| Model Number ESS305 |
| Device Problems
Material Fragmentation (1261); Difficult to Insert (1316); Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Vitreous Floaters (1866); Hair Loss (1877); Itching Sensation (1943); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Cramp(s) (2193); Complaint, Ill-Defined (2331)
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Event Type
Injury
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Event Description
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This case has been identified during monitoring of postings an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting taking place in (b)(6) 2015.This is a spontaneous case report received from a regulatory authority (case#(b)(4) ) in united states on (b)(6) 2015 which refers to a 42-year-old female consumer who had essure (fallopian tube occlusion insert) inserted in 2013.The consumer reported that at time of the insertion procedure she was 42 with 6 kids and therefore would like a tubal ligation.In office, the procedure that would take about 10 minutes took almost 2 hours.She had horrible cramps and her period was old brown dotty blood, she figured it was the procedure.At her 3 month dye test the doctor said one tube was blocked but couldn't find the other coil, the physician said it would not hurt her and would do just snip that tube and she would be fine.She started having weird things going on like a molar got loose and just fell out and she was losing hair; and her body ached and she was getting a lot of weird eye floaters and kaleidoscope vision.In (b)(6) 2014, she was working and got hit with a ton of bricks, drop you to your knees, abdominal pain and sciatic pain, and she was pooping blood clots.In the next morning she went to the er and cat scan was performed and found one coil was poking out of her tube and the other was embedded in her uterus.The doctor said those had to come out and schedule her with a gynecologist.She read up on removal and talked to doctor, she had her own idea that she could pull them out, the consumer begged for her not to and told her that whatever organ they were in had to be river (nos) or they break and she would be left with fragments and pet fibers in and she only wanted to have surgery once.The physician did it her way and promised she got it all intact but she did not show the consumer any pathology report or pic proving they were gone and drew her picture of surgery and send the consumer away.The consumer requested all records and scans and they left fragments behind and there was one whole coil missing.She stated she was still in horrible pain had to quit her job.The daily pain was unbelievable; her second doctor couldn't believe what she went through and did a complete hysterectomy and there was a half a coil embedded in her uterus but still was sing (nos) that other coil.She felt so much better after essure was out of her body; she reported it was so bad, she itched all over all day every day; broke out in a rash wearing a bra.She stated that they thought she had crohn's disease because she was so inflamed from essure.She had 2 surgeries in 4 months and lost all her lady parts.Company causality comment: this non-medically confirmed, spontaneous case report refers to a 42-year-old female consumer who had essure (fallopian tube occlusion insert) inserted and one micro-insert was poking out of her tube and other was embedded in her uterus.Apparently, during surgery for removal, fragments were left behind.She also experienced pooping blood dots.These events, seen as device embedment, device dislocation, device breakage and haematotochezia respectively, are serious due medical importance (except breakage which is non-serious).Dislocation, embedment and breakage are listed, while haematochezia is unlisted in the reference safety information for essure.During essure use, there is a risk that the device could move out of fallopian tubes (dislocation).Also, a partial perforation (device embedment) of fallopian tubes or uterine wall may occur.Additionally, during difficult removals, device breakage has been reported.In this case the exact mechanism and characteristics of dislocation, partial perforation and breakage are not known; however, given their nature, the reported events are assessed as related to essure use.Regarding haematochezia, considering essure's local action in fallopian tubes, causality with suspect insert is very unlikely.Since an intervention was required for essure removal (hysterectomy), this case is regarded as incident.No further information is expected.
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Manufacturer Narrative
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Product technical complaint investigation and final assessment were received on 02-sep-2015: this adverse event report is related to a product technical complaint and was initiated due to a product technical issue.In addition, the ae case refers to a usability issue.The bayer reference number for the ptc report is (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 product technical issue reported in the context of the complicated removal of a reportedly embedded device.The ae case refers to a usability issue.Neither batch number nor complaint sample was available for a technical investigation.The technical assessment concluded unconfirmed quality defect.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.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 a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and one micro-insert was poking out of her tube and other was embedded in her uterus.Apparently, during surgery for removal, fragments were left behind.She also experienced pooping blood dots.These events, seen as device embedment, device dislocation, device breakage and haematotochezia respectively, are serious due medical importance (except breakage which is non-serious).Dislocation, embedment and breakage are listed, while haematochezia is unlisted in the reference safety information for essure.During essure use, there is a risk that the device could move out of fallopian tubes (dislocation).Also, a partial perforation (device embedment) of fallopian tubes or uterine wall may occur.Additionally, during difficult removals, device breakage has been reported.In this case the exact mechanism and characteristics of dislocation, partial perforation and breakage are not known; however, given their nature, the reported events are assessed as related to essure use.Regarding haematochezia, considering essure's local action in fallopian tubes, causality with suspect insert is very unlikely.Since an intervention was required for essure removal (hysterectomy), this case is regarded as incident.Based on available information, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.
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Manufacturer Narrative
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Internal correction on 24-nov-2015 during internal review it was notified that the previously reported initial receipt date 06-aug-2015 is incorrect.The correct initial receipt date of the case is 09-aug-2015.
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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 fda (reference number: (b)(4)) on 06-aug-2015.The most recent information was received on 29-nov-2017.This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("the other coil was missing and embedded in uterus/ migration of essure"), device dislocation ("one poking oul of her tube"), device breakage (" they lett fragments behind and there was one whole coil missing") and haematochezia ("pooping blood dots") in a (b)(6)-year-old female patient who had essure (batch no.952111) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "they left fragments behind and there was one whole coil missing." the patient's past medical history included multigravida, parity 6 (dates of birth: (b)(6)), miscarriage, twin pregnancy in 2003 and c-section.Plaintiff cannot wear cheap jewelry, shave, or have underwire bras; she breaks out in rashes.Previously administered products included for birth control: oral contraceptive nos in 2013.Concurrent conditions included overweight.Concomitant products included oxycocet (percocet) in 2013 for surgery.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("horrible cramps").In 2014, the patient experienced arthralgia ("joint pain (achy almost like a tooth ache, in hips)").In (b)(6) 2014, the patient experienced sciatica ("sciatic pain (hurt so bad, i limped)").In (b)(6) 2014, the patient experienced haematochezia (seriousness criterion medically significant) and abdominal pain ("got hrt with a ton of bricks horrible drop you to your knees abdominal pain").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant) , menstrual disorder ("my period was old brown clotty blood"), pruritus generalised ("constant itching/ itchy rash all over body"), rash generalised ("constant itching/ itchy rash all over body"), pain ("body ached"), tooth loss ("dental breakage/ loose teeth/ teeth breaking and falling out"), tooth fracture ("dental breakage/ loose teeth/ teeth breaking and falling out"), alopecia ("loosing hair bad/ hair loss/ hair started falling out"), vitreous floaters ("weird eye fioalers"), visual impairment ("kaleidoscope vision"), inflammation ("so inflamed from esure"), complication of device removal ("they left fragments behind and there was one whole coil missing."), genital haemorrhage ("bleeding severely"), lethargy ("lethargy"), joint swelling ("swelling/ swelling of ankles"), abdominal distension ("extreme bloating"), weight loss poor ("hard time losing weight"), blindness and visual impairment (¿weak vision/ loss of vision¿), rectal haemorrhage (¿rectal bleeding¿), headache (¿headache¿), vision blurred (¿kaleidoscope vision¿), dysgeusia (¿metallic taste in mouth¿), dysmenorrhoea (¿horrible periods¿), memory impairment and amnesia (¿memory problems/ memory loss¿), dyspareunia (¿painful intercourse¿), night sweats (¿night sweats¿), irritable bowel syndrome (¿irritable bowel syndrome¿), allergy to metals and dermatitis allergic (¿nickel allergy/ hypersensitivity reaction/ after essure was placed, i got more sensitive¿), and skin irritation (¿irritation to any metals¿).The patient was treated with surgery (salpingectomy on (b)(6) 2015 on and hysterectomy on (b)(6) 2015 with essure coil removal from uterus).Essure was removed on (b)(6) 2015.At the time of the report, abdominal distension and weight loss poor had not resolved.The abdominal pain, abdominal pain lower, tooth fracture, alopecia, sciatica, lethargy, joint swelling, and arthralgia had resolved.The embedded device, device dislocation, haematochezia, device breakage, menstrual disorder, pruritus generalised, rash generalised, pain, tooth loss, vitreous floaters, visual impairment, inflammation, complication of device removal, genital haemorrhage, blindness, visual impairment, rectal haemorrhage, headache, vision blurred, dysgeusia, dysmenorrhoea, memory impairment, amnesia, dyspareunia, night sweats, irritable bowel syndrome, allergy to metals, dermatitis allergic, and skin irritation outcome was unknown.The reporter considered abdominal distension, weight loss poor, abdominal pain, abdominal pain lower, tooth fracture, alopecia, sciatica, lethargy, joint swelling, arthralgia, embedded device, device dislocation, haematochezia, device breakage, menstrual disorder, pruritus generalised, rash generalised, pain, tooth loss, vitreous floaters, visual impairment, inflammation, complication of device removal, genital haemorrhage, blindness, visual impairment, rectal haemorrhage, headache, vision blurred, dysgeusia, dysmenorrhoea, memory impairment, amnesia, dyspareunia, night sweats, irritable bowel syndrome, allergy to metals, dermatitis allergic, and skin irritation to be related to essure.The reporter commented: on plaintiff fact sheet (pfs) that two surgeries were performed to remove the essure coils; in the first surgery she only received half of a coil.According to medical records (mr), the plaintiff complains of stress incontinence and premenstrual syndrome.Her pms is associated with mood changes and breast tenderness.Before the essure insertion she received half a dose of xanax orally before arrival at the office, and then a half dose after the pregnancy test was performed.She received 60mg of toradol.Both tubal ostia were identified.The procedure was then terminated after a total of 10 minutes.After the procedure, the devices were in good position with 7 trailing coils on the right side and 4 trailing coils on the left side.The plaintiff tolerated the procedure with minimal discomfort.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: dysmenorrhea, device dislocation, abdominal pain, haematochezia, weight loss poor, rectal haemorrhage, abdominal pain lower, arthralgia, rash generalised, allergy to metals, inflammatory bowel disease, joint swelling, abdominal distention, pruritus generalised, and headache.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.6 kg/sqm.Colonoscopy ¿ on (b)(6) 2015: or rectal bleeding and irritable bowel syndrome.Computerised tomogram ¿ in (b)(6) 2014: 1 coil poking out of tube and other embedded.Hysterosalpingogram ¿ on (b)(6) 2013: left tube was blocked (cont.).Pregnancy test urine ¿ on (b)(6) 2013: negative.On (b)(6) 2013: hysterosalpingogram (cont.) - the other coil was missing and embedded in uterus.Doctor said they could remove the one tube that migrated.On (b)(6) 2014: ct abdomen pelvis w contrast - essure devices appear malpositioned with the right essure device coiled within the endometrial cavity.The left essure device may be protruding through the fundal portion of the endometrium.On (b)(6) 2014: ct abdomen/pelvis - malpositioned essure with erosion through uterine wall, question of colonic thickening, diverticulosis.There is diverticulosis without diverticulitis.The sigmoid and ascending colonic walls appear slightly thickened although the bowel is collapsed.The appendix appears normal.There is no enlarged adnexal mass.Essure devices appear malpositioned with the right essure device coiled within the endometrial cavity.The left essure device may be protruding through the fundal portion of the endometrium.On (b)(6) 2015: bilateral digital screening mammogram with cad - there are scattered fibroglandular elements in both breasts that could obscure a lesion on mammography.There are grouped amorphous punctate calcifications in the left axillary tail.There also is a focal asymmetry in the left breast at 12 o'clock middle depth.Impression: incomplete: needs additional imaging evaluation.On (b)(6) 2015: unilateral left digital diagnostic mammogram - impression: suspicious of malignancy.On (b)(6) 2015: ultrasound of left breast - clinical: indications: left breast asymmetry.Impression: incomplete: needs additional imaging evaluation, the 7 mm cyst in the left breast appears benign.On (b)(6) 2015: stereotactic guided biopsy left breast using vacuum device with marking device inserted and post mammographic imaging - clinical: stereotactic breast biopsy, left microcalcifications, 1.7 cm punctate calcifications in linear distribution.Impression: stereotactic guided biopsy benign.On (b)(6) 2015: ct abd/pelvis - expected free air status post laparoscopic surgery.Trace free fluid in the pelvis.On (b)(6) 2015: us abdomen limited - impression: unremarkable right upper quadrant ultrasound.On (b)(6) 2015: ct scan - possible retained essure coils.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 29-nov-2017: plaintiff fact sheet (pfs) and medical records ¿ new reporters (lawyer and healthcare facilities); demographic data; medical and drug history; concomitant medications and treatments; essure indication; insertion date update ((b)(6) 2013); lot number (952111); expiration date (feb-2015); removal date ((b)(6) 2015 and (b)(6) 2015); onset date of previous reported events; new events (bleeding severely, lethargy, swelling, hip pain, extreme bloating, hard time losing weight, among others); and imaging exams.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (fda, reference number: (b)(4)) on 06-aug-2015.The most recent information was received on 02-feb-2018.This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("the other coil was missing and embedded in uterus/ migration of essure"), device dislocation ("one poking oul of her tube/they didnt know about the other coil"), haematochezia ("pooping blood dots"), blindness ("weak vision/ loss of vision") and device breakage ("they lett fragmenls behind and tihere was one whole coil missing") in a (b)(6) year-old female patient who had essure (batch no.952111) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "first surgery, coil left in me/ they left fragments behind and there was one whole coil missing" on (b)(6) 2015.The patient's past medical history included multigravida, parity 6 (dates of birth: (b)(6) 1988, (b)(6) 2000, (b)(6) 2002, (b)(6) 2003 and (b)(6) 2007), miscarriage, twin pregnancy in 2003, c-section, broken leg and chickenpox.Plaintiff cannot wear cheap jewelry, shave, or have underwire bras; she breaks out in rashes.Previously administered products included for birth control: oral contraceptive nos in 2013.Concurrent conditions included overweight, social alcohol drinker and smoker (smokes 10 cigarettes per day and is thinking about trying to quit).Concomitant products included oxycocet (percocet) since 2013 for fracture repair.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("horrible cramps").In (b)(6) 2013, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with abdominal pain and back pain.In 2014, the patient experienced arthralgia ("joint pain (achy almost like a tooth ache, in hips)") and headache ("headache").In (b)(6) 2014, the patient experienced sciatica ("severe and persistent back pain/ sciatic pain (hurt so bad, i limped)").In (b)(6) 2014, the patient experienced haematochezia (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced complication of device removal ("first surgery, coil left in me/ they left fragments behind and there was one whole coil missing") and malaise ("still sick after first surgery").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), blindness (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), menstrual disorder ("my period was old brown clotty blood"), pruritus generalised ("constant itching/ itchy rash all over body"), rash generalised ("constant itching/ itchy rash all over body"), pain ("body ached"), tooth loss ("dental breakage/ loose teeth/ teeth breaking and falling out"), tooth fracture ("dental breakage/ loose teeth/ teeth breaking and falling out"), alopecia ("loosing hair bad/ hair loss/ hair started falling out"), vitreous floaters ("weird eye fioalers"), visual impairment ("weak vision/ loss of vision"), inflammation ("so inflamed from esure"), genital haemorrhage ("bleeding severely/ blood clots"), lethargy ("lethargy"), joint swelling ("swelling/ swelling of ankles"), abdominal distension ("extreme bloating"), weight loss poor ("hard time losing weight"), rectal haemorrhage ("rectal bleeding"), vision blurred ("kaleidoscope vision"), dysgeusia ("metallic taste in mouth"), dysmenorrhoea ("horrible periods"), memory impairment ("memory problems/ memory loss"), amnesia ("memory problems/ memory loss"), dyspareunia ("painful intercourse"), night sweats ("night sweats"), irritable bowel syndrome ("irritable bowel syndrome"), allergy to metals ("nickel allergy/ hypersensitivity reaction/ after essure was placed, i got more sensitive"), dermatitis allergic ("nickel allergy/ hypersensitivity reaction/ after essure was placed, i got more sensitive"), skin irritation ("irritation to any metals"), mental disorder ("aggravated any psychiatric and/or psychological condition") and device expulsion ("one in uterus had essure for almost 2 yrs").The patient was treated with analgesics and surgery (salpingectomy on (b)(6) 2015 on and hysterectomy on (b)(6) 2015 with essure coil removal from uterus).Essure was removed on (b)(6) 2015.On (b)(6) 2015, the sciatica, pruritus generalised, tooth fracture, alopecia, lethargy, joint swelling and arthralgia had resolved.In 2015, the headache had resolved.At the time of the report, the embedded device, device dislocation, haematochezia, blindness, device breakage, abdominal pain lower, menstrual disorder, rash generalised, pain, tooth loss, vitreous floaters, visual impairment, inflammation, complication of device removal, genital haemorrhage, rectal haemorrhage, dysgeusia, dysmenorrhoea, memory impairment, amnesia, dyspareunia, night sweats, irritable bowel syndrome, allergy to metals, dermatitis allergic, skin irritation and mental disorder outcome was unknown and the abdominal distension, weight loss poor and malaise had not resolved.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, amnesia, arthralgia, blindness, complication of device removal, dermatitis allergic, device breakage, device dislocation, device expulsion, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, genital haemorrhage, haematochezia, headache, inflammation, irritable bowel syndrome, joint swelling, lethargy, malaise, memory impairment, menstrual disorder, mental disorder, night sweats, pain, pruritus generalised, rash generalised, rectal haemorrhage, sciatica, skin irritation, tooth fracture, tooth loss, vision blurred, visual impairment, vitreous floaters and weight loss poor to be related to essure.The reporter commented: on plaintiff fact sheet (pfs) that two surgeries were performed to remove the essure coils; in the first surgery she only received half of a coil.According to medical records (mr), the plaintiff complains of stress incontinence and premenstrual syndrome.Her pms is associated with mood changes and breast tenderness.Before the essure insertion she received half a dose of xanax orally before arrival at the office, and then a half dose after the pregnancy test was performed.She received 60mg of toradol.Both tubal ostia were identified.The procedure was then terminated after a total of 10 minutes.After the procedure, the devices were in good position with 7 trailing coils on the right side and 4 trailing coils on the left side.The plaintiff tolerated the procedure with minimal discomfort.Patient had surgery on 12-feb and called pathology to get her coils and they said there was only one coil.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.6 kg/sqm.Colonoscopy - on (b)(6) 2015: for rectal bleeding and irritable bowel syndrome computerised tomogram - in (b)(6) 2014: 1 coil poking out of tube and other embedded hysterosalpingogram - on (b)(6) 2013: left tube was blocked (cont.) pregnancy test urine - on (b)(6) 2013: negative.(b)(6) 2013: hysterosalpingogram (cont.) - the other coil was missing and embedded in uterus.Doctor said they could remove the one tube that migrated.(b)(6) 2014: ct abdomen pelvis w contrast - essure devices appear malpositioned with the right essure device coiled within the endometrial cavity.The left essure device may be protruding through the fundal portion of the endometrium.(b)(6) 2014: ct abdomen/pelvis - malpositioned essure with erosion through uterine wall, question of colonic thickening , diverticulosis.There is diverticulosis without diverticulitis.The sigmoid and ascending colonic walls appear slightly thickened although the bowel is collapsed.The appendix appears normal.There is no enlarged adnexal mass.Essure devices appear malpositioned with the right essure device coiled within the endometrial cavity.The left essure device may be protruding through the fundal portion of the endometrium.(b)(6) 2015: bilateral digital screening mammogram with cad - there are scattered fibroglandular elements in both breasts that could obscure a lesion on mammography.There are grouped amorphous punctate calcifications in the left axillary tail.There also is a focal asymmetry in the left breast at 12 o'clock middle depth.Impression: incomplete: needs additional imaging evaluation.(b)(6) 2015: unilateral left digital diagnostic mammogram - impression: suspicious of malignancy.(b)(6) 2015: ultrasound of left breast - clinical: indications: left breast asymmetry.Impression: incomplete: needs additional imaging evaluation, the 7 mm cyst in the left breast appears benign.(b)(6) 2015: stereotactic guided biopsy left breast using vacuum device with marking device inserted and post mammographic imaging - clinical: stereotactic breast biopsy, left microcalcifications, 1.7 cm punctate calcifications in linear distribution.Impression: stereotactic guided biopsy benign.(b)(6) 2015: ct abd/pelvis - expected free air status post laparoscopic surgery.Trace free fluid in the pelvis.(b)(6) 2015: us abdomen limited - impression: unremarkable right upper quadrant ultrasound.(b)(6) 2015: ct scan - possible retained essure coils.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: dysmenorrhea, device dislocation, abdominal pain, haematochezia, weight loss poor, rectal haemorrhage, abdominal pain lower, arthralgia, rash generalised, allergy to metals, inflammatory bowel disease, joint swelling, abdominal distention, pruritus generalised,headache and device expulsion.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 2-feb-2018: new event partial expulsion was added.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("embedded in uterus"), device dislocation ("one poking out of her tube/they didn't know about the other coil/migration of essure/the other coil was missing"), device breakage ("they left fragments behind and there was one whole coil missing"), genital haemorrhage ("bleeding severely/ blood clots"), haematochezia ("pooping blood dots"), blindness ("weak vision/ loss of vision") and rectal haemorrhage ("rectal bleeding") in a 42-year-old female patient who had essure (batch no.952111) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "first surgery, coil left in me/ they left fragments behind and there was one whole coil missing" on (b)(6) 2015.The patient's past medical history included multigravida, parity 6 (dates of birth: (b)(6) 1988, (b)(6) 2000, (b)(6) 2002, (b)(6) 2003 and (b)(6) 2007), miscarriage, twin pregnancy in 2003, c-section, broken leg and chickenpox.Plaintiff cannot wear cheap jewelry, shave, or have underwire bras; she breaks out in rashes.Previously administered products included for birth control: oral contraceptive nos in 2013.Concurrent conditions included overweight, social alcohol drinker and smoker (smokes 10 cigarettes per day and is thinking about trying to quit).Concomitant products included oxycocet (percocet) since 2013 for fracture repair.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("horrible cramps").In (b)(6) 2013, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with abdominal pain and back pain.In 2014, the patient experienced arthralgia ("joint pain (achy almost like a tooth ache, in hips)") and headache ("headache").In (b)(6) 2014, the patient experienced sciatica ("severe and persistent back pain/ sciatic pain (hurt so bad, i limped)").In (b)(6) 2014, the patient experienced haematochezia (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced complication of device removal ("first surgery, coil left in me/ they left fragments behind and there was one whole coil missing") and malaise ("still sick after first surgery").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), blindness (seriousness criterion medically significant), menstrual disorder ("my period was old brown clotty blood"), pruritus generalised ("constant itching/ itchy rash all over body"), rash generalised ("constant itching/ itchy rash all over body"), pain ("body ached"), tooth loss ("dental breakage/ loose teeth/ teeth breaking and falling out"), tooth fracture ("dental breakage/ loose teeth/ teeth breaking and falling out"), alopecia ("loosing hair bad/ hair loss/ hair started falling out"), vitreous floaters ("weird eye fioalers"), visual impairment ("weak vision/ loss of vision"), inflammation ("so inflamed from esure"), lethargy ("lethargy"), joint swelling ("swelling/ swelling of ankles"), abdominal distension ("extreme bloating"), weight loss poor ("hard time losing weight"), rectal haemorrhage (seriousness criterion medically significant), vision blurred ("kaleidoscope vision"), dysgeusia ("metallic taste in mouth"), dysmenorrhoea ("horrible periods"), memory impairment ("memory problems/ memory loss"), amnesia ("memory problems/ memory loss"), dyspareunia ("painful intercourse"), night sweats ("night sweats"), irritable bowel syndrome ("irritable bowel syndrome"), allergy to metals ("nickel allergy/ hypersensitivity reaction/ after essure was placed, i got more sensitive"), dermatitis allergic ("nickel allergy/ hypersensitivity reaction/ after essure was placed, i got more sensitive"), skin irritation ("irritation to any metals"), mental disorder ("aggravated any psychiatric and/or psychological condition") and device expulsion ("one in uterus had essure for almost 2 yrs").The patient was treated with analgesics and surgery (salpingectomy on (b)(6) 2015 on and hysterectomy on (b)(6) 2015 with essure coil removal from uterus).Essure was removed on (b)(6) 2015.On (b)(6) 2015, the sciatica, pruritus generalised, tooth fracture, alopecia, lethargy, joint swelling and arthralgia had resolved.In 2015, the headache had resolved.At the time of the report, the embedded device, device dislocation, device breakage, genital haemorrhage, haematochezia, blindness, abdominal pain lower, menstrual disorder, rash generalised, pain, tooth loss, vitreous floaters, visual impairment, inflammation, complication of device removal, rectal haemorrhage, dysgeusia, dysmenorrhoea, memory impairment, amnesia, dyspareunia, night sweats, irritable bowel syndrome, allergy to metals, dermatitis allergic, skin irritation, mental disorder and device expulsion outcome was unknown and the abdominal distension, weight loss poor and malaise had not resolved.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, amnesia, arthralgia, blindness, complication of device removal, dermatitis allergic, device breakage, device dislocation, device expulsion, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, genital haemorrhage, haematochezia, headache, inflammation, irritable bowel syndrome, joint swelling, lethargy, malaise, memory impairment, menstrual disorder, mental disorder, night sweats, pain, pruritus generalised, rash generalised, rectal haemorrhage, sciatica, skin irritation, tooth fracture, tooth loss, vision blurred, visual impairment, vitreous floaters and weight loss poor to be related to essure.The reporter commented: on plaintiff fact sheet (pfs) that two surgeries were performed to remove the essure coils; in the first surgery she only received half of a coil.According to medical records (mr), the plaintiff complains of stress incontinence and premenstrual syndrome.Her pms is associated with mood changes and breast tenderness.Before the essure insertion she received half a dose of xanax orally before arrival at the office, and then a half dose after the pregnancy test was performed.She received 60mg of toradol.Both tubal ostia were identified.The procedure was then terminated after a total of 10 minutes.After the procedure, the devices were in good position with 7 trailing coils on the right side and 4 trailing coils on the left side.The plaintiff tolerated the procedure with minimal discomfort.Patient had surgery on 12-feb and called pathology to get her coils and they said there was only one coil.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.6 kg/sqm.Colonoscopy - on (b)(6) 2015: for rectal bleeding and irritable bowel syndrome computerised tomogram - in (b)(6) 2014: 1 coil poking out of tube and other embedded.Hysterosalpingogram - on (b)(6) 2013: left tube was blocked (cont.).Pregnancy test urine - on (b)(6) 2013: negative.(b)(6) 2013: hysterosalpingogram (cont.) - the other coil was missing and embedded in uterus.Doctor said they could remove the one tube that migrated.(b)(6) 2014: ct abdomen pelvis w contrast - essure devices appear malpositioned with the right essure device coiled within the endometrial cavity.The left essure device may be protruding through the fundal portion of the endometrium.(b)(6) 2014: ct abdomen/pelvis - malpositioned essure with erosion through uterine wall, question of colonic thickening , diverticulosis.There is diverticulosis without diverticulitis.The sigmoid and ascending colonic walls appear slightly thickened although the bowel is collapsed.The appendix appears normal.There is no enlarged adnexal mass.Essure devices appear malpositioned with the right essure device coiled within the endometrial cavity.The left essure device may be protruding through the fundal portion of the endometrium.(b)(6) 2015: bilateral digital screening mammogram with cad - there are scattered fibroglandular elements in both breasts that could obscure a lesion on mammography.There are grouped amorphous punctate calcifications in the left axillary tail.There also is a focal asymmetry in the left breast at 12 o'clock middle depth.Impression: incomplete: needs additional imaging evaluation.(b)(6) 2015: unilateral left digital diagnostic mammogram - impression: suspicious of malignancy.(b)(6) 2015: ultrasound of left breast - clinical: indications: left breast asymmetry.Impression: incomplete: needs additional imaging evaluation, the 7 mm cyst in the left breast appears benign.(b)(6) 2015: stereotactic guided biopsy left breast using vacuum device with marking device inserted and post mammographic imaging - clinical: stereotactic breast biopsy, left microcalcifications, 1.7 cm punctate calcifications in linear distribution.Impression: stereotactic guided biopsy benign.(b)(6) 2015: ct abd/pelvis - expected free air status post laparoscopic surgery.Trace free fluid in the pelvis.(b)(6) 2015: us abdomen limited - impression: unremarkable right upper quadrant ultrasound.(b)(6) 2015: ct scan - possible retained essure coils.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: dysmenorrhea, device dislocation, abdominal pain, haematochezia, weight loss poor, rectal haemorrhage, abdominal pain lower, arthralgia, rash generalised, allergy to metals, inflammatory bowel disease, joint swelling, abdominal distention, pruritus generalised,headache and device expulsion.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 28-jun-2018: quality safety evaluation of product technical complaint.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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