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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Biocompatibility (2886); Insufficient Information (3190)

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Uterine Perforation (2121); Dizziness (2194); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device breakage ("possibly a fragment of essure left"), genital haemorrhage ("blood clots") and post procedural haemorrhage ("i might have internal bleeding (after hysterectomy)") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: fibromyalgia was ruled out.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, 2 years 2 months after insertion of essure, the patient experienced procedural pain ("a lot of pain especially under ribs").In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), pruritus ("skin is itchy"), dizziness ("get dizzy / light headed"), allergy to metals ("nickel is still lingering in me") with rash, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was (b)(6)") and complication of device removal ("possibly a fragment of essure left").On an unknown date, the patient experienced blood pressure increased ("blood pressure began to rise"), palpitations ("racing heart"), blood potassium decreased ("potassium was slightly low"), headache ("constant headaches"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain"), the first episode of abdominal discomfort ("fluttering in stomach"), dry skin ("skin is dry"), vision blurred ("blurred vision"), dysgeusia ("taste of metal in my mouth"), the second episode of abdominal discomfort ("burning feeling near where my tubes are") and muscle twitching ("twitch often").The patient was treated with surgery (removal of tubes and coils on (b)(6) 2013; vaginal hysterectomy on (b)(6) 2014).Essure was removed.At the time of the report, the pelvic pain and dizziness had resolved, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain and complication of device removal outcome was unknown, the genital haemorrhage, post procedural discomfort and pruritus had not resolved and the blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, vision blurred, dysgeusia, the last episode of abdominal discomfort and muscle twitching had not resolved.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, vision blurred, the first episode of abdominal discomfort and the second episode of abdominal discomfort with essure.The reporter considered breast mass, breast pain, complication of device removal, device breakage, feeling abnormal, oropharyngeal pain, post procedural haemorrhage and procedural pain to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: not provided x-ray coils looked fine.Pathology reports there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: social media posts.Added events oropharyngeal pain , procedural pain, complication of device removal, device breakage, post procedural hemorrhage.Added removal information for essure.Added surgery treatment for "pelvic pain".Added relevant lab data.On (b)(6) 2018: quality safety evaluation for ptc.Updated fda evaluation codes and product technical complaint reference number.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

Spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device breakage ("possibly a fragment of essure left"), genital haemorrhage ("blood clots") and post procedural haemorrhage ("i might have internal bleeding (after hysterectomy)") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: fibromyalgia was ruled out.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, 2 years 2 months after insertion of essure, the patient experienced procedural pain ("a lot of pain especially under ribs").In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), pruritus ("skin is itchy"), dizziness ("get dizzy / light headed"), allergy to metals ("nickel is still lingering in me") with rash, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33") and complication of device removal ("possibly a fragment of essure left").On an unknown date, the patient experienced blood pressure increased ("blood pressure began to rise"), palpitations ("racing heart"), blood potassium decreased ("potassium was slightly low"), headache ("constant headaches"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain"), the first episode of abdominal discomfort ("fluttering in stomach"), dry skin ("skin is dry"), vision blurred ("blurred vision"), dysgeusia ("taste of metal in my mouth"), the second episode of abdominal discomfort ("burning feeling near where my tubes are") and muscle twitching ("twitch often").The patient was treated with surgery (removal of tubes and coils on (b)(6) 2013; vaginal hysterectomy on (b)(6) 2014).Essure was removed.At the time of the report, the pelvic pain and dizziness had resolved, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain and complication of device removal outcome was unknown, the genital haemorrhage, post procedural discomfort and pruritus had not resolved and the blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, vision blurred, dysgeusia, the last episode of abdominal discomfort and muscle twitching had not resolved.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, vision blurred, the first episode of abdominal discomfort and the second episode of abdominal discomfort with essure.The reporter considered breast mass, breast pain, complication of device removal, device breakage, feeling abnormal, oropharyngeal pain, post procedural haemorrhage and procedural pain to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: not provided, x-ray, coils looked fine.Pathology reports there is no mention o:f some coils still being in the tubes.It mentions the coils were released to the patient.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 14-aug-2018: quality-safety evaluation of product technical complaint.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 breakage ("possibly a fragment of essure left"), pelvic pain ("severe pelvic pain/pain severe and persistent pain"), genital haemorrhage ("blood clots") and post procedural haemorrhage ("i might have internal bleeding (after hysterectomy)") in a 33-year-old female patient who had essure (batch no.Dk1043-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Fibromyalgia was ruled out.X-ray coils looked fine.Pathology reports there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.24 jan 2012 : essure confirmation test was performed.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since october 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since march 2015 and hydroxychloroquine since 2015 to january 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), the second episode of abdominal discomfort ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left") and coccydynia ("tail bone"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced the first episode of abdominal discomfort ("fluttering in stomach").The patient was treated with blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma and removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral) and blood transfusion after hysterectomy.Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma and tooth disorder outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, the last episode of abdominal discomfort, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder and hypertension had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, vision blurred, the first episode of abdominal discomfort and the second episode of abdominal discomfort with essure.The reporter considered alopecia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, hypertension, menorrhagia, migraine, nausea, oropharyngeal pain, post procedural haematoma, post procedural haemorrhage, procedural pain, raynaud's phenomenon, tooth disorder, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on 30-dec-2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.Ultrasound scan - on an unknown date:.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-may-2019: pfs received.Medical history and concomitant drug were added.Event verbatim were updated as severe pelvic pain/pain severe and persistent pain.Outcome of the event hair loss, nausea, fatigue were updated.Incident no valid 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.

Manufacturer Narrative

Safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device breakage ("possibly a fragment of essure left"), genital haemorrhage ("blood clots") and post procedural haemorrhage ("i might have internal bleeding (after hysterectomy)") in a 33-year-old female patient who had essure (batch no.Dk1043) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: fibromyalgia was ruled out.Concomitant products included amlodipine (norvasc) since 2012, gabapentin since 2015 and hydroxychloroquine phosphate (plaquenil) since 2015 to january 2017.On (b)(6) 2011, the patient had essure inserted.In december 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In january 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In december 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, 2 years 2 months after insertion of essure, the patient experienced procedural pain ("a lot of pain especially under ribs").In august 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.In march 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), blood pressure increased ("blood pressure began to rise"), abdominal pain ("abdominal pain"), back pain ("back pain"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), allergy to metals ("nickel is still lingering in me") with rash, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), skin reaction ("allergic or hypersensitivity reaction type: skin reactions"), haematoma ("hematoma") and coccydynia ("tail bone").On an unknown date, the patient experienced palpitations ("racing heart"), blood potassium decreased ("potassium was slightly low"), hot flush ("hot flashes"), the first episode of abdominal discomfort ("fluttering in stomach"), dry skin ("skin is dry"), the second episode of abdominal discomfort ("burning feeling near where my tubes are") and muscle twitching ("twitch often").The patient was treated with surgery (removal of tubes and coils on (b)(6) -2013; hysterectomy (full), salpingectomy bilateral).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, dizziness, vision blurred, migraine, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye and coccydynia had resolved, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, haematoma, nausea, tooth disorder, fatigue and alopecia outcome was unknown, the genital haemorrhage, post procedural discomfort, blood pressure increased, headache, abdominal pain, back pain, pruritus, dysgeusia, raynaud's phenomenon, fibromyalgia, connective tissue disorder and hypertension had not resolved, the palpitations, blood potassium decreased, hot flush, dry skin, the last episode of abdominal discomfort and muscle twitching had not resolved and the skin reaction was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, vision blurred, the first episode of abdominal discomfort and the second episode of abdominal discomfort with essure.The reporter considered alopecia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, device breakage, dry eye, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, haematoma, hypertension, menorrhagia, migraine, nausea, oropharyngeal pain, post procedural haemorrhage, procedural pain, raynaud's phenomenon, skin reaction, tooth disorder, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on(b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: not provided hysterosalpingogram - on an unknown date: fallopian tubes were confirmed to be blocked x-ray coils looked fine.Pathology reports there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on(b)(6) 2018: plaintiff fact sheet received.Lot number added.Events added from pfs- abnormal bleeding (vaginal, menorrhagia), allergic or hypersensitivity reaction type: skin reactions, autoimmune disorder type of disorder: raynaud's, fibromyalgia, and connective tissue disease, migraines, blood or heart disorder/condition type: high blood pressure and hematoma, nausea, dental problems, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), vaginal discharge, dry eyes, fatigue, hair loss, tail bone.Outcomne of event vision blurred were update from not recovered / not resolved to recovered / resolved.Concomitant drug, plaintiff name, date of birth, lab data 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 on a supplemental report.

Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device breakage ("possibly a fragment of essure left"), genital haemorrhage ("blood clots") and post procedural haemorrhage ("i might have internal bleeding (after hysterectomy)") in a 33-year-old female patient who had essure (batch no.Dk1043-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: fibromyalgia was ruled out.Concomitant products included amlodipine (norvasc) since 2012, gabapentin since 2015 and hydroxychloroquine phosphate (plaquenil) since 2015 to (b)(6) 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, 2 years 2 months after insertion of essure, the patient experienced procedural pain ("a lot of pain especially under ribs").In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), blood pressure increased ("blood pressure began to rise"), abdominal pain ("abdominal pain"), back pain ("back pain"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions") and coccydynia ("tail bone").On an unknown date, the patient experienced palpitations ("racing heart"), blood potassium decreased ("potassium was slightly low"), hot flush ("hot flashes"), the first episode of abdominal discomfort ("fluttering in stomach"), dry skin ("skin is dry"), the second episode of abdominal discomfort ("burning feeling near where my tubes are") and muscle twitching ("twitch often").The patient was treated with blood transfusion, auxiliary products and surgery (removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, dizziness, vision blurred, migraine, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye and coccydynia had resolved, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, nausea, tooth disorder, fatigue and alopecia outcome was unknown, the genital haemorrhage, post procedural discomfort, blood pressure increased, headache, abdominal pain, back pain, pruritus, dysgeusia, raynaud's phenomenon, fibromyalgia, connective tissue disorder and hypertension had not resolved, the palpitations, blood potassium decreased, hot flush, dry skin, the last episode of abdominal discomfort and muscle twitching had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, vision blurred, the first episode of abdominal discomfort and the second episode of abdominal discomfort with essure.The reporter considered alopecia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, hypertension, menorrhagia, migraine, nausea, oropharyngeal pain, post procedural haematoma, post procedural haemorrhage, procedural pain, raynaud's phenomenon, tooth disorder, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 20, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: not provided hysterosalpingogram - on an unknown date: fallopian tubes were confirmed to be blocked ultrasound scan - on an unknown date: x-ray coils looked fine.Pathology reports there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.(b)(6) 2012 : essure confirmation test was performed.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-oct-2018: update of information (batch is not valid).Incident no valid 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

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device breakage ("possibly a fragment of essure left"), genital haemorrhage ("blood clots") and post procedural haemorrhage ("i might have internal bleeding (after hysterectomy)") in a 33-year-old female patient who had essure (batch no.Dk1043) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: fibromyalgia was ruled out.Concomitant products included amlodipine (norvasc) since 2012, gabapentin since 2015 and hydroxychloroquine phosphate (plaquenil) since 2015 to (b)(6) 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, 2 years 2 months after insertion of essure, the patient experienced procedural pain ("a lot of pain especially under ribs").In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), blood pressure increased ("blood pressure began to rise"), abdominal pain ("abdominal pain"), back pain ("back pain"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions") and coccydynia ("tail bone").On an unknown date, the patient experienced palpitations ("racing heart"), blood potassium decreased ("potassium was slightly low"), hot flush ("hot flashes"), the first episode of abdominal discomfort ("fluttering in stomach"), dry skin ("skin is dry"), the second episode of abdominal discomfort ("burning feeling near where my tubes are") and muscle twitching ("twitch often").The patient was treated with blood transfusion, auxiliary products and surgery (removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, dizziness, vision blurred, migraine, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye and coccydynia had resolved, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, nausea, tooth disorder, fatigue and alopecia outcome was unknown, the genital haemorrhage, post procedural discomfort, blood pressure increased, headache, abdominal pain, back pain, pruritus, dysgeusia, raynaud's phenomenon, fibromyalgia, connective tissue disorder and hypertension had not resolved, the palpitations, blood potassium decreased, hot flush, dry skin, the last episode of abdominal discomfort and muscle twitching had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, vision blurred, the first episode of abdominal discomfort and the second episode of abdominal discomfort with essure.The reporter considered alopecia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, hypertension, menorrhagia, migraine, nausea, oropharyngeal pain, post procedural haematoma, post procedural haemorrhage, procedural pain, raynaud's phenomenon, tooth disorder, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: not provided hysterosalpingogram - on an unknown date: fallopian tubes were confirmed to be blocked ultrasound scan - on an unknown date: x-ray coils looked fine.Pathology reports there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.*(b)(6) 2012: essure confirmation test was performed.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-oct-2018: pfs received : new event, "hematoma after hysterectomy" was added.Treatment medication was added.Lab data was 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

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), pelvic pain ('severe pelvic pain/pain severe and persistent pain'), genital haemorrhage ('blood clots') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Fibromyalgia was ruled out.X-ray coils looked fine.Pathology reports: there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.On (b)(6) 2012 : essure confirmation test was performed.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since (b)(6) 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since (b)(6) 2015 and hydroxychloroquine since 2015 to january 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone"), pain ("i am in pain now just from the little walk we did") and crying ("crying"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma, removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral and tubes and coils removed) and blood transfusion after hysterectomy.Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder, pain and crying outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder and hypertension had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, crying, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, hypertension, menorrhagia, migraine, nausea, oropharyngeal pain, pain, post procedural haematoma, post procedural haemorrhage, procedural pain, raynaud's phenomenon, tooth disorder, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage, pain upon movement, crying.Concerning the injuries reported in this case, the following ones were reported via social media: crying.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-dec-2019: social media received.Reporter's information was added.Added event crying.Incident: no valid 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), pelvic pain ('severe pelvic pain/pain severe and persistent pain'), genital haemorrhage ('blood clots') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Fibromyalgia was ruled out.X-ray coils looked fine.Pathology reports there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.On (b)(6) 2012 : essure confirmation test was performed.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since (b)(6) 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since march 2015 and hydroxychloroquine since 2015 to january 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone") and pain ("i am in pain now just from the little walk we did"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma and removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral) and blood transfusion after hysterectomy.Essure was removed on (b)(6) 2014.At the time of the report, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder and pain outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder and hypertension had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, hypertension, menorrhagia, migraine, nausea, oropharyngeal pain, pain, post procedural haematoma, post procedural haemorrhage, procedural pain, raynaud's phenomenon, tooth disorder, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage, pain upon movement.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2019: social media received- new event added- i am in pain now just from the little walk we did.Reporters were added.Incident: no valid 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), pelvic pain ('severe pelvic pain/pain severe and persistent pain / i'm in pain '), genital haemorrhage ('blood clots') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Fibromyalgia was ruled out.X-ray.Coils looked fine.Pathology reports there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.On (b)(6) 2012 : essure confirmation test was performed.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since (b)(6) 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since (b)(6) 2015 and hydroxychloroquine since 2015 to (b)(6) 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy / hematoma").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone"), pain ("i am in pain now just from the little walk we did"), crying ("crying"), loss of consciousness ("i kept passing out ") and asthenia ("7 week post op and still have no energy"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma, removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral and tubes and coils removed) and blood transfusion after hysterectomy.Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder, pain, crying and loss of consciousness outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder, hypertension and asthenia had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, asthenia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, crying, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, hypertension, loss of consciousness, menorrhagia, migraine, nausea, oropharyngeal pain, pain, post procedural haematoma, post procedural haemorrhage, procedural pain, raynaud's phenomenon, tooth disorder, vaginal discharge and vaginal haemorrhage to be related to essure.No further causality assessment were provided for the product.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage, pain upon movement, crying.Concerning the injuries reported in this case, the following ones were reported via social media: crying.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: upon internal review it was found that case (b)(4) found to be duplicate of this case ((b)(4)), events- "i kept passing out ,7 week post op and still have no energy", reference section and documents from case (b)(4) was transfer to this case.No new follow-up information was received from the reporter.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), embedded device ('piece of coil broken off and embedded in uterus'), pelvic pain ('severe pelvic pain/pain severe and persistent pain / i'm in pain') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043- not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since (b)(6) 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since (b)(6) 2015 and hydroxychloroquine since 2015 to (b)(6) 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy / hematoma").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("blood clots"), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone"), pain ("i am in pain now just from the little walk we did"), crying ("crying"), loss of consciousness ("i kept passing out "), asthenia ("7 week post op and still have no energy"), vitamin d deficiency ("vitamin d deficiency") and pelvic discomfort ("right coil was poking my tailbone"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma, removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral and tubes and coils removed,hysterectomy) and blood transfusion after hysterectomy.Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, embedded device, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder, pain, crying, loss of consciousness, vitamin d deficiency and pelvic discomfort outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder, hypertension and asthenia had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, asthenia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, crying, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, fibromyalgia, hypertension, loss of consciousness, menorrhagia, migraine, nausea, oropharyngeal pain, pain, pelvic discomfort, post procedural haematoma, post procedural haemorrhage, procedural pain, raynaud's phenomenon, tooth disorder, vaginal discharge, vaginal haemorrhage and vitamin d deficiency to be related to essure.No further causality assessment were provided for the product.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage, pain upon movement, crying.Concerning the injuries reported in this case, the following ones were reported via social media: crying.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-feb-2020: update of information (batch is not valid).Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), embedded device ('piece of coil broken off and embedded in uterus'), pelvic pain ('severe pelvic pain/pain severe and persistent pain / i'm in pain') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Fibromyalgia was ruled out.X-ray coils looked fine.Pathology reports there is no mention of some coils still being in the tubes.It mentions the coils were released to the patient.(b)(6) 2012 : essure confirmation test was performed.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since october 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since march 2015 and hydroxychloroquine since 2015 to january 2017.On (b)(6) 2011, the patient had essure inserted.In december 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In january 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In december 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In august 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy / hematoma").In march 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("blood clots"), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone"), pain ("i am in pain now just from the little walk we did"), crying ("crying"), loss of consciousness ("i kept passing out "), asthenia ("7 week post op and still have no energy"), vitamin d deficiency ("vitamin d deficiency") and pelvic discomfort ("right coil was poking my tailbone"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma, removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral and tubes and coils removed,hysterectomy) and blood transfusion after hysterectomy.Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, embedded device, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder, pain, crying, loss of consciousness, vitamin d deficiency and pelvic discomfort outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder, hypertension and asthenia had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, asthenia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, crying, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, fibromyalgia, hypertension, loss of consciousness, menorrhagia, migraine, nausea, oropharyngeal pain, pain, pelvic discomfort, post procedural haematoma, post procedural haemorrhage, procedural pain, raynaud's phenomenon, tooth disorder, vaginal discharge, vaginal haemorrhage and vitamin d deficiency to be related to essure.No further causality assessment were provided for the product.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Concerning the injuries reported in this case, the following ones were reported via social media: breast pain, lump,oropharyngeal pain , procedural pain, complication of device removal , device breakage,post procedural haemorrhage, pain upon movement, crying.Concerning the injuries reported in this case, the following ones were reported via social media: crying quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: content from social media received.Events vitamin d deficiency, piece of coil broken off and embedded in uterus and right coil was poking my tailbone were added.On (b)(6) 2020: fu27 and fu28 were processed together.Reporter information was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), embedded device ('piece of coil broken off and embedded in uterus'), pelvic pain ('severe pelvic pain/pain severe and persistent pain / i'm in pain') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043- not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since (b)(6)2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since (b)(6)2015 and hydroxychloroquine since 2015 to (b)(6)2017.On (b)(6)2011, the patient had essure inserted.In (b)(6)2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6)2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6)2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6)2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6)2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6)2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy / hematoma").In (b)(6)2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("blood clots"), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone"), pain ("i am in pain now just from the little walk we did"), crying ("crying"), loss of consciousness ("i kept passing out "), asthenia ("7 week post op and still have no energy"), vitamin d deficiency ("vitamin d deficiency"), pelvic discomfort ("right coil was poking my tailbone"), rash ("rash after work out"), skin burning sensation ("feeling a burning sensation"), livedo reticularis ("livedo reticularis") and infection ("infection nos"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with antihypertensives, blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma, removal of tubes and coils on (b)(6)2013; hysterectomy (full), salpingectomy bilateral, tubes and coils removed,hysterectomy and tubes and coils removed,hysterectomy,laproscopic) and blood transfusion after hysterectomy.Essure was removed on (b)(6)2014.At the time of the report, the device breakage, embedded device, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder, pain, crying, loss of consciousness, vitamin d deficiency, pelvic discomfort, rash, skin burning sensation, livedo reticularis and infection outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder, hypertension and asthenia had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, asthenia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, crying, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, fibromyalgia, hypertension, infection, livedo reticularis, loss of consciousness, menorrhagia, migraine, nausea, oropharyngeal pain, pain, pelvic discomfort, post procedural haematoma, post procedural haemorrhage, procedural pain, rash, raynaud's phenomenon, skin burning sensation, tooth disorder, vaginal discharge, vaginal haemorrhage and vitamin d deficiency to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6)2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6)2013 but informs that was essure free after a second surgery on (b)(6)2014.Discrepancy in date of removal (b)(6)2013 and (b)(6)2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Concerning the injuries reported in this case, the following ones were reported via social media : liver reticularis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: content from plaintiff fact sheet: new event infection were added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), embedded device ('piece of coil broken off and embedded in uterus'), pelvic pain ('severe pelvic pain/pain severe and persistent pain / i'm in pain') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043- not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since (b)(6) 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since (b)(6) 2015 and hydroxychloroquine since 2015 to (b)(6) 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy / hematoma").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("blood clots"), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone"), pain ("i am in pain now just from the little walk we did"), crying ("crying"), loss of consciousness ("i kept passing out "), asthenia ("7 week post op and still have no energy"), vitamin d deficiency ("vitamin d deficiency"), pelvic discomfort ("right coil was poking my tailbone"), rash ("rash after work out"), skin burning sensation ("feeling a burning sensation"), livedo reticularis ("livedo reticularis") and infection ("infection nos"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with antihypertensives, blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma, removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral, tubes and coils removed,hysterectomy and tubes and coils removed,hysterectomy,laproscopic) and blood transfusion after hysterectomy.Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, embedded device, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder, pain, crying, loss of consciousness, vitamin d deficiency, pelvic discomfort, rash, skin burning sensation, livedo reticularis and infection outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder, hypertension and asthenia had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, asthenia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, crying, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, fibromyalgia, hypertension, infection, livedo reticularis, loss of consciousness, menorrhagia, migraine, nausea, oropharyngeal pain, pain, pelvic discomfort, post procedural haematoma, post procedural haemorrhage, procedural pain, rash, raynaud's phenomenon, skin burning sensation, tooth disorder, vaginal discharge, vaginal haemorrhage and vitamin d deficiency to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Concerning the injuries reported in this case, the following ones were reported via social media : liver reticularis lot number ( dk1043 ) is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-apr-2020: quality-safety evaluation of product technical complaint.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), embedded device ('piece of coil broken off and embedded in uterus'), pelvic pain ('severe pelvic pain/pain severe and persistent pain / i'm in pain') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043- not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since october 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since (b)(6) 2015 and hydroxychloroquine since 2015 to (b)(6) 2017.On (b)(6)2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy / hematoma").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("blood clots"), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone"), pain ("i am in pain now just from the little walk we did"), crying ("crying"), loss of consciousness ("i kept passing out"), asthenia ("7 week post op and still have no energy"), vitamin d deficiency ("vitamin d deficiency"), pelvic discomfort ("right coil was poking my tailbone"), rash ("rash after work out") and skin burning sensation ("feeling a burning sensation"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with antihypertensives, blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma, removal of tubes and coils on (b)(6)2013; hysterectomy (full), salpingectomy bilateral, tubes and coils removed,hysterectomy and tubes and coils removed,hysterectomy,laproscopic) and blood transfusion after hysterectomy.Essure was removed on (b)(6)2013.At the time of the report, the device breakage, embedded device, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder, pain, crying, loss of consciousness, vitamin d deficiency, pelvic discomfort, rash and skin burning sensation outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder, hypertension and asthenia had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, asthenia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, crying, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, fibromyalgia, hypertension, loss of consciousness, menorrhagia, migraine, nausea, oropharyngeal pain, pain, pelvic discomfort, post procedural haematoma, post procedural haemorrhage, procedural pain, rash, raynaud's phenomenon, skin burning sensation, tooth disorder, vaginal discharge, vaginal haemorrhage and vitamin d deficiency to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6)2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6)2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6)2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6)2020: social media received.Reporter added.Event ¿rash after work out¿, ¿feeling a burning sensation¿ added.Processed with fu 42 43,44,45.On (b)(6) 2020: processed with fu 42., 43,44,45.On (b)(6) 2020: processed with fu 42 43,44,45.On (b)(6) 2020: social media documents revived, new reporter added ,processed with fu 42 43,44,45.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('possibly a fragment of essure left'), embedded device ('piece of coil broken off and embedded in uterus'), pelvic pain ('severe pelvic pain/pain severe and persistent pain / i'm in pain') and post procedural haemorrhage ('i might have internal bleeding (after hysterectomy)') in a 33-year-old female patient who had essure (batch no.Dk1043- not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache and procedural bleeding.Concurrent conditions included attention deficit/hyperactivity disorder.Concomitant products included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (adderall) since (b)(6) 2011 for hematoma as well as amlodipine besilate (norvasc) since 2012, gabapentin since (b)(6) 2015 and hydroxychloroquine since 2015 to (b)(6) 2017.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced headache ("constant headaches"), dizziness ("get dizzy / light headed / neurological conditions or problems type: dizziness"), vision blurred ("blurred vision / vision/eye problems type: blurry vision"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: skin reactions"), migraine ("migraines"), hypertension ("blood or heart disorder/condition type: high blood pressure"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dry eye ("dry eye") and alopecia ("hair loss").In (b)(6) 2013, the patient experienced oropharyngeal pain ("sore throat").On (b)(6) 2013, the patient experienced procedural pain ("a lot of pain especially under ribs"), 2 years 2 months after insertion of essure.In (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant) with haemoglobin decreased.On (b)(6) 2014, the patient experienced post procedural haematoma ("hematoma after hysterectomy / hematoma").In (b)(6) 2015, the patient experienced raynaud's phenomenon ("autoimmune disorder type of disorder: raynaud's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and connective tissue disorder ("autoimmune disorder type of disorder: connective tissue disease").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("blood clots"), post procedural discomfort ("procedure was uncomfortable"), palpitations ("racing heart"), hot flush ("hot flashes"), abdominal pain ("abdominal pain"), back pain ("back pain/ i had major back pain"), dry skin ("skin is dry"), pruritus ("skin is itchy"), dysgeusia ("taste of metal in my mouth"), burning sensation in abdomen ("burning feeling near where my tubes are"), muscle twitching ("twitch often"), allergy to metals ("nickel is still lingering in me") with dermatitis allergic, breast pain ("pain in breasts before periods"), breast mass ("lumps"), feeling abnormal ("her body feels like she was 80 year old and she was 33"), complication of device removal ("possibly a fragment of essure left"), coccydynia ("tail bone"), pain ("i am in pain now just from the little walk we did"), crying ("crying"), loss of consciousness ("i kept passing out "), asthenia ("7 week post op and still have no energy"), vitamin d deficiency ("vitamin d deficiency"), pelvic discomfort ("right coil was poking my tailbone"), rash ("rash after work out"), skin burning sensation ("feeling a burning sensation") and livedo reticularis ("livedo reticularis"), was found to have blood pressure increased ("blood pressure began to rise") and blood potassium decreased ("potassium was slightly low") and experienced stomach discomfort ("fluttering in stomach").The patient was treated with antihypertensives, blood transfusion, auxiliary products, blood transfusion, surgery (laparoscopic removal of hematoma, removal of tubes and coils on (b)(6) 2013; hysterectomy (full), salpingectomy bilateral, tubes and coils removed,hysterectomy and tubes and coils removed,hysterectomy, laproscopic) and blood transfusion after hysterectomy.Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, embedded device, post procedural haemorrhage, allergy to metals, breast pain, breast mass, feeling abnormal, oropharyngeal pain, procedural pain, complication of device removal, vaginal haemorrhage, menorrhagia, post procedural haematoma, tooth disorder, pain, crying, loss of consciousness, vitamin d deficiency, pelvic discomfort, rash, skin burning sensation and livedo reticularis outcome was unknown, the pelvic pain, dizziness, vision blurred, migraine, nausea, dysmenorrhoea, dyspareunia, vaginal discharge, dry eye, fatigue, alopecia and coccydynia had resolved, the genital haemorrhage, post procedural discomfort, blood pressure increased, palpitations, blood potassium decreased, headache, hot flush, abdominal pain, back pain, dry skin, pruritus, dysgeusia, burning sensation in abdomen, muscle twitching, raynaud's phenomenon, fibromyalgia, connective tissue disorder, hypertension and asthenia had not resolved, the stomach discomfort had not resolved and the dermatitis allergic was resolving.The reporter provided no causality assessment for abdominal pain, allergy to metals, back pain, blood potassium decreased, blood pressure increased, dizziness, dry skin, dysgeusia, genital haemorrhage, headache, hot flush, muscle twitching, palpitations, pelvic pain, post procedural discomfort, pruritus, stomach discomfort, vision blurred and burning sensation in abdomen with essure.The reporter considered alopecia, asthenia, breast mass, breast pain, coccydynia, complication of device removal, connective tissue disorder, crying, dermatitis allergic, device breakage, dry eye, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, fibromyalgia, hypertension, livedo reticularis, loss of consciousness, menorrhagia, migraine, nausea, oropharyngeal pain, pain, pelvic discomfort, post procedural haematoma, post procedural haemorrhage, procedural pain, rash, raynaud's phenomenon, skin burning sensation, tooth disorder, vaginal discharge, vaginal haemorrhage and vitamin d deficiency to be related to essure.The reporter commented: since cervix is part of uterus it has been exposed to pet fiber.It is best to have it removed.As per patient post in social media on (b)(6) 2013, the coils were far in tubes and they did not hang in her uterus.The physician checked for fragments after removal and she was clear.Patient reports having coils removed on (b)(6) 2013 but informs that was essure free after a second surgery on (b)(6) 2014.Discrepancy in date of removal (b)(6) 2013 and (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: results: not provided.Hysterosalpingogram - on an unknown date: results: fallopian tubes were confirmed to be blocked.X-ray - on an unknown date: coils clear as day.Concerning the injuries reported in this case, the following ones were reported via social media : liver reticularis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media received.Reporter and event : livedo reticularis added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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: 7649293
• MDR Text Key: 112708670
• Report Number: 2951250-2018-02887
• 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,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: DK1043- NOT VALID
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADDERALL; ADDERALL; ADDERALL; ADDERALL; ADDERALL; ADDERALL; ADDERALL; ADDERALL; ADDERALL; ADDERALL; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; GABAPENTIN; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; NORVASC; PLAQUENIL; PLAQUENIL; PLAQUENIL
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR