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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Pain (1994); Perforation (2001); Rash (2033); Swelling (2091); Irritability (2421); Heavier Menses (2666); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("horrific periods"), rash ("breaking out"), swelling ("swelling"), mood altered ("moodiness when get cycle") and irritability ("irritability when get cycle").The patient was treated with surgery (tubes and coils removed).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, rash, swelling, mood altered and irritability outcome was unknown.The reporter considered irritability, menorrhagia, mood altered, pelvic pain, rash and swelling to be related to essure.Concerning the injuries reported in this case, the following one/ones were reported via social media: pelvic pain, menorrhagia, swelling, rash.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: events moodiness when get cycle and irritability when get cycle added.Essure was removed on (b)(6) 2016.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 perforation ('perforation'), pelvic pain ('pelvic pain associated with essure implants') and device dislocation ('migration') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), menorrhagia ("horrific periods"), rash ("breaking out"), swelling ("swelling"), mood altered ("moodness when get cycle") and irritability ("irritability when get cycle").The patient was treated with surgery (laparoscopic partial bilateral salpingectomy, laparoscopic removal of foreign body x2).Essure was removed on (b)(6) 2016.At the time of the report, the perforation, pelvic pain, device dislocation, rash, swelling, mood altered and irritability outcome was unknown.The reporter considered device dislocation, irritability, menorrhagia, mood altered, pelvic pain, perforation, rash and swelling to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-jul-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 spontaneous case was reported by a lawyer, and describes the occurrence of perforation ('perforation'), pelvic pain ('pain') and device dislocation ('migration').In a female patient who had essure inserted for female sterilisation.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, perforation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), menorrhagia ("horrific periods"), rash ("breaking out"), swelling ("swelling"), mood altered ("moodness, when get cycle") and irritability ("irritability, when get cycle").The patient was treated with surgery (tubes and coils removed).Essure was removed on (b)(6) 2016.At the time of the report, the perforation, pelvic pain, device dislocation, rash, swelling, mood altered and irritability outcome was unknown.The reporter considered device dislocation, irritability, menorrhagia, mood altered, pelvic pain, perforation, rash and swelling to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020, pif received: newly added events: perforation, essure insertion date were updated, reporter was added, product indication was added.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: 10019569
• MDR Text Key: 189718613
• Report Number: 2951250-2020-06482
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention