| Model Number ESS305 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Diarrhea (1811); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Keratitis (1944); Menstrual Irregularities (1959); Pain (1994); Pelvic Inflammatory Disease (2000); Rash (2033); Swelling (2091); Uterine Perforation (2121); Visual Impairment (2138); Discomfort (2330); Arthralgia (2355); Numbness (2415); Abdominal Distention (2601); Heavier Menses (2666)
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| Event Date 09/01/2011 |
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (fda, reference number: fda-2014-n-0736 -2287) on (b)(6) 2015.The most recent information was received on (b)(6) 2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pain"), genital haemorrhage ("bleeding / bleeding is so heavy, spotting dark brown , passed a clot bigger than my fist"), autoimmune hepatitis ("autoimmune hepatitis"), ulcerative keratitis ("corneal ulcers") and sjogren's syndrome ("autoimmune disorder called sjogren's syndrome") in a (b)(6) female patient who had essure (batch no.740669, 12407573) 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) 1995, (b)(6) 2007 and (b)(6) 2011), vaginal delivery, c-section (compound presentation) in 2007, multigravida, thrombocytopenia on (b)(6) 2011 and platelet transfusion.Previously administered products included for contraception: mirena from 2007 to 2010, loestrin from 2006 to 2007 and loestrin from 1996 to 2005; for an unreported indication: benicar hct from 1998 to (b)(6) 2018, centrum multivitamin from 2007 to (b)(6) 2018, flaxseed oil from 2007 to (b)(6) 2018 and calcium with vitamin d-3 from 2007 to (b)(6) 2018.Concurrent conditions included postpartum state, obesity, hypertension since 1998, type ii diabetes mellitus since 2016, kidney stones since 2016 and glaucoma since 2016 and hip arthroplasty.Concomitant products included anaesthetics (anesthesia), hydrochlorothiazide from 2016 to 2017, ibuprofen (motrin), latanoprost from 2016 to 2017, metformin since 2015, potassium citrate from 2016 to 2017 and rabeprazole sodium (aciphex) from 2016 to 2017.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, 2 months 12 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal distension ("bloating, other injuries or complications (severe abdominal bloating), bulge in upper abdomen"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), bladder disorder ("bladder or urinary problems or changes") with bladder pain, dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse) (severe)"), fatigue ("fatigue") and liver function test increased ("elevated eft's").On (b)(6) 2013, the patient experienced sjogren's syndrome (seriousness criterion medically significant) with arthralgia, hypoaesthesia, paraesthesia, rash, inflammation, eye disorder, visual impairment, dry eye, vision blurred, platelet count decreased, c-reactive protein increased, fibrin d dimer increased and liver function test abnormal.On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), autoimmune hepatitis (seriousness criterion medically significant) with abdominal pain, diarrhoea, gastric ulcer, abdominal pain lower and vomiting, ulcerative keratitis (seriousness criterion medically significant), gastrointestinal disorder ("gastrointestinal problems") with gastrointestinal pain, joint injury ("joint damage"), migraine ("migraines (severe intermittent)"), stomatitis ("mouth sores"), nasal discomfort ("nasal sore"), alopecia ("hair loss"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), headache ("headaches (severe intermittent)"), pain in extremity ("neurological conditions or problems (type- numbness, tingling and pain in the feet), numbness in limbs, foot pain (severe intermittent)"), uterine pain ("pain/ uterine pain (severe)"), abdominal discomfort ("pressure"), postoperative wound infection ("incision above her belly button is infected"), decreased appetite ("haven¿t had much an appetite today"), lung disorder ("fluid in her lungs"), back pain ("back pain"), blood urine present ("blood in my urine"), sinusitis ("sinus infection"), endometriosis ("essure causing all the problems with endometriosis and adenomyosis"), adenomyosis ("essure causing all the problems with endometriosis and adenomyosis"), malaise ("sick"), vulvovaginal swelling ("swollen, vaginal canal was swollen"), weight increased ("gained 45lbs in less than 6 months"), breast pain ("sore breasts"), amnesia ("short-term memory loss"), uterine leiomyoma ("two huge fibroids that were bigger than my uterus"), gait disturbance ("barely walk"), hernia repair ("hernia repair") and complication of device removal ("complication of device removal ").The patient was treated with surgery (hysterectomy (full) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, autoimmune hepatitis, ulcerative keratitis, sjogren's syndrome, gastrointestinal disorder, joint injury, stomatitis, nasal discomfort, alopecia, bladder disorder, dyspareunia, fatigue, liver function test increased, headache, postoperative wound infection, decreased appetite, lung disorder, back pain, blood urine present, sinusitis, endometriosis, adenomyosis, malaise, vulvovaginal swelling, weight increased, breast pain, amnesia, uterine leiomyoma, gait disturbance, hernia repair and complication of device removal outcome was unknown, the genital haemorrhage, migraine, abdominal distension, vaginal haemorrhage, menorrhagia, female sexual dysfunction, dysmenorrhoea, uterine pain and abdominal discomfort had resolved and the pain in extremity was resolving.The reporter considered abdominal discomfort, abdominal distension, adenomyosis, alopecia, amnesia, autoimmune hepatitis, back pain, bladder disorder, blood urine present, breast pain, complication of device removal, decreased appetite, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, gait disturbance, gastrointestinal disorder, genital haemorrhage, headache, hernia repair, joint injury, liver function test increased, lung disorder, malaise, menorrhagia, migraine, nasal discomfort, pain in extremity, pelvic pain, postoperative wound infection, sinusitis, sjogren's syndrome, stomatitis, ulcerative keratitis, uterine leiomyoma, uterine pain, vaginal haemorrhage, vulvovaginal swelling and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Computerised tomogram - on an unknown date: kidney stones on both sides.Nuclear magnetic resonance imaging - on (b)(6) 2014: adenomyosis.In approx.(b)(6) 2011 patient underwent essure confirmation test, hysterosalpingogram where normal uterine cavity identified, bilateral devices observed in fallopian tube demonstrating appropriate placement and satisfactory tubal occlusion noted.On (b)(6) 2014 endometrial biopsy: fragments of endometrium in proliferative phase (no polyp, hyperplasia or malignancy) source:endometrium, biopsy.Gross description: an aggregate of tan-brown tissue and mucus is 3,0 x 3.0 x 0,2 cm current height: (b)(6).Current weight: (b)(6).Approximate weight at the time of essure placement: (b)(6).Quality-safety evaluation of ptc: final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: 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 or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs &mr received: new reporters, patient dob, product indication updated, lot no, historical drugs, concomitant drugs and conditions added.New events vaginal bleeding, menorrhagia, bladder disorder, dysmenorrhea, dyspareunia, fatigue, diarrhoea, eft, headache, leg pain, uterine pain, pressure, infection, decreased appetite, lung disorder, back pain, blood urine, sinus infection, endometriosis, adenomyosis, malaise, swelling, weight gain, vomiting, uterine fibroid, can' walk, hernia repair, arthralgia and abdomen bulge.Event outcomes vaginal bleeding, menorrhagia, apareunia, cramping, migraine, uterine pain, abdominal discomfort, complication of device removal added.Essure legal manufacture has changed from bayer healthcare, (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 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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The case was initially received via regulatory authority (fda, reference number: fda-2014-n-0736 -2287) on 28-oct-2015.The most recent information was received on 16-jul-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pain"), genital haemorrhage ("bleeding / bleeding is so heavy, spotting dark brown, passed a clot bigger than my fist"), autoimmune hepatitis ("autoimmune hepatitis"), ulcerative keratitis ("corneal ulcers") and sjogren's syndrome ("autoimmune disorder called sjogren's syndrome") in a 35-year-old female patient who had essure (batch no.740669, 12407573) 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) 1995, (b)(6) 2007 and (b)(6) 2011), vaginal delivery, c-section (compound presentation) in 2007, multigravida, thrombocytopenia on (b)(6) 2011 and platelet transfusion.Previously administered products included for contraception: mirena from 2007 to 2010, loestrin from 2006 to 2007 and loestrin from 1996 to 2005; for an unreported indication: benicar hct from 1998 to (b)(6) 2018, centrum multivitamin from 2007 to (b)(6) 2018, flaxseed oil from 2007 to (b)(6) 2018 and calcium with vitamin d-3 from 2007 to (b)(6) 2018.Concurrent conditions included postpartum state, obesity, hypertension since 1998, type ii diabetes mellitus since 2016, kidney stones since 2016, glaucoma since 2016 and hip replacement.Concomitant products included anaesthetics (anesthesia), hydrochlorothiazide from 2016 to 2017, ibuprofen (motrin), latanoprost from 2016 to 2017, metformin since 2015, potassium citrate from 2016 to 2017 and rabeprazole sodium (aciphex) from 2016 to 2017.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, 2 months 12 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal distension ("bloating, other injuries or complications (severe abdominal bloating), bulge in upper abdomen"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), bladder disorder ("bladder or urinary problems or changes") with bladder pain, dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse) (severe)"), fatigue ("fatigue") and liver function test increased ("elevated eft's").On (b)(6) 2013, the patient experienced sjogren's syndrome (seriousness criterion medically significant) with arthralgia, hypoaesthesia, paraesthesia, rash, inflammation, eye disorder, visual impairment, dry eye, vision blurred, platelet count decreased, c-reactive protein increased, fibrin d dimer increased, liver function test abnormal and hepatic enzyme increased.On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), autoimmune hepatitis (seriousness criterion medically significant) with abdominal pain, diarrhoea, gastric ulcer, abdominal pain lower and vomiting, ulcerative keratitis (seriousness criterion medically significant), gastrointestinal disorder ("gastrointestinal problems") with gastrointestinal pain, joint injury ("joint damage"), migraine ("migraines (severe intermittent)"), stomatitis ("mouth sores"), nasal discomfort ("nasal sore"), alopecia ("hair loss"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), headache ("headaches (severe intermittent)"), pain in extremity ("neurological conditions or problems (type- numbness, tingling and pain in the feet), numbness in limbs, foot pain (severe intermittent)"), uterine pain ("pain/ uterine pain (severe)"), abdominal discomfort ("pressure"), postoperative wound infection ("incision above her belly button is infected"), decreased appetite ("haven¿t had much an appetite today"), lung disorder ("fluid in her lungs"), back pain ("back pain"), blood urine present ("blood in my urine"), sinusitis ("sinus infection"), endometriosis ("essure causing all the problems with endometriosis and adenomyosis"), adenomyosis ("essure causing all the problems with endometriosis and adenomyosis"), malaise ("sick"), vulvovaginal swelling ("swollen, vaginal canal was swollen"), weight increased ("gained 45lbs in less than 6 months"), breast pain ("sore breasts"), amnesia ("short-term memory loss"), uterine leiomyoma ("two huge fibroids that were bigger than my uterus"), gait disturbance ("barely walk"), hernia repair ("hernia repair") and complication of device removal ("complication of device removal ").The patient was treated with surgery (hysterectomy (full) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, autoimmune hepatitis, ulcerative keratitis, sjogren's syndrome, gastrointestinal disorder, joint injury, stomatitis, nasal discomfort, alopecia, bladder disorder, dyspareunia, fatigue, liver function test increased, headache, postoperative wound infection, decreased appetite, lung disorder, back pain, blood urine present, sinusitis, endometriosis, adenomyosis, malaise, vulvovaginal swelling, weight increased, breast pain, amnesia, uterine leiomyoma, gait disturbance, hernia repair and complication of device removal outcome was unknown, the genital haemorrhage, migraine, abdominal distension, vaginal haemorrhage, menorrhagia, female sexual dysfunction, dysmenorrhoea, uterine pain and abdominal discomfort had resolved and the pain in extremity was resolving.The reporter considered abdominal discomfort, abdominal distension, adenomyosis, alopecia, amnesia, autoimmune hepatitis, back pain, bladder disorder, blood urine present, breast pain, complication of device removal, decreased appetite, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, gait disturbance, gastrointestinal disorder, genital haemorrhage, headache, hernia repair, joint injury, liver function test increased, lung disorder, malaise, menorrhagia, migraine, nasal discomfort, pain in extremity, pelvic pain, postoperative wound infection, sinusitis, sjogren's syndrome, stomatitis, ulcerative keratitis, uterine leiomyoma, uterine pain, vaginal haemorrhage, vulvovaginal swelling and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Computerised tomogram - on an unknown date: kidney stones on both sides.Nuclear magnetic resonance imaging - on (b)(6) 2014: adenomyosis.In approx.(b)(6) 2011/ (b)(6) 2011 patient underwent essure confirmation test, hysterosalpingogram where normal uterine cavity identified, bilateral devices observed in fallopian tube demonstrating appropriate placement and satisfactory tubal occlusion noted.On (b)(6) 2014 endometrial biopsy: fragments of endometrium in proliferative phase (no polyp, hyperplasia or malignancy) source: endometrium, biopsy.Gross description: an aggregate of tan-brown tissue and mucus is 3,0 x 3.0 x 0,2 cm.Current height: 5¿10¿.Current weight: 185lbs.Approximate weight at the time of essure placement: 210lbs.Batch number: 12407573, manufacturing date: 2009/07, expiration date: 2012/06.Batch number: 740669, manufacturing date: 2010/06, expiration date: 2013/06.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 16-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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This case was initially received via regulatory authority (fda, reference number: fda-2014-n-0736 -2287) on 28-oct-2015.The most recent information was received on 18-jan-2019.Quality-safety evaluation of ptc: unable to confirm complaint.This spontaneous case was reported by a lawyer and describes the occurrence of salpingitis ("chronic salpingitis"), pelvic pain ("severe and persistent pain"), embedded device ("embedded within the proximal end of the fallopian tubes"), genital haemorrhage ("bleeding / bleeding is so heavy, spotting dark brown , passed a clot bigger than my fist"), autoimmune hepatitis ("autoimmune hepatitis"), ulcerative keratitis ("corneal ulcers") and sjogren's syndrome ("autoimmune disorder called sjogren's syndrome") in a 35-year-old female patient who had essure (batch no.740669, 12407573) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 3 (b)(6)1995, (b)(6)2007 and (b)(6)2011), vaginal delivery, c-section (compound presentation) in 2007, multigravida, thrombocytopenia on (b)(6)2011, platelet transfusion, breast discharge and fibroids.Current height: 5¿10¿.Current weight: 185lbs.Approximate weight at the time of essure placement: 210lbs.Approx sep(as written) and healthcare provider told that essure was working properly and i no longer needed to use backup birth control.Previously administered products included for contraception: mirena from 2007 to 2010, loestrin from 2006 to 2007 and loestrin from 1996 to 2005; for an unreported indication: benicar hct from 1998 to (b)(6)2019, centrum multivitamin from 2007 to (b)(6)2019, flaxseed oil from 2007 to (b)(6)2019 and calcium with vitamin d-3 from 2007 to (b)(6)2019.Concurrent conditions included postpartum state, obesity, hypertension since 1998, type ii diabetes mellitus since 2016, kidney stones since 2016, glaucoma since 2016, hip replacement, dysuria, excessive menstruation, heavy periods and anemia.Concomitant products included anaesthetics (anesthesia), hydrochlorothiazide from 2016 to 2017, ibuprofen (motrin), latanoprost from 2016 to 2017, metformin since 2015, potassium citrate from 2016 to 2017 and rabeprazole sodium (aciphex) from 2016 to 2017.On (b)(6)2011, the patient had essure inserted.On (b)(6)2011, the patient was found to have liver function test increased ("elevated eft's"), 2 months 12 days after insertion of essure.In (b)(6)2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal distension ("bloating, other injuries or complications (severe abdominal bloating), bulge in upper abdomen"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), bladder disorder ("bladder or urinary problems or changes") with bladder pain, dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse) (severe)") and fatigue ("fatigue").In (b)(6)2011, the patient experienced migraine ("migraines (severe intermittent)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and headache ("headaches (severe intermittent)").In (b)(6)2013, the patient experienced sjogren's syndrome (seriousness criterion medically significant) with arthralgia, hypoaesthesia, paraesthesia, rash, inflammation, eye disorder, visual impairment, dry eye, vision blurred, platelet count decreased, c-reactive protein increased, fibrin d dimer increased, liver function test abnormal and hepatic enzyme increased.In (b)(6)2013, the patient experienced pain in extremity ("neurological conditions or problems (type- numbness, tingling and pain in the feet), numbness in limbs, foot pain (severe intermittent)").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), autoimmune hepatitis (seriousness criterion medically significant) with abdominal pain, diarrhoea, gastric ulcer, abdominal pain lower and vomiting, ulcerative keratitis (seriousness criterion medically significant), gastrointestinal disorder ("gastrointestinal problems") with gastrointestinal pain, joint injury ("joint damage"), stomatitis ("mouth sores"), nasal discomfort ("nasal sore"), alopecia ("hair loss"), uterine pain ("pain/ uterine pain (severe)"), abdominal discomfort ("pressure"), postoperative wound infection ("incision above her belly button is infected"), decreased appetite ("haven¿t had much an appetite today"), lung disorder ("fluid in her lungs"), back pain ("back pain"), sinusitis ("sinus infection"), endometriosis ("essure causing all the problems with endometriosis and adenomyosis"), adenomyosis ("essure causing all the problems with endometriosis and adenomyosis"), malaise ("sick"), vulvovaginal swelling ("swollen, vaginal canal was swollen"), breast pain ("sore breasts"), amnesia ("short-term memory loss"), gait disturbance ("barely walk") and complication of device removal ("complication of device removal"), was found to have blood urine present ("blood in my urine"), weight increased ("gained 45lbs in less than 6 months") and uterine leiomyoma ("two huge fibroids that were bigger than my uterus") and underwent hernia repair ("hernia repair").The patient was treated with surgery (hysterectomy (full) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6)2016.At the time of the report, the salpingitis, pelvic pain, embedded device, autoimmune hepatitis, ulcerative keratitis, sjogren's syndrome, gastrointestinal disorder, joint injury, stomatitis, nasal discomfort, alopecia, bladder disorder, dyspareunia, fatigue, liver function test increased, headache, postoperative wound infection, decreased appetite, lung disorder, back pain, blood urine present, sinusitis, endometriosis, adenomyosis, malaise, vulvovaginal swelling, weight increased, breast pain, amnesia, uterine leiomyoma, gait disturbance, hernia repair and complication of device removal outcome was unknown, the genital haemorrhage, migraine, abdominal distension, vaginal haemorrhage, menorrhagia, female sexual dysfunction, dysmenorrhoea, uterine pain and abdominal discomfort had resolved and the pain in extremity was resolving.The reporter considered abdominal discomfort, abdominal distension, adenomyosis, alopecia, amnesia, autoimmune hepatitis, back pain, bladder disorder, blood urine present, breast pain, complication of device removal, decreased appetite, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, female sexual dysfunction, gait disturbance, gastrointestinal disorder, genital haemorrhage, headache, hernia repair, joint injury, liver function test increased, lung disorder, malaise, menorrhagia, migraine, nasal discomfort, pain in extremity, pelvic pain, postoperative wound infection, salpingitis, sinusitis, sjogren's syndrome, stomatitis, ulcerative keratitis, uterine leiomyoma, uterine pain, vaginal haemorrhage, vulvovaginal swelling and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Biopsy endometrium - on (b)(6)2014: endometrial biopsy: fragments of endometrium in proliferative phase (no polyp, hyperplasia or malignancy) source:endometrium, biopsy.Gross description: an aggregate of tan-brown tissue and mucus is 3,0 x 3.0 x 0,2 cm.Computerised tomogram - on an unknown date: results: kidney stones on both sides.Nuclear magnetic resonance imaging - on (b)(6)2014: results: adenomyosis.Batch number: 12407573 manufacturing date: 2009/07 expiration date: 2012/06 batch number: 740669 manufacturing date: 2010/06 expiration date: 2013/06 ¿concerning the injuries reported in this case, the following one/ones were described in medical record : salpingitis, embedded device." quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 18-jan-2019: new pfs + mr received- new events added: salpingitis and embedded device.Historical and concomitant conditions were 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 case was initially received via regulatory authority (fda, reference number: (b)(4)) on 28-oct-2015.The most recent information was received on 18-jun-2020.This spontaneous case was reported by a lawyer and describes the occurrence of salpingitis ('chronic salpingitits'), pelvic pain ('severe and persistent pain') and embedded device ('embedded within the proximal end of the fallopian tubes') in a 35-year-old female patient who had essure (batch no.740669, 12407573) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included thrombocytopenia on (b)(6) 2011, c-section (compound presentation) in 2007, parity 3 ((b)(6) 1995, (b)(6) 2007 and (b)(6) 2011), vaginal delivery, multigravida, platelet transfusion, breast discharge and fibroids.Current height: 5¿10¿.Current weight: 185lbs.Approximate weight at the time of essure placement: 210lbs.Approx sep(as written) and healthcare provider told that essure was working properly and i no longer needed to use backup birth control.Previously administered products included for contraception: mirena from 2007 to 2010, loestrin from 2006 to 2007 and loestrin from 1996 to 2005; for an unreported indication: benicar hct from 1998 to (b)(6) 2020, centrum multivitamin from 2007 to (b)(6) 2020, flaxseed oil from 2007 to (b)(6) 2020 and calcium with vitamin d-3 from 2007 to 8-jul-2020.Concurrent conditions included type ii diabetes mellitus since 2016, kidney stones since 2016, glaucoma since 2016, hypertension since 1998, postpartum state, obesity, hip replacement, dysuria, excessive menstruation, heavy periods and anemia.Concomitant products included anesthetics, hydrochlorothiazide from 2016 to 2017, latanoprost from 2016 to 2017, metformin since 2015, potassium citrate from 2016 to 2017 and rabeprazole sodium (aciphex) from 2016 to 2017.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient was found to have liver function test increased ("elevated eft's"), 2 months 12 days after insertion of essure.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal distension ("bloating, other injuries or complications (severe abdominal bloating), bulge in upper abdomen"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), bladder disorder ("bladder or urinary problems or changes") with bladder pain, dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse) (severe)") and fatigue ("fatigue").In (b)(6) 2011, the patient experienced migraine ("migraines (severe intermittent)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and headache ("headaches (severe intermittent)").In (b)(6) 2013, the patient experienced sjogren's syndrome ("autoimmune disorder called sjogren's syndrome") with arthralgia, hypoaesthesia, paraesthesia, rash, inflammation, eye disorder, visual impairment, dry eye, vision blurred, platelet count decreased, c-reactive protein increased, fibrin d dimer increased, liver function test abnormal and hepatic enzyme increased.In (b)(6) 2013, the patient experienced pain in extremity ("neurological conditions or problems (type- numbness, tingling and pain in the feet), numbness in limbs, foot pain (severe intermittent)").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("bleeding / bleeding is so heavy, spotting dark brown , passed a clot bigger than my fist"), autoimmune hepatitis ("autoimmune hepatitis") with abdominal pain, diarrhoea, gastric ulcer, abdominal pain lower and vomiting, ulcerative keratitis ("corneal ulcers"), gastrointestinal disorder ("gastrointestinal problems") with gastrointestinal pain, joint injury ("joint damage"), stomatitis ("mouth sores"), nasal discomfort ("nasal sore"), alopecia ("hair loss"), uterine pain ("pain/ uterine pain (severe)"), abdominal discomfort ("pressure"), postoperative wound infection ("incision above her belly button is infected"), decreased appetite ("haven¿t had much an appetite today"), lung disorder ("fluid in her lungs"), back pain ("back pain"), sinusitis ("sinus infection"), endometriosis ("essure causing all the problems with endometriosis and adenomyosis"), adenomyosis ("essure causing all the problems with endometriosis and adenomyosis"), malaise ("sick"), vulvovaginal swelling ("swollen, vaginal canal was swollen"), breast pain ("sore breasts"), amnesia ("short-term memory loss"), gait disturbance ("barely walk"), complication of device removal ("complication of device removal") and hypoaesthesia ("numbness in feet"), was found to have blood urine present ("blood in my urine"), weight increased ("gained 45lbs in less than 6 months"), uterine leiomyoma ("two huge fibroids that were bigger than my uterus") and vitamin d decreased ("it was low vitamin d") and underwent hernia repair ("hernia repair").The patient was treated with surgery (hysterectomy (full) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, pelvic pain, embedded device, autoimmune hepatitis, ulcerative keratitis, sjogren's syndrome, gastrointestinal disorder, joint injury, stomatitis, nasal discomfort, alopecia, bladder disorder, dyspareunia, fatigue, liver function test increased, headache, postoperative wound infection, decreased appetite, lung disorder, back pain, blood urine present, sinusitis, endometriosis, adenomyosis, malaise, vulvovaginal swelling, weight increased, breast pain, amnesia, uterine leiomyoma, gait disturbance, hernia repair, complication of device removal, vitamin d decreased and hypoaesthesia outcome was unknown, the genital haemorrhage, migraine, abdominal distension, vaginal haemorrhage, menorrhagia, female sexual dysfunction, dysmenorrhoea, uterine pain and abdominal discomfort had resolved and the pain in extremity was resolving.The reporter considered abdominal discomfort, abdominal distension, adenomyosis, alopecia, amnesia, autoimmune hepatitis, back pain, bladder disorder, blood urine present, breast pain, complication of device removal, decreased appetite, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, female sexual dysfunction, gait disturbance, gastrointestinal disorder, genital haemorrhage, headache, hernia repair, hypoaesthesia, joint injury, liver function test increased, lung disorder, malaise, menorrhagia, migraine, nasal discomfort, pain in extremity, pelvic pain, postoperative wound infection, salpingitis, sinusitis, sjogren's syndrome, stomatitis, ulcerative keratitis, uterine leiomyoma, uterine pain, vaginal haemorrhage, vitamin d decreased, vulvovaginal swelling and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Biopsy endometrium - on (b)(6) 2014: endometrial biopsy: fragments of endometrium in proliferative phase (no polyp, hyperplasia or malignancy) source:endometrium, biopsy.Gross description: an aggregate of tan-brown tissue and mucus is 3,0 x 3.0 x 0,2 cm.Computerised tomogram - on an unknown date: results: kidney stones on both sides.Magnetic resonance imaging - on (b)(6) 2014: results: adenomyosis.Batch number: 12407573, manufacturing date: 2009/07, expiration date: 2012/06.Batch number: 740669, manufacturing date: 2010/06, expiration date: 2013/06.¿concerning the injuries reported in this case, the following one/ones were described in medical record : salpingitis, embedded device." quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 18-jun-2020: social media received: vitamin d decreased and numbness in feet added as a event.Reporter was added.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (fda, reference number: (b)(4) on 28-oct-2015.The most recent information was received on 13-jul-2020.This spontaneous case was reported by a lawyer and describes the occurrence of salpingitis ('chronic salpingitis'), pelvic pain ('severe and persistent pain') and embedded device ('embedded within the proximal end of the fallopian tubes') in a 35-year-old female patient who had essure (batch no: 740669, 12407573) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included thrombocytopenia on (b)(6) 2011, c-section (compound presentation) in 2007, parity 3 (on (b)(6) 1995, on (b)(6) 2007 and on (b)(6) 2011), vaginal delivery, multigravida, platelet transfusion, breast discharge and fibroids.Current height: 5¿10¿.Current weight: 185lbs.Approximate weight at the time of essure placement: 210lbs.Approx sep (as written) and healthcare provider told that essure was working properly and i no longer needed to use backup birth control.Previously administered products included for contraception: mirena from 2007 to 2010, loestrin from 2006 to 2007 and loestrin from 1996 to 2005; for an unreported indication: benicar hct from 1998 to on (b)(6) 2020, centrum multivitamin from 2007 to on (b)(6) 2020, flaxseed oil from 2007 to on (b)(6) 2020 and calcium with vitamin d-3 from 2007 to on (b)(6) 2020.Concurrent conditions included type ii diabetes mellitus since 2016, kidney stones since 2016, glaucoma since 2016, hypertension since 1998, postpartum state, obesity, hip replacement, dysuria, excessive menstruation, heavy periods and anemia.Concomitant products included anesthetics, hydrochlorothiazide from 2016 to 2017, latanoprost from 2016 to 2017, metformin since 2015, potassium citrate from 2016 to 2017 and rabeprazole sodium (aciphex) from 2016 to 2017.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient was found to have liver function test increased ("elevated eft's"), 2 months 12 days after insertion of essure.On (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal distension ("bloating, other injuries or complications (severe abdominal bloating), bulge in upper abdomen"), vaginal haemorrhage ("abnormal bleeding (vaginal / menorrhagia)"), bladder disorder ("bladder or urinary problems or changes") with bladder pain, dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse) (severe)") and fatigue ("fatigue").On (b)(6) 2011, the patient experienced migraine ("migraines (severe intermittent)"), menorrhagia ("abnormal bleeding (vaginal / menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and headache ("headaches (severe intermittent)").On (b)(6) 2013, the patient experienced sjogren's syndrome ("autoimmune disorder called sjogren's syndrome") with arthralgia, hypoaesthesia, paraesthesia, rash, inflammation, eye disorder, visual impairment, dry eye, vision blurred, platelet count decreased, c-reactive protein increased, fibrin d dimer increased, liver function test abnormal and hepatic enzyme increased.On (b)(6) 2013, the patient experienced pain in extremity ("neurological conditions or problems (type- numbness, tingling and pain in the feet), numbness in limbs, foot pain (severe intermittent)").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("bleeding / bleeding is so heavy, spotting dark brown , passed a clot bigger than my fist"), autoimmune hepatitis ("autoimmune hepatitis") with abdominal pain, diarrhoea, gastric ulcer, abdominal pain lower and vomiting, ulcerative keratitis ("corneal ulcers"), gastrointestinal disorder ("gastrointestinal problems") with gastrointestinal pain, joint injury ("joint damage"), stomatitis ("mouth sores"), nasal discomfort ("nasal sore"), alopecia ("hair loss"), uterine pain ("pain/ uterine pain (severe)"), abdominal discomfort ("pressure"), postoperative wound infection ("incision above her belly button is infected"), decreased appetite ("haven't had much an appetite today"), lung disorder ("fluid in her lungs"), back pain ("back pain"), sinusitis ("sinus infection"), endometriosis ("essure causing all the problems with endometriosis and adenomyosis"), adenomyosis ("essure causing all the problems with endometriosis and adenomyosis"), malaise ("sick"), vulvovaginal swelling ("swollen, vaginal canal was swollen"), breast pain ("sore breasts"), amnesia ("short-term memory loss"), gait disturbance ("barely walk"), complication of device removal ("complication of device removal") and hypoaesthesia ("numbness in feet"), was found to have blood urine present ("blood in my urine"), weight increased ("gained 45lbs in less than 6 months"), uterine leiomyoma ("two huge fibroids that were bigger than my uterus") and vitamin d decreased ("it was low vitamin d") and underwent hernia repair ("hernia repair").The patient was treated with surgery (hysterectomy (full) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, pelvic pain, embedded device, autoimmune hepatitis, ulcerative keratitis, sjogren's syndrome, gastrointestinal disorder, joint injury, stomatitis, nasal discomfort, alopecia, bladder disorder, dyspareunia, fatigue, liver function test increased, headache, postoperative wound infection, decreased appetite, lung disorder, back pain, blood urine present, sinusitis, endometriosis, adenomyosis, malaise, vulvovaginal swelling, weight increased, breast pain, amnesia, uterine leiomyoma, gait disturbance, hernia repair, complication of device removal, vitamin d decreased and hypoaesthesia outcome was unknown, the genital haemorrhage, migraine, abdominal distension, vaginal haemorrhage, menorrhagia, female sexual dysfunction, dysmenorrhoea, uterine pain and abdominal discomfort had resolved and the pain in extremity was resolving.The reporter considered abdominal discomfort, abdominal distension, adenomyosis, alopecia, amnesia, autoimmune hepatitis, back pain, bladder disorder, blood urine present, breast pain, complication of device removal, decreased appetite, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, female sexual dysfunction, gait disturbance, gastrointestinal disorder, genital haemorrhage, headache, hernia repair, hypoaesthesia, joint injury, liver function test increased, lung disorder, malaise, menorrhagia, migraine, nasal discomfort, pain in extremity, pelvic pain, postoperative wound infection, salpingitis, sinusitis, sjogren's syndrome, stomatitis, ulcerative keratitis, uterine leiomyoma, uterine pain, vaginal haemorrhage, vitamin d decreased, vulvovaginal swelling and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Biopsy endometrium: on (b)(6) 2014: endometrial biopsy: fragments of endometrium in proliferative phase (no polyp, hyperplasia or malignancy) source:endometrium, biopsy.Gross description: an aggregate of tan-brown tissue and mucus is 3,0 x 3.0 x 0,2 cm.Computerised tomogram: on an unknown date: results: kidney stones on both sides.Magnetic resonance imaging: on (b)(6) 2014: results: adenomyosis.Batch number: 12407573, manufacturing date: 2009/07, expiration date: 2012/06.Batch number: 740669 ,manufacturing date: 2010/06, expiration date: 2013/06.¿concerning the injuries reported in this case, the following one / ones were described.In medical record: salpingitis, embedded device." quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 13-jul-2020: quality safety evaluation of ptc.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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