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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Pain (1994)

Event Date 01/01/2018

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (mhra, reference number: (b)(4)) on 17-nov-2020.This spontaneous case was reported by a consumer and describes the occurrence of autoimmune thyroiditis ('hashimotos hypothyroidism') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On (b)(6) 2012, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant), fatigue ("fatigue"), constipation ("constipation") and feeling abnormal ("brain fog").Essure treatment was not changed.At the time of the report, the autoimmune thyroiditis, fatigue, constipation and feeling abnormal outcome was unknown.The reporter considered autoimmune thyroiditis, constipation, fatigue and feeling abnormal to be related to essure.The reporter commented: the device has not be investigated since being implanted but it likely to have leaved chemicals into her body causing an autoimmune reaction resulting in hypothyroidism.She has been taken medication for hypothyroidism treatment.Consumer reported serious injury for the symptoms she developed 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 case was initially received via regulatory authority (mhra, reference number: (b)(4)) on 17-nov-2020.The most recent information was received on 20-nov-2020.This spontaneous case was reported by a consumer and describes the occurrence of autoimmune thyroiditis ('hashimotos hypothyroidism') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On (b)(6) 2012, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant), fatigue ("fatigue"), constipation ("constipation") and feeling abnormal ("brain fog").Essure treatment was not changed.At the time of the report, the autoimmune thyroiditis, fatigue, constipation and feeling abnormal outcome was unknown.The reporter considered autoimmune thyroiditis, constipation, fatigue and feeling abnormal to be related to essure.The reporter commented: the device has not be investigated since being implanted but it likely to have leaved chemicals into her body causing an autoimmune reaction resulting in hypothyroidism.She has been taken medication for hypothyroidism treatment.Consumer reported seriousinjury for the symptoms she developed quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: 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 case was initially received via regulatory authority (mhra, reference number: (b)(4)) on 17-nov-2020.The most recent information was received on 21-sep-2021.This spontaneous case was reported by a lawyer and describes the occurrence of autoimmune thyroiditis ('hashimotos hypothyroidism') in an adult female patient who had essure (batch no.A20062, 6826185) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant), fatigue ("fatigue"), constipation ("constipation") and feeling abnormal ("brain fog").Essure treatment was not changed.At the time of the report, the autoimmune thyroiditis, fatigue, constipation and feeling abnormal outcome was unknown.The reporter considered autoimmune thyroiditis, constipation, fatigue and feeling abnormal to be related to essure.The reporter commented: the device has not be investigated since being implanted but it likely to have leaved chemicals into her body causing an autoimmune reaction resulting in hypothyroidism.She has been taken medication for hypothyroidism treatment.Consumer reported seriousinjury for the symptoms she developed event onset date reported as (b)(6) 2012 for events feeling abnormal, constipation, fatigue, autoimmune thyroiditis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-sep-2021: reporter information, lot number, device insertion date added.Case updated to potential legal case.We received a lot number in this case.A technical investigation will be 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 case was initially received via regulatory authority (mhra, reference number: (b)(4)) on 17-nov-2020.The most recent information was received on 29-sep-2021.This spontaneous case was reported by a lawyer and describes the occurrence of autoimmune thyroiditis ('hashimotos hypothyroidism') in an adult female patient who had essure (batch no.A20062-val, 6826185-inv) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant), fatigue ("fatigue"), constipation ("constipation") and feeling abnormal ("brain fog").Essure treatment was not changed.At the time of the report, the autoimmune thyroiditis, fatigue, constipation and feeling abnormal outcome was unknown.The reporter considered autoimmune thyroiditis, constipation, fatigue and feeling abnormal to be related to essure.The reporter commented: the device has not be investigated since being implanted but it likely to have leaved chemicals into her body causing an autoimmune reaction resulting in hypothyroidism.She has been taken medication for hypothyroidism treatment.Consumer reported seriousinjury for the symptoms she developed event onset date reported as (b)(6) 2012 for events feeling abnormal, constipation, fatigue, autoimmune thyroiditis.Lot number: 6826185 is not valid.Lot number: a20062, manufacturing date: 2012-06, and expiration date: 2015-06.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 29-sep-2021: 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.

Manufacturer Narrative

The below report was received by health authority mhra reference number: (b)(4) on 17-nov-2020.The most recent information was received on 13-apr-2023.This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of autoimmune thyroiditis ("hashimotos hypothyroidism") in an adult female patient who had essure inserted (lot no.A20062) for hypothyroidism.Additional non-serious events are detailed below.Product or product use issues identified: device ineffective ("failure of essure to occlude left tube").The patient had a medical history of parity 4.Concurrent conditions were listed as drug allergy (to elastoplast (rash reaction)), hypothyroidism, eyebrow loss of, weight gain, bloating, depression, heavy periods, pain in joint involving lower leg, localised muscle pain and irritable bowel syndrome.The only concomitant product mentioned was levothyroxine.On (b)(6) 2012, the patient had essure inserted.In 2018 she experienced autoimmune thyroiditis (seriousness criterion intervention required).Essure was removed on (b)(6) 2021.An unknown time later she experienced fatigue ("fatigue/ chronic fatigue without reason"), constipation ("constipation") and feeling abnormal ("brain fog").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy).At the time of the report, the outcomes for autoimmune thyroiditis, fatigue, constipation and feeling abnormal were unknown.The reporter considered autoimmune thyroiditis, constipation, fatigue and feeling abnormal to be related to essure administration.The reporter commented: the device has not be investigated since being implanted but it likely to have leaved chemicals into her body causing an autoimmune reaction resulting in hypothyroidism.She has been taken medication for hypothyroidism treatment.Consumer reported serious injury for the symptoms she developed.Event onset date reported as (b)(6) 2012 for events feeling abnormal, constipation, fatigue, autoimmune thyroiditis.In (b)(6) 2013 she had a laparoscopic sterilisation procedure, due to failure of essure to occlude left tube.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] in (b)(6) 2013: left tube not occluded.[laparoscopy] in (b)(6) 2013: both essure devices were noted to be correctly sited, interestingly the tubes appeared blocked when tested with the dye; on (b)(6) 2021: laparoscopic hysterectomy uneventful, specimen examined to check that the essure devices were completely removed.[pathology test] on (b)(6) 2021: specimen: uterus, cervix and both tubes.Macroscopy: intact corpus and cervix, 83mm si x 52mm ml x 40mm ap.Attached right fallopian tube, including the fimbrial end, 60mm in length.A metal filshie clip and an essure coil within the tube lumen is present at the proximal end.Attached left fallopian tube, including the fimbrial end, 65mm in length.A metal filshie clip and an essure coil within the tube lumen is present at the proximal end.Microscopy: the fallopian tubes are unremarkable.There is no atypia, endometriosis or inflammation.The endometrium is extensively autolysed.Glandular morphology is no longer recognizable.However the glands appear well separated by stroma.There is no evidence of gland crowding or atypia.Benign leiomyomas are seen.The cervix shows no evidence of cin or cgin.Diagnosis: uterus and both tubes - benign leiomyomas [x-ray] in (b)(6) 2013: there was a failure of tubal occlusion on the left side so in (b)(6) 2013 there was a laparoscopic sterilization procedure.Lot number a20062, manufacturing date: 2012-06, expiration date: 2015-06.Lot number 6826185 is not valid.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: 13-apr-2023: medical records received.Surgical pathology report added.Medical history and concomitant drug added.Lab data updated.Patient and reporter information updated.Event failure of essure to occlude left tube was 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

The below report was received by health authority mhra (reference number: (b)(6)) on 17-nov-2020.The most recent information was received on 30-jan-2024.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 an adult female patient who had essure inserted (lot no.A20062) for hypothyroidism.Additional non-serious events are detailed below.Product or product use issues identified: device ineffective ("failure of essure to occlude left tube").The patient had a medical history of parity 4.Concurrent conditions were listed as drug allergy (to elastoplast (rash reaction)), hypothyroidism, eyebrow loss of, weight gain, bloating, depression, heavy periods, pain in joint involving lower leg, localised muscle pain and irritable bowel syndrome.The only concomitant product mentioned was levothyroxine.On (b)(6) 2012, the patient had essure inserted.In 2018 she experienced autoimmune thyroiditis ("hashimotos hypothyroidism").On unknown date she experienced pelvic pain (seriousness criterion medically important), chronic fatigue ("fatigue/ chronic fatigue without reason"), a first episode of constipation ("constipation"), brain fog ("brain fog"), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("llergic or hypersensitivity reaction including polymorphic light eruption;"), polymorphic light eruption ("polymorphic light eruption"), mental disorder ("psychological issues"), hypothyroidism ("hypothyroidism"), fatigue ("fatigue"), abdominal distension ("bloating"), a second episode of constipation ("constipation"), arthralgia (" joint pain") and alopecia ("hair loss").Essure was removed on (b)(6) 2021.The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy).At the time of the report, the outcomes for autoimmune thyroiditis, fatigue and brain fog were unknown.The reporter considered abdominal distension, alopecia, arthralgia, autoimmune thyroiditis, brain fog, the first episode of constipation, the second episode of constipation, chronic fatigue, fatigue, genital haemorrhage, hypersensitivity, hypothyroidism, mental disorder, pelvic pain and polymorphic light eruption to be related to essure administration.The reporter commented: the device has not be investigated since being implanted but it likely to have leaved chemicals into her body causing an autoimmune reaction resulting in hypothyroidism.She has been taken medication for hypothyroidism treatment.Consumer reported serious injury for the symptoms she developed.Event onset date reported as 01-sep-2012 for events feeling abnormal, constipation, fatigue, autoimmune thyroiditis.In (b)(6) 2013 she had a laparoscopic sterilisation procedure, due to failure of essure to occlude left tube.Discrepancy noted: insertion date as per argus 01-dec-2012 as per mr 04-dec-2012 / 10dec2012 3 coils left 1 coil right - ¿ bit too far in hsg showed spill in left tube.Therefore, essure not successful.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] in (b)(6) 2013: left tube not occluded; on (b)(6) 2013: the right tube to be blocked, the left tube does not appear to be; on (b)(6) 2013: the right tube to be blocked, the left tube does not appear to be; on (b)(6) 2013: patient underwent laparoscopic sterilization the indication being the apparent failure of tubal occlusion on the left side following an essure sterilization.At laparoscopy doctor did push dye through tubes and unlike previous hysterosalpingogram we were unable to demonstrate under direct vision any tubal filling despite getting good pressures of blue dye within the uterus.One would see the implants were in the tube and they seemed perfectly sited.Doctors did go ahead and perform the laparoscopic sterilization for completeness.[laparoscopy] on (b)(6) 2013: both essure devices were noted to be correctly sited, interestingly the tubes appeared blocked when tested with the dye; on (b)(6) 2021: laparoscopic hysterectomy uneventful, specimen examined to check that the essure devices were completely removed [pathology test] on (b)(6) 2021: specimen: uterus, cervix and both tubes.Macroscopy: intact corpus and cervix, 83mm si x 52mm ml x 40mm ap.Attached right fallopian tube, including the fimbrial end, 60mm in length.A metal filshie clip and an essure coil within the tube lumen is present at the proximal end.Attached left fallopian tube, including the fimbrial end, 65mm in length.A metal filshie clip and an essure coil within the tube lumen is present at the proximal end.Microscopy: the fallopian tubes are unremarkable.There is no atypia, endometriosis or inflammation.The endometrium is extensively autolysed.Glandular morphology is no longer recognizable.However the glands appear well separated by stroma.There is no evidence of gland crowding or atypia.Benign leiomyomas are seen.The cervix shows no evidence of cin or cgin.Diagnosis: uterus and both tubes - benign leiomyomas [x-ray] in march 2013: there was a failure of tubal occlusion on the left side so in may-2013 there was a laparoscopic sterilization procedure lot number a20062 manufacturing date:2012-06 expiration date: 2015-06 lot number 6826185 is not valid.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: (b)(6) 2024: mr received : reporters information patient medical history, lab data and events - "pelvic pain female, abnormal genital bleeding, allergic reaction, polymorphic light eruption, psychological disorder, hypothyroidism, fatigue, bloating and constipation, joint pain and hair loss" were added.Rcc updated.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: 10859874
• MDR Text Key: 216935796
• Report Number: 2951250-2020-15685
• Device Sequence Number: 1
• Product Code: HHS
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: ESS305
• Device Lot Number: A20062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: LEVOTHYROXINE; LEVOTHYROXINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female