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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Neurological Deficit/Dysfunction (1982); Pain (1994); Arthralgia (2355); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain: pelvic") in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failed essure, implants in appropriate position however, tubes remained patent".The patient's past medical history included cholecystectomy and dermatitis psoriasiform.Previously administered products included for an unreported indication: birth control pills from 1992 to 2009.Concurrent conditions included depression.Concomitant products included medroxyprogesterone (depo provera) since 2013.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), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), allergy to metals ("nickel allergy"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain ("pain: abdominal"), fatigue ("fatigue"), pain ("body aches"), insomnia ("insomnia"), confusional state ("confusion"), arthralgia ("worsening joint pain"), hypersensitivity ("allergic or hypersensitivity reaction type (unspecified)"), autoimmune disorder ("autoimmune disorder type of disorder (unspecified)") and nervous system disorder ("neurological conditions or problems (unspecified)").The patient was treated with surgery (hysterectomy (full), bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, female sexual dysfunction, migraine, allergy to metals, headache, dyspareunia, abdominal pain, fatigue, pain, insomnia, confusional state, arthralgia, hypersensitivity, autoimmune disorder and nervous system disorder outcome was unknown.The reporter considered abdominal pain, allergy to metals, arthralgia, autoimmune disorder, confusional state, dyspareunia, fatigue, female sexual dysfunction, headache, hypersensitivity, insomnia, menorrhagia, migraine, nervous system disorder, pain, pelvic pain and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: failure to occlude fallopian tubes most recent follow-up information incorporated above includes: on 28-feb-2018: the case was upgraded in the incident the category.The reporter information was updated.This case concerns adult patient.Patient demographic was updated.Her historical condition/medication and concomitant disease were added.Lab data was added.Concomitant medication was added.Essure insertion date and removal date was added.Essure indication was added.Events: pain: pelvic, abnormal bleeding (vaginal, menorrhagia), apareunia (inability to have sexual intercourse), migraines, nickel allergy, headaches, dyspareunia (painful sexual intercourse), pain: abdominal, fatigue, body aches, insomnia, confusion, worsening joint pain, failed essure: implants in appropriate position however, tubes remained patent, allergic or hypersensitivity reaction type (unspecified) and neurological conditions or problems (unspecified).Essure legal manufacture 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: 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 ("pain: pelvic") in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failed essure, implants in appropriate position however, tubes remained patent".The patient's past medical history included cholecystectomy and dermatitis psoriasiform.Previously administered products included for an unreported indication: birth control pills from 1992 to 2009.Concurrent conditions included depression and endometriosis.Concomitant products included gabapentin and medroxyprogesterone (depo provera) since 2013.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), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), allergy to metals ("nickel allergy"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain ("pain: abdominal"), fatigue ("fatigue"), pain ("body aches"), insomnia ("insomnia"), confusional state ("confusion"), arthralgia ("worsening joint pain"), hypersensitivity ("allergic or hypersensitivity reaction type (unspecified)"), autoimmune disorder ("autoimmune disorder type of disorder (unspecified)"), nervous system disorder ("neurological conditions or problems (unspecified)"), skin reaction ("skin reaction") and abdominal pain lower ("cramping").The patient was treated with surgery (hysterectomy (full), bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, female sexual dysfunction, migraine, fatigue, insomnia, confusional state, autoimmune disorder, nervous system disorder and skin reaction outcome was unknown, the vaginal haemorrhage, menorrhagia and headache had resolved and the allergy to metals, dyspareunia, abdominal pain, pain, arthralgia, hypersensitivity and abdominal pain lower was resolving.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, arthralgia, autoimmune disorder, confusional state, dyspareunia, fatigue, female sexual dysfunction, headache, hypersensitivity, insomnia, menorrhagia, migraine, nervous system disorder, pain, pelvic pain, skin reaction and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: failure to occlude fallopian tubes.Most recent follow-up information incorporated above includes: on 5-jun-2018: pfs received:the event skin reaction, cramping added.Reporters, events outcome and concurrent condition 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 pelvic pain ('pain: pelvic') and autoimmune disorder ('autoimmune disorder type of disorder (unspecified)') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failed essure, implants in appropriate position however, tubes remained patent/tubes did not close." the patient's medical history included cholecystectomy and dermatitis psoriasiform.Previously administered products included for an unreported indication: birth control pills from 1992 to 2009.Concurrent conditions included depression and endometriosis.Concomitant products included gabapentin and medroxyprogesterone acetate (depo provera) since 2013.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), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), allergy to metals ("nickel allergy"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain ("pain: abdominal"), fatigue ("fatigue"), pain ("body aches"), insomnia ("insomnia"), confusional state ("confusion"), arthralgia ("worsening joint pain"), hypersensitivity ("allergic or hypersensitivity reaction type (unspecified)"), autoimmune disorder (seriousness criterion medically significant), nervous system disorder ("neurological conditions or problems (unspecified)"), skin reaction ("skin reaction"), abdominal pain lower ("cramping"), constipation ("constipation"), abdominal distension ("bloating"), flatulence ("horrendous gas") and diarrhoea ("diarrhea").The patient was treated with surgery (hysterectomy (full), bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, female sexual dysfunction, migraine, fatigue, insomnia, confusional state, autoimmune disorder, nervous system disorder, skin reaction, constipation, abdominal distension, flatulence and diarrhoea outcome was unknown, the vaginal haemorrhage, menorrhagia and headache had resolved and the allergy to metals, dyspareunia, abdominal pain, pain, arthralgia, hypersensitivity and abdominal pain lower was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, arthralgia, autoimmune disorder, confusional state, constipation, diarrhoea, dyspareunia, fatigue, female sexual dysfunction, flatulence, headache, hypersensitivity, insomnia, menorrhagia, migraine, nervous system disorder, pain, pelvic pain, skin reaction and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: failure to occlude fallopian tubes.Tubes did not close.Concerning the injuries reported in this case, the following one/ones were reported via social media: constipation, bloating, horrendous gas and diarrhea.Most recent follow-up information incorporated above includes: on 17-jul-2019: pfs and social media report received ¿ new events constipation, bloating, horrendous gas and diarrhea were added.New reporter were added.Lab data were added.Incident no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, 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: 7436878
• MDR Text Key: 105723228
• Report Number: 2951250-2018-01850
• 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
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO PROVERA; DEPO PROVERA; DEPO PROVERA; GABAPENTIN; GABAPENTIN; DEPO PROVERA
• Patient Outcome(s): Other; Required Intervention