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

Model Number ESS305

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ('pain in the abdomen, the pain was so severe and could be compared to strong labour pains') in a (b)(6) year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "mechanical complications with intrauterine contraceptive" in (b)(6) 2019.The patient's medical history included parity, pregnancy, menses painful and hypomenorrhoea.On (b)(6) 2017, the patient had essure inserted.In (b)(6) 2019, the patient was found to have cervix neoplasm ("population-based screening due to tumour in cervix").On an unknown date, the patient experienced pelvic pain (seriousness criterion intervention required), heavy menstrual bleeding ("profuse bleeding during menstruation"), headache ("headache"), nausea ("nausea"), polymenorrhoea ("period twice a month with profuse bleeding"), dysmenorrhoea ("pain during menstruation"), adnexa uteri pain ("the ¿burning¿ of my fallopian tubes") and adnexa uteri cyst ("paraovarian cysts").The patient was treated with surgery (essure removal via laparoscopic salpingectomy and extirpation of paraovarian cysts on (b)(6) 2020).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, headache and nausea had not resolved, the heavy menstrual bleeding was resolving and the polymenorrhoea, adnexa uteri pain and adnexa uteri cyst outcome was unknown.The reporter considered adnexa uteri cyst, adnexa uteri pain, cervix neoplasm, dysmenorrhoea, headache, heavy menstrual bleeding, nausea, pelvic pain and polymenorrhoea to be related to essure.The reporter commented: she notice the side effects on (b)(6) 2018 and she seek medical attention due to side effects in (b)(6) 2018.After the essure removal, her bleeding has got significantly better, and she does not bleed so much that she had to be bedridden during the first few days of her period.But her pain has not got notably better and on many occasions she is bedridden for 1-2 days at the beginning of my period.She also get a lot of headaches and nausea.Diagnostic results (normal ranges are provided in parenthesis if available): smear test - in 2019: cell samples were taken and i was told that i had cell changes.Specialist consultation - in (b)(6) 2019: she was diagnosed with mechanical complications with intrauterine contraceptive and population-based screening due to tumour in cervix.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 consumer and describes the occurrence of pelvic pain ('pain in the abdomen, the pain was so severe and could be compared to strong labour pains') in a 29-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "mechanical complications with intrauterine contraceptive" in (b)(6) 2019.The patient's medical history included parity, pregnancy, menses painful and hypomenorrhoea.On (b)(6) 2017, the patient had essure inserted.In (b)(6) 2019, the patient was found to have cervix neoplasm ("population-based screening due to tumour in cervix").On an unknown date, the patient experienced pelvic pain (seriousness criterion intervention required), heavy menstrual bleeding ("profuse bleeding during menstruation"), headache ("headache"), nausea ("nausea"), polymenorrhoea ("period twice a month with profuse bleeding"), dysmenorrhoea ("pain during menstruation"), adnexa uteri pain ("the ¿burning¿ of my fallopian tubes") and adnexa uteri cyst ("paraovarian cysts").The patient was treated with surgery (essure removal via laparoscopic sapingectomy and extirpation of paraovarian cysts on (b)(6) 2020).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, headache and nausea had not resolved, the heavy menstrual bleeding was resolving and the polymenorrhoea, adnexa uteri pain and adnexa uteri cyst outcome was unknown.The reporter considered adnexa uteri cyst, adnexa uteri pain, cervix neoplasm, dysmenorrhoea, headache, heavy menstrual bleeding, nausea, pelvic pain and polymenorrhoea to be related to essure.The reporter commented: she noticed the side effects on (b)(6) 2018 and she saught medical attention due to side effects in (b)(6) 2018.After the essure removal, her bleeding has got significantly better, and she does not bleed so much that she had to be bedridden during the first few days of her period.But her pain has not got notably better and on many occasions she is bedridden for 1-2 days at the beginning of period.She also gets a lot of headaches and nausea.Diagnostic results (normal ranges are provided in parenthesis if available): smear test - in 2019: cell samples were taken and i was told that i had cell changes.Specialist consultation - in (b)(6) 2019: she was diagnosed with mechanical complications with intrauterine contraceptive and population-based screening due to tumour in cervix.Amendment: the report was amended for the following reason: nullification: due to internal review this report was detected to be a duplicate to record # (b)(4) to which all information will be transferred, then this duplicate record # (b)(4) will be deleted in bayer safety database.No new follow-up information was received from the reporter.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.

• 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: 12604757
• MDR Text Key: 280750032
• Report Number: 2951250-2021-03311
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• 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: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR