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); Appropriate Term/Code Not Available (3191)

Patient Problems Emotional Changes (1831); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Myalgia (2238); Arthralgia (2355); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ("allergic reaction to nickel"), swelling ("swelling"), metrorrhagia ("metrorrhagia"), pelvic pain ("pelvic pain") and alopecia ("alopecia") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2013, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criterion intervention required), swelling, metrorrhagia, pelvic pain, alopecia, paraesthesia ("paresthesia on lower limbs"), myalgia ("muscle pains"), arthralgia ("joints pain"), inflammation ("abdominal inflammation"), uterine spasm ("uterine contractions"), adverse event ("aesthetic damage") and mental disorder ("psychological sequels").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the allergy to metals, swelling, metrorrhagia, pelvic pain, alopecia, paraesthesia, myalgia, arthralgia, inflammation, uterine spasm, adverse event and mental disorder outcome was unknown.The reporter considered adverse event, allergy to metals, alopecia, arthralgia, inflammation, mental disorder, metrorrhagia, myalgia, paraesthesia, pelvic pain, swelling and uterine spasm to be related to essure.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 terms: allergy to metals ¿ analysis in the global safety database revealed 428 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 these 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 allergy to metals ('allergic reaction to nickel') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2013, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), swelling ("swelling"), intermenstrual bleeding ("metrorrhagia"), pelvic pain ("pelvic pain"), alopecia ("alopecia"), paraesthesia ("paresthesia on lower limbs"), myalgia ("muscle pains"), arthralgia ("joints pain"), inflammation ("abdominal inflammation"), uterine spasm ("uterine contractions"), adverse event ("aesthetic damage") and mental disorder ("psychological sequels").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the allergy to metals, swelling, intermenstrual bleeding, pelvic pain, alopecia, paraesthesia, myalgia, arthralgia, inflammation, uterine spasm, adverse event and mental disorder outcome was unknown.The reporter considered adverse event, allergy to metals, alopecia, arthralgia, inflammation, intermenstrual bleeding, mental disorder, myalgia, paraesthesia, pelvic pain, swelling and uterine spasm to be related to essure.Most recent follow-up information incorporated above includes: on 21-mar-2022: reporter information updated, annex e and f updated, adverse event updated to related.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 allergy to metals ('allergic reaction to nickel') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2013, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), swelling ("swelling"), intermenstrual bleeding ("metrorrhagia"), pelvic pain ("pelvic pain"), alopecia ("alopecia"), paraesthesia ("paresthesia on lower limbs"), myalgia ("muscle pains"), arthralgia ("joints pain"), inflammation ("abdominal inflammation"), uterine spasm ("uterine contractions"), adverse event ("aesthetic damage") and mental disorder ("psychological sequels").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the allergy to metals, swelling, intermenstrual bleeding, pelvic pain, alopecia, paraesthesia, myalgia, arthralgia, inflammation, uterine spasm, adverse event and mental disorder outcome was unknown.The reporter considered adverse event, allergy to metals, alopecia, arthralgia, inflammation, intermenstrual bleeding, mental disorder, myalgia, paraesthesia, pelvic pain, swelling and uterine spasm to be related to essure.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 11-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ('allergic reaction to nickel') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2013, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), swelling ("swelling"), intermenstrual bleeding ("metrorrhagia"), pelvic pain ("pelvic pain"), alopecia ("alopecia"), paraesthesia ("paresthesia on lower limbs"), myalgia ("muscle pains"), arthralgia ("joints pain"), inflammation ("abdominal inflammation"), uterine spasm ("uterine contractions"), adverse event ("aesthetic damage") and mental disorder ("psychological sequels").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the allergy to metals, swelling, intermenstrual bleeding, pelvic pain, alopecia, paraesthesia, myalgia, arthralgia, inflammation, uterine spasm, adverse event and mental disorder outcome was unknown.The reporter considered adverse event, allergy to metals, alopecia, arthralgia, inflammation, intermenstrual bleeding, mental disorder, myalgia, paraesthesia, pelvic pain, swelling and uterine spasm to be related to essure.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 11-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: 7564959
• MDR Text Key: 109908129
• Report Number: 2951250-2018-02457
• 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,Followup
• Report Date: 01/28/2023

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: 06/04/2018
• Supplement Dates Manufacturer Received: 03/21/2022; 04/11/2022; 04/11/2022
• Supplement Dates FDA Received: 03/29/2022; 04/13/2022; 01/28/2023
• 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; Other
• Patient Sex: Female