| Model Number ESS305 |
| Device Problem
Patient-Device Incompatibility (2682)
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| Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Menstrual Irregularities (1959); Pain (1994); Swelling (2091); Tissue Damage (2104); Disability (2371); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191); Constipation (3274)
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| Event Date 01/01/2009 |
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a female consumer via regulatory authority fda (case# mw5032160) in united states on 11-dec-2013 which refers to herself (unspecified age) who had essure (fallopian tube occlusion insert) inserted and she had uterine enlargement resulting in adenomyosis.No information given on consumer's history, past drugs concurrent conditions, and concomitant medication.On (b)(6) 2013 the consumer had essure (fallopian tube occlusion insert) inserted.On (b)(6) 2013 the consumer had uterine enlargement resulting in adenomyosis and a total hysterectomy was performed on (b)(6) 2013 and essure was removed.Reporter causality: the reporter assessment was not reported.Follow-up information received from consumer on 14-jan-2014: the consumer's birthdate was provided.She was (b)(6)at the time of first symptom onset.She was (b)(6) height and (b)(6) weight (bmi: (b)(6)).She considered herself perfectly healthy before having the essure inserted and she did not have relevant medical history or concurrent conditions.She had the essure inserted in (b)(6) 2009, after her last delivery (dated on (b)(6) 2009).Depo-provera was administered on the same of essure insertion for backup contraception.The hysterosalpingography was performed in 2010, showing both tubes occluded.Heavy bleeding, pelvic pain, pain with intercourse, pain during her cycles (pain never let up) started after essure's insertion, and from 2012 it had been really bothering.She had visited her doctor every 6 months concerning these symptoms and tried birth control.The diagnosis of adenomyosis was provided.On (b)(6) 2013, the consumer underwent to an x-ray test and the essure coils were seen to be bent.The consumer wanted to have the essure removed in order for the pain to go away and the doctor also recommended it.On (b)(6) 2013, the consumer had laparoscopic hysterectomy (ovaries were kept) and essure's removal, being hospitalized during the hysterectomy (time frame was not provided).During surgery, it had been found that essure inserts were still in fallopian tubes.Pathology results were in possession of her physician.She had recovered from the essure removal procedure.The consumer was feeling better/great at the time of report and had recovered from pelvic pain and pain with intercourse.The reporting consumer has considered that the essure caused these issues since all symptoms started after insertion.Result and assessment of the product technical complaint investigation received on 26-jan-2014: 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." method: no testing methods performed.Results: no results available since no evaluation performed.Conclusions: unable to confirm complaint; device not returned.Medical assessment: the medical events reported are not indicative for a quality defect per se.The reported medical events were assessed as being not related to the product.No complaint sample was provided for further technical investigation.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.The technical investigation concluded "unconfirmed quality defect".In summary, based on the available information there is no reason to suspect quality defect.Follow-up information received on 23-jan-2014: no new information provided.Follow-up information was received on 12-aug-2015.This case has been identified during monitoring of postings on an fda hosted docket website (#(b)(4)), which has been established in preparation of a public fda advisory committee meeting taking place in (b)(4) 2015.Essure ruined her life, her marriage and her body.She was experiencing pain as result of essure.According to the consumer, removing essure was one of the best decisions she has made for her life.Follow-up information received on 22-aug-2015.This follow-up has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting taking place in (b)(4) 2015 ((b)(4)).Around christmas 2010 was when she began noticing a change in her weight, pms and cycles.She was retaining more and more weight verse it falling off as it did with her son and was given the mirena after him.She noticed a change but it was not significant enough for a concern.She put it off as the change and adjustment to the essure since it was placed 4-6 months ago.Her period had than settle into a different day and became consistent again at that point her period start dates were the 11th of each month for 5 to 6 days.After passing the change off to her body adjusting to this foreign device, her mood really changed.She was gaining weight, she didn't have the energy to cook, clean and have sex.After she had gotten the essure procedure her life fell apart; she was mean and rude to babies and constant mode changes, lack of energy, lack of sexual drive and unwillingness.As she was still having sex, around (b)(6) 2011 she began having the weird feelings symptoms and sensation of being pregnant.As a woman who underwent a sterilization procedure she knew she could not be pregnant she was just going crazy, but her symptoms got stronger.She decided to take a home pregnancy test and it was negative, so she waited a week still no period and took another pregnancy test and still negative.After that she decided to have a routine pap smear.A third pregnancy test was done and it was also negative.Physician asked if she ever had the hsg done and she replied no, so the dye test was done in (b)(6) 2011 and was 100% blocked.She stated that her hcg hormones were not strong and they were causing false negatives when she was in fact pregnant.The same thing happened to her son (the tester told her it was negative and she had to take a second test before a positive appeared).She decided to call her doctor to schedule a pregnancy test and the physician thought she was crazy.Later that month her period came and it was extremely heavy with flesh partial or blood clots in it, in which she believed was a miscarriage (no medical supporting documents just her knowing her body).The pains were consistent they started to come every day at a point.Each time she attempted to have sex it would hurt so bad.She had issues with passing her stool.She had extreme sharp pain streak down her abdomen down through her vagina and rectum.Her rectum hurt so badly that she was unable to sit.She began bloating and gaining weight 10 pounds at a time.She went to the physician regarding her issues because she knew it was essure related because she found the essure problem group on facebook and other women have been having the same issues.She also had period heavy, duty pads within an hour or less, rectum pains, knife stabbing feeling in abdomen each month, debilitating sharp pains in abdomen, swollen sore to the touch uterus, constipation, painful sex, hair falling out and imitability.Her pap was not normal and she had a bladder infection and was instructed to take flagyl.Company causality comment: this spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and experienced uterine enlargement resulting in adenomyosis, heavy bleeding and pelvic pain.Essure inserts were removed.Heavy bleeding and pelvic pain are listed, while uterine enlargement and adenomyosis are unlisted in the reference safety information for essure.Adenomyosis refers to a disorder in which ectopic endometrial tissue grows into the uterine musculature.Risk factors for adenomyosis include: prior uterine surgery, middle age, and childbirth.In the present case, uterine enlargement had probably occurred as a consequence of adenomyosis.Considering the pathophysiology of adenomyosis, causality with essure is unlikely.It is also unlikely that essure had caused an enlargement of uterus.Consumer also reported heavy bleeding after essure insertion that started 4 years before the date of the report.Considering her diagnosis of adenomyosis (a plausible alternative explanation), causality between this event and essure use can be excluded.In this case, the consumer stated she was experiencing pain as a result of essure.Although the temporal relationship is unclear, considering that essure may cause pelvic pain, this event is assessed as related.Additional non-serious events were reported.This case is regarded as incident since a device removal was required.The initial product technical complaint analysis concluded there is no reason to suspect quality defect.An updated analysis is expected.
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Manufacturer Narrative
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12/23/2015 - case closed.
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Manufacturer Narrative
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Follow-up information received on 11-feb-2016 from consumer: the consumer reported painful sex, depression, and weight gain which finally went away after she got essure removed via hysterectomy.Follow-up received on 17-feb-2016: no new information received.Company causality comment: this spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and experienced uterine enlargement resulting in adenomyosis, heavy bleeding and pelvic pain.Essure inserts were removed via hysterectomy.Heavy bleeding and pelvic pain are listed, while uterine enlargement and adenomyosis are unlisted in the reference safety information for essure.Adenomyosis refers to a disorder in which ectopic endometrial tissue grows into the uterine musculature.Risk factors for adenomyosis include: prior uterine surgery, middle age, and childbirth.In the present case, uterine enlargement had probably occurred as a consequence of adenomyosis.Considering the pathophysiology of adenomyosis, causality with essure is unlikely.It is also unlikely that essure had caused an enlargement of uterus.Consumer also reported heavy bleeding after essure insertion that started 4 years before the date of the report.Considering her diagnosis of adenomyosis (a plausible alternative explanation), causality between this event and essure use can be excluded.In this case, the consumer stated she was experiencing pain as a result of essure.Although the temporal relationship is unclear, considering that essure may cause pelvic pain, this event is assessed as related.Additional non-serious events were reported.This case is regarded as incident since a device removal (via hysterectomy) was required.The product technical complaint analysis concluded there is no reason to suspect quality defect.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This case was initially received via regulatory authority food and drug administration (reference number: mw5032160) on 11-dec-2013.The most recent information was received on 22-nov-2017.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain / pain never let up/pelvic pains/ left and right pelvis (stabbing pain debilitating unable to move)/debilitating side pains"), vulvovaginal pain ("vagina pain/ persistent vaginal pain/ vaginal wall pain"), pregnancy with contraceptive device ("pregnancy"), abortion spontaneous ("miscarriage"), the first episode of uterine enlargement ("caused uterus to enlarge resulting in adenomyosis / enlarged uterus"), adenomyosis ("caused uterus to enlarge resulting in adenomyosis") and genital haemorrhage ("heavy bleeding") in a (b)(6) year-old 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 kink "essure coils were bent" and device ineffective "device ineffective".The patient's past medical history included delivery on (b)(6) 2009, cesarean section in 2006, gravida ii and parity 2 (((b)(6))).Previously administered products included for an unreported indication: nova ring and mirena.Concurrent conditions included obesity and mood swings.Concomitant products included medroxyprogesterone acetate (depo-provera) in (b)(6) 2009.In 2009, 92 days before insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dyspareunia ("pain with intercourse / painful sex") and dysmenorrhoea ("pain during her cycles").In september 2009, the patient had essure inserted.In 2010, the patient experienced vulvovaginal pain (seriousness criteria medically significant and intervention required).On (b)(6) 2013, the patient experienced the first episode of uterine enlargement (seriousness criterion hospitalization).On an unknown date, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant), abortion spontaneous (seriousness criterion medically significant), adenomyosis (seriousness criterion hospitalization), weight increased ("change in my weight / weight gain"), premenstrual syndrome ("pms"), menstrual disorder ("change in cycles"), mood altered ("mood changed/ mood swings"), asthenia ("lack of energy"), loss of libido ("lack of sexual drive"), apathy ("unwillingness"), feeling abnormal ("having the weird feelings, symptoms and sensation of being pregnant/ mental fog/mental unclearness due to essure"), menorrhagia ("period came and it was extremely heavy with flesh partial or blood clots in it/ extremely heavy periods"), gastrointestinal motility disorder ("issues with passing my stool"), abdominal pain ("extreme sharp pain streak down in abdomen / knife stabbing feeling in abdomen"), proctalgia ("rectum pain"), abdominal distension ("bloating"), the second episode of uterine enlargement ("swollen uterus"), uterine pain ("sore uterus"), constipation ("constipation"), alopecia ("hair falling out"), irritability ("irritability"), smear cervix abnormal ("my pap was not normal"), cystitis ("bladder infection"), depression ("depression / mental depression following surgery for removal") and weight decreased ("weight loss").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with metronidazole (flagyl), surgery (she underwent hysterectomy.), surgery (underwent hysterectomy) and surgery (she underwent hysterectomy).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, vulvovaginal pain, adenomyosis, genital haemorrhage, dyspareunia, dysmenorrhoea, weight increased, mood altered, feeling abnormal, menorrhagia, abdominal distension and depression had resolved and the pregnancy with contraceptive device, abortion spontaneous, premenstrual syndrome, menstrual disorder, asthenia, loss of libido, apathy, gastrointestinal motility disorder, abdominal pain, proctalgia, the last episode of uterine enlargement, uterine pain, constipation, alopecia, irritability, smear cervix abnormal, cystitis and weight decreased outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abdominal pain, abortion spontaneous, adenomyosis, alopecia, apathy, asthenia, constipation, cystitis, dysmenorrhoea, dyspareunia, feeling abnormal, gastrointestinal motility disorder, genital haemorrhage, irritability, loss of libido, menorrhagia, menstrual disorder, mood altered, pelvic pain, pregnancy with contraceptive device, premenstrual syndrome, proctalgia, smear cervix abnormal, uterine pain, vulvovaginal pain, weight decreased, weight increased and the second episode of uterine enlargement to be related to essure.The reporter provided no causality assessment for depression and the first episode of uterine enlargement with essure.The reporter commented: she had not sought medical treatment for miscarriage diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2011: essure placement was successful.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.Medical assessment: the medical events reported are not indicative for a quality defect per se.The reported medical events were assessed as being not related to the product.No complaint sample was provided for further technical investigation.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.The technical investigation concluded "unconfirmed quality defect".In summary, based on the available information there is no reason to suspect quality defect.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 22-nov-2017: new reporter added.Events updated: pelvic pain / pain never let up/pelvic pains/ left and right pelvis (stabbing pain debilitating unable to move)/debilitating side pains, caused uterus to enlarge resulting in adenomyosis / enlarged uterus, vagina pain/ persistent vaginal pain/ vaginal wall pain, mood changed/ mood swings, having the weird feelings, weight loss, symptoms and sensation of being pregnant/ mental fog/mental unclearness due to essure, period came and it was extremely heavy with flesh partial or blood clots in it/ extremely heavy periods, depression / mental depression following surgery for removal.New events added: miscarriage, pregnancy, weight loss and device ineffective.¿essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only¿.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5032160) on 11-dec-2013.The most recent information was received on 27-jun-2018.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain / pain never let up/pelvic pains/ left and right pelvis (stabbing pain debilitating unable to move)/debilitating side pains"), vulvovaginal pain ("vagina pain/ persistent vaginal pain/ vaginal wall pain"), pregnancy with contraceptive device ("pregnancy"), abortion spontaneous ("miscarriage"), the second episode of uterine enlargement ("caused uterus to enlarge resulting in adenomyosis / enlarged uterus"), adenomyosis ("caused uterus to enlarge resulting in adenomyosis") and genital haemorrhage ("heavy bleeding") in a 24-year-old 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 kink "essure coils were bent" and device ineffective "device ineffective".The patient's past medical history included delivery on (b)(6) 2009, cesarean section in 2006, gravida ii, parity 2 (((b)(6) 2006, (b)(6) 2009)) and breast lump removal in (b)(6) 2014.Previously administered products included for an unreported indication: nova ring and mirena.Concurrent conditions included obesity, mood swings, leiomyoma nos, paratubal cyst, cervicitis and pelvic adhesions.Concomitant products included ibuprofen, ketorolac tromethamine (toradol), medroxyprogesterone acetate (depo-provera) since (b)(6) 2009, paracetamol (acetaminophen) and prenatal vitamins (prenatal vitamins [vit c,vit h,min nos,vit pp,retinol,vit e,vit b nos,).In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dyspareunia ("pain with intercourse / painful sex/dyspareunia") and dysmenorrhoea ("pain during her cycles").In (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced abdominal distension ("bloating").In (b)(6) 2010, the patient experienced vulvovaginal pain (seriousness criteria medically significant and intervention required) and abdominal pain ("extreme sharp pain streak down in abdomen / knife stabbing feeling in abdomen").In (b)(6) 2010, the patient experienced mood altered ("mood changed/ mood swings"), feeling abnormal ("having the weird feelings, symptoms and sensation of being pregnant/ mental fog/mental unclearness due to essure") and depression ("depression / mental depression following surgery for removal").In (b)(6) 2010, the patient experienced weight increased ("change in my weight / weight gain").In 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) and abortion spontaneous (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced menorrhagia ("period came and it was extremely heavy with flesh partial or blood clots in it/ extremely heavy periods").In (b)(6) 2013, the patient experienced the first episode of uterine enlargement ("swollen uterus").On (b)(6) 2013, the patient experienced the second episode of uterine enlargement (seriousness criterion hospitalization).On an unknown date, the patient experienced adenomyosis (seriousness criterion hospitalization), premenstrual syndrome ("pms"), menstrual disorder ("change in cycles"), asthenia ("lack of energy"), loss of libido ("lack of sexual drive"), apathy ("unwillingness"), gastrointestinal motility disorder ("issues with passing my stool"), proctalgia ("rectum pain"), uterine pain ("sore uterus"), constipation ("constipation"), alopecia ("hair falling out"), irritability ("irritability"), smear cervix abnormal ("my pap was not normal"), cystitis ("bladder infection") and weight decreased ("weight loss").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with metronidazole (flagyl), surgery (she underwent hysterectomy.), surgery (underwent hysterectomy) and surgery (she underent hysterectomy).Essure was removed on (b)(6) 2013.On (b)(6) 2013, the last episode of uterine enlargement had resolved.At the time of the report, the pelvic pain, vulvovaginal pain, adenomyosis, genital haemorrhage, dyspareunia, dysmenorrhoea, weight increased, mood altered, feeling abnormal, menorrhagia, abdominal distension and depression had resolved and the pregnancy with contraceptive device, abortion spontaneous, premenstrual syndrome, menstrual disorder, asthenia, loss of libido, apathy, gastrointestinal motility disorder, abdominal pain, proctalgia, uterine pain, constipation, alopecia, irritability, smear cervix abnormal, cystitis and weight decreased outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter provided no causality assessment for depression and the second episode of uterine enlargement with essure.The reporter considered abdominal distension, abdominal pain, abortion spontaneous, adenomyosis, alopecia, apathy, asthenia, constipation, cystitis, dysmenorrhoea, dyspareunia, feeling abnormal, gastrointestinal motility disorder, genital haemorrhage, irritability, loss of libido, menorrhagia, menstrual disorder, mood altered, pelvic pain, pregnancy with contraceptive device, premenstrual syndrome, proctalgia, smear cervix abnormal, uterine pain, vulvovaginal pain, weight decreased, weight increased and the first episode of uterine enlargement to be related to essure.The reporter commented: she had not sought medical treatment for miscarriage.Current weight- 198lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 39.9 kg/sqm.Ultrasound scan - on an unknown date: enlarged uterus concerning the injuries reported in this case, the following ones were described in patient¿s medical records:dysmenorrhea, dyspareunia, pelvic pain quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 27-jun-2018: quality-safety evaluation of ptc.Incident no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Search Alerts/Recalls
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