| Model Number ESS205 |
| Device Problems
Material Fragmentation (1261); Difficult to Insert (1316); Insufficient Information (3190)
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| Patient Problems
Autoimmune Disorder (1732); Pain (1994); Perforation (2001); Swelling (2091); Uterine Perforation (2121); Arthralgia (2355); Bowel Perforation (2668); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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| Event Date 01/01/2007 |
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Event Type
Injury
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Event Description
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This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting which took place in september 2015 (casefda-2014-n-0736-2340, awareness date 05-nov-2015).It refers to a (b)(6) female patient in united states who had essure (fallopian tube occlusion insert) inserted in 2007.As previous history, she had 3 kids.Consumer reported she had extreme pelvic pain when essure was inserted in 2007.In 2010 she had two surgeries to have it removed with tubes.She felt better.About a year later, she had extreme pelvic pain again.It got so bad that she was admitted to the hospital for 11 days before they figured out what was causing her this pain.She had a fragment left in her and it had punctured through the uterus and snagged her colon.She had a hysterectomy and a piece of the colon was removed because of this.She was only (b)(6) at that time.She now suffers from autoimmune issues and joint pain with swelling.The best way to describe her daily pain is like she has the flu constantly.Quality assessment: in this case, no product sample 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.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect.Company causality comment: this spontaneous non-medically confirmed report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and had extreme pelvic pain.Three years after essure insertion she had surgery to have it removed with her tubes.A year later it was found that a fragment was left in her (interpreted as device breakage) and essure had punctured through her uterus and snagged her colon (interpreted as uterine perforation and traumatic intestinal perforation).She underwent a hysterectomy and a piece of her colon was removed.These events are listed in the reference safety information for essure, except for device breakage, considered listed according to product technical analysis.Extreme pelvic pain was considered serious due to medical significance, the other events due to hospitalization.In this case it is unknown whether the perforation had already occurred when the consumer started having the first episode of pelvic pain.However, given the nature of the event extreme pelvic pain, causality with essure cannot be excluded.The exact date and mechanism of the device breakage were not reported, however given the nature of this event, causality with essure cannot be excluded.Internal organs perforation may occur with essure, due to device migration or during insertion procedure.In this case, uterine and bowel perforation were diagnosed 4 years after essure insertion.The exact date and the mechanism of perforation are not known.A causal relationship between essure and the events cannot be excluded.This case was regarded as incident since hospitalization and surgical interventions were required.Based on the available information, there is no relationship between the reported events and a quality defect.No active follow-up will be pursued, as this case was identified during health authority website monitoring.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This case was initially received via regulatory authority fda (reference number: (b)(4)) on 05-nov-2015.The most recent information was received on 22-nov-2017.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragment left in me"), uterine perforation ("essure had punctured through my uterus and snagged my colon / perforation(uterus/colon)"), gastrointestinal injury ("essure had punctured through my uterus and snagged my colon"), pelvic inflammatory disease ("pelvic inflammatory disease / inflammation"), migration( essure micro-insert migration ) with pelvic pain and genital haemorrhage ("abnormal periods / constant bleeding / heave bleeding") in a (b)(6) year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3 ((b)(6) 1999, (b)(6) 2000, (b)(6) 2007) and gravida ii.Historical drugs received iud nos and depo provera.In (b)(6) 2007, the patient had essure (ess205) inserted.In 2011, the patient experienced device breakage (seriousness criteria hospitalization and intervention required) with abdominal pain and gastrointestinal injury (seriousness criteria hospitalization and intervention required) with abdominal distension and gastrointestinal disorder.On an unknown date, the patient experienced uterine perforation (seriousness criteria hospitalization and intervention required) with abdominal pain lower, pelvic inflammatory disease (seriousness criterion medically significant, intervention required) with vaginal discharge and inflammation, essure micro-insert migration disease (seriousness criterion medically significant, intervention required) with pelvic pain.In 2007, tooth disorder ("tooth issues"), menstrual disorder ( abnormal periods/abnormal menstrual cycle ), dyspareunia ("painful intercourse") with coital bleeding, libido decreased ("low libido"), urinary tract infection ("urinary tract infections") with micturition urgency, menopause ("urinary urgency/frequency, early menopause"), with breast pain, mood swings, weight increased, hyperhidrosis, pyrexia and hot flush, dizziness( dizziness ), anxiety( anxiety ), memory impairment ("forgetfulness/memory issues"), hypertension ("high blood pressure"), allergy to metals ("nickel allergy") with pruritus, skin burning sensation, hypersensitivity, furuncle, erythema, urticarial, rash, dermal cyst, burning sensation, acne and skin irritation, hair growth in new places( hair growth abnormal ), vision issues( vision disorder ), degenerative bone disease( arthropathy degenerative ) with joint swelling, arthralgia and back pain, fibromyalgia( fibromyalgia ) with muscle spasm, hypoesthesia and neuralgia, complication of device removal ("fragment left in me"), device monitoring error ( he wasnt able to remove, essure confirmation test was not done, ), ovarian cyst with ovulation pain, premenstrual dysphoric disorder ( pmdd ), night sweats( night sweats ), nausea, feeling abnormal, tremor, increased tendency to brusing, food allergy, seasonal allergy, palpitation with dyspepsia, alopecia, insomnia, vision blurred with headache, autoimmune disorder ("autoimmune issues").The patient was treated with surgery (removal of fragments and a hysterectomy in (b)(6) 2010) and (removal of fragments and hysterectomy on (b)(6) 2012).At the time of the report, the uterine perforation had resolved and the other events outcome was unknown.The reporter considered the events to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.6 kg/sqm.Reporter commented: essure removal procedure: doctor was not able do remove through the belly button.She saw a specialist and the product was removed with a similar procedure to a c-section in (b)(6) 2010.There was a third procedure around (b)(6) 2012 there was procedure based on extreme pain and was kept in the hospital for 12 days.Md saw that a piece of the essure was still in the body and needed to perform an emergency hysterectomy to remove the piece of essure.The device had punctured through the uterus and snagged the fatty tissue from the colon and was suspended in air.Quality-safety evaluation of ptc: quality assessment: in this case, no product sample 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.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect.Further company follow-up with the regulatory authority, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 22-nov-2017: pfs received: reporter updated, historical condition and drug added.Events added: fragment left in me, essure had punctured through my uterus and snagged my colon/ perforation (uterus/colon), pelvic inflammatory disease, migration, constant bleeding/heavy bleeding/spotting, tooth issues/dental, abnormal periods/ abnormal menstrual cycle, painful intercourse, low libido, urinary tract infections, early menopause, dizziness, anxiety, forgetfulness/memory issues, high blood pressure, nickel allergy, hair growth in new places, vision issues, degenerative bone disease, fibromyalgia, fragment left in me, in through the belly button and remove the device.He wasnt able to remove, essure confirmation test was not done, ovarian cysts, pmdd, night sweats, bleeding after intercourse, nausea, brain fog, tremors, unexplained easy bruising, food sensitivities, seasonal allergies, heart palpitations, hair loss, insomnia/sleep, blurred vision.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), 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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E was initially received via regulatory authority (fda, reference number: fda-(b)(4)) on 05-nov-2015.The most recent information was received on 25-jun-2018.Quality-safety evaluation of ptc: quality assessment: in this case, no product sample 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.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragment left in me"), uterine perforation ("essure had punctured through my uterus and snagged my colon / perforation(uterus/colon)"), gastrointestinal injury ("essure had punctured through my uterus and snagged my colon"), pelvic inflammatory disease ("pelvic inflammatory disease"), device dislocation ("migration"), genital haemorrhage ("constant bleeding / heave bleeding/ spotting"), autoimmune disorder ("autoimmune issues") and surgery ("surgery for blocked salivary gland") in a 26-year-old female patient who had essure (ess205) 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 "essure confirmation test not done".The patient's past medical history included parity 3 ((b)(6) 1999, (b)(6) 2000, (b)(6) 2007) and multigravida.Previously administered products included for an unreported indication: iud from 2004 to 2006 and depo from 2002 to 2004.Past adverse reactions to the above products included adverse event with iud.In (b)(6) 2007, the patient had essure (ess205) inserted.In 2007, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required) with vaginal discharge and inflammation, genital haemorrhage (seriousness criterion medically significant), tooth disorder ("tooth issues/dental"), menstrual disorder ("abnormal periods/abnormal menstrual cycle"), dyspareunia ("painful intercourse") with coital bleeding, libido decreased ("low libido"), urinary tract infection ("urinary tract infections") with micturition urgency, dizziness ("dizziness"), allergy to metals ("nickel allergy") with pruritus, skin burning sensation, dermatitis allergic, urticaria, rash, furuncle, dermal cyst, erythema, burning sensation, acne and skin irritation, visual impairment ("vision issues"), abdominal pain lower ("cramping") and incontinence ("incontinence").In (b)(6) 2007, the patient experienced premature menopause ("early manopause") with breast pain, mood swings, weight increased, hyperhidrosis, pyrexia and hot flush.In 2008, the patient experienced anxiety ("anxiety"), memory impairment ("forgetfulness/memory issues,"), hypertension ("high blood pressure"), osteoarthritis ("degenerative bone disease") with back pain, arthralgia and joint swelling, alopecia ("hair loss / hair growth in new place") and insomnia ("insomnia/ sleep").In 2010, the patient experienced uterine perforation (seriousness criteria hospitalization and intervention required) with abdominal rigidity and device dislocation (seriousness criterion medically significant) with pelvic pain.In 2011, the patient experienced device breakage (seriousness criteria hospitalization and intervention required) with abdominal pain and gastrointestinal injury (seriousness criteria medically significant and intervention required) with gastrointestinal disorder and abdominal distension.In 2012, the patient experienced fibromyalgia ("fibromyalgia") with hypoaesthesia, neuralgia and muscle spasms.On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), hair growth abnormal ("hair growth in new places"), complication of device removal ("fragment left in me,in through the belly button and remove the device.He wasn't able to remove"), ovarian cyst ("ovarian cysts") with ovulation pain, premenstrual dysphoric disorder ("pmdd (premenstrual dysphoric disorder)"), night sweats ("night sweats"), nausea ("nausea"), feeling abnormal ("brain fog"), tremor ("tremors"), increased tendency to bruise ("unexplained easy bruising"), food allergy ("food sensitivities"), seasonal allergy ("seasonal allergies"), palpitations ("heart palpitations") with dyspepsia, vision blurred ("blurred vision") with headache, pollakiuria ("urinary frequency") and surgery (seriousness criterion medically significant).The patient was treated with surgery (removal of fragments and a hysterectomy in (b)(6) 2010), surgery (removal of fragments and hysterectomy on (b)(6) 2012).Essure (ess205) was removed on (b)(6) 2012.At the time of the report, the device breakage, gastrointestinal injury, pelvic inflammatory disease, device dislocation, genital haemorrhage, autoimmune disorder, tooth disorder, menstrual disorder, dyspareunia, libido decreased, urinary tract infection, premature menopause, dizziness, anxiety, memory impairment, hypertension, allergy to metals, hair growth abnormal, visual impairment, osteoarthritis, fibromyalgia, complication of device removal, ovarian cyst, premenstrual dysphoric disorder, night sweats, nausea, feeling abnormal, tremor, increased tendency to bruise, seasonal allergy, palpitations, alopecia, insomnia, vision blurred, abdominal pain lower, incontinence, pollakiuria and surgery outcome was unknown and the uterine perforation had resolved.The reporter considered abdominal pain lower, allergy to metals, alopecia, anxiety, autoimmune disorder, complication of device removal, device breakage, device dislocation, dizziness, dyspareunia, feeling abnormal, fibromyalgia, food allergy, gastrointestinal injury, genital haemorrhage, hair growth abnormal, hypertension, incontinence, increased tendency to bruise, insomnia, libido decreased, memory impairment, menstrual disorder, nausea, night sweats, osteoarthritis, ovarian cyst, palpitations, pelvic inflammatory disease, pollakiuria, premature menopause, premenstrual dysphoric disorder, seasonal allergy, surgery, tooth disorder, tremor, urinary tract infection, uterine perforation, vision blurred and visual impairment to be related to essure (ess205).The reporter commented: essure removal procedure: doctor was not able do remove through the belly button.She saw a specialist and the product was removed with a similar procedure to a c-section in (b)(6) 2010.There was a third procedure around (b)(6) 2012 there was procedure based on extreme pain and was kept in the hospital for 12 days.Md saw that a piece of the essure was still in the body and needed to perform an emergency hysterectomy to remove the piece of essure.The device had punctured through the uterus and snagged the fatty tissue from the colon and was suspended in air.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.6 kg/sqm.Quality-safety evaluation of ptc: quality assessment: in this case, no product sample 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.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect.Further company follow-up with the regulatory authority, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 25-jun-2018: pfs received - new event "cramping, incontinence, urinary frequency and surgery for blocked salivary gland" 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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E was initially received via regulatory authority (fda, reference number: fda-2014-n-0736-2340) on 05-nov-2015.The most recent information was received on 30-oct-2018.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragment left in me"), uterine perforation ("essure had punctured through my uterus and snagged my colon / perforation(uterus/colon)"), gastrointestinal injury ("essure had punctured through my uterus and snagged my colon"), pelvic inflammatory disease ("pelvic inflammatory disease"), device dislocation ("migration"), embedded device ("found that one of the essure coils was imbedded in her muscle(as per mr)"), genital haemorrhage ("constant bleeding / heave bleeding/ spotting"), autoimmune disorder ("autoimmune issues") and salivary gland operation ("surgery for blocked salivary gland") in a 26-year-old female patient who had essure (ess205) 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 "essure confirmation test not done".The patient's past medical history included parity 3 (b)(6)1999, (b)(6)2000, (b)(6)2007) and multigravida.Previously administered products included for an unreported indication: iud from 2004 to 2006 and depo from 2002 to 2004.Past adverse reactions to the above products included adverse event with iud.Concurrent conditions included menorrhagia, uterine fibroids, dysfunctional uterine bleeding, mastodynia, biliary colic and rectal pain.In (b)(6)2007, the patient had essure (ess205) inserted.In 2007, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required) with vaginal discharge and inflammation, genital haemorrhage (seriousness criterion medically significant), tooth disorder ("tooth issues/dental"), menstrual disorder ("abnormal periods/abnormal menstrual cycle"), dyspareunia ("painful intercourse") with coital bleeding, libido decreased ("low libido"), urinary tract infection ("urinary tract infections") with micturition urgency, dizziness ("dizziness"), allergy to metals ("nickel allergy") with pruritus, skin burning sensation, dermatitis allergic, urticaria, rash, furuncle, dermal cyst, erythema, burning sensation, acne and skin irritation, visual impairment ("vision issues"), abdominal pain lower ("cramping") and incontinence ("incontinence").In (b)(6)2007, the patient experienced premature menopause ("early manopause") with breast pain, mood swings, weight increased, hyperhidrosis, pyrexia and hot flush.In 2008, the patient experienced anxiety ("anxiety"), memory impairment ("forgetfulness/memory issues,"), hypertension ("high blood pressure"), osteoarthritis ("degenerative bone disease") with back pain, arthralgia and joint swelling, alopecia ("hair loss / hair growth in new place") and insomnia ("insomnia/ sleep").In 2010, the patient experienced uterine perforation (seriousness criteria hospitalization and intervention required) with abdominal rigidity and device dislocation (seriousness criterion medically significant) with pelvic pain.In 2011, the patient experienced device breakage (seriousness criteria hospitalization and intervention required) with abdominal pain and gastrointestinal injury (seriousness criteria medically significant and intervention required) with gastrointestinal disorder and abdominal distension.In 2012, the patient experienced fibromyalgia ("fibromyalgia") with hypoaesthesia, neuralgia and muscle spasms.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), hair growth abnormal ("hair growth in new places"), complication of device removal ("fragment left in me,in through the belly button and remove the device.He wasn't able to remove"), ovarian cyst ("ovarian cysts") with ovulation pain, premenstrual dysphoric disorder ("pmdd (premenstrual dysphoric disorder)"), night sweats ("night sweats"), nausea ("nausea"), feeling abnormal ("brain fog"), tremor ("tremors"), increased tendency to bruise ("unexplained easy bruising"), food allergy ("food sensitivities"), seasonal allergy ("seasonal allergies"), palpitations ("heart palpitations") with dyspepsia, vision blurred ("blurred vision") with headache, pollakiuria ("urinary frequency") and salivary gland operation (seriousness criterion medically significant).The patient was treated with surgery (removal of fragments and a hysterectomy in august-september 2010), surgery (removal of fragments and hysterectomy on (b)(6) 2012), surgery (removal of fragments and hysterectomy on (b)(6) 2012) and surgery (diagnostic laparoscopy and laparoscopic supracervical hysterectomy).Essure (ess205) was removed on (b)(6)2012.At the time of the report, the device breakage, gastrointestinal injury, pelvic inflammatory disease, device dislocation, embedded device, genital haemorrhage, autoimmune disorder, tooth disorder, menstrual disorder, dyspareunia, libido decreased, urinary tract infection, premature menopause, dizziness, anxiety, memory impairment, hypertension, allergy to metals, hair growth abnormal, visual impairment, osteoarthritis, fibromyalgia, complication of device removal, ovarian cyst, premenstrual dysphoric disorder, night sweats, nausea, feeling abnormal, tremor, increased tendency to bruise, seasonal allergy, palpitations, alopecia, insomnia, vision blurred, abdominal pain lower, incontinence, pollakiuria and salivary gland operation outcome was unknown and the uterine perforation had resolved.The reporter considered abdominal pain lower, allergy to metals, alopecia, anxiety, autoimmune disorder, complication of device removal, device breakage, device dislocation, dizziness, dyspareunia, embedded device, feeling abnormal, fibromyalgia, food allergy, gastrointestinal injury, genital haemorrhage, hair growth abnormal, hypertension, incontinence, increased tendency to bruise, insomnia, libido decreased, memory impairment, menstrual disorder, nausea, night sweats, osteoarthritis, ovarian cyst, palpitations, pelvic inflammatory disease, pollakiuria, premature menopause, premenstrual dysphoric disorder, salivary gland operation, seasonal allergy, tooth disorder, tremor, urinary tract infection, uterine perforation, vision blurred and visual impairment to be related to essure (ess205).The reporter commented: essure removal procedure: doctor was not able do remove through the belly button.She saw a specialist and the product was removed with a similar procedure to a c-section in (b)(6)2010.There was a third procedure around (b)(6)2012 there was procedure based on extreme pain and was kept in the hospital for 12 days.Md saw that a piece of the essure was still in the body and needed to perform an emergency hysterectomy to remove the piece of essure.The device had punctured through the uterus and snagged the fatty tissue from the colon and was suspended in air.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.6 kg/sqm.Computerised tomogram - on (b)(6)2012: rectal mass.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, dysmenorrhea, dyspareunia,back pain,abdominal pain quality-safety evaluation of ptc: quality assessment: in this case, no product sample 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.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 30-oct-2018: mr received.Reporters information updated.Event: device embedded 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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Search Alerts/Recalls
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