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

Model Number ESS305

Device Problems Fracture (1260); Difficult to Insert (1316); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Bowel Perforation (2668); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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Event Description

This literature case describes the occurrence of pelvic pain ("worsening of chronic pelvic pain") and dyspareunia ("worsening of dyspareunia") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Literature reference: johal t, kuruba n, sule m, mukhopadhyay s, raje g, laparoscopic salpingectomy and removal of essure hysteroscopic sterilisation device: a case series, european journal of contraception and reproductive health care, 2018:1-4.The patient's past medical history included pelvic pain and dyspareunia.No allergy to nickel.On an unknown date, the patient had essure inserted.The duration of use was 18 months.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia (seriousness criteria medically significant and intervention required), complication of device insertion ("unilateral placement, procedure stopped due to acute pain") and procedural pain ("unilateral placement, procedure stopped due to acute pain").The patient was treated with laparoscopic right salpingectomy for essure removal.At the time of the report, the pelvic pain and dyspareunia had resolved and complication of device insertion and procedural pain outcome was unknown.The reporter provided no causality assessment for complication of device insertion, dyspareunia, pelvic pain and procedural pain with essure.Diagnostic results: unilateral placement only, procedure stopped due to acute pain (left coil not inserted, right side: 5 coils seen) histology after salpingectomy: removed right fallopian tube normal, no salpingitis.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred terms: pelvic pain: 11.588 cases.Dyspareunia: 159 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 pts.Abstract: object: tubal sterilisation using essure is a minimally invasive technique for permanent contraception, with high rates of patient satisfaction.However, some women subsequently choose removal of the inserts, due to side effects such as pelvic pain, abnormal bleeding, dyspareunia or allergic dermatitis.This case series presents the management of eight women who underwent laparoscopic removal of essure inserts in conjunction with salpingectomy.We describe our surgical technique, its underlying principles and immediate surgical outcomes.Methods: eight patients were identified as having undergone removal of essure inserts between jul-2015 and jul-2017, via an electronic search of the surgical procedures database.A retrospective review of case records was undertaken.Primary outcome was safety and feasibility of the laparoscopic salpingectomy approach.Secondary outcome measures included implant fracture rate, operative time, blood loss and length of patient stay.Results: all eight women were able to undergo laparoscopic salpingectomy and removal of the essure inserts without the need for laparotomy or hysterectomy.There were no incidences of fracture or incomplete removal of the insert.Immediate postoperative recovery was uncomplicated in all eight women; the mean length of stay was 17 h.One patient had a small bowel serosal tear attributed to laparoscopic entry.Conclus.: laparoscopic salpingectomy suggested for removal of essure inserts, it is safe and feasible.Numbers were small.Consistent use of a laparoscopic approach in these eight patients indicates that this procedure is a feasible and suitable alternative to hysterectomy.Record-patient #4: pre-existing chronic pelvic pain and dyspareunia, no allergy to nickel.Unilateral placement, procedure stopped due to acute pain (left coil not inserted, 5 coils on the right).Removal for worsening of chronic pelvic pain and dyspareunia 18 months after insertion, 89 mins, minimal blood loss.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 literature case describes the occurrence of pelvic pain ("worsening of chronic pelvic pain") and dyspareunia ("worsening of dyspareunia") in a 38-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Literature reference: johal t, kuruba n, sule m, mukhopadhyay s, raje g, laparoscopic salpingectomy and removal of essure hysteroscopic sterilisation device: a case series, european journal of contraception and reproductive health care, 2018:1-4.The patient's past medical history included pelvic pain and dyspareunia.No allergy to nickel.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), dyspareunia (seriousness criteria medically significant and intervention required), complication of device insertion ("unilateral placement, procedure stopped due to acute pain") and procedural pain ("unilateral placement, procedure stopped due to acute pain").The patient was treated with surgery (laparoscopic right salpingectomy for essure removal for 89 minutes, minimal blood loss).Essure was removed.At the time of the report, the pelvic pain and dyspareunia had resolved and the complication of device insertion and procedural pain outcome was unknown.The reporter provided no causality assessment for complication of device insertion, dyspareunia, pelvic pain and procedural pain with essure.Diagnostic results: unilateral placement only, procedure stopped due to acute pain (left coil not inserted, right side: 5 coils seen).Histology after salpingectomy: removed right fallopian tube normal, no salpingitis.Quality-safety evaluation of ptc: unable to confirm complaint.Abstract object.: tubal sterilisation using essure is a minimally invasive technique for permanent contraception, with high rates of patient satisfaction.However, some women subsequently choose removal of the inserts, due to side effects such as pelvic pain, abnormal bleeding, dyspareunia or allergic dermatitis.This case series presents the management of eight women who underwent laparoscopic removal of essure inserts in conjunction with salpingectomy.We describe our surgical technique, its underlying principles and immediate surgical outcomes.Methods: eight patients were identified as having undergone removal of essure inserts between jul-2015 and jul-2017, via an electronic search of the surgical procedures database.A retrospective review of case records was undertaken.Primary outcome was safety and feasibility of the laparoscopic salpingectomy approach.Secondary outcome measures included implant fracture rate, operative time, blood loss and length of patient stay.Results: all eight women were able to undergo laparoscopic salpingectomy and removal of the essure inserts without the need for laparotomy or hysterectomy.There were no incidences of fracture or incomplete removal of the insert.Immediate postoperative recovery was uncomplicated in all eight women; the mean length of stay was 17 h.One patient had a small bowel serosal tear attributed to laparoscopic entry.Conclus.: laparoscopic salpingectomy suggested for removal of essure inserts, it is safe and feasible.Numbers were small.Consistent use of a laparoscopic approach in these eight patients indicates that this procedure is a feasible and suitable alternative to hysterectomy.Record-patient #4: pre-existing chronic pelvic pain and dyspareunia, no allergy to nickel.Unilateral placement, procedure stopped due to acute pain (left coil not inserted, 5 coils on the right).Removal for worsening of chronic pelvic pain and dyspareunia 18 months after insertion, 89 mins, minimal blood loss.Most recent follow-up information incorporated above includes: on 22-aug-2018: quality-safety evaluation of ptc.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 literature case describes the occurrence of pelvic pain ("worsening of chronic pelvic pain") and dyspareunia ("worsening of dyspareunia") in a 38-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Literature reference: johal t, kuruba n, sule m, mukhopadhyay s, raje g, laparoscopic salpingectomy and removal of essure hysteroscopic sterilisation device: a case series, european journal of contraception and reproductive health care, 2018:1-4.The patient's past medical history included pelvic pain and dyspareunia.No allergy to nickel.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), dyspareunia (seriousness criteria medically significant and intervention required), complication of device insertion ("unilateral placement, procedure stopped due to acute pain") and procedural pain ("unilateral placement, procedure stopped due to acute pain").The patient was treated with surgery (laparoscopic right salpingectomy for essure removal for 89 minutes, minimal blood loss).Essure was removed.At the time of the report, the pelvic pain and dyspareunia had resolved and the complication of device insertion and procedural pain outcome was unknown.The reporter provided no causality assessment for complication of device insertion, dyspareunia, pelvic pain and procedural pain with essure.Diagnostic results: unilateral placement only, procedure stopped due to acute pain (left coil not inserted, right side: 5 coils seen) histology after salpingectomy: removed right fallopian tube normal, no salpingitis.Quality-safety evaluation of ptc: unable to confirm complaint.Abstract: object.: tubal sterilisation using essure is a minimally invasive technique for permanent contraception, with high rates of patient satisfaction.However, some women subsequently choose removal of the inserts, due to side effects such as pelvic pain, abnormal bleeding, dyspareunia or allergic dermatitis.This case series presents the management of eight women who underwent laparoscopic removal of essure inserts in conjunction with salpingectomy.We describe our surgical technique, its underlying principles and immediate surgical outcomes.Methods: eight patients were identified as having undergone removal of essure inserts between (b)(6) 2015 and (b)(6) 2017, via an electronic search of the surgical procedures database.A retrospective review of case records was undertaken.Primary outcome was safety and feasibility of the laparoscopic salpingectomy approach.Secondary outcome measures included implant fracture rate, operative time, blood loss and length of patient stay.Results: all eight women were able to undergo laparoscopic salpingectomy and removal of the essure inserts without the need for laparotomy or hysterectomy.There were no incidences of fracture or incomplete removal of the insert.Immediate postoperative recovery was uncomplicated in all eight women; the mean length of stay was 17 h.One patient had a small bowel serosal tear attributed to laparoscopic entry.Conclus.: laparoscopic salpingectomy suggested for removal of essure inserts, it is safe and feasible.Numbers were small.Consistent use of a laparoscopic approach in these eight patients indicates that this procedure is a feasible and suitable alternative to hysterectomy.Record-patient #4: pre-existing chronic pelvic pain and dyspareunia, no allergy to nickel.Unilateral placement, procedure stopped due to acute pain (left coil not inserted, 5 coils on the right).Removal for worsening of chronic pelvic pain and dyspareunia 18 months after insertion, 89 mins, minimal blood loss most recent follow-up information incorporated above includes: on 22-aug-2018: quality-safety evaluation of ptc.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.

• 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: 7613180
• MDR Text Key: 111460097
• Report Number: 2951250-2018-02678
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 09/07/2018
• Supplement Dates FDA Received: 08/23/2018; 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR