| Lot Number A66685 |
| Device Problems
Difficult or Delayed Positioning (1157); Defective Device (2588); Biocompatibility (2886); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
|
| Patient Problems
Inflammation (1932); Itching Sensation (1943); Pain (1994); Rash (2033); Uterine Perforation (2121); Tingling (2171); Numbness (2415)
|
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("third coil attached to my endometrial wall / coil embedded in my uterus"), endometriosis ("endometriosis(endometriosis on bladder as well)") and the first episode of cystitis interstitial ("interstitial cystitis") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "had difficulty getting the left coil to deploy", device use issue "three coils were inserted instead of two" and device use issue "third coil attached to my endometrial wall".The patient's past medical history included gravida ii and parity 3 ((b)(6) 1993, (b)(6) 2008 and (b)(6) 2013).Concurrent conditions included body mass index normal and dysmenorrhoea since(b)(6) 2013.Concomitant products included amitriptyline hydrochloride (elavil) in (b)(6) 2016, imipramine in (b)(6) 2015 and pentosan polysulfate sodium (elmiron) in (b)(6) 2016 for cystitis interstitial, ibuprofen in 2013 for inflammation, pyricarbate (pyridinin) in (b)(6) 2015, sucralfate (urbal) in (b)(6) 2015 and urelle in (b)(6) 2015 for micturition disorder, fluconazole (diflucan) in 2015 for yeast infection as well as d-mannose and tamsulosin.In 2013, 4 days before insertion of essure, the patient experienced pruritus generalised ("itched all over").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced endometriosis (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced the first episode of cystitis interstitial (seriousness criterion medically significant).In 2016, the patient experienced abdominal distension ("bloating").In (b)(6) 2017, the patient experienced adenomyosis ("endometriosis and adenomyosis").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), menorrhagia ("bleed 21 days a month / excessive bleeding / my menstrual cycles dropped from 21 days of flow to 14 day"), device expulsion ("third coil attached to my endometrial wall"), headache ("headaches"), device deployment issue ("device did not deploy"), mental disorder ("caused or aggravated any psychiatric and/or psychological condition(s)"), allergy to metals ("hypersensitivity reaction to nickel / any other component of essure"), nausea ("bouts of nausea"), diarrhoea ("diarrhea"), bladder pain ("bladder pain (constant pressure and pain.Unable to void completely.Constant feeling of having urinary tract infection)"), pain ("i still reel the left side pain sometimes"), cyst ("have had surgery twice before to remove almost 3- 4" cysts"), paraesthesia ("has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal"), hypoaesthesia ("has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal"), rash pruritic ("my naval incision started burning again like itchy sunburn and still hurts/just itches and bum on the skin below my belly button and inside"), muscular weakness ("have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time"), alopecia ("major hair loss still after removal"), bladder disorder ("pain is mostly bladder issues "), urinary tract infection ("horrible uti") and the second episode of cystitis interstitial ("interstitial cystitis").The patient was treated with surgery (underwent laparoscopic vaginally assisted hysterectomy removing uterus,cervix and fallopian tubes.), surgery (laproscopy to remove essure and excise endometriosis) and surgery (cystoscopy with hydrodistention followed by medications (imipramine,uribel)).Essure was removed on (b)(6) 2013.At the time of the report, the embedded device, device expulsion, endometriosis, device deployment issue, adenomyosis, mental disorder, allergy to metals, abdominal distension, bladder pain, pain, cyst, paraesthesia, hypoaesthesia, rash pruritic, muscular weakness, alopecia, bladder disorder, urinary tract infection and the last episode of cystitis interstitial outcome was unknown, the menorrhagia was resolving, the headache had not resolved and the pruritus generalised, nausea and diarrhoea had resolved.The reporter considered abdominal distension, adenomyosis, allergy to metals, alopecia, bladder disorder, bladder pain, cyst, device deployment issue, diarrhoea, embedded device, endometriosis, headache, hypoaesthesia, menorrhagia, mental disorder, muscular weakness, nausea, pain, paraesthesia, pruritus generalised, rash pruritic, urinary tract infection, the first episode of cystitis interstitial and the second episode of cystitis interstitial to be related to essure.The reporter provided no causality assessment for device expulsion with essure.The reporter commented: she received treatment endometriosis, interstitial cystitis and endometriosis and adenomyosis.She did not claim that allergic to nickel or any other component of essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.9 kg/sqm.On (b)(6) 2013 hsg confirmation test: both tubes are blocked completely and in correct postition, but has a third coil attached to endometrium.On (b)(6) 2017, surgical pathology- microscopic description: histologic sections of the hysterectomy specimen reveal acute and chronic inflammation of the uterine cervix.The inflammation surrounds benign nabothian cysts.There is no evidence of cervical dysplasia or malignancy.Section of the endometrium reveals a small benign polyp.The polyp is present in a background of a proliferative phase pattern.There is no evidence of endometrial hyperplasia or malignancy.Sections of the myometrium are histologically unremarkable.There is no evidence of a myometrial neoplasm.Representative sections of the uterine serosa show benign fibro vascular adhesions.There are no serosal tumor implants or endometriosis.Sections of the left fallopian tube are remarkable for a benign para tubal cyst.There is no significant tubal inflammation or malignancy.Sections of the left ovary reveal hemorrhagic luteal cysts and small follicular cysts.There is no evidence of an ovarian malignancy.Concerning the injuries reported in this case, the following one/ones were reported via social media-events i still reel the left side pain sometimes, have had surgery twice before to remove almost 3- 4" cysts, has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal, my naval incision started burning again like itchy sunburn and still hurts.Had to go back on the pain meds just to sleep and bear it, just itches and bum on the skin below my belly button and inside, have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time, interstitial cystitis, horrible uti, pain is mostly bladder issues, major hair loss still after removal were added quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in wi-03635, ¿processing essure cases in dev@com.¿ medical assessment: the reported medical events are not indicative for a quality deficit per se.The case refers also to a deployment issue.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At the time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.Most recent follow-up information incorporated above includes: on 21-nov-2017: follow-up 5 and 6 processed together.Events i still reel the left side pain sometimes, have had surgery twice before to remove almost 3- 4" cysts, has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal, my naval incision started burning again like itchy sunburn and still hurts.Had to go back on the pain meds just to sleep and bear it, just itches and bum on the skin below my belly button and inside, have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time, interstitial cystitis, horrible uti, pain is mostly bladder issues, major hair loss still after removal 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.
|
| |
|
Manufacturer Narrative
|
|
This case was initially received via regulatory authority (reference number: mw5031985) on 25-oct-2013.The most recent information was received on 06-jan-2020 this spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('third coil attached to my endometrial wall / coil embedded in my uterus'), endometriosis ('endometriosis(endometriosis on bladder as well)') and multiple episodes of cystitis interstitial ('interstitial cystitis', 'interstitial cystitis') in a 36-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "third coil attached to my endometrial wall", device deployment issue "device did not deploy", device use issue "three coils were inserted instead of two" and device difficult to use "had difficulty getting the left coil to deploy".The patient's medical history included multigravida and parity 3 (b)(6) 1993, (b)(6) 2008 and (b)(6) 2013).Concurrent conditions included dysmenorrhoea since (b)(6) 2013 and body mass index normal.Concomitant products included imipramine from (b)(6) 2015 to (b)(6) 2016 and pentosan polysulfate sodium (elmiron) from (b)(6) 2016 to (b)(6) 2016 for cystitis interstitial, ibuprofen since 2013 for inflammation, hyoscyamine sulfate;methenamine;methylthioninium chloride;phenyl salicylate;phosphoric acid sodium (urelle) from (b)(6) 2015 to (b)(6) 2016, pyricarbate (pyridinin) from (b)(6) 2015 to (b)(6) 2016 and sucralfate (urbal) from (b)(6) 2015 to (b)(6) 2016 for micturition disorder, fluconazole (diflucan) since 2015 for yeast infection as well as from (b)(6) 2016 to (b)(6) 2016, d-mannose and tamsulosin.In 2013, the patient experienced pruritus ("itched all over").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced endometriosis (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced the first episode of cystitis interstitial (seriousness criterion medically significant).In 2016, the patient experienced abdominal distension ("bloating").In (b)(6) 2017, the patient experienced adenomyosis ("endometriosis and adenomyosis").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, menorrhagia ("bleed 21 days a month / excessive bleeding / my menstrual cycles dropped from 21 days of flow to 14 day/my period lasts almost two weeks & its heavy for 10 of those 14 days "), device expulsion ("third coil attached to my endometrial wall"), headache ("headaches"), mental disorder ("caused or aggravated any psychiatric and/or psychological condition(s)"), allergy to metals ("hypersensitivity reaction to nickel / any other component of essure"), nausea ("bouts of nausea"), diarrhoea ("diarrhea"), bladder pain ("bladder pain (constant pressure and pain.Unable to void completely.Constant feeling of having urinary tract infection)"), pain ("i still reel the left side pain sometimes"), cyst ("have had surgery twice before to remove almost 3- 4" cysts"), paraesthesia ("has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal"), hypoaesthesia ("has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal"), rash pruritic ("my naval incision started burning again like itchy sunburn and still hurts/just itches and bum on the skin below my belly button and inside"), muscular weakness ("have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time"), alopecia ("major hair loss still after removal"), bladder disorder ("pain is mostly bladder issues "), urinary tract infection ("horrible uti") and the second episode of cystitis interstitial ("interstitial cystitis").The patient was treated with surgery (cystoscopy with hydrodistention followed by medications (imipramine,uribel), laproscopy to remove essure and excise endometriosis and underwent laparoscopic vaginally assisted hysterectomy removing uterus,cervix and fallopian tubes.).Essure was removed on (b)(6) 2013.At the time of the report, the embedded device, device expulsion, endometriosis, adenomyosis, mental disorder, allergy to metals, abdominal distension, bladder pain, pain, cyst, paraesthesia, hypoaesthesia, rash pruritic, muscular weakness, alopecia, bladder disorder, urinary tract infection and the last episode of cystitis interstitial outcome was unknown, the menorrhagia was resolving, the headache had not resolved and the pruritus, nausea and diarrhoea had resolved.The reporter provided no causality assessment for device expulsion with essure.The reporter considered abdominal distension, adenomyosis, allergy to metals, alopecia, bladder disorder, bladder pain, cyst, diarrhoea, embedded device, endometriosis, headache, hypoaesthesia, menorrhagia, mental disorder, muscular weakness, nausea, pain, paraesthesia, pruritus, rash pruritic, urinary tract infection, the first episode of cystitis interstitial and the second episode of cystitis interstitial to be related to essure.The reporter commented: she received treatment endometriosis, interstitial cystitis and endometriosis and adenomyosis.She did not claim that allergic to nickel or any other component of essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.9 kg/sqm.On (b)(6) 2013 hsg confirmation test: both tubes are blocked completely and in correct position, but has a third coil attached to endometrium.On (b)(6) 2017, surgical pathology- microscopic description: histologic sections of the hysterectomy specimen reveal acute and chronic inflammation of the uterine cervix.The inflammation surrounds benign nabothian cysts.There is no evidence of cervical dysplasia or malignancy.Section of the endometrium reveals a small benign polyp.The polyp is present in a background of a proliferative phase pattern.There is no evidence of endometrial hyperplasia or malignancy.Sections of the myometrium are histologically unremarkable.There is no evidence of a myometrial neoplasm.Representative sections of the uterine serosa show benign fibro vascular adhesions.There are no serosal tumor implants or endometriosis.Sections of the left fallopian tube are remarkable for a benign para tubal cyst.There is no significant tubal inflammation or malignancy.Sections of the left ovary reveal hemorrhagic luteal cysts and small follicular cysts.There is no evidence of an ovarian malignancy.Concerning the injuries reported in this case, the following one/ones were reported via social media-events i still reel the left side pain sometimes, have had surgery twice before to remove almost 3- 4" cysts, has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal, my naval incision started burning again like itchy sunburn and still hurts.Had to go back on the pain meds just to sleep and bear it, just itches and bum on the skin below my belly button and inside, have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time, interstitial cystitis, horrible uti, pain is mostly bladder issues, major hair loss still after removal were added.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in wi-03635, ¿processing essure cases in (b)(4)." fda evaluation codes: method: 3323 ¿ no testing methods performed.Results: 3221 ¿ no results available since no evaluation performed.Conclusions: 67 ¿ unable to confirm complaint.92 ¿ device not returned.Medical assessment: the reported medical events are not indicative for a quality deficit per se.The case refers also to a deployment issue.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At the time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.Most recent follow-up information incorporated above includes: on 6-jan-2020: all source documents and references from deletion case (b)(4) were transferred to this case.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 case was initially received via regulatory authority (reference number: mw5031985) on 25-oct-2013.The most recent information was received on 21-aug-2020.This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('third coil attached to my endometrial wall / coil embedded in my uterus') in a 36-year-old female patient who had essure (batch no.A66685) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "third coil attached to my endometrial wall", device deployment issue "device did not deploy", device use issue "three coils were inserted instead of two" and device difficult to use "had difficulty getting the left coil to deploy".The patient's medical history included multigravida, parity 3 ((b)(6) 1993, (b)(6) 2008 and (b)(6) 2013) and nabothian cyst.On (b)(6) 2013 hsg confirmation test: both tubes are blocked completely and in correct postition, but has a third coil attached to endometrium.On (b)(6) 2017, surgical pathology- microscopic description: histologic sections of the hysterectomy specimen reveal acute and chronic inflammation of the uterine cervix.The inflammation surrounds benign nabothian cysts.There is no evidence of cervical dysplasia or malignancy.Section of the endometrium reveals a small benign polyp.The polyp is present in a background of a proliferative phase pattern.There is no evidence of endometrial hyperplasia or malignancy.Sections of the myometrium are histologically unremarkable.There is no evidence of a myometrial neoplasm.Representative sections of the uterine serosa show benign fibro vascular adhesions.There are no serosal tumor implants or endometriosis.Sections of the left fallopian tube are remarkable for a benign para tubal cyst.There is no significant tubal inflammation or malignancy.Sections of the left ovary reveal hemorrhagic luteal cysts and small follicular cysts.There is no evidence of an ovarian malignancy.Concurrent conditions included dysmenorrhoea since (b)(6) 2013 and body mass index normal.Concomitant products included imipramine from (b)(6) 2015 to (b)(6) 2016 and pentosan polysulfate sodium (elmiron) from (b)(6) 2016 to (b)(6) 2016 for cystitis interstitial, ibuprofen since 2013 for inflammation, hyoscyamine sulfate;methenamine;methylthioninium chloride;phenyl salicylate;phosphoric acid sodium (urelle) from (b)(6) 2015 to (b)(6) 2016, pyricarbate (pyridinin) from (b)(6) 2015 to (b)(6) 2016 and sucralfate (urbal) from (b)(6) 2015 to (b)(6) 2016 for micturition disorder, fluconazole (diflucan) since 2015 for yeast infection as well as from (b)(6) 2016 to (b)(6) 2016, d-mannose and tamsulosin.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced pruritus ("itched all over").In (b)(6) 2013, the patient experienced endometriosis ("endometriosis(endometriosis on bladder as well)").In (b)(6) 2015, the patient experienced the first episode of cystitis interstitial ("interstitial cystitis").In 2016, the patient experienced abdominal distension ("bloating").In (b)(6) 2017, the patient experienced adenomyosis ("endometriosis and adenomyosis").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, menorrhagia ("bleed 21 days a month / excessive bleeding / my menstrual cycles dropped from 21 days of flow to 14 day/my period lasts almost two weeks & its heavy for 10 of those 14 days "), device expulsion ("third coil attached to my endometrial wall"), headache ("headaches"), mental disorder ("caused or aggravated any psychiatric and/or psychological condition(s)"), allergy to metals ("hypersensitivity reaction to nickel / any other component of essure"), nausea ("bouts of nausea"), diarrhoea ("diarrhea"), bladder pain ("bladder pain (constant pressure and pain.Unable to void completely.Constant feeling of having urinary tract infection)"), pain ("i still reel the left side pain sometimes"), cyst ("have had surgery twice before to remove almost 3- 4" cysts"), paraesthesia ("has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal"), hypoaesthesia ("has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal"), rash pruritic ("my naval incision started burning again like itchy sunburn and still hurts/just itches and bum on the skin below my belly button and inside"), muscular weakness ("have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time"), alopecia ("major hair loss still after removal"), bladder disorder ("pain is mostly bladder issues "), urinary tract infection ("horrible uti") and the second episode of cystitis interstitial ("interstitial cystitis").The patient was treated with surgery (cystoscopy with hydrodistention followed by medications (imipramine,uribel), laproscopy to remove essure and excise endometriosis and underwent laparoscopic vaginally assisted hysterectomy removing uterus,cervix and fallopian tubes.Oo).Essure was removed on (b)(6) 2013.At the time of the report, the embedded device, device expulsion, endometriosis, adenomyosis, mental disorder, allergy to metals, abdominal distension, bladder pain, pain, cyst, paraesthesia, hypoaesthesia, rash pruritic, muscular weakness, alopecia, bladder disorder, urinary tract infection and the last episode of cystitis interstitial outcome was unknown, the menorrhagia was resolving, the headache had not resolved and the pruritus, nausea and diarrhoea had resolved.The reporter provided no causality assessment for device expulsion with essure.The reporter considered abdominal distension, adenomyosis, allergy to metals, alopecia, bladder disorder, bladder pain, cyst, diarrhoea, embedded device, endometriosis, headache, hypoaesthesia, menorrhagia, mental disorder, muscular weakness, nausea, pain, paraesthesia, pruritus, rash pruritic, urinary tract infection, the first episode of cystitis interstitial and the second episode of cystitis interstitial to be related to essure.The reporter commented: she received treatment endometriosis, interstitial cystitis and endometriosis and adenomyosis.She did not claim that allergic to nickel or any other component of essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: effective placement of essure fallopian tube sterllization devices without any extravasation of contrast through the fallopian tubes into the pelvis.Concerning the injuries reported in this case, the following one/ones were reported via social media-events i still reel the left side pain sometimes, have had surgery twice before to remove almost 3- 4" cysts, has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal, my naval incision started burning again like itchy sunburn and still hurts.Had to go back on the pain meds just to sleep and bear it, just itches and bum on the skin below my belly button and inside, have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time, interstitial cystitis, horrible uti, pain is mostly bladder issues, major hair loss still after removal were added.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-aug-2020: quality safety evaluation of ptc (product technical complaint).We received a lot number in this case.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.
|
| |
|
Manufacturer Narrative
|
|
This case was initially received via regulatory authority (reference number: mw5031985) on 25-oct-2013.The most recent information was received on 29-jul-2020.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in (b)(4), ¿processing essure cases in dev@com.¿ fda evaluation codes: method: 3323 ¿ no testing methods performed.Results: 3221 ¿ no results available since no evaluation performed.Conclusions: 67 ¿ unable to confirm complaint.92 ¿ device not returned.Medical assessment: the reported medical events are not indicative for a quality deficit per se.The case refers also to a deployment issue.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At the time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('third coil attached to my endometrial wall / coil embedded in my uterus'), endometriosis ('endometriosis(endometriosis on bladder as well)') and multiple episodes of cystitis interstitial ('interstitial cystitis', 'interstitial cystitis') in a 36-year-old female patient who had essure (batch no.A66685) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "third coil attached to my endometrial wall", device deployment issue "device did not deploy", device use issue "three coils were inserted instead of two" and device difficult to use "had difficulty getting the left coil to deploy".The patient's medical history included multigravida, parity 3 ((b)(6) 1993, (b)(6) 2008 and (b)(6) 2013) and nabothian cyst.On (b)(6) 2013 hsg confirmation test: both tubes are blocked completely and in correct postition, but has a third coil attached to endometrium.On (b)(6) 2017, surgical pathology- microscopic description: histologic sections of the hysterectomy specimen reveal acute and chronic inflammation of the uterine cervix.The inflammation surrounds benign nabothian cysts.There is no evidence of cervical dysplasia or malignancy.Section of the endometrium reveals a small benign polyp.The polyp is present in a background of a proliferative phase pattern.There is no evidence of endometrial hyperplasia or malignancy.Sections of the myometrium are histologically unremarkable.There is no evidence of a myometrial neoplasm.Representative sections of the uterine serosa show benign fibro vascular adhesions.There are no serosal tumor implants or endometriosis.Sections of the left fallopian tube are remarkable for a benign para tubal cyst.There is no significant tubal inflammation or malignancy.Sections of the left ovary reveal hemorrhagic luteal cysts and small follicular cysts.There is no evidence of an ovarian malignancy.Concurrent conditions included dysmenorrhoea since (b)(6) 2013 and body mass index normal.Concomitant products included imipramine from (b)(6) 2015 to (b)(6) 2016 and pentosan polysulfate sodium (elmiron) from (b)(6) 2016 for cystitis interstitial, ibuprofen since 2013 for inflammation, hyoscyamine sulfate;methenamine;methylthioninium chloride;phenyl salicylate;phosphoric acid sodium (urelle) from (b)(6) 2015 to (b)(6) 2016, pyricarbate (pyridinin) from (b)(6) 2015 to (b)(6) 2016 and sucralfate (urbal) from (b)(6) 2015 to (b)(6) 2016 for micturition disorder, fluconazole (diflucan) since 2015 for yeast infection as well as from (b)(6) 2016, d-mannose and tamsulosin.In 2013, the patient experienced pruritus ("itched all over").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced endometriosis (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced the first episode of cystitis interstitial (seriousness criterion medically significant).In 2016, the patient experienced abdominal distension ("bloating").In (b)(6) 2017, the patient experienced adenomyosis ("endometriosis and adenomyosis").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, menorrhagia ("bleed 21 days a month / excessive bleeding / my menstrual cycles dropped from 21 days of flow to 14 day/my period lasts almost two weeks & its heavy for 10 of those 14 days "), device expulsion ("third coil attached to my endometrial wall"), headache ("headaches"), mental disorder ("caused or aggravated any psychiatric and/or psychological condition(s)"), allergy to metals ("hypersensitivity reaction to nickel / any other component of essure"), nausea ("bouts of nausea"), diarrhoea ("diarrhea"), bladder pain ("bladder pain (constant pressure and pain.Unable to void completely.Constant feeling of having urinary tract infection)"), pain ("i still reel the left side pain sometimes"), cyst ("have had surgery twice before to remove almost 3- 4" cysts"), paraesthesia ("has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal"), hypoaesthesia ("has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal"), rash pruritic ("my naval incision started burning again like itchy sunburn and still hurts/just itches and bum on the skin below my belly button and inside"), muscular weakness ("have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time"), alopecia ("major hair loss still after removal"), bladder disorder ("pain is mostly bladder issues "), urinary tract infection ("horrible uti") and the second episode of cystitis interstitial ("interstitial cystitis").The patient was treated with surgery (cystoscopy with hydrodistention followed by medications (imipramine,uribel), laproscopy to remove essure and excise endometriosis and underwent laparoscopic vaginally assisted hysterectomy removing uterus,cervix and fallopian tubes.Oo).Essure was removed on (b)(6) 2013.At the time of the report, the embedded device, device expulsion, endometriosis, adenomyosis, mental disorder, allergy to metals, abdominal distension, bladder pain, pain, cyst, paraesthesia, hypoaesthesia, rash pruritic, muscular weakness, alopecia, bladder disorder, urinary tract infection and the last episode of cystitis interstitial outcome was unknown, the menorrhagia was resolving, the headache had not resolved and the pruritus, nausea and diarrhoea had resolved.The reporter provided no causality assessment for device expulsion with essure.The reporter considered abdominal distension, adenomyosis, allergy to metals, alopecia, bladder disorder, bladder pain, cyst, diarrhoea, embedded device, endometriosis, headache, hypoaesthesia, menorrhagia, mental disorder, muscular weakness, nausea, pain, paraesthesia, pruritus, rash pruritic, urinary tract infection, the first episode of cystitis interstitial and the second episode of cystitis interstitial to be related to essure.The reporter commented: she received treatment endometriosis, interstitial cystitis and endometriosis and adenomyosis.She did not claim that allergic to nickel or any other component of essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: effective placement of essure fallopian tube sterllization devices without any extravasation of contrast through the fallopian tubes into the pelvis.Concerning the injuries reported in this case, the following one/ones were reported via social media-events i still reel the left side pain sometimes, have had surgery twice before to remove almost 3- 4" cysts, has had numbness in the top of legs like a tingling feeling.Had that real bad the week leading up to my removal, my naval incision started burning again like itchy sunburn and still hurts.Had to go back on the pain meds just to sleep and bear it, just itches and bum on the skin below my belly button and inside, have leg weakness.I did prior to my removal as well as the feeling my legs were asleep all the time, interstitial cystitis, horrible uti, pain is mostly bladder issues, major hair loss still after removal were added.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in (b)(4), ¿processing essure cases in dev@com.¿ fda evaluation codes: method: 3323 ¿ no testing methods performed.Results: 3221 ¿ no results available since no evaluation performed.Conclusions: 67 ¿ unable to confirm complaint.92 ¿ device not returned.Medical assessment: the reported medical events are not indicative for a quality deficit per se.The case refers also to a deployment issue.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At the time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.Most recent follow-up information incorporated above includes: on 29-jul-2020: mr received: reporter added, lot number added, medical history added.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
|
| |
|
Search Alerts/Recalls
|
|
