| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Reaction (1733); Hair Loss (1877); Headache (1880); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Hot Flashes/Flushes (2153); Sleep Dysfunction (2517); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5033895) on 18-feb-2014.The most recent information was received on 01-jun-2018.This spontaneous case was reported by a lawyer and describes the occurrence of cholecystectomy ("gallbladder removal"), pain ("everyday pain / allover body aches/pain"), device breakage ("fragments of essure had been left behind") and autoimmune disorder ("autoimmune reaction") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, 14 days after insertion of essure, the patient experienced migraine ("migraines").On an unknown date, the patient underwent cholecystectomy (seriousness criterion medically significant), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), weight increased ("weight gain"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be (b)(6)"), arthralgia ("joint/hip pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain ("spine pain"), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), the first episode of paraesthesia ("tingling sensations / tingling in hands"), hypoaesthesia ("numbness / numbness in hands"), the second episode of paraesthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), uterine pain ("pain in uterus"), scar ("scar tissue"), endometriosis ("endometriosis"), device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain") and autoimmune disorder (seriousness criterion medically significant).The patient was treated with surgery (she had fragments removed laparoscopically).Essure was removed.At the time of the report, the cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, scar, endometriosis, device breakage, complication of device removal, gastrointestinal pain and autoimmune disorder outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, hypoaesthesia, the last episode of paraesthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, affective disorder, alopecia, anxiety, arthralgia, autoimmune disorder, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hot flush, hyperhidrosis, hypoaesthesia, insomnia, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, neck pain, neuralgia, night sweats, ovulation pain, pain, pain in extremity, panic attack, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased, the first episode of paraesthesia and the second episode of paraesthesia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media: scar tissue,endometriosis,device breakage,bowel pain,device removal complication.Quality-safety evaluation of ptc: final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert, in this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: no product quality defect was confirmed therefore a relationship to the reported medical events is excluded.The reported medical events are not indicative of a quality deficit per se.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical events and a quality defect.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 1-jun-2018: pfs received: the event scar tissue, endometriosis, device breakage, complication during device removal, bowel pain, autoimmune reaction added.Reporters, lab data added.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5033895) on 18-feb-2014.The most recent information was received on 06-mar-2019 this spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fregments of essure had been left behind"), cholecystectomy ("gallbladder removal"), pain ("everyday pain / allover body aches/pain") and autoimmune disorder ("autoimmune reaction") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraines"), 14 days after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant)"), arthralgia ("joint/hip pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain ("spine pain"), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), the first episode of paraesthesia ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), the second episode of paraesthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain") and autoimmune disorder (seriousness criterion medically significant), underwent cholecystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain") and hormone level abnormal ("my hormones are out of whack").The patient was treated with surgery (she had fragments removed laparoscopically).Essure was removed.At the time of the report, the device breakage, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain, autoimmune disorder and hormone level abnormal outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, hypoaesthesia, the last episode of paraesthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, affective disorder, alopecia, anxiety, arthralgia, autoimmune disorder, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hormone level abnormal, hot flush, hyperhidrosis, hypoaesthesia, insomnia, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, neck pain, neuralgia, night sweats, ovulation pain, pain, pain in extremity, panic attack, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased, the first episode of paraesthesia and the second episode of paraesthesia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media:scar tissue,endometriosis,device breakage,bowel pain,device removal complication quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 6-mar-2019: social media received.Reporters information updated.Event:hormone values changed were added.Incident no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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It was initially received via regulatory authority (food and drug administration, reference number: mw (b)(4)) on 18-feb-2014.The most recent information was received on 29-aug-2018.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fregments of essure had been left behind"), cholecystectomy ("gallbladder removal"), pain ("everyday pain / allover body aches/pain") and autoimmune disorder ("autoimmune reaction") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, 14 days after insertion of essure, the patient experienced migraine ("migraines").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), cholecystectomy (seriousness criterion medically significant), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), weight increased ("weight gain"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant)"), arthralgia ("joint/hip pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain ("spine pain"), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), the first episode of paraesthesia ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), the second episode of paraesthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain") and autoimmune disorder (seriousness criterion medically significant).The patient was treated with surgery (she had fragments removed laparoscopically).Essure was removed.At the time of the report, the device breakage, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain and autoimmune disorder outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, hypoaesthesia, the last episode of paraesthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, affective disorder, alopecia, anxiety, arthralgia, autoimmune disorder, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hot flush, hyperhidrosis, hypoaesthesia, insomnia, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, neck pain, neuralgia, night sweats, ovulation pain, pain, pain in extremity, panic attack, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased, the first episode of paraesthesia and the second episode of paraesthesia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: radiology to confirm fragment have removed concerning the injuries reported in this case, the following ones were reported via social media:scar tissue,endometriosis,device breakage,bowel pain,device removal complication.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 29-aug-2018: quality safety evaluation of product technical complaints.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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5033895) on 18-feb-2014.The most recent information was received on 06-may-2019.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fregments of essure had been left behind"), cholecystectomy ("gallbladder removal"), pain ("everyday pain / allover body aches/pain") and autoimmune disorder ("autoimmune reaction") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraines"), 14 days after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant)"), arthralgia ("joint/hip pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain ("spine pain"), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), the first episode of paraesthesia ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), the second episode of paraesthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain") and autoimmune disorder (seriousness criterion medically significant), underwent cholecystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain") and hormone level abnormal ("my hormones are out of whack").The patient was treated with surgery (she had fragments removed laparoscopically).Essure was removed.At the time of the report, the device breakage, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain, autoimmune disorder and hormone level abnormal outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, hypoaesthesia, the last episode of paraesthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, affective disorder, alopecia, anxiety, arthralgia, autoimmune disorder, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hormone level abnormal, hot flush, hyperhidrosis, hypoaesthesia, insomnia, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, neck pain, neuralgia, night sweats, ovulation pain, pain, pain in extremity, panic attack, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased, the first episode of paraesthesia and the second episode of paraesthesia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media:scar tissue,endometriosis,device breakage,bowel pain,device removal complication." quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 6-may-2019: the significant correction regarding follow up receipt date: the follow up receipt date was 06-may-2019 (previously reported as 06-mar-2019 which was incorrect).Incident: no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fregments of essure had been left behind'), cholecystectomy ('gallbladder removal') and pain ('everyday pain / allover body aches/pain') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraines"), 14 days after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant) / stomach swells"), arthralgia ("joint/hip pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain ("spine pain"), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), paraesthesia hand ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), paresthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain"), gastritis ("autoimmune reaction /gastritis") and abdominal pain upper ("stomach hurts really bad"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain") and hormone level abnormal ("my hormones are out of whack").The patient was treated with surgery (she had fragments removed laparoscopically).Essure was removed.At the time of the report, the device breakage, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain, gastritis, hormone level abnormal and abdominal pain upper outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, paraesthesia hand, hypoaesthesia, paresthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, affective disorder, alopecia, anxiety, arthralgia, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, gastritis, gastrointestinal disorder, gastrointestinal pain, headache, hormone level abnormal, hot flush, hyperhidrosis, hypoaesthesia, insomnia, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, neck pain, neuralgia, night sweats, ovulation pain, pain, pain in extremity, panic attack, paraesthesia hand, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased and paresthesia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media:scar tissue,endometriosis,device breakage,bowel pain,device removal complication." quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 2-dec-2019: fu 16 and 17 processed together.Social media received: events: stomach hurts added.Autoimmune disorder changed to gastritis.Reporter added.No lot number 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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5033895) on 18-feb-2014.The most recent information was received on 30-apr-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fregments of essure had been left behind / fragments embedded in my iliac vessel / chewed my coil and split it all through my pelvic cavity'), embedded device ('fragments embedded in my iliac vessel'), cholecystectomy ('gallbladder removal'), pain ('everyday pain / allover body aches/pain/ mine has hurting like hell') and spinal pain ('spine pain') in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraines"), 14 days after insertion of essure.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), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps / bad cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses / bleeding"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant) / stomach swells"), arthralgia ("joint pain/knee pain/hip pain/elbow pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain / stabbing pain in my pelvic area"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix / inflammed cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain (seriousness criterion medically significant), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), paraesthesia hand ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), paresthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain"), chronic gastritis ("autoimmune reaction /gastritis"), abdominal pain upper ("stomach hurts really bad"), adrenomegaly ("my adrenal glands being enlarged"), osteoarthritis ("osteoarthritis all through my body including spine"), noninfective oophoritis ("ovary inflammation"), musculoskeletal pain ("shoulder pain"), pain in jaw ("jaw pain"), ovarian cyst ("ovarian cysts post hysterectomy") and intervertebral disc degeneration ("degenerative disk disease"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain"), hormone level abnormal ("my hormones are out of whack") and antinuclear antibody positive ("autoimmune responses: positive ana").The patient was treated with surgery (partial hysterectomy, removed tubes and coils, uterus and ovary, she had fragments removed laparoscopically and spinal surgery).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, embedded device, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain, chronic gastritis, hormone level abnormal, abdominal pain upper, adrenomegaly, antinuclear antibody positive, osteoarthritis, noninfective oophoritis, musculoskeletal pain, pain in jaw, ovarian cyst and intervertebral disc degeneration outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, paraesthesia hand, hypoaesthesia, paresthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, adrenomegaly, affective disorder, alopecia, antinuclear antibody positive, anxiety, arthralgia, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, chronic gastritis, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hormone level abnormal, hot flush, hyperhidrosis, hypoaesthesia, insomnia, intervertebral disc degeneration, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, musculoskeletal pain, neck pain, neuralgia, night sweats, noninfective oophoritis, osteoarthritis, ovarian cyst, ovulation pain, pain, pain in extremity, pain in jaw, panic attack, paraesthesia hand, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased and paresthesia to be related to essure.The reporter commented: discrepancy noted regarding essure insertion date ((b)(6) 2008 and 2007).Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media: scar tissue, endometriosis, device breakage, bowel pain, device removal complication, adrenomegaly.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 30-apr-2020: quality safety evaluation of ptc.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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5033895) on 18-feb-2014.The most recent information was received on 20-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fregments of essure had been left behind / fragments embedded in my iliac vessel / chewed my coil and split it all through my pelvic cavity'), embedded device ('fragments embedded in my iliac vessel'), cholecystectomy ('gallbladder removal'), pain ('everyday pain / allover body aches/pain') and spinal pain ('spine pain') in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraines"), 14 days after insertion of essure.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), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses / bleeding"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/ loss of libido"), dyspareunia ("intercourse is very painful"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant) / stomach swells"), arthralgia ("joint pain/knee pain/hip pain/elbow pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain / stabbing pain in my pelvic area"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix / inflammed cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain (seriousness criterion medically significant), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), paraesthesia hand ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), paresthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain"), chronic gastritis ("autoimmune reaction /gastritis"), abdominal pain upper ("stomach hurts really bad"), adrenomegaly ("my adrenal glands being enlarged"), osteoarthritis ("osteoarthritis all through my body including spine"), noninfective oophoritis ("ovary inflammation"), musculoskeletal pain ("shoulder pain") and pain in jaw ("jaw pain"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain"), hormone level abnormal ("my hormones are out of whack") and antinuclear antibody positive ("autoimmune responses: positive ana").The patient was treated with surgery (partial hysterectomy, removed tubes and coils, uterus and ovary, she had fragments removed laparoscopically and spinal surgery).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, embedded device, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain, chronic gastritis, hormone level abnormal, abdominal pain upper, adrenomegaly, antinuclear antibody positive, osteoarthritis, noninfective oophoritis, musculoskeletal pain and pain in jaw outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, paraesthesia hand, hypoaesthesia, paresthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, adrenomegaly, affective disorder, alopecia, antinuclear antibody positive, anxiety, arthralgia, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, chronic gastritis, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hormone level abnormal, hot flush, hyperhidrosis, hypoaesthesia, insomnia, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, musculoskeletal pain, neck pain, neuralgia, night sweats, noninfective oophoritis, osteoarthritis, ovulation pain, pain, pain in extremity, pain in jaw, panic attack, paraesthesia hand, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased and paresthesia to be related to essure.The reporter commented: discrepancy noted regarding essure insertion date ((b)(6) 2008 and 2007).Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media: scar tissue, endometriosis, device breakage, bowel pain, device removal complication, adrenomegaly.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Amendment: the report was amended for the following reason: information from deleted duplicate case (b)(4) (mfr number 2951250-2020-01171) transferred.Reporter¿s information was updated, and new reporters were added.Essure indication and removal date were provided, and the events embedded device, antinuclear antibody positive, generalized osteoarthritis, ovary inflammation, shoulder pain and jaw pain were added.Furthermore, the event spinal pain was upgrade to serious, due to surgery information.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fragments of essure had been left behind / fragments embedded in my iliac vessel / chewed my coil and split it all through my pelvic cavity'), embedded device ('fragments embedded in my iliac vessel'), cholecystectomy ('gallbladder removal'), pain ('everyday pain / allover body aches/pain/ mine has hurting like hell') and spinal pain ('spine pain') in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraines"), 14 days after insertion of essure.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), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps / bad cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses / bleeding"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant) / stomach swells"), arthralgia ("joint pain/knee pain/hip pain/elbow pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain / stabbing pain in my pelvic area"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix / inflamed cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain (seriousness criterion medically significant), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), paraesthesia hand ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), paresthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain"), chronic gastritis ("autoimmune reaction /gastritis"), abdominal pain upper ("stomach hurts really bad"), adrenomegaly ("my adrenal glands being enlarged"), osteoarthritis ("osteoarthritis all through my body including spine"), noninfective oophoritis ("ovary inflammation"), musculoskeletal pain ("shoulder pain"), pain in jaw ("jaw pain") and ovarian cyst ("ovarian cysts post hysterectomy"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain"), hormone level abnormal ("my hormones are out of whack") and antinuclear antibody positive ("autoimmune responses: positive ana").The patient was treated with surgery (partial hysterectomy, removed tubes and coils, uterus and ovary, she had fragments removed laparoscopically and spinal surgery).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, embedded device, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain, chronic gastritis, hormone level abnormal, abdominal pain upper, adrenomegaly, antinuclear antibody positive, osteoarthritis, noninfective oophoritis, musculoskeletal pain, pain in jaw and ovarian cyst outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, paraesthesia hand, hypoaesthesia, paresthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, adrenomegaly, affective disorder, alopecia, antinuclear antibody positive, anxiety, arthralgia, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, chronic gastritis, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hormone level abnormal, hot flush, hyperhidrosis, hypoaesthesia, insomnia, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, musculoskeletal pain, neck pain, neuralgia, night sweats, noninfective oophoritis, osteoarthritis, ovarian cyst, ovulation pain, pain, pain in extremity, pain in jaw, panic attack, paraesthesia hand, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased and paresthesia to be related to essure.No further causality assessment were provided for the product.The reporter commented: discrepancy noted regarding essure insertion date (b)(6) 2008 and 2007).Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media: scar tissue, endometriosis, device breakage, bowel pain, device removal complication, adrenomegaly.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 23-mar-2020: content received from social media: new event was add: ovarian cyst.Reported event abdomen cramps was updated to abdomen cramps / bad cramps.New reporter 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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5033895) on 18-feb-2014.The most recent information was received on 20-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fragments of essure had been left behind'), cholecystectomy ('gallbladder removal') and pain ('everyday pain / allover body aches/pain') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraines"), 14 days after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant) / stomach swells"), arthralgia ("joint/hip pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain"), vaginal hemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain ("spine pain"), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), paraesthesia hand ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), paresthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain"), chronic gastritis ("autoimmune reaction /gastritis"), abdominal pain upper ("stomach hurts really bad") and adrenomegaly ("my adrenal glands being enlarged"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain") and hormone level abnormal ("my hormones are out of whack").The patient was treated with surgery (she had fragments removed laparoscopically).Essure was removed.At the time of the report, the device breakage, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain, chronic gastritis, hormone level abnormal, abdominal pain upper and adrenomegaly outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal hemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, paraesthesia hand, hypoaesthesia, paresthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, adrenomegaly, affective disorder, alopecia, anxiety, arthralgia, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, chronic gastritis, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hormone level abnormal, hot flush, hyperhidrosis, hypoaesthesia, insomnia, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, neck pain, neuralgia, night sweats, ovulation pain, pain, pain in extremity, panic attack, paraesthesia hand, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased and paresthesia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media:scar tissue,endometriosis,device breakage,bowel pain,device removal complication." adrenomegaly.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 20-mar-2020: fu 20 and 21 were processed together.Social media received.New reporter was added.Event : my adrenal glands being enlarged added.On 20-mar-2020: fu 20 and 21 were processed together.Social media received.New reporter was added.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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5033895) on 18-feb-2014.The most recent information was received on 23-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fregments of essure had been left behind / fragments embedded in my iliac vessel / chewed my coil and split it all through my pelvic cavity'), embedded device ('fragments embedded in my iliac vessel'), cholecystectomy ('gallbladder removal'), pain ('everyday pain / allover body aches/pain/ mine has hurting like hell') and spinal pain ('spine pain') in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraines"), 14 days after insertion of essure.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), pain (seriousness criterion medically significant), neuralgia ("nerve pain"), back pain ("extreme lower back pain"), abdominal pain ("abdomen cramps / bad cramps"), menorrhagia ("huge blood clots along with unreliable periods/abnormal menses / bleeding"), polymenorrhoea ("unreliable periods that can last between and eight days every three weeks"), vaginal discharge ("constantly have discharge"), loss of libido ("lack of sex drive/loss of libido"), dyspareunia ("intercourse is very painful"), tooth disorder ("dental problems/issues"), dysgeusia ("metallic taste in my mouth"), fatigue ("constantly tired"), insomnia ("have trouble sleeping/insomnia"), dry skin ("dry skin"), alopecia ("hair is now falling out / hair loss"), abdominal distension ("severe bloating (to where she looks as if she could be nine months pregnant) / stomach swells"), arthralgia ("joint pain/knee pain/hip pain/elbow pain"), pelvic pain ("sharp/stabbing pelvic pain / chronic pelvic pain / stabbing pain in my pelvic area"), vaginal haemorrhage ("constant spotting"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), night sweats ("night sweats"), coital bleeding ("bleeding/spotting after sex"), dysmenorrhoea ("painful periods"), swelling ("swelling"), cervix inflammation ("inflammation of the cervix / inflammed cervix"), vulvovaginal inflammation ("inflammation of the vagina"), vulvovaginal pruritus ("itching of vaginal entrance"), vulvovaginal burning sensation ("burning of vaginal entrance"), vulvovaginal pain ("stinging/stabbing vaginal entrance"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), muscle spasms ("abdominal spasms/muscle spasms"), muscle twitching ("abdominal twitching/fluttering"), chest pain ("chest pain"), pain in extremity ("leg pain"), neck pain ("neck pain"), spinal pain (seriousness criterion medically significant), gastrointestinal disorder ("gastrointestinal") with nausea, flatulence, diarrhoea and dyspepsia, headache ("headaches"), dizziness ("dizziness"), uterine pain ("pain in uterus"), paraesthesia hand ("tingling sensations / tingling in hands"), endometriosis ("endometriosis"), hypoaesthesia ("numbness / numbness in hands"), paresthesia ("brain shocks"), feeling abnormal ("brain fog/cloudiness/ feeling like i got ran over by a truck"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), tinnitus ("ringing in ears"), scar ("scar tissue"), affective disorder ("mood disorders"), hyperhidrosis ("excessive sweating"), dry eye ("dry eyes"), complication of device removal ("complication during device removal"), gastrointestinal pain ("bowel pain"), chronic gastritis ("autoimmune reaction /gastritis"), abdominal pain upper ("stomach hurts really bad"), adrenomegaly ("my adrenal glands being enlarged"), osteoarthritis ("osteoarthritis all through my body including spine"), noninfective oophoritis ("ovary inflammation"), musculoskeletal pain ("shoulder pain"), pain in jaw ("jaw pain"), ovarian cyst ("ovarian cysts post hysterectomy") and intervertebral disc degeneration ("degenerative disk disease"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain"), hormone level abnormal ("my hormones are out of whack") and antinuclear antibody positive ("autoimmune responses: positive ana").The patient was treated with surgery (partial hysterectomy, removed tubes and coils, uterus and ovary, she had fragments removed laparoscopically and spinal surgery).Essure was removed.At the time of the report, the device breakage, embedded device, cholecystectomy, polymenorrhoea, loss of libido, tooth disorder, fatigue, insomnia, arthralgia, gastrointestinal disorder, uterine pain, endometriosis, scar, complication of device removal, gastrointestinal pain, chronic gastritis, hormone level abnormal, abdominal pain upper, adrenomegaly, antinuclear antibody positive, osteoarthritis, noninfective oophoritis, musculoskeletal pain, pain in jaw, ovarian cyst and intervertebral disc degeneration outcome was unknown and the pain, neuralgia, migraine, back pain, abdominal pain, menorrhagia, vaginal discharge, dyspareunia, weight increased, dysgeusia, dry skin, alopecia, abdominal distension, pelvic pain, vaginal haemorrhage, hot flush, ovulation pain, night sweats, dysmenorrhoea, swelling, cervix inflammation, vulvovaginal inflammation, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, muscle twitching, chest pain, pain in extremity, neck pain, spinal pain, headache, dizziness, paraesthesia hand, hypoaesthesia, paresthesia, feeling abnormal, memory impairment, anxiety, panic attack, mood swings, tinnitus, affective disorder, hyperhidrosis and dry eye had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, adrenomegaly, affective disorder, alopecia, antinuclear antibody positive, anxiety, arthralgia, back pain, breast pain, breast tenderness, cervix inflammation, chest pain, cholecystectomy, chronic gastritis, coital bleeding, complication of device removal, device breakage, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, feeling abnormal, gastrointestinal disorder, gastrointestinal pain, headache, hormone level abnormal, hot flush, hyperhidrosis, hypoaesthesia, insomnia, intervertebral disc degeneration, loss of libido, memory impairment, menorrhagia, migraine, mood swings, muscle spasms, muscle twitching, musculoskeletal pain, neck pain, neuralgia, night sweats, noninfective oophoritis, osteoarthritis, ovarian cyst, ovulation pain, pain, pain in extremity, pain in jaw, panic attack, paraesthesia hand, pelvic pain, polymenorrhoea, scar, spinal pain, swelling, tinnitus, tooth disorder, uterine pain, vaginal discharge, vaginal haemorrhage, vulvovaginal burning sensation, vulvovaginal inflammation, vulvovaginal pain, vulvovaginal pruritus, weight increased and paresthesia to be related to essure.The reporter commented: discrepancy noted regarding essure insertion date (b)(6) 2008 and 2007).Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: radiology to confirm fragment have removed.Concerning the injuries reported in this case, the following ones were reported via social media: scar tissue, endometriosis, device breakage, bowel pain, device removal complication, adrenomegaly.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 23-mar-2020: fu 29 & 30 process together.Event "degenerative disc disease" was added.Reporter information was added.On 23-mar-2020: fu 29 & 30 process 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.
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