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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Expulsion (2933); Migration (4003)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Pain (1994); Swelling (2091); Uterine Perforation (2121); Myalgia (2238); Arthralgia (2355); Fungal Infection (2419); Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("uterus perforation / the product migrated to the uterus"), device breakage ("essure fragments / product remains") and vulvovaginal candidiasis ("vaginal candidiasis") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2012, the patient had essure inserted.In 2013, the patient experienced device expulsion ("essure loss").On an unknown date, the patient experienced uterine perforation (seriousness criteria disability and intervention required), device breakage (seriousness criteria medically significant and intervention required), vulvovaginal candidiasis (seriousness criterion medically significant), complication of device removal ("essure fragments / product remains"), swelling ("swelling"), pelvic pain ("pelvic pain"), fatigue ("chronic tiredness"), myalgia ("muscle pain"), arthralgia ("chronic joint pain"), dyspepsia ("digestive problems"), abdominal pain ("abdominal pain") and unevaluable event ("cosmetic damage").The patient was treated with surgery (essure had to be removed through a subtotal hysterectomy on (b)(6) 2017) and surgery (laparoscopy was performed on (b)(6) 2018).At the time of the report, the uterine perforation, vulvovaginal candidiasis, swelling, pelvic pain, fatigue, myalgia, arthralgia, dyspepsia, abdominal pain and unevaluable event outcome was unknown, the device breakage and complication of device removal had not resolved and the device expulsion had resolved.The reporter provided no causality assessment for abdominal pain, arthralgia, complication of device removal, device breakage, device expulsion, dyspepsia, fatigue, myalgia, pelvic pain, swelling, unevaluable event, uterine perforation and vulvovaginal candidiasis with essure.The reporter commented: first essure insertion occurred in 2012, and as consequence of the device loss in 2013, it was placed again on an unspecified date.Due to the lack of the removal protocol, there were product remains; therefore, a new surgical intervention must be scheduled.At the time of this report she continued with remains and a third intervention must be performed.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: uterine perforation ¿ analysis in the global safety database revealed 1.350 cases.Device breakage ¿ analysis in the global safety database revealed 2.566 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('uterus perforation / the product migrated to the uterus'), device breakage ('essure fragments / product remains') and vulvovaginal candidiasis ('vaginal candidiasis') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "essure fragments / product remains".In 2012, the patient had essure inserted.In 2013, the patient experienced device expulsion ("essure loss").On an unknown date, the patient experienced uterine perforation (seriousness criteria disability and intervention required), device breakage (seriousness criteria medically significant and intervention required), vulvovaginal candidiasis (seriousness criterion medically significant), swelling ("swelling"), pelvic pain ("pelvic pain"), fatigue ("chronic tiredness"), myalgia ("muscle pain"), arthralgia ("chronic joint pain"), dyspepsia ("digestive problems"), abdominal pain ("abdominal pain") and unevaluable event ("cosmetic damage").The patient was treated with surgery (essure had to be removed through a subtotal hysterectomy on (b)(6) 2017 and laparoscopy was performed on (b)(6) 2018).At the time of the report, the uterine perforation, vulvovaginal candidiasis, swelling, pelvic pain, fatigue, myalgia, arthralgia, dyspepsia, abdominal pain and unevaluable event outcome was unknown, the device breakage had not resolved and the device expulsion had resolved.The reporter provided no causality assessment for abdominal pain, arthralgia, device breakage, device expulsion, dyspepsia, fatigue, myalgia, pelvic pain, swelling, unevaluable event, uterine perforation and vulvovaginal candidiasis with essure.The reporter commented: first essure insertion occurred in 2012, and as consequence of the device loss in 2013, it was placed again on an unspecified date.Due to the lack of the removal protocol, there were product remains; therefore, a new surgical intervention must be scheduled.At the time of this report she continued with remains and a third intervention must be performed.Most recent follow-up information incorporated above includes: on 21-mar-2022: reporter information was updated, annex e and f updated.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 lawyer and describes the occurrence of uterine perforation ('uterus perforation / the product migrated to the uterus'), device breakage ('essure fragments / product remains') and vulvovaginal candidiasis ('vaginal candidiasis') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "essure fragments / product remains".In 2012, the patient had essure inserted.In 2013, the patient experienced device expulsion ("essure loss").On an unknown date, the patient experienced uterine perforation (seriousness criteria disability and intervention required), device breakage (seriousness criteria medically significant and intervention required), vulvovaginal candidiasis (seriousness criterion medically significant), swelling ("swelling"), pelvic pain ("pelvic pain"), fatigue ("chronic tiredness"), myalgia ("muscle pain"), arthralgia ("chronic joint pain"), dyspepsia ("digestive problems"), abdominal pain ("abdominal pain") and unevaluable event ("cosmetic damage").The patient was treated with surgery (essure had to be removed through a subtotal hysterectomy on (b)(6) 2017 and laparoscopy was performed on (b)(6) 2018).Essure was removed.At the time of the report, the uterine perforation, vulvovaginal candidiasis, swelling, pelvic pain, fatigue, myalgia, arthralgia, dyspepsia, abdominal pain and unevaluable event outcome was unknown, the device breakage had not resolved and the device expulsion had resolved.The reporter provided no causality assessment for abdominal pain, arthralgia, device breakage, device expulsion, dyspepsia, fatigue, myalgia, pelvic pain, swelling, unevaluable event, uterine perforation and vulvovaginal candidiasis with essure.The reporter commented: first essure insertion occurred in 2012, and as consequence of the device loss in 2013, it was placed again on an unspecified date.Due to the lack of the removal protocol, there were product remains; therefore, a new surgical intervention must be scheduled.At the time of this report she continued with remains and a third intervention must be performed.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 12-apr-2022: 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.

• 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, NJ 07981
• MDR Report Key: 7568787
• MDR Text Key: 110072053
• Report Number: 2951250-2018-02492
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 03/21/2022; 04/12/2022
• Supplement Dates FDA Received: 03/29/2022; 04/13/2022
• 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): Disability; Required Intervention; Other
• Patient Sex: Female