Concomitant products included metformin from (b)(6) 2016 to (b)(6) 2016, pregabalin from (b)(6) 2016 to (b)(6) 2016, propranolol from (b)(6) 2016 to (b)(6) 2016 and sertraline from (b)(6) 2016 to (b)(6) 2016.On (b)(6) 2015, the patient had essure inserted.From (b)(6) 2016 to (b)(6) 2017 the patient received dihydrocodeine 30 mg at an unspecified frequency.From (b)(6) 2016 to (b)(6) 2016, the patient received diazepam 2 mg at an unspecified frequency.Essure was removed on (b)(6) 2023.On unknown dates she experienced pelvic pain (seriousness criterion intervention required), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergic or hypersensitivty reaction"), dyspareunia ("dyspareunia"), mental disorder ("psychological issues"), dysuria ("dysuria"), fatigue ("fatigue"), vision blurred ("blurred vision") and chest pain ("chest pain").The patient was treated with surgery (bilateral salpingectomy).The reporter considered chest pain, dyspareunia, dysuria, fatigue, genital haemorrhage, hypersensitivity, mental disorder, pelvic pain and vision blurred to be related to essure administration.The reporter commented: procedure note:4 coils in left and 3 coils in right.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2016: not reported.[ultrasound pelvis] on (b)(6) 2016: total endometrial thickness: 10mm both implants seen from outer edge of myometrium right ovary within normal limits left ovary contains a 2.8cm simple cyst appearance of correct placement of essure implants.Concerning the injuries reported in this case, the following one/ones were described in patient's medical records: dysuria, fatigue, blurred vision, and chest pain.Batch no.: d35379.Production date: 2014-12-05.Expiration date: 2017-12-28.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 24-jan-2024: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, 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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17508395
• MDR Text Key: 320855884
• Report Number: 2951250-2023-02788
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: ESS305
• Device Lot Number: D35379
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Date Device Manufactured: 12/05/2014
• 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
• Treatment: METFORMIN; METFORMIN; PREGABALIN; PREGABALIN; PROPRANOLOL; PROPRANOLOL; SERTRALINE; SERTRALINE
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female