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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Anemia (1706); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Gastritis (1874); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Depression (2361)

Event Date 12/29/2010

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain: pelvic"), genital haemorrhage ("abnormal bleeding (general)"), uterine haemorrhage ("abnormal uterine bleeding") and uterine polypectomy ("endometrial polypectomy") in a (b)(6)female patient who had essure (batch no.735709, 735709) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test , device ineffective" on (b)(6) 2015.The patient's previously administered products included for birth control: birth control pills from 2007 to 2008.On (b)(6) 2010, the patient had essure inserted.In 2010, the patient experienced anaemia ("anemia").On (b)(6) 2010, 4 months 3 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and abdominal pain ("pain: abdominal").In 2011, the patient experienced genital haemorrhage (seriousness criterion medically significant).In 2012, the patient experienced mood swings ("mood swings") and dyspareunia ("pain: dyspareunia (painful sexual intercourse)").On (b)(6) 2015, the patient underwent uterine polypectomy (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced dysmenorrhoea ("pain: dysmenorrhea (cramping)").On (b)(6) 2015, the patient experienced diarrhoea ("diarrhea"), gastritis ("gastritis") and nausea ("nausea").On an unknown date, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("depression"), migraine ("pain: migraines"), headache ("headaches"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").The patient was treated with surgery (hysteroscopy/hysterectomy(partial) with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, vaginal haemorrhage, migraine, headache, anaemia, dysmenorrhoea, dyspareunia, fatigue, abdominal pain and nausea had resolved and the uterine haemorrhage, uterine polypectomy, mood swings, menorrhagia, female sexual dysfunction, depression, vaginal discharge, diarrhoea and gastritis outcome was unknown.The reporter considered abdominal pain, anaemia, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastritis, genital haemorrhage, headache, menorrhagia, migraine, mood swings, nausea, pelvic pain, uterine haemorrhage, uterine polypectomy, vaginal discharge and vaginal haemorrhage to be related to essure.Most recent follow-up information incorporated above includes: on 28-feb-2018: case is now incident.Reporter information, demographic detail, historical medication, essure insertion/removal date, indication was added and lot number was added.Event: physical injuries was updated to mood swings, abnormal bleeding (general), abnormal bleeding (vaginal, menorrhagia), apareunia, depression, migraines/headaches, anemia, dysmenorrhea, endometrial polypectomy, dyspareunia, pelvic pain, vaginal discharge, fatigue, diarrhea, gastritis, abnormal uterine bleeding, abdominal pain, nausea and no essure confirmation test performed.Recovered from events: pelvic pain, abdominal pain, dysmenorrhea, dyspareunia and migraines.Essure legal manufacturer has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident at the time of reporting, 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 in a supplemental report.

Manufacturer Narrative

The spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain: pelvic"), genital haemorrhage ("abnormal bleeding (general)"), uterine haemorrhage ("abnormal uterine bleeding") and uterine polypectomy ("endometrial polypectomy") in a 43-year-old female patient who had essure (batch no.735709) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test , device ineffective" on (b)(6) 2015.The patient's past medical history included multiparous, pregnancy, cesarean section, spontaneous abortion, termination of pregnancy - elective and lightheadedness on (b)(6) 2011.She has no family history of ovarian cancer.Previously administered products included for birth control: birth control pills from (b)(6) to (b)(6).Concurrent conditions included gallbladder disease since (b)(6) , uterine myoma, ovarian cyst, fibroids since (b)(6) 2015, dizziness since (b)(6) 2011, vertigo since (b)(6) 2011, numbness since (b)(6) 2011, tingling, low back pain, uterine fibroid, uterine fibroid embolization and vomiting.Concomitant products included esomeprazole magnesium (nexium), ibuprofen (advil), norethisterone acetate (aygestin) and sucralfate (carafate).On (b)(6) 2010, the patient had essure inserted.In (b)(6) , the patient experienced anaemia ("anemia") and fatigue ("fatigue").On (b)(6) 2010, 4 months 3 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and abdominal pain ("pain: abdominal").In (b)(6) , the patient experienced genital haemorrhage (seriousness criterion medically significant).In (b)(6) , the patient experienced mood swings ("mood swings"), depression ("depression"), migraine ("pain: migraines"), headache ("headaches"), dyspareunia ("pain: dyspareunia (painful sexual intercourse)") and vaginal discharge ("vaginal discharge").On (b)(6) 2015, the patient underwent uterine polypectomy (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced dysmenorrhoea ("pain: dysmenorrhea (cramping)").On (b)(6) 2015, the patient experienced diarrhoea ("diarrhea"), gastritis ("gastritis") and nausea ("nausea").On an unknown date, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").The patient was treated with ondansetron (zofran), oxycocet (percocet), surgery (hysteroscopy/hysterectomy(partial) with bilateral salpingectomy, hysteroscopy / endometrial polypectomy) and surgery.Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, uterine haemorrhage, vaginal haemorrhage, menorrhagia, migraine, headache, anaemia, dysmenorrhoea, dyspareunia, vaginal discharge, fatigue, abdominal pain and nausea had resolved and the uterine polypectomy, mood swings, female sexual dysfunction, depression, diarrhoea and gastritis outcome was unknown.The reporter considered abdominal pain, anaemia, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastritis, genital haemorrhage, headache, menorrhagia, migraine, mood swings, nausea, pelvic pain, uterine haemorrhage, uterine polypectomy, vaginal discharge and vaginal haemorrhage to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-sep-2018: plaintiff fact sheet received.Event outcome was changed for the event: abnormal uterine bleeding, menorrhagia, vaginal discharge.Treatment drugs were added.Incident: at the time of reporting, 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 in a supplemental report.

Manufacturer Narrative

Contaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain: pelvic"), genital haemorrhage ("abnormal bleeding (general)"), uterine haemorrhage ("abnormal uterine bleeding") and uterine polypectomy ("endometrial polypectomy") in a 43-year-old female patient who had essure (batch no.735709) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test , device ineffective" on (b)(6) 2015.The patient's past medical history included multiparous, pregnancy, cesarean section, spontaneous abortion, termination of pregnancy - elective and lightheadedness on (b)(6) 2011.She has no family history of ovarian cancer.Previously administered products included for birth control: birth control pills from 2007 to 2008.Concurrent conditions included gallbladder disease since 2014, uterine myoma, ovarian cyst, fibroids since (b)(6) 2015, dizziness since (b)(6) 2011, vertigo since (b)(6) 2011, numbness since (b)(6) 2011, tingling, low back pain, uterine fibroid, uterine fibroid embolization and vomiting.Concomitant products included esomeprazole magnesium (nexium), ibuprofen (advil), norethisterone acetate (aygestin) and sucralfate (carafate).In 2010, the patient experienced anaemia ("anemia").On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, 4 months 3 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and abdominal pain ("pain: abdominal").In 2011, the patient experienced genital haemorrhage (seriousness criterion medically significant).In 2012, the patient experienced mood swings ("mood swings") and dyspareunia ("pain: dyspareunia (painful sexual intercourse)").On (b)(6) 2015, the patient underwent uterine polypectomy (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced dysmenorrhoea ("pain: dysmenorrhea (cramping)").On (b)(6) 2015, the patient experienced diarrhoea ("diarrhea"), gastritis ("gastritis") and nausea ("nausea").On an unknown date, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("depression"), migraine ("pain: migraines"), headache ("headaches"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").The patient was treated with surgery (hysteroscopy/hysterectomy(partial) with bilateral salpingectomy) and surgery.Essure was removed on (b)(6)) 2016.At the time of the report, the pelvic pain, genital haemorrhage, vaginal haemorrhage, migraine, headache, anaemia, dysmenorrhoea, dyspareunia, fatigue, abdominal pain and nausea had resolved and the uterine haemorrhage, uterine polypectomy, mood swings, menorrhagia, female sexual dysfunction, depression, vaginal discharge, diarrhoea and gastritis outcome was unknown.The reporter considered abdominal pain, anaemia, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastritis, genital haemorrhage, headache, menorrhagia, migraine, mood swings, nausea, pelvic pain, uterine haemorrhage, uterine polypectomy, vaginal discharge and vaginal haemorrhage 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) 2018: quality-safety evaluation of product technical problem update.Incident at the time of reporting, 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 in 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: 7451264
• MDR Text Key: 106194228
• Report Number: 2951250-2018-01932
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2018

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 Expiration Date: 05/01/2013
• Device Model Number: ESS305
• Device Lot Number: 735709
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 09/25/2018
• Supplement Dates FDA Received: 08/08/2018; 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVIL; ADVIL; AYGESTIN; AYGESTIN; CARAFATE; CARAFATE; NEXIUM; NEXIUM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR