| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Pyrosis/Heartburn (1883); Inflammation (1932); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Skin Irritation (2076); Swelling (2091); Anxiety (2328); Depression (2361); Abdominal Distention (2601); Multiple Organ Failure (3261); Constipation (3274)
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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 ("persistent lower abdominal pain"), abdominal pain lower ("persistent lower abdominal pain"), back pain ("lower back pain") and gallbladder non-functioning ("gallbladder failed") in a (b)(6) female patient who had essure (batch no.A14898) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii, parity 2, laparotomy (abscesses on ovari) in 2005, cesarean section (complications during labor) in 2009, endometrial ablation (remove inside of uterus to stop bleeding each month due to anemia) in 2017, pid pelvic inflammatory disease, live birth in 2003 and live birth in 2009.Previously administered products included for an unreported indication: birth control pill from 2006 to 2008.Concomitant products included clonazepam (klonopin) in 2016, fluoxetine hydrochloride (prozac) in 1997 and gabapentin (neurontin) in 2016 for depression and anxiety as well as anovlar (loestrin) and sertraline (zoloft).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient experienced gallbladder non-functioning (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain, abdominal pain lower and back pain (seriousness criteria medically significant and intervention required), abdominal adhesions ("adhesions in abdomen which caused uterus to become stuck to the wall of abdomen"), ovarian adhesion ("adhesions on fallopian tubes"), dysmenorrhoea ("long painful periods"), abdominal distension ("abdominal distention-severe/felt like i was constantly swollen in the pelvic area"), menorrhagia ("long heavy periods"), mood swings ("mood swings"), nausea ("nausea"), fatigue ("extreme fatigue"), depression ("depression"), dyspepsia ("heart burn / indigestion, digestive issues"), irritable bowel syndrome ("irritable bowel on a daily basis"), diarrhoea ("diarrhea"), constipation ("constipation"), metrorrhagia ("spotting between periods"), acne ("acne"), eczema ("eczema"), seborrhoea ("oily hair and skin"), treatment noncompliance ("she did not use birth control or contraception at any time following essure placement") and allergy to metals ("allergic to nickel or any other component of essure anytime i wear it my skin turns green, gets red, itchy and/ hypersensitivity reaction") with erythema, pruritus, dermatitis and skin discolouration.The patient was treated with surgery (hysterectomy / bilateral salpingectomy with essure removal in 2014).At the time of the report, the pelvic pain, back pain, gallbladder non-functioning , abdominal adhesions, diarrhoea, constipation, metrorrhagia, eczema, seborrhoea, treatment noncompliance and allergy to metals outcome was unknown, the abdominal pain lower had not resolved and the dysmenorrhoea, abdominal distension, menorrhagia, mood swings, nausea, fatigue, depression, dyspepsia, irritable bowel syndrome and acne had resolved.The reporter considered abdominal adhesions, abdominal distension, abdominal pain lower, acne, allergy to metals, back pain, constipation, depression, diarrhoea, dysmenorrhoea, dyspepsia, eczema, fatigue, gallbladder non-functioning, irritable bowel syndrome, menorrhagia, metrorrhagia, mood swings, nausea, ovarian adhesion, pelvic pain and seborrhoea to be related to essure.The reporter provided no causality assessment for treatment noncompliance with essure.The reporter commented: current weight: (b)(6).Approximate weight at the time of essure placement: (b)(6).She received treatment for injuries 2013; 2014 with removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: essure confirmation test: yes.Findings: normal uterine cavity.Pretreatment of endometrial lining with low-dose oral contraceptive two months prior to the procedure.Both ostia were visualized.There was adequate number of coil seen within the uterine cavity from the tubal ostia at the end of the procedure.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 ("persistent lower abdominal pain"), abdominal pain lower ("persistent lower abdominal pain"), back pain ("lower back pain") and gallbladder hypofunction ("gallbladder failed") in a 31-year-old female patient who had essure (batch no.A14898) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii, parity 2, laparotomy (abscesses on ovary) in 2005, cesarean section (complications during labor) in 2009, endometrial ablation (remove inside of uterus to stop bleeding each month due to anemia) in 2017, pid pelvic inflammatory disease, live birth in 2003 and live birth in 2009.Previously administered products included for an unreported indication: birth control pill from 2006 to 2008.Concomitant products included clonazepam (klonopin) since 2016, fluoxetine hydrochloride (prozac) since 1997 and gabapentin (neurontin) since 2016 for depression and anxiety as well as anovlar (loestrin) and sertraline (zoloft).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient experienced gallbladder hypofunction (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain, abdominal pain lower and back pain (seriousness criteria medically significant and intervention required), abdominal adhesions ("adhesions in abdomen which caused uterus to become stuck to the wall of abdomen"), ovarian adhesion ("adhesions on fallopian tubes"), dysmenorrhoea ("long painful periods"), abdominal distension ("abdominal distention-severe/felt like i was constantly swollen in the pelvic area"), menorrhagia ("long heavy periods"), mood swings ("mood swings"), nausea ("nausea"), fatigue ("extreme fatigue"), depression ("depression"), dyspepsia ("heart burn / indigestion, digestive issues"), irritable bowel syndrome ("irritable bowel on a daily basis"), diarrhoea ("diarrhea"), constipation ("constipation"), metrorrhagia ("spotting between periods"), acne ("acne"), eczema ("eczema"), seborrhoea ("oily hair and skin"), treatment noncompliance ("she did not use birth control or contraception at any time following essure placement") and allergy to metals ("allergic to nickel or any other component of essure anytime i wear it my skin turns green, gets red, itchy and/ hypersensitivity reaction") with erythema, pruritus, dermatitis and skin discolouration.The patient was treated with surgery (hysterectomy / bilateral salpingectomy).Essure was removed in 2014.At the time of the report, the pelvic pain, back pain, gallbladder hypofunction, abdominal adhesions, diarrhoea, constipation, metrorrhagia, eczema, seborrhoea, treatment noncompliance and allergy to metals outcome was unknown, the abdominal pain lower had not resolved and the dysmenorrhoea, abdominal distension, menorrhagia, mood swings, nausea, fatigue, depression, dyspepsia, irritable bowel syndrome and acne had resolved.The reporter provided no causality assessment for treatment noncompliance with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain lower, acne, allergy to metals, back pain, constipation, depression, diarrhoea, dysmenorrhoea, dyspepsia, eczema, fatigue, gallbladder hypofunction, irritable bowel syndrome, menorrhagia, metrorrhagia, mood swings, nausea, ovarian adhesion, pelvic pain and seborrhoea to be related to essure.The reporter commented: current weight: 150 approximate weight at the time of essure placement: 145 she received treatment for injuries 2013; 2014 with removal diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: essure confirmation test: yes findings: normal uterine cavity.Pretreatment of endometrial lining with low-dose oral contraceptive two months prior to the procedure.Both ostia were visualized.There was adequate number of coil seen within the uterine cavity from the tubal ostia at the end of the procedure most recent follow-up information incorporated above includes: on 15-jun-2018: quality safety evaluation of product technical complaint.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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Spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("persistent lower abdominal pain/suffered from severe and persistent pain as a result of the essure implantation"), abdominal pain lower ("persistent lower abdominal pain"), back pain ("lower back pain"), pelvic adhesions ("fallopian tube adhesion/excessive pelvic adhesion") and gallbladder hypofunction ("gallbladder failed") in a 31-year-old female patient who had essure (batch no.A14898) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: treatment noncompliance "she did not use birth control or contraception at any time following essure placement".The patient's past medical history included gravida ii, parity 2, laparotomy (abscesses on ovari) in 2005, cesarean section (complications during labor) in 2009, endometrial ablation (remove inside of uterus to stop bleeding each month due to anemia) in 2017, pid pelvic inflammatory disease, live birth in 2003 and live birth in 2009.Previously administered products included for an unreported indication: birth control pill from 2006 to 2008.Concomitant products included clonazepam (klonopin) since 2016, fluoxetine hydrochloride (prozac) since 1997 and gabapentin (neurontin) since 2016 for depression and anxiety as well as anovlar (loestrin) and sertraline (zoloft).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient experienced gallbladder hypofunction (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower (seriousness criteria medically significant and intervention required), back pain (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criterion medically significant), abdominal adhesions ("adhesions in abdomen which caused uterus to become stuck to the wall of abdomen"), ovarian adhesion ("adhesions on fallopian tubes"), dysmenorrhoea ("long painful heavy periods"), abdominal distension ("abdominal distention-severe/felt like i was constantly swollen in the pelvic area/swollen in the pelvic area"), menorrhagia ("long heavy periods/ long painful heavy periods"), mood swings ("mood swings"), nausea ("nausea"), fatigue ("extreme fatigue"), depression ("depression"), dyspepsia ("heart burn / indigestion, digestive issues"), irritable bowel syndrome ("irritable bowel on a daily basis"), diarrhoea ("diarrhea"), constipation ("constipation"), metrorrhagia ("spotting between periods"), acne ("acne"), eczema ("eczema"), seborrhoea ("oily hair and skin") and allergy to metals ("allergic to nickel or any other component of essure anytime i wear it my skin turns green, gets red, itchy and/ hypersensitivity reaction") with erythema, pruritus, dermatitis and skin discolouration.The patient was treated with surgery (hysterectomy / bilateral salpingectomy), surgery (hysterectomy / bilateral salpingectomy), surgery (essure removed / hysterectomy) and surgery (had to have it removed).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, back pain, pelvic adhesions, gallbladder hypofunction, abdominal adhesions, diarrhoea, constipation, metrorrhagia, eczema, seborrhoea and allergy to metals outcome was unknown, the abdominal pain lower had not resolved and the dysmenorrhoea, abdominal distension, menorrhagia, mood swings, nausea, fatigue, depression, dyspepsia, irritable bowel syndrome and acne had resolved.The reporter considered abdominal adhesions, abdominal distension, abdominal pain lower, acne, allergy to metals, back pain, constipation, depression, diarrhoea, dysmenorrhoea, dyspepsia, eczema, fatigue, gallbladder hypofunction, irritable bowel syndrome, menorrhagia, metrorrhagia, mood swings, nausea, ovarian adhesion, pelvic adhesions, pelvic pain and seborrhoea to be related to essure.The reporter commented: current weight: 150.Approximate weight at the time of essure placement: 145.She received treatment for injuries 2013; 2014 with removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: essure confirmation test: yes findings: normal uterine cavity.Pretreatment of endometrial lining with low-dose oral contraceptive two months prior to the procedure.Both ostia were visualized.There was adequate number of coil seen within the uterine cavity from the tubal ostia at the end of the procedure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-aug-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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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("persistent lower abdominal pain/suffered from severe and persistent pain as a result of the essure implantation"), pelvic adhesions ("fallopian tube adhesion/excessive pelvic adhesion"), abdominal pain lower ("persistent lower abdominal pain"), back pain ("lower back pain") and gallbladder hypofunction ("gallbladder failed") in a 31-year-old female patient who had essure (batch no.A14898) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: treatment noncompliance "she did not use birth control or contraception at any time following essure placement".The patient's past medical history included gravida ii, parity 2, laparotomy (abscesses on ovari) in 2005, cesarean section (complications during labor) in 2009, endometrial ablation (remove inside of uterus to stop bleeding each month due to anemia) in 2017, pid pelvic inflammatory disease, live birth in 2003 and live birth in 2009.Previously administered products included for an unreported indication: birth control pill from 2006 to 2008.Concomitant products included clonazepam (klonopin) since 2016, fluoxetine hydrochloride (prozac) since 1997 and gabapentin (neurontin) since 2016 for depression and anxiety as well as anovlar (loestrin) and sertraline (zoloft).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient experienced gallbladder hypofunction (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criterion medically significant), abdominal pain lower (seriousness criteria medically significant and intervention required), back pain (seriousness criteria medically significant and intervention required), abdominal adhesions ("adhesions in abdomen which caused uterus to become stuck to the wall of abdomen"), ovarian adhesion ("adhesions on fallopian tubes"), dysmenorrhoea ("long painful heavy periods"), abdominal distension ("abdominal distention-severe/felt like i was constantly swollen in the pelvic area/swollen in the pelvic area"), menorrhagia ("long heavy periods/ long painful heavy periods"), mood swings ("mood swings"), nausea ("nausea"), fatigue ("extreme fatigue"), depression ("depression"), dyspepsia ("heart burn / indigestion, digestive issues"), irritable bowel syndrome ("irritable bowel on a daily basis"), diarrhoea ("diarrhea"), constipation ("constipation"), metrorrhagia ("spotting between periods"), acne ("acne"), eczema ("eczema"), seborrhoea ("oily hair and skin") and allergy to metals ("allergic to nickel or any other component of essure anytime i wear it my skin turns green, gets red, itchy and/ hypersensitivity reaction") with erythema, pruritus, dermatitis and skin discolouration.The patient was treated with surgery (hysterectomy / bilateral salpingectomy), surgery (hysterectomy / bilateral salpingectomy), surgery (essure removed / hysterectomy) and surgery (had to have it removed).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, pelvic adhesions, back pain, gallbladder hypofunction, abdominal adhesions, diarrhoea, constipation, metrorrhagia, eczema, seborrhoea and allergy to metals outcome was unknown, the abdominal pain lower had not resolved and the dysmenorrhoea, abdominal distension, menorrhagia, mood swings, nausea, fatigue, depression, dyspepsia, irritable bowel syndrome and acne had resolved.The reporter considered abdominal adhesions, abdominal distension, abdominal pain lower, acne, allergy to metals, back pain, constipation, depression, diarrhoea, dysmenorrhoea, dyspepsia, eczema, fatigue, gallbladder hypofunction, irritable bowel syndrome, menorrhagia, metrorrhagia, mood swings, nausea, ovarian adhesion, pelvic adhesions, pelvic pain and seborrhoea to be related to essure.The reporter commented: current weight: 150 approximate weight at the time of essure placement: 145 she received treatment for injuries 2013; 2014 with removal diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: essure confirmation test: yes findings: normal uterine cavity.Pretreatment of endometrial lining with low-dose oral contraceptive two months prior to the procedure.Both ostia were visualized.There was adequate number of coil seen within the uterine cavity from the tubal ostia at the end of the procedure.Most recent follow-up information incorporated above includes: on 25-jun-2018: plaintiff fact sheet received: reporters details added.Event added as fallopian tube adhesion/excessive pelvic adhesion.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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