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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Erythema (1840); Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Vomiting (2144); Dizziness (2194); Abdominal Cramps (2543); Abdominal Distention (2601); Heavier Menses (2666); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 04/01/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ("unable locate the left essure micro-insert/ did not reveal the location of the missing device/ left essure micro-insert was located in the uterus") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "patency of the left fallopian tube".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain"), menorrhagia ("abnormally heavy bleeding during menses/ prolonged menses"), abdominal pain lower ("sever lower abdominal pain/severe abdominal cramping"), pelvic pain ("severe pelvic pain"), back pain ("severe back pain"), uterine pain ("uterine pain"), decreased appetite ("loss of appetite"), abdominal distension ("abdominal bloating"), vomiting ("vomiting"), photophobia ("photophobia"), dizziness ("dizziness"), gastrointestinal disorder ("gastrointestinal issues"), diarrhoea ("diarrhea"), defaecation urgency ("fecal urgency"), gingival erythema ("reddened gums"), nausea ("nausea"), dyspareunia ("pain during intercourse"), migraine ("migraine headaches"), alopecia ("hair loss"), vaginal infection ("vaginal infections"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").The patient was treated with surgery (underwent an exploratory laparoscopy).At the time of the report, the device expulsion, dysmenorrhoea, menorrhagia, abdominal pain lower, pelvic pain, back pain, uterine pain, decreased appetite, abdominal distension, vomiting, photophobia, dizziness, gastrointestinal disorder, diarrhoea, defaecation urgency, gingival erythema, nausea, dyspareunia, migraine, alopecia, vaginal infection, vaginal discharge and fatigue had not resolved.The reporter considered abdominal distension, abdominal pain lower, alopecia, back pain, decreased appetite, defaecation urgency, device expulsion, diarrhoea, dizziness, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, gingival erythema, menorrhagia, migraine, nausea, pelvic pain, photophobia, uterine pain, vaginal discharge, vaginal infection and vomiting to be related to essure.The reporter commented: plaintiff has not yet been able to have the right essure device removed.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: ; in (b)(6) 2011: unable locate the left essure micro-insert.Nuclear magnetic resonance imaging - in (b)(6) 2011: did not reveal the location of the missing device.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 device expulsion ("unable locate the left essure micro-insert/ did not reveal the location of the missing device/ left essure micro-insert was located in the uterus") and uterine perforation ("perforation (uterus)") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "patency of the left fallopian tube".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain"), the first episode of menorrhagia ("abnormally heavy bleeding during menses/ prolonged menses,abnormal bleeding (menorrhagia)"), abdominal pain lower ("sever lower abdominal pain/severe abdominal cramping"), pelvic pain ("severe pelvic pain"), back pain ("severe back pain"), uterine pain ("uterine pain"), decreased appetite ("loss of appetite"), abdominal distension ("abdominal bloating"), vomiting ("vomiting"), photophobia ("photophobia"), dizziness ("dizziness"), gastrointestinal disorder ("gastrointestinal issues"), diarrhoea ("diarrhea"), defaecation urgency ("fecal urgency"), gingival erythema ("reddened gums"), nausea ("nausea"), dyspareunia ("pain during intercourse"), migraine ("migraine"), alopecia ("hair loss"), vaginal infection ("vaginal infections"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), the second episode of menorrhagia ("abnormal bleeding (menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), headache ("headaches") and pain in extremity ("pain left side, radiates into legs").The patient was treated with surgery (underwent an exploratory laparoscopy) and surgery (exploratory laparoscopy and foreign body extraction to remove essure left insert).Essure was removed on (b)(6) 2011.At the time of the report, the device expulsion, dysmenorrhoea, abdominal pain lower, pelvic pain, back pain, uterine pain, decreased appetite, abdominal distension, vomiting, photophobia, dizziness, gastrointestinal disorder, diarrhoea, defaecation urgency, gingival erythema, nausea, dyspareunia, migraine, alopecia, vaginal infection, vaginal discharge and fatigue had not resolved and the uterine perforation, vaginal haemorrhage, the last episode of menorrhagia, female sexual dysfunction, headache and pain in extremity outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, back pain, decreased appetite, defaecation urgency, device expulsion, diarrhoea, dizziness, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, gingival erythema, headache, migraine, nausea, pain in extremity, pelvic pain, photophobia, uterine pain, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vomiting, the first episode of menorrhagia and the second episode of menorrhagia to be related to essure.The reporter commented: plaintiff has not yet been able to have the right essure device removed.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: ; in (b)(6) 2011: unable locate the left essure micro-insert nuclear magnetic resonance imaging - in (b)(6) 2011: did not reveal the location of the missing device most recent follow-up information incorporated above includes: on 27-feb-2018: pfs received: new events: uterine perforation, vaginal haemorrhage, menorrhagia, female sexual dysfunction, headache, pain in extremity were added.Reporter, patient demographic information, concomitant medication,product stop date added.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 device expulsion ('unable locate the left essure micro-insert/ did not reveal the location of the missing device/ left essure micro-insert was located in the uterus') and uterine perforation ('perforation (uterus)') in a 37-year-old female patient who had essure (batch no.740657) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "patency of the left fallopian tube".The patient's medical history included breast biopsy in 2011 and colonoscopy.Concurrent conditions included weight decreased, stress, flu, lactose intolerance, helicobacter pylori infection, blurry vision, spots before eyes, vertigo, dyspepsia, urinary frequency, cholecystectomy and fibroidectomy.Concomitant products included alprazolam and ranitidine.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain"), migraine ("migraine") and headache ("headaches"), 5 days after insertion of essure.On (b)(6) 2011, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain"), prolonged heavy periods ("abnormally heavy bleeding during menses/ prolonged menses,abnormal bleeding (menorrhagia)"), abdominal pain lower ("sever lower abdominal pain/severe abdominal cramping"), back pain ("severe back pain"), uterine pain ("uterine pain"), decreased appetite ("loss of appetite"), abdominal distension ("abdominal bloating"), vomiting ("vomiting"), photophobia ("photophobia"), dizziness ("dizziness"), gastrointestinal disorder ("gastrointestinal issues"), diarrhoea ("diarrhea"), defaecation urgency ("fecal urgency"), gingival erythema ("reddened gums"), nausea ("nausea"), dyspareunia ("pain during intercourse"), alopecia ("hair loss"), vaginal infection ("vaginal infections"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and pain ("pain left side, radiates into legs").The patient was treated with surgery (exploratory laparoscopy and foreign body extraction to remove essure left insert and exploratory laparoscopy and foreign body extraction to remove left essure).Essure was removed on (b)(6) 2011.At the time of the report, the device expulsion, dysmenorrhoea, prolonged heavy periods, abdominal pain lower, pelvic pain, back pain, uterine pain, decreased appetite, abdominal distension, vomiting, photophobia, dizziness, gastrointestinal disorder, diarrhoea, defaecation urgency, gingival erythema, nausea, dyspareunia, migraine, alopecia, vaginal infection, vaginal discharge and fatigue had not resolved and the uterine perforation, vaginal haemorrhage, menorrhagia, female sexual dysfunction, headache and pain outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, back pain, decreased appetite, defaecation urgency, device expulsion, diarrhoea, dizziness, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, gingival erythema, headache, migraine, nausea, pain, pelvic pain, photophobia, prolonged heavy periods, uterine pain, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vomiting and menorrhagia to be related to essure.The reporter commented: plaintiff has not yet been able to have the right essure device removed.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: resulted in normal uterine cavity, left fallopian tube, and nonfunctioning left essure device.The essure device on the right appears to be functioning; on (b)(6) 2010: results: left fallopian tube, and nonfunctioning left devic; in (b)(6) 2011: results: unable locate the left essure micro-insert.Nuclear magnetic resonance imaging - in (b)(6) 2011: results: did not reveal the location of the missing device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-may-2019: quality-safety evaluation of product technical complaint.Incident we received a lot number in this case.A technical investigation will be conducted, including a batch review and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('unable locate the left essure micro-insert/ did not reveal the location of the missing device/ left essure micro-insert was located in the uterus') and uterine perforation ('perforation (uterus)') in a 38-year-old female patient who had essure (batch no.740657) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "patency of the left fallopian tube".The patient's medical history included breast biopsy in 2011 and colonoscopy.Concurrent conditions included weight decreased, stress, flu, lactose intolerance, helicobacter pylori infection, blurry vision, spots before eyes, vertigo, dyspepsia, urinary frequency, cholecystectomy and fibroidectomy.Concomitant products included alprazolam and ranitidine.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2011, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), 7 months 5 days after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain"), prolonged heavy periods ("abnormally heavy bleeding during menses/ prolonged menses,abnormal bleeding (menorrhagia)"), abdominal pain lower ("sever lower abdominal pain/severe abdominal cramping"), pelvic pain ("severe pelvic pain"), back pain ("severe back pain"), uterine pain ("uterine pain"), decreased appetite ("loss of appetite"), abdominal distension ("abdominal bloating"), vomiting ("vomiting"), photophobia ("photophobia"), dizziness ("dizziness"), gastrointestinal disorder ("gastrointestinal issues"), diarrhoea ("diarrhea"), defaecation urgency ("fecal urgency"), gingival erythema ("reddened gums"), nausea ("nausea"), dyspareunia ("pain during intercourse"), migraine ("migraine"), alopecia ("hair loss"), vaginal infection ("vaginal infections"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), headache ("headaches") and pain ("pain left side, radiates into legs").The patient was treated with surgery (exploratory laparoscopy and foreign body extraction to remove essure left insert and underwent an exploratory laparoscopyand foreign body extraction).Essure was removed on (b)(6) 2011.At the time of the report, the device expulsion, dysmenorrhoea, prolonged heavy periods, abdominal pain lower, pelvic pain, back pain, uterine pain, decreased appetite, abdominal distension, vomiting, photophobia, dizziness, gastrointestinal disorder, diarrhoea, defaecation urgency, gingival erythema, nausea, dyspareunia, migraine, alopecia, vaginal infection, vaginal discharge and fatigue had not resolved and the uterine perforation, vaginal haemorrhage, menorrhagia, female sexual dysfunction, headache and pain outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, back pain, decreased appetite, defaecation urgency, device expulsion, diarrhoea, dizziness, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, gingival erythema, headache, migraine, nausea, pain, pelvic pain, photophobia, prolonged heavy periods, uterine pain, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vomiting and menorrhagia to be related to essure.The reporter commented: plaintiff has not yet been able to have the right essure device removed.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: results: unable locate the left essure micro-insert.Nuclear magnetic resonance imaging - in (b)(6) 2011: results: did not reveal the location of the missing device.Diagnostic results: on (b)(6) 2010 patient underwent hysterosalpingogram resulted in normal uterine cavity, left fallopian tube, and nonfunctioning left essure device.The essure device on the right appears to be functioning.Most recent follow-up information incorporated above includes: on 17-may-2019: medical records received : reporter added, aka name added, lot number added.We received a lot number in this case.A technical investigation will be conducted, including a batch review and other non-conformances data; should any new and reportable information become available as a result, this 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: 6803506
• MDR Text Key: 83025879
• Report Number: 2951250-2017-02979
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2013
• Device Model Number: ESS305
• Device Lot Number: 740657
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM; ALPRAZOLAM; RANITIDINE; RANITIDINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR