| Model Number ESS305 |
| Device Problems
Device Or Device Fragments Location Unknown (2590); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Bruise/Contusion (1754); Fatigue (1849); Headache (1880); Pain (1994); Tissue Damage (2104); Urinary Tract Infection (2120); Uterine Perforation (2121); Arthralgia (2355); Disability (2371); Fungal Infection (2419); Foreign Body In Patient (2687)
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| Event Date 01/01/2014 |
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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 consumer's mother in (b)(6) 2015 which refers to an adult female consumer who had essure (fallopian tube occlusion insert) inserted in 2009.The consumer's mother reported that since insertion, her daughter experienced joint pain, back pain, headaches, fatigue, pain in her right ovary, and bruising from her hips to her toes.She had a hysterectomy in (b)(6) 2014, and was told that one device was not in her fallopian tube.Since her hysterectomy, she had 4 (b)(6), cannot get out of bed and fatigue.Ptc investigation result was received on 05-aug-2015.This adverse event report is related to a product technical complaint (ptc).(b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse events considered related are known, possible, undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample were available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this non-medically confirmed, spontaneous case report refers to an adult female consumer who had essure (fallopian tube occlusion insert) inserted and one device was not in her fallopian tube (interpreted as device dislocation).She underwent a hysterectomy; since this surgery she experienced (b)(4).The reported events were considered serious due to medical importance.Only device dislocation is listed according to essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into the uterus or out of the body) or dislocation (into fallopian tube or to peritoneal cavity).Although, in this particular case, the exact mechanism of the event is unknown, given its nature; causality with the suspect device cannot be excluded.Regarding the reported (b)(4); considering the negative temporal relationship with essure therapy (event occurred after hysterectomy); it was considered as unrelated to the suspect insert.Additionally, non-serious events were reported.This case was regarded as incident since an intervention was required.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information is being sought.
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Manufacturer Narrative
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Follow-up received on 04-nov-2015: the required number of follow-up attempts have been completed, with no response to date.No further information will be provided.Company causality comment: this non-medically confirmed, spontaneous case report refers to an adult female consumer who had essure (fallopian tube occlusion insert) inserted and one device was not in her fallopian tube (interpreted as device dislocation).She underwent a hysterectomy; since this surgery she experienced 4 urinary tract infections.The reported events were considered serious due to medical importance.Only device dislocation is listed according to essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into the uterus or out of the body) or dislocation (into fallopian tube or to peritoneal cavity).Although, in this particular case, the exact mechanism of the event is unknown, given its nature; causality with the suspect device cannot be excluded.Regarding the reported urinary tract infection; considering the negative temporal relationship with essure therapy (event occurred after hysterectomy); it was considered as unrelated to the suspect insert.Additionally, non-serious events were reported.This case was regarded as incident since an intervention was required.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information could not be obtained.
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Manufacturer Narrative
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Data correction: the product code knh was replaced with hhs.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one device was not in her fallopian tube"), perforation ("perforation of organs") and urinary tract infection ("4 urinary tract infections") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2009, 61 days before insertion of essure, the patient experienced arthralgia ("joint pain"), back pain ("back pain"), headache ("headaches"), fatigue ("fatigue/cannot get out of bed"), adnexa uteri pain ("pain in her right ovary") and contusion ("bruising from her hips to her toes").In (b)(6) 2009, the patient had essure inserted.In (b)(6) 2014, the patient experienced urinary tract infection (seriousness criterion medically significant) and fungal infection ("yeast infections").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and perforation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (had surgery to remove the essure implant) and surgery (had surgery to remove the essure implant).Essure was removed in (b)(6) 2015.At the time of the report, the device dislocation, perforation, urinary tract infection, arthralgia, back pain, headache, fatigue, adnexa uteri pain, contusion and fungal infection outcome was unknown.The reporter provided no causality assessment for device dislocation, fungal infection and urinary tract infection with essure.The reporter considered adnexa uteri pain, arthralgia, back pain, contusion, fatigue, headache and perforation to be related to essure.The reporter commented: patient need for additional surgery.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse events considered related are known, possible, undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample were available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Most recent follow-up information incorporated above includes: on 16-nov-2017: event "perforation of organs ", reporter lawyer added from summon received.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma ag, (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one device was not in her fallopian tube"), fallopian tube perforation ("perforation (fallopian tube(s))/on the left the coil had penetrated muscular portion of the tube"), uterine perforation ("perforation (uterus)/the serosa was covering the tip of the coil") and urinary tract infection ("4 urinary tract infections") in an adult female patient who had essure (batch no.646519) inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight, endometriosis and galactorrhea.Concomitant products included alprazolam (xanax) since 2012, citalopram since 2012, escitalopram oxalate (lexapro), medroxyprogesterone acetate (depo-provera), naproxen, ondansetron (zofran) and tramadol since 2012.In 2009, the patient experienced arthralgia ("joint pain"), back pain ("back pain / lower back pain"), headache ("headaches"), fatigue ("fatigue/cannot get out of bed"), the first episode of adnexa uteri pain ("pain in her right ovary") and the first episode of contusion ("bruising from her hips to her toes").In (b)(6)2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),") and vaginal discharge ("vaginal discharge").On (b)(6)2009, the patient had essure inserted.In (b)(6)2010, the patient experienced migraine ("migraines").In (b)(6)2011, the patient experienced depression ("depression") and anxiety ("anxiety").In (b)(6)2011, the patient experienced dysuria ("painful urination"), pollakiuria ("frequent urination") and urinary incontinence ("bladder leakage").In (b)(6) 2011, the patient experienced mood swings ("hormonal changes describe: mood swings") and hot flush ("hot flashes").In (b)(6)2011, the patient experienced the second episode of contusion ("bruising") and rash ("rashes").In (b)(6)2012, the patient experienced nausea ("nausea").In (b)(6)2012, the patient experienced abdominal pain ("abdominal pain").In (b)(6)2013, the patient was found to have weight increased ("weight gain").In 2014, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and uterine perforation (seriousness criteria medically significant and intervention required).In (b)(6)2014, the patient experienced urinary tract infection (seriousness criterion medically significant) and fungal infection ("yeast infections").In (b)(6)2015, the patient experienced vaginal infection ("vaginitis").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), allergy to metals ("nickel allergy"), dyspareunia ("dyspareunia (painful sexual intercourse),"), the second episode of adnexa uteri pain ("right side ovary area"), vulvovaginal pain ("shootin pain in vagina") and menstrual disorder ("problem with period").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6)2014.At the time of the report, the device dislocation, fallopian tube perforation, uterine perforation, urinary tract infection, arthralgia, headache, fatigue, fungal infection, mood swings, hot flush, depression, anxiety, the last episode of contusion, rash, dysuria, pollakiuria, migraine, nausea, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, urinary incontinence and menstrual disorder outcome was unknown, the back pain, abdominal pain, the last episode of adnexa uteri pain and vulvovaginal pain was resolving and the vaginal haemorrhage and menorrhagia had resolved.The reporter provided no causality assessment for device dislocation, fungal infection and urinary tract infection with essure.The reporter considered abdominal pain, allergy to metals, anxiety, arthralgia, back pain, depression, dysmenorrhoea, dyspareunia, dysuria, fallopian tube perforation, fatigue, headache, hot flush, menorrhagia, menstrual disorder, migraine, mood swings, nausea, pollakiuria, rash, urinary incontinence, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal pain, weight increased, the first episode of adnexa uteri pain, the first episode of contusion, the second episode of adnexa uteri pain and the second episode of contusion to be related to essure.The reporter commented: patient need for additional surgery.Discrepancy noted: date of implant: (b)(6)2009 , (b)(6)2009.Date of explant: (b)(6)2015 , (b)(6)2014.Current weight 135 lbs.Hte essure devices were placed according to manufacturers directions in each tubal ostia.Coils visible outside of right tube 3, coils visible outside of left tube 3.Procedures: 1.Total laparoscopic hysterectomy.2.Bilateral salpingectomy.3.Abdominal repair of vaginal prolapse with a modified mccall culdoplasty.Findings: examination under anesthesia revealed prolapse of the uterus to the introitus.The fallopian tube was normal on the right side.The fallopian tube on the left side had extrusion of her essure coil from the muscular portion of the tube, but the serosa of the fallopian tube was intact.Both ovaries appeared normal.The uterus appeared boggy and had tortuous pelvic vasculature, most likely from the uterine prolapse.The appendix appeared normal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.1 kg/sqm.Hysterosalpingogram - on (b)(6)2009: occluded oviducts bilaterally.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain ,right lower quadrant pain, menorrhagia, contusion.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse events considered related are known, possible, undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample were available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Most recent follow-up information incorporated above includes: on 24-jan-2019: pfs and mr received.Reporters information updated.Lot no.Added.Event: perforation update dto fallopian tube perforation.Events:hormonal changes describe: mood swings, hot flashes, abnormal bleeding (vaginal, menorrhagia), urinary infections, depression, anxiety, rashes or skin conditions type: bruising and rashes, bladder or urinary problems or changes, migraines / headaches, nausea, nickel allergy, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pain, vaginal discharge,)), fatigue, perforation (uterus), weight gain,problem with period were added.Outcome of event: pain , bleeding were updated.Medical history , concomitant drugs, lab data were added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one device was not in her fallopian tube"), fallopian tube perforation ("perforation (fallopian tube(s))/on the left the coil had penetrated muscular portion of the tube"), uterine perforation ("perforation (uterus)/the serosa was covering the tip of the coil") and urinary tract infection ("4 urinary tract infections") in an adult female patient who had essure (batch no.646519) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included d & c.Concurrent conditions included weight normal, endometriosis and galactorrhea.Concomitant products included alprazolam (xanax) since 2012, citalopram since 2012, escitalopram oxalate (lexapro), medroxyprogesterone acetate (depo-provera), naproxen, ondansetron (zofran) and tramadol since 2012.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced arthralgia ("joint pain"), back pain ("back pain / lower back pain"), headache ("headaches"), fatigue ("fatigue/cannot get out of bed"), the first episode of adnexa uteri pain ("pain in her right ovary") and the first episode of contusion ("bruising from her hips to her toes").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),") and vaginal discharge ("vaginal discharge").In (b)(6) 2010, the patient experienced migraine ("migraines").In (b)(6) 2011, the patient experienced depression ("depression") and anxiety ("anxiety").In (b)(6) 2011, the patient experienced dysuria ("painful urination"), pollakiuria ("frequent urination") and urinary incontinence ("bladder leakage").In (b)(6) 2011, the patient experienced mood swings ("hormonal changes describe: mood swings") and hot flush ("hot flashes").In (b)(6) 2011, the patient experienced the second episode of contusion ("bruising") and rash ("rashes").In (b)(6) 2012, the patient experienced nausea ("nausea").In (b)(6) 2012, the patient experienced abdominal pain ("abdominal pain").In (b)(6) 2013, the patient was found to have weight increased ("weight gain").In 2014, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and uterine perforation (seriousness criteria medically significant and intervention required).In (b)(6) 2014, the patient experienced urinary tract infection (seriousness criterion medically significant) and fungal infection ("yeast infections").In (b)(6) 2015, the patient experienced vaginal infection ("vaginitis").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), allergy to metals ("nickel allergy"), dyspareunia ("dyspareunia (painful sexual intercourse),"), the second episode of adnexa uteri pain ("right side ovary area"), vulvovaginal pain ("shootin pain in vagina") and menstrual disorder ("problem with period").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, fallopian tube perforation, uterine perforation, urinary tract infection, arthralgia, headache, fatigue, fungal infection, mood swings, hot flush, depression, anxiety, the last episode of contusion, rash, dysuria, pollakiuria, migraine, nausea, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, urinary incontinence and menstrual disorder outcome was unknown, the back pain, abdominal pain, the last episode of adnexa uteri pain and vulvovaginal pain was resolving and the vaginal haemorrhage and menorrhagia had resolved.The reporter provided no causality assessment for device dislocation, fungal infection and urinary tract infection with essure.The reporter considered abdominal pain, allergy to metals, anxiety, arthralgia, back pain, depression, dysmenorrhoea, dyspareunia, dysuria, fallopian tube perforation, fatigue, headache, hot flush, menorrhagia, menstrual disorder, migraine, mood swings, nausea, pollakiuria, rash, urinary incontinence, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal pain, weight increased, the first episode of adnexa uteri pain, the first episode of contusion, the second episode of adnexa uteri pain and the second episode of contusion to be related to essure.The reporter commented: patient need for additional surgery.Discrepancy noted: date of implant: (b)(6) 2009 , (b)(6) 2009 date of explant: (b)(6) 2015 , (b)(6) 2014 current weight (b)(6).Hte essure devices were placed according to manufacturers directions in each tubal ostia.Coils visible outside of right tube 3, coils visible outside of left tube 3.Procedures: 1.Total laparoscopic hysterectomy.2.Bilateral salpingectomy.3.Abdominal repair of vaginal prolapse with a modified mccall culdoplasty.Findings: examination under anesthesia revealed prolapse of the uterus to the introitus.The fallopian tube was normal on the right side.The fallopian tube on the left side had extrusion of her essure coil from the muscular portion of the tube, but the serosa of the fallopian tube was intact.Both ovaries appeared normal.The uterus appeared boggy and had tortuous pelvic vasculature, most likely from the uterine prolapse.The appendix appeared normal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Hysterosalpingogram - on (b)(6) 2009: occluded oviducts bilaterally.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain ,right lower quadrant pain, menorrhagia, contusion.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of ptc incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('one device was not in her fallopian tube'), fallopian tube perforation ('perforation (fallopian tube(s))/on the left the coil had penetrated muscular portion of the tube,the coil was coming out of my right tube'), uterine perforation ('perforation (uterus)/the serosa was covering the tip of the coil') and urinary tract infection ('4 urinary tract infections') in an adult female patient who had essure (batch no.646519) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included d & c.Concurrent conditions included weight normal, endometriosis and galactorrhea.Concomitant products included alprazolam (xanax) since 2012, citalopram since 2012, escitalopram oxalate (lexapro), medroxyprogesterone acetate (depo-provera), naproxen, ondansetron (zofran) and tramadol since 2012.In 2009, the patient experienced arthralgia ("joint pain"), back pain ("back pain / lower back pain"), headache ("headaches"), fatigue ("fatigue/cannot get out of bed"), adnexa uteri pain ("pain in her right ovary") and contusion ("bruising from her hips to her toes").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),") and vaginal discharge ("vaginal discharge").On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2010, the patient experienced migraine ("migraines").In (b)(6) 2011, the patient experienced depression ("depression") and anxiety ("anxiety").In (b)(6) 2011, the patient experienced dysuria ("painful urination"), pollakiuria ("frequent urination") and urinary incontinence ("bladder leakage").In (b)(6) 2011, the patient experienced mood swings ("hormonal changes describe: mood swings") and hot flush ("hot flashes").In (b)(6) 2011, the patient experienced bruising ("bruising") and rash ("rashes").In (b)(6) 2012, the patient experienced nausea ("nausea").In (b)(6) 2012, the patient experienced abdominal pain ("abdominal pain").In (b)(6) 2013, the patient was found to have weight increased ("weight gain").In 2014, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and uterine perforation (seriousness criteria medically significant and intervention required).In (b)(6) 2014, the patient experienced urinary tract infection (seriousness criterion medically significant) and fungal infection ("yeast infections").In (b)(6) 2015, the patient experienced vaginal infection ("vaginitis").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), allergy to metals ("nickel allergy"), dyspareunia ("dyspareunia (painful sexual intercourse),"), ovarian pain ("right side ovary area"), vulvovaginal pain ("shooting pain in vagina") and menstrual disorder ("problem with period") and was found to have hormone level abnormal ("no hormones").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, fallopian tube perforation, uterine perforation, urinary tract infection, arthralgia, headache, fatigue, adnexa uteri pain, contusion, fungal infection, mood swings, hot flush, depression, anxiety, bruising, rash, dysuria, pollakiuria, migraine, nausea, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, urinary incontinence and menstrual disorder outcome was unknown, the back pain, abdominal pain, ovarian pain and vulvovaginal pain was resolving and the vaginal haemorrhage and menorrhagia had resolved.The reporter provided no causality assessment for device dislocation, fungal infection and urinary tract infection with essure.The reporter considered abdominal pain, adnexa uteri pain, allergy to metals, anxiety, arthralgia, back pain, contusion, depression, dysmenorrhoea, dyspareunia, dysuria, fallopian tube perforation, fatigue, headache, hormone level abnormal, hot flush, menorrhagia, menstrual disorder, migraine, mood swings, nausea, pollakiuria, rash, urinary incontinence, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal pain, weight increased, bruising and ovarian pain to be related to essure.The reporter commented: patient need for additional surgery.Discrepancy noted: date of implant: (b)(6) 2009 , (b)(6) 2009.Date of explant: (b)(6) 2015 , (b)(6) 2014.Current weight 135 lbs.The essure devices were placed according to manufacturers directions in each tubal ostia.Coils visible outside of right tube 3, coils visible outside of left tube 3.Procedures: 1.Total laparoscopic hysterectomy.2.Bilateral salpingectomy.3.Abdominal repair of vaginal prolapse with a modified mccall culdoplasty.Findings: examination under anesthesia revealed prolapse of the uterus to the introitus.The fallopian tube was normal on the right side.The fallopian tube on the left side had extrusion of her essure coil from the muscular portion of the tube, but the serosa of the fallopian tube was intact.Both ovaries appeared normal.The uterus appeared boggy and had tortuous pelvic vasculature, most likely from the uterine prolapse.The appendix appeared normal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: occluded oviducts bilaterally.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-apr-2020: extension of expected date of next report.Incident 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('one device was not in her fallopian tube'), fallopian tube perforation ('perforation (fallopian tube(s))/on the left the coil had penetrated muscular portion of the tube,the coil was coming out of my right tube'), uterine perforation ('perforation (uterus)/the serosa was covering the tip of the coil') and urinary tract infection ('4 urinary tract infections') in an adult female patient who had essure (batch no.646519) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included d & c.Concurrent conditions included weight normal, endometriosis and galactorrhea.Concomitant products included alprazolam (xanax) since 2012, citalopram since 2012, escitalopram oxalate (lexapro), medroxyprogesterone acetate (depo-provera), naproxen, ondansetron (zofran) and tramadol since 2012.In 2009, the patient experienced arthralgia ("joint pain"), back pain ("back pain / lower back pain"), headache ("headaches"), fatigue ("fatigue/cannot get out of bed"), adnexa uteri pain ("pain in her right ovary") and contusion ("bruising from her hips to her toes").In july 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),") and vaginal discharge ("vaginal discharge").On (b)(6) 2009, the patient had essure inserted.In november 2010, the patient experienced migraine ("migraines").In january 2011, the patient experienced depression ("depression") and anxiety ("anxiety").In february 2011, the patient experienced dysuria ("painful urination"), pollakiuria ("frequent urination") and urinary incontinence ("bladder leakage").In august 2011, the patient experienced mood swings ("hormonal changes describe: mood swings") and hot flush ("hot flashes").In december 2011, the patient experienced bruising ("bruising") and rash ("rashes").In january 2012, the patient experienced nausea ("nausea").In august 2012, the patient experienced abdominal pain ("abdominal pain").In january 2013, the patient was found to have weight increased ("weight gain").In 2014, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and uterine perforation (seriousness criteria medically significant and intervention required).In december 2014, the patient experienced urinary tract infection (seriousness criterion medically significant) and fungal infection ("yeast infections").In january 2015, the patient experienced vaginal infection ("vaginitis").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), allergy to metals ("nickel allergy"), dyspareunia ("dyspareunia (painful sexual intercourse),"), ovarian pain ("right side ovary area"), vulvovaginal pain ("shootin pain in vagina") and menstrual disorder ("problem with period") and was found to have hormone level abnormal ("no hormones").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, fallopian tube perforation, uterine perforation, urinary tract infection, arthralgia, headache, fatigue, adnexa uteri pain, contusion, fungal infection, mood swings, hot flush, depression, anxiety, bruising, rash, dysuria, pollakiuria, migraine, nausea, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, urinary incontinence and menstrual disorder outcome was unknown, the back pain, abdominal pain, ovarian pain and vulvovaginal pain was resolving and the vaginal haemorrhage and menorrhagia had resolved.The reporter provided no causality assessment for device dislocation, fungal infection and urinary tract infection with essure.The reporter considered abdominal pain, adnexa uteri pain, allergy to metals, anxiety, arthralgia, back pain, contusion, depression, dysmenorrhoea, dyspareunia, dysuria, fallopian tube perforation, fatigue, headache, hormone level abnormal, hot flush, menorrhagia, menstrual disorder, migraine, mood swings, nausea, pollakiuria, rash, urinary incontinence, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal pain, weight increased, bruising and ovarian pain to be related to essure.No further causality assessment were provided for the product.The reporter commented: patient need for additional surgery.Discrepancy noted: date of implant: (b)(6) 2009 , -aug-2009 date of explant: -dec-2015 , (b)(6) 2014 current weight 135 lbs.Hte essure devices were placed according to manufacturers directions in each tubal ostia.Coils visible outside of right tube 3, coils visible outside of left tube 3.Procedures: 1.Total laparoscopic hysterectomy.2.Bilateral salpingectomy.3.Abdominal repair of vaginal prolapse with a modified mccall culdoplasty.Findings: examination under anesthesia revealed prolapse of the uterus to the introitus.The fallopian tube was normal on the right side.The fallopian tube on the left side had extrusion of her essure coil from the muscular portion of the tube, but the serosa of the fallopian tube was intact.Both ovaries appeared normal.The uterus appeared boggy and had tortuous pelvic vasculature, most likely from the uterine prolapse.The appendix appeared normal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: occluded oviducts bilaterally.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: social media content received, new reporter and event no hormones added and the coil was coming out of my right tube clubbed with pervious event fallopian tube perforation.Incident 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('one device was not in her fallopian tube'), fallopian tube perforation ('perforation (fallopian tube(s))/on the left the coil had penetrated muscular portion of the tube,the coil was coming out of my right tube'), uterine perforation ('perforation (uterus)/the serosa was covering the tip of the coil') and urinary tract infection ('4 urinary tract infections') in an adult female patient who had essure (batch no.646519) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included d & c.Concurrent conditions included weight normal, endometriosis and galactorrhea.Concomitant products included alprazolam (xanax) since 2012, citalopram since 2012, escitalopram oxalate (lexapro), medroxyprogesterone acetate (depo-provera), naproxen, ondansetron (zofran) and tramadol since 2012.In 2009, the patient experienced arthralgia ("joint pain"), back pain ("back pain / lower back pain"), headache ("headaches"), fatigue ("fatigue/cannot get out of bed"), adnexa uteri pain ("pain in her right ovary") and contusion ("bruising from her hips to her toes").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),") and vaginal discharge ("vaginal discharge").On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2010, the patient experienced migraine ("migraines").In (b)(6) 2011, the patient experienced depression ("depression") and anxiety ("anxiety").In (b)(6) 2011, the patient experienced dysuria ("painful urination"), pollakiuria ("frequent urination") and urinary incontinence ("bladder leakage").In (b)(6) 2011, the patient experienced mood swings ("hormonal changes describe: mood swings") and hot flush ("hot flashes").In (b)(6) 2011, the patient experienced bruising ("bruising") and rash ("rashes").In (b)(6) 2012, the patient experienced nausea ("nausea").In (b)(6) 2012, the patient experienced abdominal pain ("abdominal pain").In (b)(6) 2013, the patient was found to have weight increased ("weight gain").In 2014, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and uterine perforation (seriousness criteria medically significant and intervention required).In (b)(6) 2014, the patient experienced urinary tract infection (seriousness criterion medically significant) and fungal infection ("yeast infections").In (b)(6) 2015, the patient experienced vaginal infection ("vaginitis").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), allergy to metals ("nickel allergy"), dyspareunia ("dyspareunia (painful sexual intercourse),"), ovarian pain ("right side ovary area"), vulvovaginal pain ("shootin pain in vagina") and menstrual disorder ("problem with period") and was found to have hormone level abnormal ("no hormones").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, fallopian tube perforation, uterine perforation, urinary tract infection, arthralgia, headache, fatigue, adnexa uteri pain, contusion, fungal infection, mood swings, hot flush, depression, anxiety, bruising, rash, dysuria, pollakiuria, migraine, nausea, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, urinary incontinence and menstrual disorder outcome was unknown, the back pain, abdominal pain, ovarian pain and vulvovaginal pain was resolving and the vaginal haemorrhage and menorrhagia had resolved.The reporter provided no causality assessment for device dislocation, fungal infection and urinary tract infection with essure.The reporter considered abdominal pain, adnexa uteri pain, allergy to metals, anxiety, arthralgia, back pain, contusion, depression, dysmenorrhoea, dyspareunia, dysuria, fallopian tube perforation, fatigue, headache, hormone level abnormal, hot flush, menorrhagia, menstrual disorder, migraine, mood swings, nausea, pollakiuria, rash, urinary incontinence, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal pain, weight increased, bruising and ovarian pain to be related to essure.The reporter commented: patient need for additional surgery.Discrepancy noted: date of implant: (b)(6) 2009 , (b)(6) 2009 date of explant:(b)(6) 2015 , (b)(6) 2014 current weight 135 lbs.Hte essure devices were placed according to manufacturers directions in each tubal ostia.Coils visible outside of right tube 3, coils visible outside of left tube 3.Procedures: 1.Total laparoscopic hysterectomy.2.Bilateral salpingectomy.3.Abdominal repair of vaginal prolapse with a modified mccall culdoplasty.Findings: examination under anesthesia revealed prolapse of the uterus to the introitus.The fallopian tube was normal on the right side.The fallopian tube on the left side had extrusion of her essure coil from the muscular portion of the tube, but the serosa of the fallopian tube was intact.Both ovaries appeared normal.The uterus appeared boggy and had tortuous pelvic vasculature, most likely from the uterine prolapse.The appendix appeared normal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: occluded oviducts bilaterally.Lot number: 646519, manufacturing date: 2009-06, expiration date: 2012-06.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-may-2020: quality safety evaluation of product technical complaint.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.
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