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 Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ('continuous pain, pelvic pain, increased in frequency and severity') in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "left side seems bent".Medical conditions: no tests were carried out on pathologies, possible allergies, or any other opportune tests in regard to the contraceptive before essure insertion.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), abdominal pain ("cramps"), menstrual disorder ("alterations of the menstrual cycle") and discomfort ("discomfort").The patient was hospitalized from an unknown date until (b)(6) 2017.The patient was treated with surgery (bilateral salpingectomy with essure removal).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, abdominal pain, menstrual disorder and discomfort outcome was unknown.The reporter considered abdominal pain, discomfort, menstrual disorder and pelvic pain to be related to essure.The reporter commented: after the insertion, i began to experience several symptoms.After many years being in pain, i was referred to the general gynecology department on (b)(6) 2016, where i was prescribed treatment for 20 days and a check-up after 3 months.After that period, the pelvic pain and abnormal bleeding returned.On (b)(6) 2016, physician proposed the removal of essure and a bilateral salpingectomy, as there were clear indications that the only cause of these disorders was the essure device.After the complementary tests, it was confirmed that the ¿left side seems bent,¿ which undoubtedly aggravated the present situation.The removal procedure was conducted on (b)(6) 2017.The hospital discharge was issued on (b)(6) 2017, after a postoperative examination.Diagnostic results (normal ranges are provided in parenthesis if available): scan - on (b)(6) 2016: essure check: left side seems bent.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

The case describes the occurrence of pelvic pain ('continuous pain, pelvic pain, increased in frequency and severity').The occurrence of additional non-serious events is detailed below.Co-suspect products included essure for birth control.Other product or product use issues identified: device physical property issue "left side seems bent".Medical conditions: no tests were carried out on pathologies, possible allergies, or any other opportune tests in regard to the contraceptive before essure insertion.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), abdominal pain ("cramps"), menstrual disorder ("alterations of the menstrual cycle") and discomfort ("discomfort").The patient was hospitalized from an unknown date until (b)(6) 2017.The patient was treated with surgery (bilateral salpingectomy with essure removal).At the time of the report, the pelvic pain, abdominal pain, menstrual disorder and discomfort outcome was unknown.The reporter considered abdominal pain, discomfort, menstrual disorder and pelvic pain to be related to essure.The reporter commented: after the insertion, i began to experience several symptoms.After many years being in pain, i was referred to the general gynecology department on (b)(6) 2016, where i was prescribed treatment for 20 days and a check-up after 3 months.After that period, the pelvic pain and abnormal bleeding returned.On (b)(6) 2016, physician proposed the removal of essure and a bilateral salpingectomy, as there were clear indications that the only cause of these disorders was the essure device.After the complementary tests, it was confirmed that the ¿left side seems bent,¿ which undoubtedly aggravated the present situation.The removal procedure was conducted on (b)(6) 2017.The hospital discharge was issued on (b)(6) 2017, after a postoperative examination.Diagnostic results (normal ranges are provided in parenthesis if available): scan - on (b)(6) 2016: essure check: left side seems bent.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 16-jun-2021: 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
• MDR Report Key: 11907120
• MDR Text Key: 263554136
• Report Number: 2951250-2021-02480
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention