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); Diarrhea (1811); Fatigue (1849); Hair Loss (1877); Headache (1880); Itching Sensation (1943); Nausea (1970); Pain (1994); Rash (2033); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 09/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") and abdominal pain lower ("severe, lower abdominal pain/ abdominal cramping") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower (seriousness criteria medically significant and intervention required), dysgeusia ("metallic taste in her mouth"), dyspareunia ("pain during intercourse"), alopecia ("hair loss"), rash ("rashes on/of her abdomen, neck, and face") with pruritus, headache ("headaches"), fatigue ("fatigue"), weight fluctuation ("weight fluctuation"), diarrhoea ("diarrhea"), abdominal distension ("bloating") and nausea ("nausea").The patient was treated with surgery (right salpingo-oophorectomy on (b)(6) 2015, total hysterectomy and left salpingectomy (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, abdominal pain lower, dysgeusia, dyspareunia, alopecia, rash, headache, fatigue, weight fluctuation, diarrhoea, abdominal distension and nausea outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, diarrhoea, dysgeusia, dyspareunia, fatigue, headache, nausea, pelvic pain, rash and weight fluctuation to be related to essure.The reporter commented: (b)(6) 2015, she underwent a right salpingo-oophorectomy.However, despite having surgery, her abdominal and pelvic pain continued, and on (b)(6) 2016, she underwent a total hysterectomy and left salpingectomy.Since her most recent removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: confirmed full occlusion of fallopian tubes.Company causality comment: 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 pelvic pain ("pelvic pain"), abdominal pain lower ("severe, lower abdominal pain/ abdominal cramping") and menorrhagia ("menorrhagia") in a 33-year-old female patient who had essure (batch no.2925514) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "essure followed by a novasure".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 19 days after insertion of essure, the patient experienced pelvic pain, abdominal pain lower, menorrhagia (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse"), headache ("headaches"), vaginal haemorrhage ("abnormal vaginal bleeding"), migraine ("migraines") and allergy to metals ("nickel allergy").On (b)(6) 2013, the patient experienced weight fluctuation ("weight fluctuation").On (b)(6) 2014, the patient experienced alopecia ("hair loss") and fatigue ("fatigue").On an unknown date, the patient experienced dysgeusia ("metallic taste in her mouth"), rash ("rashes on/of her abdomen, neck, and face") with pruritus, diarrhoea ("diarrhea"), abdominal distension ("bloating"), nausea ("nausea"), back pain ("back pain") and abdominal pain ("abdominal pain").The patient was treated with surgery (right salpingo-oophorectomy on (b)(6) 2015, total hysterectomy and left salpingectomy) and surgery (ablation).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, abdominal pain lower, dysgeusia, dyspareunia, alopecia, rash, headache, fatigue, weight fluctuation, diarrhoea, abdominal distension, nausea, vaginal haemorrhage, allergy to metals, back pain and abdominal pain outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, alopecia, back pain, diarrhoea, dysgeusia, dyspareunia, fatigue, headache, menorrhagia, migraine, nausea, pelvic pain, rash, vaginal haemorrhage and weight fluctuation to be related to essure.The reporter commented: on (b)(6) 2015, she underwent a right salpingo-oophorectomy.However, despite having surgery, her abdominal and pelvic pain continued, and on (b)(6) 2016, she underwent a total hysterectomy and left salpingectomy.Since her most recent removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 82.54 kgs.Hysterosalpingogram - on (b)(6) 2013: confirmed full occlusion of fallopian tubes.On (b)(6) 2013: endometrial biopsy.Most recent follow-up information incorporated above includes: on 2-mar-2018: pfs and medical record received: event abnormal vaginal bleeding, migraines, nickel allergy, back pain, abdominal pain, menorrhagia and essure followed by a novasure added.Reporter and lot number 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 on a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain"), abdominal pain lower ("severe, lower abdominal pain/ abdominal cramping") and menorrhagia ("menorrhagia") in a 33-year-old female patient who had essure (batch no.2925514-invalid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "essure followed by a novasure".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 19 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse"), headache ("headaches"), vaginal haemorrhage ("abnormal vaginal bleeding"), migraine ("migraines") and allergy to metals ("nickel allergy").On (b)(6) 2013, the patient experienced weight fluctuation ("weight fluctuation").On (b)(6) 2014, the patient experienced alopecia ("hair loss") and fatigue ("fatigue").On an unknown date, the patient experienced dysgeusia ("metallic taste in her mouth"), rash ("rashes on/of her abdomen, neck, and face") with pruritus, diarrhoea ("diarrhea"), abdominal distension ("bloating"), nausea ("nausea"), back pain ("back pain") and abdominal pain ("abdominal pain").The patient was treated with surgery (right salpingo-oophorectomy on (b)(6) 2015, total hysterectomy and left salpingectomy (b)(6) 2016), surgery (right salpingo-oophorectomy on (b)(6) 2015, total hysterectomy and left salpingectomy (b)(6) 2016) and surgery (ablation).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, abdominal pain lower, dysgeusia, dyspareunia, alopecia, rash, headache, fatigue, weight fluctuation, diarrhoea, abdominal distension, nausea, vaginal haemorrhage, allergy to metals, back pain and abdominal pain outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, alopecia, back pain, diarrhoea, dysgeusia, dyspareunia, fatigue, headache, menorrhagia, migraine, nausea, pelvic pain, rash, vaginal haemorrhage and weight fluctuation to be related to essure.The reporter commented: (b)(6) 2015, she underwent a right salpingo-oophorectomy.However, despite having surgery, her abdominal and pelvic pain continued, and on (b)(6) 2016, she underwent a total hysterectomy and left salpingectomy.Since her most recent removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 82.54 kgs.Hysterosalpingogram - on (b)(6) 2013: confirmed full occlusion of fallopian tubes.(b)(6) 2013: endometrial biopsy.Most recent follow-up information incorporated above includes: on 28-aug-2018: update of information (batch is invalid).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: 6800505
• MDR Text Key: 82934401
• Report Number: 2951250-2017-03017
• 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: 08/29/2018

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
• Device Lot Number: 2925514-INVALID
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 03/02/2018; 08/28/2018
• Supplement Dates FDA Received: 05/10/2018; 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 83