| Model Number ESS305 |
| Device Problems
Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Insufficient Information (3190)
|
| Patient Problems
Abdominal Pain (1685); Inflammation (1932); Pelvic Inflammatory Disease (2000); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
| Event Date 01/01/2017 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage') and uterine inflammation ('uterine inflammation') in a (b)(6) old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and gravida ii.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criterion medically significant), device dislocation ("device dislocation"), abdominal pain lower ("cramp in lower abdomen"), breast pain ("mastalgia"), oedema ("edema and distention"), menorrhagia ("increased mentrual flow and duration (at least 15 days) with clots"), headache ("intensive headache"), peripheral swelling ("leg swelling"), pain in extremity ("leg pains"), paraesthesia ("tingling"), tremor ("shakiness"), pelvic pain ("pelvic pain"), back pain ("lower back pain"), uterine pain ("sensation of perforation in the uterus"), discomfort ("twinge"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after intercourse"), coital bleeding ("bleeding during and after intercourse"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), pain ("general pain"), vaginal discharge ("vaginal discharge with unpleasant smell"), depression ("depression"), dysmenorrhoea ("dysmenorrhea"), vulvovaginal pruritus ("itchy vaginal"), diarrhoea ("diarrhea intermittent") and abdominal distension ("edema and distention").In (b)(6) 2020, the patient experienced endometriosis ("endometriosis").On an unknown date, the patient experienced anxiety ("anxiety").At the time of the report, the device breakage, device dislocation, breast pain, oedema, back pain, discomfort, mood swings, adenomyosis, vaginal discharge, depression, endometriosis, dysmenorrhoea, vulvovaginal pruritus, diarrhoea, anxiety and abdominal distension outcome was unknown and the uterine inflammation, abdominal pain lower, menorrhagia, headache, peripheral swelling, pain in extremity, paraesthesia, tremor, pelvic pain, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, alopecia, intra-abdominal fluid collection and pain had not resolved.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, discomfort, dysmenorrhoea, dyspareunia, endometriosis, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood swings, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: the patient often went o emergency room due to pain and analgesics, anti-inflammatory were taken to control it.The reporter also stated that the patient is really worried about a possible uterine perforation occurs so, the patient was requesting essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure was not in the correct position.The devices were on the verge of punching your internal organs, more precisely the reproductive organ.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage') and uterine inflammation ('uterine inflammation') in a 28-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and parity 2.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criterion medically significant), device dislocation ("device dislocation"), abdominal pain lower ("cramp in lower abdomen"), breast pain ("mastalgia"), oedema ("edema and distention"), menorrhagia ("increased mentrual flow and duration (at least 15 days) with clots"), headache ("intensive headache"), peripheral swelling ("leg swelling"), pain in extremity ("leg pains"), paraesthesia ("tingling"), tremor ("shakiness"), pelvic pain ("pelvic pain"), back pain ("lower back pain"), uterine pain ("sensation of perforation in the uterus"), discomfort ("twinge"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after intercourse"), coital bleeding ("bleeding during and after intercourse"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), pain ("general pain"), vaginal discharge ("vaginal discharge with unpleasant smell"), depression ("depression"), dysmenorrhoea ("dysmenorrhea"), vulvovaginal pruritus ("itchy vaginal"), diarrhoea ("diarrhea intermittent") and abdominal distension ("edema and distention").In (b)(6) 2020, the patient experienced endometriosis ("endometriosis").On an unknown date, the patient experienced anxiety ("anxiety").At the time of the report, the device breakage, device dislocation, breast pain, oedema, back pain, discomfort, mood swings, adenomyosis, vaginal discharge, depression, endometriosis, dysmenorrhoea, vulvovaginal pruritus, diarrhoea, anxiety and abdominal distension outcome was unknown and the uterine inflammation, abdominal pain lower, menorrhagia, headache, peripheral swelling, pain in extremity, paraesthesia, tremor, pelvic pain, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, alopecia, intra-abdominal fluid collection and pain had not resolved.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, discomfort, dysmenorrhoea, dyspareunia, endometriosis, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood swings, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: the patient often went o emergency room due to pain and analgesics, anti-inflammatory were taken to control it.The reporter also stated that the patient is really worried about a possible uterine perforation occurs so, the patient was requesting essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on an unknown date: essure on tubes and suggestion of endometriosis.X-ray - on an unknown date: essure was not in the correct position.The devices were on the verge of punching your internal organs, more precisely the reproductive organ.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-sep-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage') and uterine inflammation ('uterine inflammation') in a 28-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and parity ii.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criterion medically significant), device dislocation ("device dislocation"), abdominal pain lower ("cramp in lower abdomen"), breast pain ("mastalgia"), oedema ("edema and distention"), menorrhagia ("increased mentrual flow and duration (at least 15 days) with clots"), headache ("intensive headache"), peripheral swelling ("leg swelling"), pain in extremity ("leg pains"), paraesthesia ("tingling"), tremor ("shakiness"), pelvic pain ("pelvic pain"), back pain ("lower back pain"), uterine pain ("sensation of perforation in the uterus"), discomfort ("twinge"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after intercourse"), coital bleeding ("bleeding during and after intercourse"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), pain ("general pain"), vaginal discharge ("vaginal discharge with unpleasant smell"), depression ("depression"), dysmenorrhoea ("dysmenorrhea"), vulvovaginal pruritus ("itchy vaginal"), diarrhoea ("diarrhea intermittent") and abdominal distension ("edema and distention").In (b)(6) 2020, the patient experienced endometriosis ("endometriosis").On an unknown date, the patient experienced anxiety ("anxiety").At the time of the report, the device breakage, device dislocation, breast pain, oedema, back pain, discomfort, mood swings, adenomyosis, vaginal discharge, depression, endometriosis, dysmenorrhoea, vulvovaginal pruritus, diarrhoea, anxiety and abdominal distension outcome was unknown and the uterine inflammation, abdominal pain lower, menorrhagia, headache, peripheral swelling, pain in extremity, paraesthesia, tremor, pelvic pain, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, alopecia, intra-abdominal fluid collection and pain had not resolved.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, discomfort, dysmenorrhoea, dyspareunia, endometriosis, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood swings, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: the patient often went o emergency room due to pain and analgesics, anti-inflammatory were taken to control it.The reporter also stated that the patient is really worried about a possible uterine perforation occurs so, the patient was requesting essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure was not in the correct position.The devices were on the verge of punching your internal organs, more precisely the reproductive organ.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-jun-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage') and uterine inflammation ('uterine inflammation') in a 28-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and parity 2.In (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced procedural pain ("the patient left the hospital with pain in her lower abdomen (after the essure insertion)").In 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine inflammation (seriousness criterion medically significant), device dislocation ("device dislocation"), abdominal pain lower ("cramp in lower abdomen"), breast pain ("mastalgia"), oedema ("edema and distention"), menorrhagia ("increased mentrual flowand duration (at least 15 days) with clots"), headache ("intensive headache"), peripheral swelling ("leg swelling"), pain in extremity ("leg pains"), paraesthesia ("tingling"), tremor ("shakiness"), pelvic pain ("pelvic pain"), back pain ("lower back pain"), uterine pain ("sensation of perforation in the uterus"), discomfort ("twinge"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after intercourse"), coital bleeding ("bleeding during and after intercourse"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), pain ("general pain"), vaginal discharge ("vaginal discharge with unpleasant smell"), depression ("depression"), dysmenorrhoea ("dysmenorrhea"), vulvovaginal pruritus ("itchy vaginal"), diarrhoea ("diarrhea intermittent") and abdominal distension ("edema and distention").In (b)(6) 2020, the patient experienced endometriosis ("endometriosis").On an unknown date, the patient experienced anxiety ("anxiety").The patient was treated with diclofenac sodium (anti-inflammatory), ibuprofen;methocarbamol (analgesic & muscle relaxant) and surgery (total hysterectomy and salpingectomy).Essure was removed on (b)(6) 2020.At the time of the report, the device breakage, uterine inflammation, device dislocation, abdominal pain lower, breast pain, oedema, menorrhagia, headache, peripheral swelling, pain in extremity, paraesthesia, tremor, pelvic pain, back pain, uterine pain, discomfort, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, depression, endometriosis, dysmenorrhoea, vulvovaginal pruritus, diarrhoea, anxiety, abdominal distension and procedural pain had resolved.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, discomfort, dysmenorrhoea, dyspareunia, endometriosis, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood swings, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, procedural pain, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: the patient often went o emergency room due to pain and analgesics, anti-inflammatory were taken to control it.The reporter also stated that the patient is really worried about a possible uterine perforation occurs so, the patient was requesting essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2020: uterine atrophy, nonspecific conical endocervicitis (mild degree), uterine body leiomyomas, intramural, endometrial cystic hyperplasia, edema and bilateral tubal congestion.Smear cervix - on (b)(6) 2019: benign cellular alterations: pronounced inflammatory, containing bacteria; presence of gardnerella vaginalis.Ultrasound scan - on an unknown date: essure on tubes and sugestion of endometriosis.X-ray - on an unknown date: essure was not in the correct position.The devices were on the verge of punching your internal organs, more precisely the reproductive organ.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-apr-2021: new informations were added: post procedural pain, treatment drugs, essure removal (total hysterectomy and salpingectomy), lab datas and the outcome for all adverse events.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage') and uterine inflammation ('uterine inflammation') in a 28-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and parity 2.In (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced procedural pain ("the patient left the hospital with pain in her lower abdomen (after the essure insertion)").In 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine inflammation (seriousness criterion medically significant), device dislocation ("device dislocation"), abdominal pain lower ("cramp in lower abdomen"), breast pain ("mastalgia"), oedema ("edema and distention"), menorrhagia ("increased mentrual flow and duration (at least 15 days) with clots"), headache ("intensive headache"), peripheral swelling ("leg swelling"), pain in extremity ("leg pains"), paraesthesia ("tingling"), tremor ("shakiness"), pelvic pain ("pelvic pain"), back pain ("lower back pain"), uterine pain ("sensation of perforation in the uterus"), discomfort ("twinge"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after intercourse"), coital bleeding ("bleeding during and after intercourse"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), pain ("general pain"), vaginal discharge ("vaginal discharge with unpleasant smell"), depression ("depression"), dysmenorrhoea ("dysmenorrhea"), vulvovaginal pruritus ("itchy vaginal"), diarrhoea ("diarrhea intermittent") and abdominal distension ("edema and distention").In march 2020, the patient experienced endometriosis ("endometriosis").On an unknown date, the patient experienced anxiety ("anxiety").The patient was treated with diclofenac sodium (anti-inflammatory), ibuprofen;methocarbamol (analgesic & muscle relaxant) and surgery (total hysterectomy and salpingectomy).Essure was removed on (b)(6) 2020.At the time of the report, the device breakage, uterine inflammation, device dislocation, abdominal pain lower, breast pain, oedema, menorrhagia, headache, peripheral swelling, pain in extremity, paraesthesia, tremor, pelvic pain, back pain, uterine pain, discomfort, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, depression, endometriosis, dysmenorrhoea, vulvovaginal pruritus, diarrhoea, anxiety, abdominal distension and procedural pain had resolved.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, discomfort, dysmenorrhoea, dyspareunia, endometriosis, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood swings, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, procedural pain, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: the patient often went o emergency room due to pain and analgesics, anti-inflammatory were taken to control it.The reporter also stated that the patient is really worried about a possible uterine perforation occurs so, the patient was requesting essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2020: uterine atrophy, nonspecific conical endocervicitis (mild degree), uterine body leiomyomas, intramural, endometrial cystic hyperplasia, edema and bilateral tubal congestion.Smear cervix - on (b)(6) 2019: benign cellular alterations: pronounced inflammatory, containing bacteria; presence of gardnerella vaginalis.Ultrasound scan - on an unknown date: essure on tubes and suggestion of endometriosis.X-ray - on an unknown date: essure was not in the correct position.The devices were on the verge of punching your internal organs, more precisely the reproductive organ.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 13-apr-2021: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device breakage ("device breakage") and uterine inflammation ("uterine inflammation") in a 28 year-old female patient who had essure inserted for contraception.Additional non-serious events are detailed below.The patient had a medical history of non-smoker, shellfish allergy, menstruation increased (patient presented this condition before essure, during use of mesigyna.), parity 2 (2007 - non planned, 9m, 1600g, rciu, pn; 2012 - non planned, 9m, 2200g, s/i, pn.) and gravida ii.Patient informed she does not have comorbidities, does not use chronic use medication, no contact allergies or to medications, no previous surgeries, no blood transfusion and non alcoholism.Previously administered products included: mesigyna and ciclo 21.The patient had a family history of skin cancer, uterine cancer and prostate cancer.On (b)(6) 2014, the patient had essure inserted.In november 2014 she experienced procedural pain ("the patient left the hospital with pain in her lower abdomen (after the essure insertion)").In 2017 she experienced device breakage (seriousness criteria medically important and intervention required), uterine inflammation (seriousness criterion medically important), device dislocation ("device dislocation"), cramp in lower abdomen ("cramp in lower abdomen"), breast pain ("mastalgia"), oedema ("edema and distention"), heavy menstrual bleeding ("increased mentrual flowand duration (at least 15 days) with clots / irregular menstrual cycle"), a first episode of headache ("intensive headache / holocranial headache regardless menstrual cycle"), peripheral swelling ("leg swelling"), pain in extremity ("leg pains"), paraesthesia ("tingling"), tremor ("shakiness"), pelvic pain ("pelvic pain"), low back pain ("lower back pain"), uterine pain ("sensation of perforation in the uterus"), discomfort ("twinge"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after intercourse / with no relation to the menstrual cycle or position"), coital bleeding ("bleeding during and after intercourse"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), pain ("general pain"), vaginal discharge ("vaginal discharge with unpleasant smell"), depression ("depression"), dysmenorrhea ("dysmenorrhea"), vulvovaginal pruritus ("itchy vaginal"), diarrhoea ("diarrhea intermittent"), abdominal distension ("edema and distention"), a first episode of nausea ("constant nausea") and lumbar pain ("continuos lumbar pain not related to her menses").On (b)(6) 2019 she experienced vaginal haemorrhage ("slight transvaginal bleeding"), lower abdominal pain ("lower abdominal pain"), a second episode of nausea ("nausea") and a second episode of headache ("headache").In february 2020 she experienced polymenorrhoea ("polymenorrhea").In march 2020 she experienced endometriosis ("endometriosis").On (b)(6) 2020 she experienced menstrual disorder ("clots, yes 2x occasionally") and menstrual cramps ("severe menstrual cramps").Essure was removed on (b)(6) 2020.An unknown time later she experienced anxiety ("anxiety").The patient was treated with anti-inflammatory (diclofenac sodium), tramal (tramadol hydrochloride), toragesic (ketorolac tromethamine), dienogeste, ibuprofen and analgesics as well as surgery (total hysterectomy and salpingectomy).At the time of the report, the device breakage, uterine inflammation, device dislocation, cramp in lower abdomen, breast pain, oedema, heavy menstrual bleeding, peripheral swelling, pain in extremity, paraesthesia, tremor, pelvic pain, low back pain, uterine pain, discomfort, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, depression, endometriosis, dysmenorrhea, vulvovaginal pruritus, diarrhoea, anxiety, abdominal distension and procedural pain had resolved.The outcomes for back pain, polymenorrhoea, menstrual disorder, dysmenorrhoea, vaginal haemorrhage, abdominal pain lower, the last episode of headache and the last episode of nausea were unknown.The reporter considered abdominal distension, cramp in lower abdomen, lower abdominal pain, adenomyosis, alopecia, anxiety, arthralgia, low back pain, lumbar pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, discomfort, dysmenorrhea, menstrual cramps, dyspareunia, endometriosis, fatigue, the first episode of headache, the second episode of headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, menstrual disorder, mood swings, the first episode of nausea, the second episode of nausea, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, tremor, uterine inflammation, uterine pain, vaginal discharge, vaginal haemorrhage and vulvovaginal pruritus to be related to essure administration.The reporter commented: the patient often went o emergency room due to pain and analgesics, anti-inflammatory were taken to control it.The reporter also stated that the patient is really worried about a possible uterine perforation occurs so, the patient was requesting essure removal.Essure removal occurred successfully, with no complications.Diagnostic results (normal ranges are provided in parenthesis if available): [magnetic resonance imaging] on (b)(6) 2020: slight thickening of the left uterosacral ligament in the uterine torus.It may be related, deep endometriosis in dependence on clinical correlation.[pathology test] on (b)(6) 2020: uterine atrophy, nonspecific conical endocervicitis (mild degree), uterine body leiomyomas, intramural, endometrial cystic hyperplasia, edema and bilateral tubal congestion.[smear cervix] on (b)(6) 2019: squamous, no glandular cells observed.Benign cellular alterations: pronounced inflammatory, containing bacteria; presence of gardnerella vaginalis.[ultrasound scan] (dates unknown): essure on tubes and sugestion of endometriosis and debris in bladded, suggesting urinary infection [ultrasound scan vagina] on (b)(6) 2019: uterus in retrovertion and anteverted, volume of 42cc, homogeneous myometrium, endometrium 3.6 mm, right ovary: 9.9 cc with polycystic pattern; left ovary: 3.4 cc; it is noticed the presence of hyperechogenic devices bilaterally on uterine topography, apparently out of the proper location.Suggestion of ct or mri for better evaluation.[weight] on (b)(6) 2020: 60 kg [x-ray] on (b)(6) 2019: shows linear metallic material in pelvis in uterus topography; (date unknown): essure was not in the correct position.The devices were on the verge of punching your internal organs, more precisely the reproductive organ.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: (b)(6) 2022: new clinical information received with the medical records from the patient: medical, drug and family history added, new events (nausea episodes, back pain, polymenorrhea, mesntrual disorder, dysmenorrhea, vaginal haemorrhage, lower abdominal pain, and episode of headache), as reported events updated (menorrhagia, dyspareunia and headache), new and updates of lab data, treatment drugs added, information about essure removal added to rcc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device breakage ("device breakage") and uterine inflammation ("uterine inflammation") in a 28 year-old female patient who had essure inserted for contraception.Additional non-serious events are detailed below.The patient had a medical history of colic (improved with the use of oral contraceptives), menorrhagia (improved with the use of oral contraceptives), non-smoker, shellfish allergy, menstruation increased (patient presented this condition before essure, during use of mesigyna.), parity 2 (2007 - non planned, 9m, 1600g, rciu, pn; 2012 - non planned, 9m, 2200g, s/i, pn.) and gravida ii.Patient informed she does not have comorbidities, does not use chronic use medication, no contact allergies or to medications, no previous surgeries, no blood transfusion and non alcoholism.Previously administered products included: mesigyna and ciclo 21.The patient had a family history of skin cancer, uterine cancer and prostate cancer.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014 she experienced procedural pain ("the patient left the hospital with pain in her lower abdomen (after the essure insertion)").In 2017 she experienced device breakage (seriousness criteria medically important and intervention required), uterine inflammation (seriousness criterion medically important), device dislocation ("device dislocation"), cramp in lower abdomen ("cramp in lower abdomen"), breast pain ("mastalgia"), oedema ("edema and distention"), heavy menstrual bleeding ("increased mentrual flowand duration (at least 15 days) with clots / irregular menstrual cycle"), a first episode of headache ("intensive headache / holocranial headache regardless menstrual cycle"), peripheral swelling ("leg swelling"), pain in extremity ("leg pains"), paraesthesia ("tingling"), tremor ("shakiness"), pelvic pain ("pelvic pain"), low back pain ("lower back pain"), uterine pain ("sensation of perforation in the uterus"), discomfort ("twinge"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after intercourse / with no relation to the menstrual cycle or position"), coital bleeding ("bleeding during and after intercourse"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), pain ("general pain"), vaginal discharge ("vaginal discharge with unpleasant smell"), depression ("depression"), dysmenorrhea ("dysmenorrhea"), vulvovaginal pruritus ("itchy vaginal"), diarrhoea ("diarrhea intermittent"), abdominal distension ("edema and distention"), a first episode of nausea ("constant nausea") and lumbar pain ("continuos lumbar pain not related to her menses").On (b)(6) 2019 she experienced vaginal haemorrhage ("slight transvaginal bleeding"), lower abdominal pain ("lower abdominal pain"), a second episode of nausea ("nausea") and a second episode of headache ("headache").In (b)(6) 2020 she experienced polymenorrhoea ("polymenorrhea").In (b)(6) 2020 she experienced endometriosis ("endometriosis").On (b)(6) 2020 she experienced menstrual disorder ("clots, yes 2x occasionally") and menstrual cramps ("severe menstrual cramps").Essure was removed on (b)(6) 2020.An unknown time later she experienced anxiety ("anxiety").The patient was treated with anti-inflammatory (diclofenac sodium), tramal (tramadol hydrochloride), toragesic (ketorolac tromethamine), dienogeste, ibuprofen and analgesics as well as surgery (total hysterectomy and salpingectomy).At the time of the report, the device breakage, uterine inflammation, device dislocation, cramp in lower abdomen, breast pain, oedema, heavy menstrual bleeding, peripheral swelling, pain in extremity, paraesthesia, tremor, pelvic pain, low back pain, uterine pain, discomfort, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, depression, endometriosis, dysmenorrhea, vulvovaginal pruritus, diarrhoea, anxiety, abdominal distension and procedural pain had resolved.The outcomes for back pain, polymenorrhoea, menstrual disorder, dysmenorrhoea, vaginal haemorrhage, abdominal pain lower, the last episode of headache and the last episode of nausea were unknown.The reporter considered abdominal distension, cramp in lower abdomen, lower abdominal pain, adenomyosis, alopecia, anxiety, arthralgia, low back pain, lumbar pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, discomfort, dysmenorrhea, menstrual cramps, dyspareunia, endometriosis, fatigue, the first episode of headache, the second episode of headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, menstrual disorder, mood swings, the first episode of nausea, the second episode of nausea, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, tremor, uterine inflammation, uterine pain, vaginal discharge, vaginal haemorrhage and vulvovaginal pruritus to be related to essure administration.The reporter commented: the patient often went o emergency room due to pain and analgesics, anti-inflammatory were taken to control it.The reporter also stated that the patient is really worried about a possible uterine perforation occurs so, the patient was requesting essure removal.Essure removal occurred successfully, with no complications.Diagnostic results (normal ranges are provided in parenthesis if available): [magnetic resonance imaging] on (b)(6) 2020: slight thickening of the left uterosacral ligament in the uterine torus.It may be related, deep endometriosis in dependence on clinical correlation.[pathology test] on (b)(6) 2020: uterine atrophy, nonspecific conical endocervicitis (mild degree), uterine body leiomyomas, intramural, endometrial cystic hyperplasia, edema and bilateral tubal congestion.[smear cervix] on (b)(6) 2019: squamous, no glandular cells observed.Benign cellular alterations: pronounced inflammatory, containing bacteria; presence of gardnerella vaginalis.[ultrasound scan] (dates unknown): essure on tubes and sugestion of endometriosis and debris in bladded, suggesting urinary infection [ultrasound scan vagina] on (b)(6) 2019: uterus in retrovertion and anteverted, volume of 42cc, homogeneous myometrium, endometrium 3.6 mm, right ovary: 9.9 cc with polycystic pattern; left ovary: 3.4 cc; it is noticed the presence of hyperechogenic devices bilaterally on uterine topography, apparently out of the proper location.Suggestion of ct or mri for better evaluation.[weight] on (b)(6) 2020: 60 kg [x-ray] on (b)(6) 2019: shows linear metallic material in pelvis in uterus topography.Essure seems well-positioned; (date unknown): essure was not in the correct position.The devices were on the verge of punching your internal organs, more precisely the reproductive organ.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 03-oct-2022: quality safety evaluation of product technical complaint.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Search Alerts/Recalls
|
|
