| Model Number ESS305 |
| Device Problems
Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Bruise/Contusion (1754); Dyspnea (1816); Fatigue (1849); Headache (1880); Itching Sensation (1943); Nausea (1970); Perforation (2001); Rash (2033); Swelling (2091); Uterine Perforation (2121); Vomiting (2144); Sleep Dysfunction (2517); Ascites (2596); Weight Changes (2607); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2013 |
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a consumer in united states on 10-jun-2014 which refers to a female consumer of unspecified age who received essure (fallopian tube occlusion insert) and experienced weight gain, rashes, different bumps on skin, and tiresome.Follow-up received on 19-may-2016 and on 24-may-2016: cases (b)(4) were identified as duplicate of this case and all information was transferred to this remaining case.Information was received via health authority (mw5042707, fda-2014-n-0736-2354 and fda-2014-n-0736-1443).A female (b)(6) consumer considered the case serious.Consumer stated that essure was implanted in (b)(6) 2012 for permanent birth control after having her second child (born in (b)(6) 2011).Within a month she started to experience nausea, vomiting approximately four times a week for no reason, several extreme headaches, fatigue, tired, continued sleeping problems (fall sleep within minutes while at home with her kids; she would easily fall asleep within minutes of laying down; however she never got good sleep because she was continuously waking up), gastrointestinal problems, weight gain, and bloated belly.The vomiting went away eventually.Due to sleep problems she was tested for narcolepsy but the test came back negative.She got two prescription, one to go to sleep at night and other to stay awake during the day.She consulted physicians and was on various medications.She also experienced back and abdominal pain.Pelvic pain became a problem and she spontaneously would get stabbing pain and aches at one side.And when it was time for menstrual cycle (which was very unpredictable), it was extremely heavy, uncomfortable doing things (she was afraid she would bleed in public).Also during time, she found it difficult to breath at certain points.Once she felt like she was unable to breath.She stated the worst part of her body affected by pain is her legs, knees and ankles.She also experienced rashes, itching skin/ scalp, easily bruising, stomach issues, severe acne, metal tasting in mouth.She was in such pain she had trouble getting out of bed, and had to have a hysterectomy at age (b)(6) performed to remove her essure devices on (b)(6) 2012 (please note that (b)(6) 2015 and 2016 were also reported as explanted date).She stated that coil had protruded through her tubes.Before she was healthy woman just minor issues.Since removal, she was improving and getting her life back.Quality-safety evaluation of ptc: ptc global number: (b)(4) (from duplicate case (b)(4)).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.No product quality defect was confirmed therefore a relationship to the reported medical event(s) is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced pelvic pain and abdominal pain.She was in such pain she had trouble getting out of bed and had to have a hysterectomy in order to remove her essure devices.It was stated that coil had protruded through her tubes.The event is considered serious and listed in the reference safety information for essure.Fallopian perforation with essure may occur, most often during insertion.In this case, pelvic pain and abdominal pain were considered symptoms of fallopian tube perforation.The exact date and mechanism of fallopian tube perforation were not known.However, considering its nature, a causal relationship with suspect insert cannot be excluded.This case was upgraded to incident upon receipt of follow-up information since surgical intervention was performed.Additionally, non-serious events were reported.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.However, an updated product technical complaint is expected.Further information (uterine/tubal perforation) is expected.
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Manufacturer Narrative
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Follow-up received on 01-aug-2016 - quality-safety evaluation of ptc: ptc global number: (b)(4).No sample available for this investigation.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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced pelvic pain and abdominal pain.She was in such pain she had trouble getting out of bed and had to have a hysterectomy in order to remove her essure devices.It was stated that coil had protruded through her tubes.The event is considered serious and listed in the reference safety information for essure.Fallopian perforation with essure may occur, most often during insertion.In this case, pelvic pain and abdominal pain were considered symptoms of fallopian tube perforation.The exact date and mechanism of fallopian tube perforation were not known.However, considering its nature, a causal relationship with suspect insert cannot be excluded.This case was upgraded to incident upon receipt of follow-up information since surgical intervention was performed.Additionally, non-serious events were reported.According to the product technical analysis, a product quality defect could not be confirmed but is considered plausible.Further information (uterine/tubal perforation) is expected.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Follow up 25-aug-2016: follow up attempts have been completed, without response to date.
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Manufacturer Narrative
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This case was initially received via regulatory authority food and drug administration (reference number: mw5042707) on 10-jun-2014.The most recent information was received on 23-oct-2017.This is a spontaneous case report received from a consumer in united states on 10-jun-2014 which refers to a female consumer of unspecified age who received essure (fallopian tube occlusion insert) and experienced weight gain, rashes, different bumps on skin, and tiresome.Follow-up received on 19-may-2016 and on 24-may-2016: cases (b)(4) were identified as duplicate of this case and all information was transferred to this remaining case.Information was received via health authority (mw5042707, (b)(4)).A female (b)(6) years old consumer considered the case serious.Consumer stated that essure was implanted in (b)(6) 2012 for permanent birth control after having her second child (born in (b)(6)).Within a month she started to experience nausea, vomiting approximately four times a week for no reason, several extreme headaches, fatigue, tired, continued sleeping problems (fall sleep within minutes while at home with her kids; she would easily fall asleep within minutes of laying down; however she never got good sleep because she was continuously waking up), gastrointestinal problems, weight gain, and bloated belly.The vomiting went away eventually.Due to sleep problems she was tested for narcolepsy but the test came back negative.She got two prescription, one to go to sleep at night and other to stay awake during the day.She consulted physicians and was on various medications.She also experienced back and abdominal pain.Pelvic pain became a problem and she spontaneously would get stabbing pain and aches at one side.And when it was time for menstrual cycle (which was very unpredictable), it was extremely heavy, uncomfortable doing things (she was afraid she would bleed in public).Also during time, she found it difficult to breath at certain points.Once she felt like she was unable to breath.She stated the worst part of her body affected by pain is her legs, knees and ankles.She also experienced rashes, itching skin/ scalp, easily bruising, stomach issues, severe acne, metal tasting in mouth.She was in such pain she had trouble getting out of bed, and had to have a hysterectomy at age (b)(6) performed to remove her essure devices on (b)(6) 2012 (please note that (b)(6) 2015 and 2016 were also reported as explanted date).She stated that coil had protruded through her tubes.Before she was healthy woman just minor issues.Since removal, she was improving and getting her life back.Quality-safety evaluation of ptc: ptc global number: (b)(4) (from duplicate case (b)(4)) 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.No product quality defect was confirmed therefore a relationship to the reported medical event(s) is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Follow-up received on 01-aug-2016 - quality-safety evaluation of ptc: ptc global number: (b)(4).No sample available for this investigation.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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no med dra llt can be provided.Follow up 25-aug-2016: follow up attempts have been completed, without response to date.Follow-up information was received on 23-oct-2017.Summons received- case become potentially legal, reporter information was added.Product start date was updated.Lab test was added.Events device breakage, menstrual pain, severe abdominal cramping, migraines, hair loss, vaginal discharge and infection, weight fluctuations, dyspareunia, anxious, depressed and complication of device removal were added.Reporter causality comment report-she was required to undergo a laparoscopic bilateral removal of the essure devices on or about (b)(6) 2014.(b)(6) 2014, she underwent a radiograph procedure where a portion of the essure device was seen in her right pelvis.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: mw5042707) on 10-jun-2014.The most recent information was received on 05-apr-2018.This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("coil had protruded through her tubes /perforation (fallopian tube(s)"), device breakage ("portion of the essure device was seen in her right pelvis /device breakage"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune thyroiditis ("hashimoto's") in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not performed essure confirmation test".The patient's past medical history included parity 2, delivery in (b)(6) 2011, depression and anxiety.Previously administered products included for an unreported indication: oral contraceptive nos.Concurrent conditions included overweight.In 2012, the patient experienced the first episode of weight increased ("weight gain").On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced fatigue ("tiresome/ fatigue"), nausea ("nausea") and sleep disorder ("sleep problems /sleep issues").In (b)(6) 2012, the patient experienced dysmenorrhoea ("menstrual pain").In 2013, the patient experienced rash ("rashes"), headache ("headache"), migraine ("migraines"), dyspareunia ("dyspareunia"), depression ("depressed /depression"), mood swings ("mood swings"), genital haemorrhage (seriousness criterion medically significant), the first episode of vaginal infection ("vaginal infection "), constipation ("constipation") and the first episode of dysgeusia ("metallic taste in mouth").In 2014, the patient experienced alopecia ("hair loss") and fibromyalgia ("fibromyalgia").On (b)(6) 2015, 2 years 8 months after insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and device breakage (seriousness criterion medically significant).In 2017, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal pain ("abdominal pain/ severe abdominal pain"), skin mass ("different bumps on skin"), vomiting ("vomiting"), gastrointestinal disorder ("gastrointestinal problems"), abdominal distension ("bloated"), back pain ("back pain /lower back"), menorrhagia ("heavy menstrual cycle/heavy menstrual bleeding/abnormal menses"), dyspnoea ("difficult to breath"), pain in extremity ("leg pain"), arthralgia ("knee and ankle pain"), pruritus ("itching skin/scalp / itching"), increased tendency to bruise ("easily bruising"), gastric disorder ("stomach issues"), the second episode of dysgeusia ("metal tasting in mouth"), menstruation irregular ("menstrual cycle (which was very unpredictable)"), acne ("severe acne"), abdominal pain lower ("severe abdominal cramping"), vaginal discharge ("vaginal discharge"), the second episode of vaginal infection ("vaginal infection"), weight fluctuation ("weight fluctuations"), anxiety ("anxious"), complication of device removal ("portion of the essure device was seen in her right pelvis"), marital problem ("marital problems") and the second episode of weight increased ("weight gain").The patient was treated with surgery ((surgical removal of coil(s), hysterectomy with bilateral salpingectomy).Essure was removed.At the time of the report, the fallopian tube perforation, rash, skin mass, fatigue, nausea, vomiting, headache, sleep disorder, gastrointestinal disorder, abdominal distension, back pain, menorrhagia, dyspnoea, pain in extremity, arthralgia, pruritus, increased tendency to bruise, gastric disorder, the last episode of dysgeusia, acne and migraine was resolving, the device breakage, dysmenorrhoea, abdominal pain lower, alopecia, vaginal discharge, the last episode of vaginal infection, weight fluctuation, dyspareunia, depression, anxiety and complication of device removal had not resolved and the menstruation irregular, mood swings, genital haemorrhage, fibromyalgia, marital problem, autoimmune thyroiditis and constipation outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, alopecia, anxiety, arthralgia, autoimmune thyroiditis, back pain, constipation, depression, device breakage, dysmenorrhoea, dyspareunia, dyspnoea, fallopian tube perforation, fatigue, fibromyalgia, gastric disorder, gastrointestinal disorder, genital haemorrhage, headache, increased tendency to bruise, marital problem, menorrhagia, menstruation irregular, migraine, mood swings, nausea, pain in extremity, pruritus, rash, skin mass, sleep disorder, vaginal discharge, vomiting, weight fluctuation, the first episode of dysgeusia, the first episode of vaginal infection, the first episode of weight increased, the second episode of dysgeusia, the second episode of vaginal infection and the second episode of weight increased to be related to essure.The reporter commented: she was required to undergo a laparoscopic bilateral removal of the essure devices on or about (b)(6) 2014.(b)(6) 2014, she underwent a radiograph procedure where a portion of the essure device was seen in her right pelvis.Patients current weight was 188 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.9 kg/sqm.Salpingectomy - on (b)(6) 2015: surgical removal of coils.X-ray - on (b)(6) 2015: confirm the position of the essure devices.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 5-apr-2018: events"mood swings, abnormal bleeding (general), vaginal infection, fibromyalgia, itching, marital problem, device breakage, pain, perforation (fallopian tube(s), constipation, metallic taste in mouth, weight gain, she did not performed essure confirmation test¿reporter added from pfs 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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E was initially received via regulatory authority (food and drug administration, reference number: mw (b)(4)) on 10-jun-2014.The most recent information was received on 10-jul-2018.This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("coil had protruded through her tubes /perforation (fallopian tube(s)"), device breakage ("portion of the essure device was seen in her right pelvis /device breakage"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune thyroiditis ("hashimoto's") in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not performed essure confirmation test".The patient's past medical history included parity 2, delivery in (b)(6) 2011, depression, anxiety, vein disorder, neck pain and mood swings.Previously administered products included for an unreported indication: oral contraceptive nos.Concurrent conditions included overweight.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced the first episode of weight increased ("weight gain").In (b)(6) 2012, the patient experienced fatigue ("tiresome/ fatigue"), nausea ("nausea") and sleep disorder ("sleep problems /sleep issues").In (b)(6) 2012, the patient experienced dysmenorrhoea ("menstrual pain").In 2013, the patient experienced rash ("rashes"), headache ("headache"), migraine ("migraines"), dyspareunia ("dyspareunia"), depression ("depressed /depression"), anxiety ("anxious"), mood swings ("mood swings"), genital haemorrhage (seriousness criterion medically significant), the first episode of vaginal infection ("vaginal infection "), constipation ("constipation") and the first episode of dysgeusia ("metallic taste in mouth").In 2014, the patient experienced alopecia ("hair loss") and fibromyalgia ("fibromyalgia").On (b)(6) 2015, 2 years 8 months after insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and device breakage (seriousness criteria medically significant and intervention required).In 2017, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal pain ("abdominal pain/ severe abdominal pain"), skin mass ("different bumps on skin"), vomiting ("vomiting"), gastrointestinal disorder ("gastrointestinal problems"), abdominal distension ("bloated"), back pain ("back pain /lower back"), menorrhagia ("heavy menstrual cycle/heavy menstrual bleeding/abnormal menses"), dyspnoea ("difficult to breath"), pain in extremity ("leg pain"), arthralgia ("knee and ankle pain"), pruritus ("itching skin/scalp / itching"), increased tendency to bruise ("easily bruising"), gastric disorder ("stomach issues"), the second episode of dysgeusia ("metal tasting in mouth"), menstruation irregular ("menstrual cycle (which was very unpredictable)"), acne ("severe acne"), abdominal pain lower ("severe abdominal cramping"), vaginal discharge ("vaginal discharge"), the second episode of vaginal infection ("vaginal infection"), weight fluctuation ("weight fluctuations"), complication of device removal ("portion of the essure device was seen in her right pelvis"), marital problem ("marital problems"), the second episode of weight increased ("weight gain") and back disorder ("back problem").The patient was treated with surgery ((surgical removal of coil(s), hysterectomy with bilateral salpingectomy) and surgery (surgical excision of essure device).Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, rash, skin mass, fatigue, nausea, vomiting, headache, sleep disorder, gastrointestinal disorder, abdominal distension, back pain, menorrhagia, dyspnoea, pain in extremity, arthralgia, pruritus, increased tendency to bruise, gastric disorder, the last episode of dysgeusia, acne, migraine and back disorder was resolving, the device breakage, dysmenorrhoea, abdominal pain lower, alopecia, vaginal discharge, the last episode of vaginal infection, weight fluctuation, dyspareunia, depression, anxiety and complication of device removal had not resolved and the menstruation irregular, mood swings, genital haemorrhage, fibromyalgia, marital problem, autoimmune thyroiditis and constipation outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, alopecia, anxiety, arthralgia, autoimmune thyroiditis, back disorder, back pain, constipation, depression, device breakage, dysmenorrhoea, dyspareunia, dyspnoea, fallopian tube perforation, fatigue, fibromyalgia, gastric disorder, gastrointestinal disorder, genital haemorrhage, headache, increased tendency to bruise, marital problem, menorrhagia, menstruation irregular, migraine, mood swings, nausea, pain in extremity, pruritus, rash, skin mass, sleep disorder, vaginal discharge, vomiting, weight fluctuation, the first episode of dysgeusia, the first episode of vaginal infection, the first episode of weight increased, the second episode of dysgeusia, the second episode of vaginal infection and the second episode of weight increased to be related to essure.The reporter commented: she was required to undergo a laparoscopic bilateral removal of the essure devices on or about (b)(6) 2014.(b)(6) 2014, she underwent a radiograph procedure where a portion of the essure device was seen in her right pelvis.Patients current weight was 188 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.9 kg/sqm.Salpingectomy - on (b)(6) 2015: surgical removal of coils.X-ray - on (b)(6) 2015: confirm the position of the essure devices.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-jul-2018: pfs received - new event "back problem" was added.New reporter was added.On 5-jul-2018: pfs received - historical conditions were added.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This report was initially received via regulatory authority (food and drug administration, reference number: mw5042707) on 10-jun-2014.The most recent information was received on 10-jul-2018.This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("coil had protruded through her tubes /perforation (fallopian tube(s)"), device breakage ("portion of the essure device was seen in her right pelvis /device breakage"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune thyroiditis ("hashimoto's") in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not performed essure confirmation test".The patient's past medical history included parity 2, delivery in (b)(6) 2011, depression, anxiety, vein disorder, neck pain and mood swings.Previously administered products included for an unreported indication: oral contraceptive nos.Concurrent conditions included overweight.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced the first episode of weight increased ("weight gain").In (b)(6) 2012, the patient experienced fatigue ("tiresome/ fatigue"), nausea ("nausea") and sleep disorder ("sleep problems /sleep issues").In (b)(6) 2012, the patient experienced dysmenorrhoea ("menstrual pain").In 2013, the patient experienced rash ("rashes"), headache ("headache"), migraine ("migraines"), dyspareunia ("dyspareunia"), depression ("depressed /depression"), anxiety ("anxious"), mood swings ("mood swings"), genital haemorrhage (seriousness criterion medically significant), the first episode of vaginal infection ("vaginal infection "), constipation ("constipation") and the first episode of dysgeusia ("metallic taste in mouth").In 2014, the patient experienced alopecia ("hair loss") and fibromyalgia ("fibromyalgia").On (b)(6) 2015, 2 years 8 months after insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and device breakage (seriousness criteria medically significant and intervention required).In 2017, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal pain ("abdominal pain/ severe abdominal pain"), skin mass ("different bumps on skin"), vomiting ("vomiting"), gastrointestinal disorder ("gastrointestinal problems"), abdominal distension ("bloated"), back pain ("back pain /lower back"), menorrhagia ("heavy menstrual cycle/heavy menstrual bleeding/abnormal menses"), dyspnoea ("difficult to breath"), pain in extremity ("leg pain"), arthralgia ("knee and ankle pain"), pruritus ("itching skin/scalp / itching"), increased tendency to bruise ("easily bruising"), gastric disorder ("stomach issues"), the second episode of dysgeusia ("metal tasting in mouth"), menstruation irregular ("menstrual cycle (which was very unpredictable)"), acne ("severe acne"), abdominal pain lower ("severe abdominal cramping"), vaginal discharge ("vaginal discharge"), the second episode of vaginal infection ("vaginal infection"), weight fluctuation ("weight fluctuations"), complication of device removal ("portion of the essure device was seen in her right pelvis"), marital problem ("marital problems"), the second episode of weight increased ("weight gain") and back disorder ("back problem").The patient was treated with hysterectomy with bilateral salpingectomy and essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, rash, skin mass, fatigue, nausea, vomiting, headache, sleep disorder, gastrointestinal disorder, abdominal distension, back pain, menorrhagia, dyspnoea, pain in extremity, arthralgia, pruritus, increased tendency to bruise, gastric disorder, the last episode of dysgeusia, acne, migraine and back disorder was resolving, the device breakage, dysmenorrhoea, abdominal pain lower, alopecia, vaginal discharge, the last episode of vaginal infection, weight fluctuation, dyspareunia, depression, anxiety and complication of device removal had not resolved and the menstruation irregular, mood swings, genital haemorrhage, fibromyalgia, marital problem, autoimmune thyroiditis and constipation outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, alopecia, anxiety, arthralgia, autoimmune thyroiditis, back disorder, back pain, constipation, depression, device breakage, dysmenorrhoea, dyspareunia, dyspnoea, fallopian tube perforation, fatigue, fibromyalgia, gastric disorder, gastrointestinal disorder, genital haemorrhage, headache, increased tendency to bruise, marital problem, menorrhagia, menstruation irregular, migraine, mood swings, nausea, pain in extremity, pruritus, rash, skin mass, sleep disorder, vaginal discharge, vomiting, weight fluctuation, the first episode of dysgeusia, the first episode of vaginal infection, the first episode of weight increased, the second episode of dysgeusia, the second episode of vaginal infection and the second episode of weight increased to be related to essure.The reporter commented: she was required to undergo a laparoscopic bilateral removal of the essure devices on or about (b)(6) 2014.(b)(6) 2014, she underwent a radiograph procedure where a portion of the essure device was seen in her right pelvis.Patients current weight was 188 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.9 kg/sqm.Salpingectomy - on (b)(6) 2015: surgical removal of coils.X-ray - on (b)(6) 2015: confirm the position of the essure devices.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-jul-2018: internal correction in the device problem codes.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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Search Alerts/Recalls
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