| Model Number ESS305 |
| Device Problems
Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Fatigue (1849); Headache (1880); Pyrosis/Heartburn (1883); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Rash (2033); Skin Irritation (2076); Urinary Tract Infection (2120); Urticaria (2278); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Sweating (2444); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)
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| Event Date 07/01/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain") in a female patient who received essure for permanent contraceptive tubal implant.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient started essure.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and clinically significant/intervention required), menometrorrhagia ("abnormally heavy and irregular menses"), weight increased ("weight gain"), back pain ("severe low back pain"), headache ("headaches"), migraine ("migraines"), nausea ("nausea"), malaise ("malaise"), abdominal distension ("severe bloating"), adenomyosis ("adenomyosis"), night sweats ("night sweats"), loss of libido ("loss of libido"), bacterial vaginosis ("bacterial vaginosis"), urinary tract infection ("urinary tract infections"), breast pain ("breast pain"), breast tenderness ("breast tenderness"), dyspepsia ("heartburn") with fatigue, arthralgia, hair growth abnormal, muscle spasms and feeling abnormal, vitamin d deficiency ("vitamin d deficiency"), urticaria ("hives"), rash ("skin rash"), skin irritation ("skin irritation"), acne ("acne"), hyperhidrosis ("excessive sweating") and dry skin ("dry skin").The patient was treated with laparoscopic hysterectomy was performed on (b)(6) 2016).In (b)(6) 2016, the patient experienced procedural pain ("following the surgery, painful post-operative recovery").Essure was withdrawn.At the time of the report, the pelvic pain, menometrorrhagia, weight increased, back pain, headache, migraine, nausea, malaise, abdominal distension, adenomyosis, night sweats, loss of libido, bacterial vaginosis, urinary tract infection, breast pain, breast tenderness, dyspepsia, vitamin d deficiency, urticaria, rash, skin irritation, acne, hyperhidrosis, dry skin and procedural pain was resolving.The reporter considered pelvic pain, menometrorrhagia, weight increased, back pain, headache, migraine, nausea, malaise, abdominal distension, adenomyosis, night sweats, loss of libido, bacterial vaginosis, urinary tract infection, breast pain, breast tenderness, dyspepsia, vitamin d deficiency, urticaria, rash, skin irritation, acne, hyperhidrosis, dry skin and procedural pain to be related to essure.The reporter commented: since having the surgery, patient's symptoms are mostly resolved.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2013: hysterosalpingogram result was confirming full occlusion of fallopian tubes.Company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced chronic pelvic pain.This event is anticipated in the reference safety information for essure.Coils were removed 3 years after insertion.Chronic pelvic pain may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.This case was regarded as incident since interventions were required.Other nonserious events were reported.A product technical analysis is being sought.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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Quality-safety evaluation of ptc: sample not available.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.Most recent follow-up information incorporated above includes: on 23-mar-2017: quality-safety evaluation of ptc was received.Company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced chronic pelvic pain.This event is anticipated in the reference safety information for essure.Coils were removed 3 years after insertion.Chronic pelvic pain may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.This case was regarded as incident since interventions were required.Other nonserious events were reported.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain"), pregnancy with contraceptive device ("pregnancy (stillbirth or miscarriage)") and abortion spontaneous ("pregnancy (stillbirth or miscarriage)") in a 42-year-old female patient who had essure (batch no.A63342, a47947) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included bacterial vaginosis.Previously administered products included for an unreported indication: copper iud.Concurrent conditions included overweight, mood disorder nos since 2012, anxiety since 2012 and fatty liver.Concomitant products included intrauterine contraceptive device (iud nos) since 2008 and medroxyprogesterone acetate (depo provera)(b)(6)2013 to july 2013 for birth control as well as sertraline (sertralin) since 2012 to april 2017.On (b)(6)2013, the patient had essure inserted.On (b)(6)2013, the patient experienced acne ("acne").In june 2013, the patient experienced headache ("headaches"), nausea ("nausea"), urinary tract infection ("urinary tract infections") and vaginal discharge ("vaginal discharge").In july 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe low back pain/pain: lower back"), arthralgia ("severe joint pain/pain: joint pain") and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6)2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In august 2013, the patient experienced night sweats ("hormonal changes: sweats/sweating excessively"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia): menstrual periods became extremely heavy") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In september 2013, the patient experienced migraine ("migraines"), breast pain ("breast pain") and breast tenderness ("breast tenderness").In january 2014, the patient was found to have weight increased ("weight gain").In 2014, the patient experienced dyspepsia ("heartburn") with fatigue.In june 2016, the patient experienced procedural pain ("following the surgery, painful post-operative recovery").On an unknown date, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and experienced abortion spontaneous (seriousness criterion medically significant), menometrorrhagia ("abnormally heavy and irregular menses"), hair growth abnormal ("abnormal hair growth"), malaise ("malaise"), abdominal distension ("severe bloating"), muscle spasms ("cramping"), adenomyosis ("adenomyosis"), loss of libido ("loss of libido"), bacterial vaginosis ("bacterial vaginosis"), vitamin d deficiency ("vitamin d deficiency"), urticaria ("hives"), rash ("skin rash/sporadic breakouts"), skin irritation ("skin irritation"), hyperhidrosis ("excessive sweating"), dry skin ("dry skin"), adnexa uteri pain ("pain: lower left quadrant (ovary)") and feeling abnormal ("brain fog").The patient was treated with ibuprofen and surgery (laparoscopic assisted vaginal hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, menometrorrhagia, weight increased, back pain, headache, migraine, nausea, malaise, abdominal distension, adenomyosis, loss of libido, bacterial vaginosis, urinary tract infection, breast pain, breast tenderness, dyspepsia, vitamin d deficiency, urticaria, rash, skin irritation, hyperhidrosis, dry skin and procedural pain was resolving, the pregnancy with contraceptive device, abortion spontaneous, arthralgia, hair growth abnormal, muscle spasms, female sexual dysfunction, vaginal discharge, adnexa uteri pain and feeling abnormal outcome was unknown and the night sweats, acne, menorrhagia, dysmenorrhoea and vaginal haemorrhage had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abortion spontaneous, acne, adenomyosis, adnexa uteri pain, arthralgia, back pain, bacterial vaginosis, breast pain, breast tenderness, dry skin, dysmenorrhoea, dyspepsia, feeling abnormal, female sexual dysfunction, hair growth abnormal, headache, hyperhidrosis, loss of libido, malaise, menometrorrhagia, menorrhagia, migraine, muscle spasms, nausea, night sweats, pelvic pain, pregnancy with contraceptive device, procedural pain, rash, skin irritation, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vitamin d deficiency and weight increased to be related to essure.The reporter commented: since having the surgery, patient¿s symptoms are mostly resolved.Per mr: the essure device appeared to be in correct location without evidence of perforation or undo inflammation.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on (b)(6)2013: results: total bilateral occlusion.Lot number: a47947 manufacture date: 2012/09 expiration date: 2015/09 lot number: a63342 manufacture date: 2012/10 expiration date: 2015/10 ¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record; miscarriage quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on(b)(6)2018: plaintiff fact sheet received - reporter information updated.New event abnormal bleeding (vaginal) was added.Treatment drug added incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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 pelvic pain ("chronic pelvic pain") in a 42-year-old female patient who had essure (batch no.A63342; a47947) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included bacterial vaginosis.Previously administered products included for an unreported indication: copper iud.Concurrent conditions included overweight, mood disorder nos since 2012, anxiety since 2012 and fatty liver.Concomitant products included intrauterine contraceptive device (iud nos) since 2008 and medroxyprogesterone (depo provera)30-may-2013 to july 2013 for birth control as well as sertraline (sertralin) since 2012 to april 2017.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced acne ("acne/soradic breakouts").In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe low back pain/pain: lower back") and dysmenorrhoea ("dysmenorrhea (cramping)").On 16-jul-2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In august 2013, the patient experienced night sweats ("hormonal changes: sweats/sweating excessively") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia): menstrual periods became extremely heavy").In january 2014, the patient experienced weight increased ("weight gain").In 2014, the patient experienced headache ("headaches"), migraine ("migraines"), breast pain ("breast pain"), breast tenderness ("breast tenderness") and the first episode of dyspepsia ("heartburn") with fatigue, arthralgia, hair growth abnormal, muscle spasms and feeling abnormal.In june 2016, the patient experienced procedural pain ("following the surgery, painful post-operative recovery").On an unknown date, the patient experienced menometrorrhagia ("abnormally heavy and irregular menses"), nausea ("nausea"), malaise ("malaise"), abdominal distension ("severe bloating"), adenomyosis ("adenomyosis"), loss of libido ("loss of libido"), bacterial vaginosis ("bacterial vaginosis"), urinary tract infection ("urinary tract infections"), vitamin d deficiency ("vitamin d deficiency"), urticaria ("hives"), rash ("skin rash"), skin irritation ("skin irritation"), hyperhidrosis ("excessive sweating"), dry skin ("dry skin"), vaginal discharge ("vaginal discharge"), adnexa uteri pain ("pain: lower left quadrant (ovary)") and the second episode of dyspepsia ("heartburn").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy and bilateral salpingectomy).Essure was removed on 16-jun-2016.At the time of the report, the pelvic pain, menometrorrhagia, weight increased, back pain, headache, migraine, nausea, malaise, abdominal distension, adenomyosis, loss of libido, bacterial vaginosis, urinary tract infection, breast pain, breast tenderness, vitamin d deficiency, urticaria, rash, skin irritation, hyperhidrosis, dry skin and procedural pain was resolving, the night sweats, acne, menorrhagia and dysmenorrhoea had resolved and the female sexual dysfunction, vaginal discharge, adnexa uteri pain and the last episode of dyspepsia outcome was unknown.The reporter considered abdominal distension, acne, adenomyosis, adnexa uteri pain, back pain, bacterial vaginosis, breast pain, breast tenderness, dry skin, dysmenorrhoea, female sexual dysfunction, headache, hyperhidrosis, loss of libido, malaise, menometrorrhagia, menorrhagia, migraine, nausea, night sweats, pelvic pain, procedural pain, rash, skin irritation, urinary tract infection, urticaria, vaginal discharge, vitamin d deficiency, weight increased, the first episode of dyspepsia and the second episode of dyspepsia to be related to essure.The reporter commented: since having the surgery, patient¿s symptoms are mostly resolved.Per mr: the essure device appeared to be in correct location without evidence of perforation or undo inflammation.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on 8-nov-2013: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 28-feb-2018: per pfs: reporter information was added.Lab data was amended.Her concurrent conditions were added.Concomitant medications were added.Essure indication was added.Essure lot number was added.Following events were added abnormal bleeding (vaginal, menorrhagia): menstrual periods became extremely heavy, apareunia (inability to have sexual intercourse), dysmenorrhea (cramping), vaginal discharge, pain: lower left quadrant (ovary) and heartburn.She had recovered form the following events: abnormal bleeding, dysmenorrhea, hormonal changes and acne.On 1-mar-2018: per mr: her demographic was updated.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain") in a 42-year-old female patient who had essure (batch no.A63342; a47947) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included bacterial vaginosis.Previously administered products included for an unreported indication: copper iud.Concurrent conditions included overweight, mood disorder nos since 2012, anxiety since 2012 and fatty liver.Concomitant products included intrauterine contraceptive device (iud nos) since 2008 and medroxyprogesterone (depo provera) (b)(6) 2013 to (b)(6) 2013 for birth control as well as sertraline (sertralin) since 2012 to (b)(6) 2017.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced acne ("acne/soradic breakouts").In (b)(6) 2013, the patient experienced headache ("headaches").In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe low back pain/pain: lower back") and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2013, the patient experienced night sweats ("hormonal changes: sweats/sweating excessively") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia): menstrual periods became extremely heavy").In (b)(6) 2013, the patient experienced migraine ("migraines"), breast pain ("breast pain") and breast tenderness ("breast tenderness").In (b)(6) 2014, the patient experienced weight increased ("weight gain").In 2014, the patient experienced the first episode of dyspepsia ("heartburn") with fatigue, arthralgia, hair growth abnormal and muscle spasms.In (b)(6) 2016, the patient experienced procedural pain ("following the surgery, painful post-operative recovery").On an unknown date, the patient experienced menometrorrhagia ("abnormally heavy and irregular menses"), nausea ("nausea"), malaise ("malaise"), abdominal distension ("severe bloating"), adenomyosis ("adenomyosis"), loss of libido ("loss of libido"), bacterial vaginosis ("bacterial vaginosis"), urinary tract infection ("urinary tract infections"), vitamin d deficiency ("vitamin d deficiency"), urticaria ("hives"), rash ("skin rash"), skin irritation ("skin irritation"), hyperhidrosis ("excessive sweating"), dry skin ("dry skin"), vaginal discharge ("vaginal discharge"), adnexa uteri pain ("pain: lower left quadrant (ovary)"), the second episode of dyspepsia ("heartburn") and feeling abnormal ("brain fog").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menometrorrhagia, weight increased, back pain, headache, migraine, nausea, malaise, abdominal distension, adenomyosis, loss of libido, bacterial vaginosis, urinary tract infection, breast pain, breast tenderness, vitamin d deficiency, urticaria, rash, skin irritation, hyperhidrosis, dry skin and procedural pain was resolving, the night sweats, acne, menorrhagia and dysmenorrhoea had resolved and the female sexual dysfunction, vaginal discharge, adnexa uteri pain, the last episode of dyspepsia and feeling abnormal outcome was unknown.The reporter considered abdominal distension, acne, adenomyosis, adnexa uteri pain, back pain, bacterial vaginosis, breast pain, breast tenderness, dry skin, dysmenorrhoea, feeling abnormal, female sexual dysfunction, headache, hyperhidrosis, loss of libido, malaise, menometrorrhagia, menorrhagia, migraine, nausea, night sweats, pelvic pain, procedural pain, rash, skin irritation, urinary tract infection, urticaria, vaginal discharge, vitamin d deficiency, weight increased, the first episode of dyspepsia and the second episode of dyspepsia to be related to essure.The reporter commented: since having the surgery, patient¿s symptoms are mostly resolved.Per mr: the essure device appeared to be in correct location without evidence of perforation or undo inflammation.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet was received.Events- brain fog was added.Reporter information was added.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain") in a 42-year-old female patient who had essure (batch no.A63342; a47947) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included bacterial vaginosis.Previously administered products included for an unreported indication: copper iud.Concurrent conditions included overweight, mood disorder nos since 2012, anxiety since 2012 and fatty liver.Concomitant products included intrauterine contraceptive device (iud nos) since 2008 and medroxyprogesterone (depo provera)(b)(6) 2013 to (b)(6) 2013 for birth control as well as sertraline (sertralin) since 2012 to (b)(6) 2017.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced acne ("acne/soradic breakouts").In (b)(6) 2013, the patient experienced headache ("headaches").In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe low back pain/pain: lower back") and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2013, the patient experienced night sweats ("hormonal changes: sweats/sweating excessively") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia): menstrual periods became extremely heavy").In (b)(6) 2013, the patient experienced migraine ("migraines"), breast pain ("breast pain") and breast tenderness ("breast tenderness").In (b)(6) 2014, the patient experienced weight increased ("weight gain").In 2014, the patient experienced the first episode of dyspepsia ("heartburn") with fatigue, arthralgia, hair growth abnormal and muscle spasms.In (b)(6) 2016, the patient experienced procedural pain ("following the surgery, painful post-operative recovery").On an unknown date, the patient experienced menometrorrhagia ("abnormally heavy and irregular menses"), nausea ("nausea"), malaise ("malaise"), abdominal distension ("severe bloating"), adenomyosis ("adenomyosis"), loss of libido ("loss of libido"), bacterial vaginosis ("bacterial vaginosis"), urinary tract infection ("urinary tract infections"), vitamin d deficiency ("vitamin d deficiency"), urticaria ("hives"), rash ("skin rash"), skin irritation ("skin irritation"), hyperhidrosis ("excessive sweating"), dry skin ("dry skin"), vaginal discharge ("vaginal discharge"), adnexa uteri pain ("pain: lower left quadrant (ovary)"), the second episode of dyspepsia ("heartburn") and feeling abnormal ("brain fog").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menometrorrhagia, weight increased, back pain, headache, migraine, nausea, malaise, abdominal distension, adenomyosis, loss of libido, bacterial vaginosis, urinary tract infection, breast pain, breast tenderness, vitamin d deficiency, urticaria, rash, skin irritation, hyperhidrosis, dry skin and procedural pain was resolving, the night sweats, acne, menorrhagia and dysmenorrhoea had resolved and the female sexual dysfunction, vaginal discharge, adnexa uteri pain, the last episode of dyspepsia and feeling abnormal outcome was unknown.The reporter considered abdominal distension, acne, adenomyosis, adnexa uteri pain, back pain, bacterial vaginosis, breast pain, breast tenderness, dry skin, dysmenorrhoea, feeling abnormal, female sexual dysfunction, headache, hyperhidrosis, loss of libido, malaise, menometrorrhagia, menorrhagia, migraine, nausea, night sweats, pelvic pain, procedural pain, rash, skin irritation, urinary tract infection, urticaria, vaginal discharge, vitamin d deficiency, weight increased, the first episode of dyspepsia and the second episode of dyspepsia to be related to essure.The reporter commented: since having the surgery, patient¿s symptoms are mostly resolved.Per mr: the essure device appeared to be in correct location without evidence of perforation or undo inflammation.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on 8-nov-2013: total bilateral occlusion lot number: a47947 manufacture date: 2012/09 expiration date: 2015/09 lot number: a63342 manufacture date: 2012/10.Expiration date: 2015/10 quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-jul-2018: quality safety evaluation of ptc.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Rospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain"), pregnancy with contraceptive device ("pregnancy (stillbirth or miscarriage)") and abortion spontaneous ("pregnancy (stillbirth or miscarriage)") in a 42-year-old female patient who had essure (batch no.A63342; a47947) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included bacterial vaginosis.Previously administered products included for an unreported indication: copper iud.Concurrent conditions included overweight, mood disorder nos since 2012, anxiety since 2012 and fatty liver.Concomitant products included intrauterine contraceptive device (iud nos) since 2008 and medroxyprogesterone (depo provera) (b)(6) 2013 for birth control as well as sertraline (sertralin) since 2012 to (b)(6) 2017.In 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced acne ("acne/soradic breakouts").In (b)(6) 2013, the patient experienced headache ("headaches").In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe low back pain/pain: lower back") and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2013, the patient experienced night sweats ("hormonal changes: sweats/sweating excessively") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia): menstrual periods became extremely heavy").In (b)(6) 2013, the patient experienced migraine ("migraines"), breast pain ("breast pain") and breast tenderness ("breast tenderness").In (b)(6) 2014, the patient experienced weight increased ("weight gain").In 2014, the patient experienced the first episode of dyspepsia ("heartburn") with fatigue, arthralgia, hair growth abnormal and muscle spasms.In (b)(6) 2016, the patient experienced procedural pain ("following the surgery, painful post-operative recovery").On an unknown date, the patient experienced abortion spontaneous (seriousness criterion medically significant), menometrorrhagia ("abnormally heavy and irregular menses"), nausea ("nausea"), malaise ("malaise"), abdominal distension ("severe bloating"), adenomyosis ("adenomyosis"), loss of libido ("loss of libido"), bacterial vaginosis ("bacterial vaginosis"), urinary tract infection ("urinary tract infections"), vitamin d deficiency ("vitamin d deficiency"), urticaria ("hives"), rash ("skin rash"), skin irritation ("skin irritation"), hyperhidrosis ("excessive sweating"), dry skin ("dry skin"), vaginal discharge ("vaginal discharge"), adnexa uteri pain ("pain: lower left quadrant (ovary)"), the second episode of dyspepsia ("heartburn") and feeling abnormal ("brain fog").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menometrorrhagia, weight increased, back pain, headache, migraine, nausea, malaise, abdominal distension, adenomyosis, loss of libido, bacterial vaginosis, urinary tract infection, breast pain, breast tenderness, vitamin d deficiency, urticaria, rash, skin irritation, hyperhidrosis, dry skin and procedural pain was resolving, the pregnancy with contraceptive device, abortion spontaneous, female sexual dysfunction, vaginal discharge, adnexa uteri pain, the last episode of dyspepsia and feeling abnormal outcome was unknown and the night sweats, acne, menorrhagia and dysmenorrhoea had resolved.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abortion spontaneous, acne, adenomyosis, adnexa uteri pain, back pain, bacterial vaginosis, breast pain, breast tenderness, dry skin, dysmenorrhoea, feeling abnormal, female sexual dysfunction, headache, hyperhidrosis, loss of libido, malaise, menometrorrhagia, menorrhagia, migraine, nausea, night sweats, pelvic pain, pregnancy with contraceptive device, procedural pain, rash, skin irritation, urinary tract infection, urticaria, vaginal discharge, vitamin d deficiency, weight increased, the first episode of dyspepsia and the second episode of dyspepsia to be related to essure.The reporter commented: since having the surgery, patient¿s symptoms are mostly resolved.Per mr: the essure device appeared to be in correct location without evidence of perforation or undo inflammation.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion.Lot number: a47947 manufacture date: 2012/09 expiration date: 2015/09.Lot number: a63342 manufacture date: 2012/10 expiration date: 2015/10.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record; miscarriage.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-sep-2018: pfs received event " pregnancy (stillbirth or miscarriage)" was added.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Search Alerts/Recalls
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