| Model Number ESS305 |
| Device Problems
Break (1069); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
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| Patient Problems
Abdominal Pain (1685); Anemia (1706); Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Muscle Spasm(s) (1966); Perforation (2001); Swelling (2091); Uterine Perforation (2121); Myalgia (2238); Arthralgia (2355); Cognitive Changes (2551); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165); Fallopian Tube Perforation (4506); Genital Bleeding (4507)
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| Event Date 05/25/2017 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of left device") and genital haemorrhage ("excessive bleeding") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), genital haemorrhage (seriousness criterion medically significant), anaemia ("anemia"), swelling ("swelling"), alopecia ("alopecia"), myalgia ("muscle pain"), arthralgia ("joints pain"), vaginal infection ("vaginal infections"), uterine spasm ("uterine contractions"), dry mouth ("mouth dryness"), candida infection ("candidiasis"), fatigue ("chronic tiredness"), dyspepsia ("digestive problems"), headache ("headaches") and mental disorder ("psychological sequels").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy via laparoscopy on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, pelvic pain, genital haemorrhage, anaemia, swelling, alopecia, myalgia, arthralgia, vaginal infection, uterine spasm, dry mouth, candida infection, fatigue, dyspepsia, headache and mental disorder outcome was unknown.The reporter considered alopecia, anaemia, arthralgia, candida infection, device dislocation, dry mouth, dyspepsia, fatigue, genital haemorrhage, headache, mental disorder, myalgia, pelvic pain, swelling, uterine spasm and vaginal infection to be related to essure.The reporter commented: not reported.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: device dislocation.The analysis in the global safety database revealed 3525 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.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 ('migration of left device') and genital haemorrhage ('excessive bleeding') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.In 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pelvic pain"), anaemia ("anemia"), swelling ("swelling"), alopecia ("alopecia"), myalgia ("muscle pain"), arthralgia ("joints pain"), vaginal infection ("vaginal infections"), uterine spasm ("uterine contractions"), dry mouth ("mouth dryness"), candida infection ("candidiasis"), fatigue ("chronic tiredness"), dyspepsia ("digestive problems"), headache ("headaches") and mental disorder ("psychological sequels").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy via laparoscopy on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, genital haemorrhage, pelvic pain, anaemia, swelling, alopecia, myalgia, arthralgia, vaginal infection, uterine spasm, dry mouth, candida infection, fatigue, dyspepsia, headache and mental disorder outcome was unknown.The reporter considered alopecia, anaemia, arthralgia, candida infection, device dislocation, dry mouth, dyspepsia, fatigue, genital haemorrhage, headache, mental disorder, myalgia, pelvic pain, swelling, uterine spasm and vaginal infection to be related to essure.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 17-sep-2021: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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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 ('migration of left device') and genital haemorrhage ('excessive bleeding') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.In 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pelvic pain"), anaemia ("anemia"), swelling ("swelling"), alopecia ("alopecia"), myalgia ("muscle pain"), arthralgia ("joints pain"), vaginal infection ("vaginal infections"), uterine spasm ("uterine contractions"), dry mouth ("mouth dryness"), candida infection ("candidiasis"), fatigue ("chronic tiredness"), dyspepsia ("digestive problems"), headache ("headaches") and mental disorder ("psychological sequels").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy via laparoscopy on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, genital haemorrhage, pelvic pain, anaemia, swelling, alopecia, myalgia, arthralgia, vaginal infection, uterine spasm, dry mouth, candida infection, fatigue, dyspepsia, headache and mental disorder outcome was unknown.The reporter considered alopecia, anaemia, arthralgia, candida infection, device dislocation, dry mouth, dyspepsia, fatigue, genital haemorrhage, headache, mental disorder, myalgia, pelvic pain, swelling, uterine spasm and vaginal infection to be related to essure.Most recent follow-up information incorporated above includes: on 15-sep-2021: the case (b)(6) is duplicated of case (b)(6).Then, case (b)(4) will be deleted from bayer database.The remained case is: (b)(4).The essure indication was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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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 ('migration of left device / not seen in the interstitial section / partial migration with no visible intracavitary'), genital haemorrhage ('excessive bleeding'), device breakage ('a small fragment of wire which when cut penetrates the uterine wall') and embedded device ('a small fragment of wire which when cut penetrates the uterine wall') in a 42-year-old female patient who had essure (batch no.A14902) inserted for contraception and female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device insertion "impossibility of placing the second device in the right tube due to contractions and spasms of" on (b)(6) 2014.The patient's medical history included candidiasis in 2003, paraesthesia (with a feeling of exhaustion and difficulty grasping objects) in 1998, menarche (at 13 years-old) in 1984, gravida ii, parity 2 (caesarean section and a eutocic delivery), uterine abrasion, kidney disorder, allergy test negative, pyelonephritis and migraine.(b)(6)1988: neurophysiology medical appointment: electroencephalogram test conclusion: signs of brain dysfunction at the level of temporo-occipital regions predominantly on the left hemisphere.Evolutionary controls are recommended.(b)(6)1989: neurophysiology medical appointment: signs of paroxysmal cerebral irritation of generalized expression with accentuation in temporal areas are observed.Concurrent conditions included breast pain female (continuous that has nothing to do with the menstrual cycle.Tenderness in the upper left quadrant, without nodules mammography and bilateral breast ultrasound: findings: breasts with marked fatty replacement, with remnants of fibro glandular tissue distributed slightly asymmetrically, more abundant in the left breast.In the craniocaudal projection of the left breast, a small increase in density is seen in the internal quadrants, without apparent underlying focal lesions, asymmetric with respect to the contralateral breast, without correspondence in the ultrasound study, probably related to fibro glandular tissue.Flattening of cooper's ligaments in both breasts and in the upper medial area of the left breast, probably related to mastopathy.Bilateral benign micro calcifications.Ultrasound : no solid or cystic nodules, distortions or other relevant or suspicious findings are visualized in the parenchyma of both breasts.Conclusion: bi-rads2) since (b)(6)2012, smoker (at precocious age, 10 cigars per day), morbid obesity (since childhood) and headache.On (b)(6)2014, the patient had essure inserted.On (b)(6)2014, the patient experienced lymphadenopathy ("left mastalgia/ findings: bilateral reactive-appearing axillary lymphadenopathies").On (b)(6)2014, the patient experienced the first episode of hot flush ("hot flashes").In 2016, the patient experienced pelvic pain ("pelvic pain").In (b)(6)2016, the patient experienced amenorrhoea ("amenorrhea "), lasting 5 months.In (b)(6)2017, the patient experienced cervical dysplasia ("squamous cell abnormalities - ascus atypical").On (b)(6)2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), hydrosalpinx (""probable" left hydrosalpinx, recurrent") and adnexa uteri cyst ("cystic left adnexal, bilobed cystic 4.4 x 2.7 / cystic left appendage").On (b)(6)2017, the patient experienced device breakage (seriousness criterion medically significant), embedded device (seriousness criterion medically significant) and salpingitis ("excisional biopsy, left tube inflammatory reaction to foreign body (essure) with fibrosis and obliteration of the lumen.").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), anaemia ("anemia"), swelling ("swelling"), alopecia ("alopecia"), myalgia ("muscle pain"), arthralgia ("joints pain, knee pain, pain in the heel or ankle"), vaginal infection ("vaginal infections"), uterine spasm ("uterine contractions"), dry mouth ("mouth dryness"), candida infection ("candidiasis"), fatigue ("chronic tiredness/ continuous tiredness"), digestion impaired ("digestive problems"), headache ("headaches"), mental disorder ("psychological sequels"), breast pain ("left mastalgia"), abdominal pain ("abdominalgia"), asthenia ("asthenia"), the second episode of hot flush ("vasomotor clinic (secondary to hormonal disorders)"), abdominal distension ("abdominal swelling / gas"), fungal infection ("yeast infection"), muscle contractions involuntary ("contractions"), female sexual dysfunction ("inability to have sex"), heartburn ("heartburn"), pain in extremity ("leg pain"), gastroenteritis ("acute gastroenteritis"), influenza ("flu") and respiratory tract infection ("acute respiratory infection") and was found to have weight increased ("weight gain").The patient was treated with bemiparin sodium (hibor), dexketoprofen trometamol (enantyum), ferric pyrophosphate (fisiogen ferro forte), hydrocortisone aceponate (suniderma), ibuprofen, metamizole magnesium (nolotil), ovule clx (rilastil), pantoprazole (pantoprazolum), paracetamol and surgery (total hysterectomy and bilateral salpingectomy via laparoscopy on (b)(6)2017).Essure was removed on (b)(6)2017.At the time of the report, the device dislocation, genital haemorrhage, device breakage, embedded device, pelvic pain, anaemia, swelling, alopecia, myalgia, arthralgia, vaginal infection, uterine spasm, dry mouth, candida infection, fatigue, digestion impaired, headache, mental disorder, breast pain, lymphadenopathy, cervical dysplasia, abdominal pain, asthenia, amenorrhoea, the last episode of hot flush, hydrosalpinx, adnexa uteri cyst, abdominal distension, fungal infection, muscle contractions involuntary, female sexual dysfunction, weight increased, heartburn, salpingitis, pain in extremity, gastroenteritis, influenza and respiratory tract infection outcome was unknown.The reporter considered abdominal distension, abdominal pain, adnexa uteri cyst, alopecia, amenorrhoea, anaemia, arthralgia, asthenia, breast pain, candida infection, cervical dysplasia, device breakage, device dislocation, digestion impaired, dry mouth, embedded device, fatigue, female sexual dysfunction, fungal infection, gastroenteritis, genital haemorrhage, headache, hydrosalpinx, influenza, lymphadenopathy, mental disorder, muscle contractions involuntary, myalgia, pain in extremity, pelvic pain, respiratory tract infection, salpingitis, swelling, uterine spasm, vaginal infection, weight increased, the first episode of hot flush, heartburn and the second episode of hot flush to be related to essure.The reporter commented: the placement of the intratubal devices was on (b)(6)2014, with the impossibility of placing the second device in the right tube due to contractions and spasms at that time, for which the patient was called again.On (b)(6)2014 reattempt to place the right device without success.Review in gynecology consultation on day (b)(6)2014 to offer laparoscopic tubal ligation.For personal reasons she preferred to get the iud implantation on (b)(6)2014 and it was removal on (b)(6)2017.The symptomatology that the patient presents that could be related to the device started at the end of 2016, attending primary care in 2017, however the device was placed in (b)(6)2014.On (b)(6)2017 she request information on oral contraceptives, contraception by iud, pregnancy, tubaritis.Essure was removal on (b)(6)2017 and postoperative with good evolution.On (b)(6)2017 she was discharged from hospital.Endocrinology consultation on (b)(6)2017 due to morbid obesity since childhood, many attempts to lose weight with little success.On (b)(6)2017 weight 100 kg, imc 37.2, smoker 1 package per day, anxious depressive status, on (b)(6)2018 she lost 5 kg of fat, maintain lean mass, complains of headache (unspecified date) and annual gynecological examination uterus in normal retro, normal adnexa, cx ectopy, normal analytics, treatment triagynon (unspecified date).Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on (b)(6)2017: epicutaneous tests with true test and metal battery with reading at 48 and 96 hours with negative result.Chest x-ray - on (b)(6)2017: normal.Electrocardiogram - on (b)(6)2017: normal.Gynaecological examination - on (b)(6)2017: general evaluation: adequate, squamocolumnar junction, type zt 2.Normal colposcopic findings: original squamous epithelium: atrophic, anormal colposcopic findings: first grade (minor): thin acetowhite epithelium,cervical pathology consultation: negative cytology.Ascus colposcopy and biopsy negative; on (b)(6)2017: speculoscopy: threads visible, cervix normal appearance.Uterus in indifferent position, linear endometrium.Iud with normal insertion; on (b)(6)2017: last period: december.External genitals and vagina are normal.Cervix is in a good status.Low vaginal discharge, obesity.Plan: high resolution ultrasound.Hormones.Human papilloma virus test - in (b)(6) 2017: negative.Hysterosalpingogram - on (b)(6)2014: in the left tube, a metallic linear image is visualized in relation to essure, observing contrast in the ampullary end and a minimum amount surrounding the metallic image without passage of contrast to the peritoneum; on (b)(6)2014: a linear image corresponding to the essure is visualized in the left tube and the right tube is filiform and permeable.Hysteroscopy - on (b)(6)2014: normal endocervical canal, uterine cavity, both tubal ostia visible, impossible to permeabilize right tubal ostium; on (b)(6)2017: 1st hysteroscopy to see if the device is expelled into the uterine cavity and could be removed this way, but it was not.Since it was placed in its place (in the tube).Pathology test - on (b)(6)2017: cervix biopsy macroscopic "description" : several microscopic fragments of tissue are received, irregular frayed, flattened with a grayish-white color that together occupy an area of 0.2 x 0.3 cm."microscopic" description: in the histological sections evaluated, three small fragments of flat stratified epithelium are observed, not oriented, with changes of squamous metaplasia.The cells do not present a perinuclear halo or evident binucleations.Mitosis is not observed.Ki 67 positive basal and the staining with p16 is negative."diagnostic": uterus (incisional biopsy, cervix): squamous metaplasia without evidence of dysplasia.; on (b)(6)2017: cervicovaginal cytology.Diagnostic : general valoration: presence of transformation zone.Inflammatory smear.Mixed flora.Morphological assessment: negative for intraepithelial lesion or malignancy; on (b)(6)2017: essure removal in the left tube.Macroscopi description: a.Marked as left tube +essure, tubectomy piece is received that measures 5x1x8x0.8 cm in maximum diameter, externally it is normal and a metallic structure in the form of a wire of 0.5 cm in maximum diameter is observed coming out of the canal.When cut and surrounded by fibrous tissue.The continuation of the essure is observed, conserving its spiral shape with a size of 2.5 cm and obliterating the tube channel.The implant is removed and left in a separate container.B.Marked as a right tube, a tubectomy piece of 5.5x1.8x1 cm of maximum diameter is received, which is externally smooth and shiny, brownish in color, with no relevant findings on cut.It does not present essure.C.A simple hysterectomy specimen was received, measuring 8.2x5.4x4.2 cm in maximum diameter, presenting an oce of 1.5 cm.Cervical canal of 3.5 cm and endometrial canal of 2.5 cm.Externally, a small fragment of wire is observed in relation to the left tube, which when cut penetrates the uterine wall by 0.4 mm.At the opening and the section, no relevant findings are found.Cs: a1-4 cervix.A5: endometrium - myometrium.A6: myometrium in relation to the metallic structure.The metal structure is removed and left in a jar next to the one found in the left tube.Microscopic description: a.In the histological sections evaluated, the fragments of the blister and the infundibulum of normal appearance with epithelium of ciliated cylindrical cells surrounded by muscle layer and normal serosa are observed.At the level of the isthmus, a fibrous obliteration of the lumen is observed, accompanied by giant cells of the foreign body type, or that form granulomas.B.In the histological sections evaluated, fragments of the ampulla, infundibulum and isthmus of normal appearance with epithelium of ciliated cylindrical cells surrounded by muscle layer and normal serosa are observed.C.In the histological sections evaluated, it is observed at the level of the cervix: mature squamous metaplastic changes with keratinization and focally papillomatous acanthosis.A focus of epithelial erosion.The stroma shows a nonspecific inflammatory infiltrate.The sections made at the level of the endometrium show this with an initial secretory pattern, made up of glands with elongated lights with few infranuclear vacuoles and with an edematous stroma.The myometrium does not show histological abnormalities, minimal fibrous changes are observed in relation to the removed device.Diagnosis: a.Uterine annex (excisional biopsy, left tube): inflammatory reaction to foreign body (essure) with fibrosis and obliteration of the lumen.B.Uterine annex (excisional biopsy, right tube): within histological normality.C.Uterus (simple hysterectomy piece): cervix: squamous metaplasis, endometrium: initial secretory type, myometrium: minimal fibrous changes in relation to the device.Pregnancy test - on (b)(6)2014: negative.Smear test - in (b)(6) 2017: previous morphological alterations: no.Cytological report:morphologic: squamous cell abnormalities: ascus atypical (squamous cells asc-us).Microbiological: microorganisms with morphologies compatible with: actinomyces.Cytology result: positive.Specialist consultation - on (b)(6)2014: gynecological consultation, the patient is well.Hysterosalpingography is requested at 3 months.Ultrasound doppler - in (b)(6)2017: doppler not suspicious in the left adnexa.Right adnexa without specific images.Ultrasound abdomen - on (b)(6)2017: complete abdominal ultrasound (includes renal).Findings: liver of normal echogenicity and structure.No focal lesions are observed.Thin-walled gallbladder, without stones inside.Intra and extra hepatic bile duct with normal characteristics.Both kidneys are of normal structure and echogenicity.There is no dilation of the excretory tract or evidence of stone images.Empty bladder.Spleen and pancreatic area visualized without alterations.Abdominal aorta of normal caliber.No evidence of free fluid.Ultrasound breast - on (b)(6)2014: clinical information: left mastalgia.Findings: no solid or cystic nodules or other significant ultrasound abnormalities are demonstrated.Bilateral reactive-appearing axillary lymphadenopathies.Conclusion: ultrasound birads 1.Ultrasound pelvis - on (b)(6)2017: uterus av.Endometrium 10,3 mm proliferative.Ovaries not visible; on (b)(6)2017: high resolution ultrasound: anteverted uterus, regular.Hypoechoic endometrium (menstruation), left ovary: adnexal image, bilobed cystic 4.4 x 2.7, right ovary: poorly defined, without specific images 2.3 x 1 cm.Left essure is not seen in the interstitial section.Echogenic foci are observed that correspond to the device without being able to visualize it in its entirety between the uterine horn and the adnexal image.Ultrasound: cystic left adnexal.Probable left hydrosalpinx.Essure partially migrated.Uterus av ovary d normal, left ovary, bilobed cyst with doppler not suspicious in left horn.Uterus no visible intrauterine tract.Weight - on (b)(6)2017: 90.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 23-feb-2022: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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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 ('migration of left device / not seen in the interstitial section / partial migration with no visible intracavitary'), genital haemorrhage ('excessive bleeding'), device breakage ('a small fragment of wire which when cut penetrates the uterine wall') and embedded device ('a small fragment of wire which when cut penetrates the uterine wall') in a 42-year-old female patient who had essure (batch no.A14902) inserted for contraception and sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included candidiasis in 2003, paraesthesia (with a feeling of exhaustion and difficulty grasping objects) in 1998, menarche (at 13 years-old) in 1984, gravida ii, parity 2 (caesarean section and a eutocic delivery), uterine abrasion, kidney disorder, allergy test negative, pyelonephritis and migraine.25-nov-1988: neurophysiology medical appointment: electroencephalogram test conclusion: signs of brain dysfunction at the level of temporo-occipital regions predominantly on the left hemisphere.Evolutionary controls are recommended.On (b)(6) 1989: neurophysiology medical appointment: signs of paroxysmal cerebral irritation of generalized expression with accentuation in temporal areas are observed.Concurrent conditions included breast pain female (continuous that has nothing to do with the menstrual cycle.Tenderness in the upper left quadrant, without nodules mammography and bilateral breast ultrasound: findings: breasts with marked fatty replacement, with remnants of fibro glandular tissue distributed slightly asymmetrically, more abundant in the left breast.In the craniocaudal projection of the left breast, a small increase in density is seen in the internal quadrants, without apparent underlying focal lesions, asymmetric with respect to the contralateral breast, without correspondence in the ultrasound study, probably related to fibro glandular tissue.Flattening of cooper's ligaments in both breasts and in the upper medial area of the left breast, probably related to mastopathy.Bilateral benign micro calcifications.Ultrasound : no solid or cystic nodules, distortions or other relevant or suspicious findings are visualized in the parenchyma of both breasts.Conclusion: bi-rads2) since (b)(6) 2012, smoker (at precocious age, 10 cigars per day), morbid obesity (since childhood) and headache.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced complication of device insertion ("impossibility of placing the second device in the right tube due to contractions and spasms of").On (b)(6) 2014, the patient experienced lymphadenopathy ("left mastalgia/ findings: bilateral reactive-appearing axillary lymphadenopathies").On (b)(6) 2014, the patient experienced the first episode of hot flush ("hot flashes").In 2016, the patient experienced pelvic pain ("pelvic pain").In (b)(6) 2016, the patient experienced amenorrhoea ("amenorrhea "), lasting 5 months.In (b)(6) 2017, the patient experienced cervical dysplasia ("squamous cell abnormalities - ascus atypical").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), hydrosalpinx ("problable left hydrosalpinx, recurrent") and adnexa uteri cyst ("cystic left adnexal, bilobed cystic 4.4 x 2.7 / cystic left appendage").On (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant), embedded device (seriousness criterion medically significant) and salpingitis ("excisional biopsy, left tube inflammatory reaction to foreign body (essure) with fibrosis and obliteration of the lumen.").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), anaemia ("anemia"), swelling ("swelling"), alopecia ("alopecia"), myalgia ("muscle pain"), arthralgia ("joints pain, knee pain, pain in the heel or ankle"), vaginal infection ("vaginal infections"), uterine spasm ("uterine contractions"), dry mouth ("mouth dryness"), candida infection ("candidiasis"), fatigue ("chronic tiredness/ continuous tiredness"), digestion impaired ("digestive problems"), headache ("headaches"), mental disorder ("psychological sequels"), breast pain ("left mastalgia"), abdominal pain ("abdominalgia"), asthenia ("asthenia"), the second episode of hot flush ("vasomotor clinic (secondary to hormonal disorders)"), abdominal distension ("abdominal swelling / gas"), fungal infection ("yeast infection"), muscle contractions involuntary ("contractions"), female sexual dysfunction ("inability to have sex"), heartburn ("heartburn"), pain in extremity ("leg pain"), gastroenteritis ("acute gastroenteritis"), influenza ("flu") and respiratory tract infection ("acute respiratory infection") and was found to have weight increased ("weight gain").The patient was treated with bemiparin sodium (hibor), dexketoprofen trometamol (enantyum), ferric pyrophosphate (fisiogen ferro forte), hydrocortisone aceponate (suniderma), ibuprofen, metamizole magnesium (nolotil), ovule clx (rilastil), pantoprazole (pantoprazolum), paracetamol and surgery (total hysterectomy and bilateral salpingectomy via laparoscopy on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, genital haemorrhage, device breakage, embedded device, pelvic pain, anaemia, swelling, alopecia, myalgia, arthralgia, vaginal infection, uterine spasm, dry mouth, candida infection, fatigue, digestion impaired, headache, mental disorder, complication of device insertion, breast pain, lymphadenopathy, cervical dysplasia, abdominal pain, asthenia, amenorrhoea, the last episode of hot flush, hydrosalpinx, adnexa uteri cyst, abdominal distension, fungal infection, muscle contractions involuntary, female sexual dysfunction, weight increased, heartburn, salpingitis, pain in extremity, gastroenteritis, influenza and respiratory tract infection outcome was unknown.The reporter considered abdominal distension, abdominal pain, adnexa uteri cyst, alopecia, amenorrhoea, anaemia, arthralgia, asthenia, breast pain, candida infection, cervical dysplasia, complication of device insertion, device breakage, device dislocation, digestion impaired, dry mouth, embedded device, fatigue, female sexual dysfunction, fungal infection, gastroenteritis, genital haemorrhage, headache, hydrosalpinx, influenza, lymphadenopathy, mental disorder, muscle contractions involuntary, myalgia, pain in extremity, pelvic pain, respiratory tract infection, salpingitis, swelling, uterine spasm, vaginal infection, weight increased, the first episode of hot flush, heartburn and the second episode of hot flush to be related to essure.The reporter commented: the placement of the intratubal devices was on (b)(6) 2014, with the impossibility of placing the second device in the right tube due to contractions and spasms at that time, for which the patient was called again.On (b)(6) 2014 reattempt to place the right device without success.Review in gynecology consultation on day (b)(6) 2014 to offer laparoscopic tubal ligation.For personal reasons she preferred to get the iud implantation on (b)(6) 2014 and it was removal on (b)(6) 2017.The symptomatology that the patient presents that could be related to the device started at the end of 2016, attending primary care in 2017, however the device was placed in (b)(6) 2014.On (b)(6) 2017 she request information on oral contraceptives, contraception by iud, pregnancy, tubaritis.Essure was removal on (b)(6) 2017 and postoperative with good evolution.On (b)(6) 2017 she was discharged from hospital.Endocrinology consultation on (b)(6) 2017 due to morbid obesity since childhood, many attempts to lose weight with little success.On (b)(6) 2017 weight 100 kg, imc 37.2, smoker 1 package per day, anxious depressive status, on (b)(6) 2018 she lost 5 kg of fat, maintain lean mass, complains of headache (unspecified date) and annual gynecological examination uterus in normal retro, normal adnexa, cx ectopy, normal analytics, treatment triagynon (unspecified date).Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on (b)(6) 2017: epicutaneous tests with true test and metal battery with reading at 48 and 96 hours with negative result.Chest x-ray - on (b)(6) 2017: normal.Electrocardiogram - on (b)(6) 2017: normal.Gynaecological examination - on (b)(6) 2017: general evaluation: adequate, squamocolumnar junction, type zt 2.Normal colposcopic findings: original squamous epithelium: atrophic, anormal colposcopic findings: first grade (minor): thin acetowhite epithelium,cervical pathology consultation: negative cytology.Ascus colposcopy and biopsy negative; on (b)(6) 2017: speculoscopy: threads visible, cervix normal appearance.Uterus in indifferent position, linear endometrium.Iud with normal insertion; on (b)(6) 2017: last period: december.External genitals and vagina are normal.Cervix is in a good status.Low vaginal discharge, obesity.Plan: high resolution ultrasound.Hormones.Human papilloma virus test - in (b)(6) 2017: negative.Hysterosalpingogram - on (b)(6) 2014: in the left tube, a metallic linear image is visualized in relation to essure, observing contrast in the ampullary end and a minimum amount surrounding the metallic image without passage of contrast to the peritoneum; on (b)(6) 2014: a linear image corresponding to the essure is visualized in the left tube and the right tube is filiform and permeable.Hysteroscopy - on (b)(6) 2014: normal endocervical canal, uterine cavity, both tubal ostia visible, impossible to permeabilize right tubal ostium; on (b)(6) 2017: 1st hysteroscopy to see if the device is expelled into the uterine cavity and could be removed this way, but it was not.Since it was placed in its place (in the tube).Pathology test - on (b)(6) 2017: cervix biopsy macroscopic disciption : several microscopic fragments of tissue are received, irregular frayed, flattened with a grayish-white color that together occupy an area of 0.2 x 0.3 cm.Microspcopic description: in the histological sections evaluated, three small fragments of flat stratified epithelium are observed, not oriented, with changes of squamous metaplasia.The cells do not present a perinuclear halo or evident binucleations.Mitosis is not observed.Ki 67 positive basal and the staining with p16 is negative.Ddiagnostic: uterus (incisional biopsy, cervix): squamous metaplasia without evidence of dysplasia.; on (b)(6) 2017: cervicovaginal cytology.Diagnostic : general valoration: presence of transformation zone.Inflammatory smear.Mixed flora.Morphological assessment: negative for intraepithelial lesion or malignancy; on (b)(6) 2017: essure removal in the left tube.Macroscopi description: a.Marked as left tube +essure, tubectomy piece is received that measures 5x1x8x0.8 cm in maximum diameter, externally it is normal and a metallic structure in the form of a wire of 0.5 cm in maximum diameter is observed coming out of the canal.When cut and surrounded by fibrous tissue.The continuation of the essure is observed, conserving its spiral shape with a size of 2.5 cm and obliterating the tube channel.The implant is removed and left in a separate container.B.Marked as a right tube, a tubectomy piece of 5.5x1.8x1 cm of maximum diameter is received, which is externally smooth and shiny, brownish in color, with no relevant findings on cut.It does not present essure.C.A simple hysterectomy specimen was received, measuring 8.2x5.4x4.2 cm in maximum diameter, presenting an oce of 1.5 cm.Cervical canal of 3.5 cm and endometrial canal of 2.5 cm.Externally, a small fragment of wire is observed in relation to the left tube, which when cut penetrates the uterine wall by 0.4 mm.At the opening and the section, no relevant findings are found.Cs: a1-4 cervix.A5: endometrium - myometrium.A6: myometrium in relation to the metallic structure.The metal structure is removed and left in a jar next to the one found in the left tube.Microscopic description: a.In the histological sections evaluated, the fragments of the blister and the infundibulum of normal appearance with epithelium of ciliated cylindrical cells surrounded by muscle layer and normal serosa are observed.At the level of the isthmus, a fibrous obliteration of the lumen is observed, accompanied by giant cells of the foreign body type, or that form granulomas.B.In the histological sections evaluated, fragments of the ampulla, infundibulum and isthmus of normal appearance with epithelium of ciliated cylindrical cells surrounded by muscle layer and normal serosa are observed.C.In the histological sections evaluated, it is observed at the level of the cervix: mature squamous metaplastic changes with keratinization and focally papillomatous acanthosis.A focus of epithelial erosion.The stroma shows a nonspecific inflammatory infiltrate.The sections made at the level of the endometrium show this with an initial secretory pattern, made up of glands with elongated lights with few infranuclear vacuoles and with an edematous stroma.The myometrium does not show histological abnormalities, minimal fibrous changes are observed in relation to the removed device.Diagnosis: a.Uterine annex (excisional biopsy, left tube): inflammatory reaction to foreign body (essure) with fibrosis and obliteration of the lumen.B.Uterine annex (excisional biopsy, right tube): within histological normality.C.Uterus (simple hysterectomy piece): cervix: squamous metaplasis, endometrium: initial secretory type, myometrium: minimal fibrous changes in relation to the device.Pregnancy test - on (b)(6) 2014: negative.Smear test - in (b)(6) 2017: previous morphological alterations: no.Cytological report:morphologic: squamous cell abnormalities: ascus atypical (squamous cells asc-us).Microbiological: microorganisms with morphologies compatible with: actinomyces.Cytology result: positive.Specialist consultation - on (b)(6) 2014: gynecological consultation, the patient is well.Hysterosalpingography is requested at 3 months.Ultrasound doppler - in (b)(6) 2017: doppler not suspicious in the left adnexa.Right adnexa without specific images.Ultrasound abdomen - on (b)(6) 2017: complete abdominal ultrasound (includes renal).Findings: liver of normal echogenicity and structure.No focal lesions are observed.Thin-walled gallbladder, without stones inside.Intra and extra hepatic bile duct with normal characteristics.Both kidneys are of normal structure and echogenicity.There is no dilation of the excretory tract or evidence of stone images.Empty bladder.Spleen and pancreatic area visualized without alterations.Abdominal aorta of normal caliber.No evidence of free fluid.Ultrasound breast - on (b)(6) 2014: clinical information: left mastalgia.Findings: no solid or cystic nodules or other significant ultrasound abnormalities are demonstrated.Bilateral reactive-appearing axillary lymphadenopathies.Conclusion: ultrasound birads 1.Ultrasound pelvis - on (b)(6) 2017: uterus av.Endometrium 10,3 mm proliferative.Ovaries not visible; on (b)(6) 2017: high resolution ultrasound: anteverted uterus, regular.Hypoechoic endometrium (menstruation), left ovary: adnexal image, bilobed cystic 4.4 x 2.7, right ovary: poorly defined, without specific images 2.3 x 1 cm.Left essure is not seen in the interstitial section.Echogenic foci are observed that correspond to the device without being able to visualize it in its entirety between the uterine horn and the adnexal image.Ultrasound: cystic left adnexal.Probable left hydrosalpinx.Essure partially migrated.Uterus av ovary d normal, left ovary, bilobed cyst with doppler not suspicious in left horn.Uterus no visible intrauterine tract.Weight - on (b)(6) 2017: 90.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on (b)(6) 2022: the follow information were include consumer's reporter updated, other health professional's , new lawyer, patient's details, medical history, lab data, product indication, lot number, other treatment products, events: device insertion failed, breast pain, lymphadenopathy axillary, hot flashes, atypical squamous cells of undetermined significance, asthenia, abdominal pain, amenorrhea, hot flashes, adnexa uteri cyst, hydrosalpinx , swelling abdomen, muscle contractions involuntary, yeast infection, female sexual dysfunction, weight gain , heartburn, device breakage, device fragment embedded, leg pain, acute gastroenteritis, flu, acute respiratory tract infection, onset date added to pelvic pain female, device dislocation, start date update from 2014 to (b)(6) 2014 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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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) with additional information received through social media and describes the occurrence of device dislocation ("migration of left device / not seen in the interstitial section / partial migration with no visible intracavitary"), genital haemorrhage ("excessive bleeding"), device breakage ("a small fragment of wire which when cut penetrates the uterine wall") and embedded device ("a small fragment of wire which when cut penetrates the uterine wall") in a 42 year-old female patient who had essure inserted (lot no.A14902) for contraception and female sterilisation.Additional non-serious events are detailed below.Other product or product use issues identified: several episodes of device insertion failed ("impossibility of placing the second device in the right tube due to contractions and spasms of" on (b)(6) 2014 and "an second try of device insertions in the right-fallopian tube failed" on (b)(6) 2014).The patient had a medical history of mastitis (non-puerperal) in 2014, candidiasis in 2003, paraesthesia (with a feeling of exhaustion and difficulty grasping objects) in 1998, menarche (at 13 years-old) in 1984 and migraine, pyelonephritis, allergy test negative, kidney disorder, uterine abrasion, parity 2 (caesarean section in (b)(6) 2003 and a eutocic delivery) and gravida ii.(b)(6) 1988: neurophysiology medical appointment: electroencephalogram test conclusion: signs of brain dysfunction at the level of temporo-occipital regions predominantly on the left hemisphere.Evolutionary controls are recommended.(b)(6) 1989: neurophysiology medical appointment: signs of paroxysmal cerebral irritation of generalized expression with accentuation in temporal areas are observed.Concurrent conditions were listed as breast pain female (continuous that has nothing to do with the menstrual cycle.Tenderness in the upper left quadrant, without nodules mammography and bilateral breast ultrasound: findings: breasts with marked fatty replacement, with remnants of fibro glandular tissue distributed slightly asymmetrically, more abundant in the left breast.In the craniocaudal projection of the left breast, a small increase in density is seen in the internal quadrants, without apparent underlying focal lesions, asymmetric with respect to the contralateral breast, without correspondence in the ultrasound study, probably related to fibro glandular tissue.Flattening of cooper's ligaments in both breasts and in the upper medial area of the left breast, probably related to mastopathy.Bilateral benign micro calcifications.Ultrasound : no solid or cystic nodules, distortions or other relevant or suspicious findings are visualized in the parenchyma of both breasts.Conclusion: bi-rads2) since 2012 as well as abdominal pain, asthenia, headache (refers headache for about 12 years), morbid obesity (since childhood) and smoker (at precocious age, 10 cigars per day).On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, 114 days after essure insertion, she experienced lymphadenopathy ("left mastalgia/ findings: bilateral reactive-appearing axillary lymphadenopathies").On (b)(6) 2014 she experienced a first episode of hot flush ("hot flashes").On (b)(6) 2015 she experienced polymenorrhoea ("two menstrual periods per month").On (b)(6) 2016 she experienced dyspareunia ("dyspareunia").On (b)(6) 2016 she experienced pregnancy with contraceptive device ("pregnancy diagnosed").In (b)(6) 2016 she experienced amenorrhoea ("amenorrhea ").In 2016 she experienced pelvic pain ("pelvic pain").In (b)(6) 2017 she experienced cervical dysplasia ("squamous cell abnormalities - ascus atypical").On (b)(6) 2017 she experienced device dislocation (seriousness criteria medically important and intervention required), hydrosalpinx ("problable left hydrosalpinx, recurrent") and adnexa uteri cyst ("cystic left adnexal, bilobed cystic 4.4 x 2.7 / cystic left appendage").On (b)(6) 2017 she experienced device breakage (seriousness criterion medically important), embedded device (seriousness criterion medically important) and salpingitis ("excisional biopsy, left tube inflammatory reaction to foreign body (essure) with fibrosis and obliteration of the lumen.").Essure was removed on (b)(6) 2017.An unknown time later she experienced genital haemorrhage (seriousness criterion medically important), anaemia ("anemia"), swelling ("swelling"), alopecia ("alopecia"), myalgia ("muscle pain"), arthralgia ("joints pain, knee pain, pain in the heel or ankle"), vaginal infection ("vaginal infections"), uterine spasm ("uterine contractions"), dry mouth ("mouth dryness"), candida infection ("candidiasis"), fatigue ("chronic tiredness/ continuous tiredness"), digestion impaired ("digestive problems"), headache ("headaches / occipital headache, bilateral frontal headache, oppressive throbbing"), mental disorder ("psychological sequels"), breast pain ("left mastalgia"), abdominal pain ("abdominalgia"), asthenia ("asthenia"), a second episode of hot flush ("vasomotor clinic (secondary to hormonal disorders)"), abdominal distension ("abdominal swelling / gas"), fungal infection ("yeast infection"), muscle contractions involuntary ("contractions"), female sexual dysfunction ("inability to have sex"), heartburn ("heartburn"), pain in extremity ("leg pain"), gastroenteritis ("acute gastroenteritis"), influenza ("flu"), respiratory tract infection ("acute respiratory infection"), urinary incontinence ("urinary incontinence"), dysmenorrhoea ("she continues with dysmenorrhea"), menstrual disorder ("menstrual disorders") and discomfort ("unspecific discomfort") and was found to have weight increased ("weight gain").The patient was treated with ibuprofen, suniderma (hydrocortisone aceponate), paracetamol, pantoprazolum (pantoprazole), enantyum (dexketoprofen trometamol), nolotil [metamizole magnesium], hibor (bemiparin sodium), fisiogen ferro forte (ferric pyrophosphate) and chlorhexidine as well as surgery (total hysterectomy and bilateral salpingectomy via laparoscopy on 18-jul-2017).At the time of the report, the pregnancy with contraceptive device had resolved and the dyspareunia and urinary incontinence had not resolved.The outcomes for device dislocation, genital haemorrhage, device breakage, embedded device, pelvic pain, anaemia, swelling, alopecia, myalgia, arthralgia, vaginal infection, uterine spasm, dry mouth, candida infection, fatigue, digestion impaired, headache, mental disorder, breast pain, lymphadenopathy, the last episode of hot flush, cervical dysplasia, abdominal pain, asthenia, amenorrhoea, hydrosalpinx, adnexa uteri cyst, abdominal distension, fungal infection, muscle contractions involuntary, female sexual dysfunction, weight increased, heartburn, salpingitis, pain in extremity, gastroenteritis, influenza, respiratory tract infection, polymenorrhoea, dysmenorrhoea, menstrual disorder and discomfort were unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.The patient's treatment dates suggest potential fetal exposure to essure during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal distension, abdominal pain, adnexa uteri cyst, alopecia, amenorrhoea, anaemia, arthralgia, asthenia, breast pain, candida infection, cervical dysplasia, device breakage, device dislocation, discomfort, dry mouth, dysmenorrhoea, dyspareunia, digestion impaired, heartburn, embedded device, fatigue, female sexual dysfunction, fungal infection, gastroenteritis, genital haemorrhage, headache, the first episode of hot flush, the second episode of hot flush, hydrosalpinx, influenza, lymphadenopathy, menstrual disorder, mental disorder, muscle contractions involuntary, myalgia, pain in extremity, pelvic pain, polymenorrhoea, pregnancy with contraceptive device, respiratory tract infection, salpingitis, swelling, urinary incontinence, uterine spasm, vaginal infection and weight increased to be related to essure administration.The reporter commented: the placement of the intratubal devices was on (b)(6) 2014, with the impossibility of placing the second device in the right tube due to contractions and spasms at that time, for which the patient was called again.Months after implantation, she went to her primary care doctor with symptoms such as headache, pelvic pain.On (b)(6) 2014 reattempt to place the right device without success.Review in gynecology consultation on day (b)(6) 2014 to offer laparoscopic tubal ligation.For personal reasons she preferred to get the iud implantation on (b)(6) 2014 and it was removal on (b)(6) 2017.The symptomatology that the patient presents that could be related to the device started at the end of 2016, attending primary care in 2017, however the device was placed in (b)(6) 2014.On (b)(6) 2017 she request information on oral contraceptives, contraception by iud, pregnancy, tubaritis.Essure was removal on (b)(6) 2017 and postoperative with good evolution.On (b)(6) 2017 she was discharged from hospital.Discrepancy date reported (the surgical extraction of both uterine tubes took place on (b)(6) 2017, the total surgical removal of the uterus on (b)(6) 2017 and the suture of the vaginal cupula on (b)(6) 2018).Endocrinology consultation on (b)(6) 2017 due to morbid obesity since childhood, many attempts to lose weight with little success.On (b)(6) 2017 weight 100 kg, imc 37.2, smoker 1 package per day, anxious depressive status, on (b)(6) 2018 she lost 5 kg of fat, maintain lean mass, complains of headache (unspecified date) and annual gynecological examination uterus in normal retro, normal adnexa, cx ectopy, normal analytics, treatment triagynon (unspecified date).Diagnostic results (normal ranges are provided in parenthesis if available): [allergy test] on (b)(6) 2017: epicutaneous tests with true test and metal battery with reading at 48 and 96 hours with negative result [chest x-ray] on (b)(6) 2017: normal [electrocardiogram] on (b)(6) 2017: normal.[gynaecological examination] on (b)(6) 2017: she continues with dysmenorrhea and menstrual disorders.Dyspareunia and discomfort.Patient wants the essures removed; on (b)(6) 2017: general evaluation: adequate, squamocolumnar junction, type zt 2.Normal colposcopic findings: original squamous epithelium: atrophic, anormal colposcopic findings: first grade (minor): thin acetowhite epithelium,cervical pathology consultation: negative cytology.Ascus colposcopy and biopsy negative; on (b)(6) 2017: speculoscopy: threads visible, cervix normal appearance.Uterus in indifferent position, linear endometrium.Iud with normal insertion; on (b)(6) 2017: last period: december.External genitals and vagina are normal.Cervix is in a good status.Low vaginal discharge, obesity.Plan: high resolution ultrasound.Hormones [human papilloma virus test] in (b)(6) 2017: negative.[hysterosalpingogram] on (b)(6) 2014: in the left tube, a metallic linear image is visualized in relation to essure, observing contrast in the ampullary end and a minimum amount surrounding the metallic image without passage of contrast to the peritoneum; on (b)(6) 2014: the right tube is filiform and permeable and shows passage of contrast to the peritoneum.In the left tube, a metallic linear image is visualized in relation to essure, observing contrast in the ampullary end and a minimum amount surrounding the metallic image without passage of contrast to the peritoneum; on (b)(6) 2014: a linear image corresponding to the essure is visualized in the left tube and the right tube is filiform and permeable [hysteroscopy] on (b)(6) : normal endocervical canal, uterine cavity, both tubal ostia visible, impossible to permeabilize right tubal ostium; on (b)(6) 2017: 1st hysteroscopy to see if the device is expelled into the uterine cavity and could be removed this way, but it was not.Since it was placed in its place (in the tube) [pathology test] on (b)(6) 2017: cervix biopsy macroscopic disciption : several microscopic fragments of tissue are received, irregular frayed, flattened with a grayish-white color that together occupy an area of 0.2 x 0.3 cm.Microspcopic description: in the histological sections evaluated, three small fragments of flat stratified epithelium are observed, not oriented, with changes of squamous metaplasia.The cells do not present a perinuclear halo or evident binucleations.Mitosis is not observed.Ki 67 positive basal and the staining with p16 is negative.Ddiagnostic: uterus (incisional biopsy, cervix): squamous metaplasia without evidence of dysplasia.And cervicovaginal cytology.Diagnostic : general valoration: presence of transformation zone.Inflammatory smear.Mixed flora.Morphological assessment: negative for intraepithelial lesion or malignancy; on (b)(6) 2017: essure removal in the left tube.Macroscopi description: a.Marked as left tube +essure, tubectomy piece is received that measures 5x1x8x0.8 cm in maximum diameter, externally it is normal and a metallic structure in the form of a wire of 0.5 cm in maximum diameter is observed coming out of the canal.When cut and surrounded by fibrous tissue.The continuation of the essure is observed, conserving its spiral shape with a size of 2.5 cm and obliterating the tube channel.The implant is removed and left in a separate container.B.Marked as a right tube, a tubectomy piece of 5.5x1.8x1 cm of maximum diameter is received, which is externally smooth and shiny, brownish in color, with no relevant findings on cut.It does not present essure.C.A simple hysterectomy specimen was received, measuring 8.2x5.4x4.2 cm in maximum diameter, presenting an oce of 1.5 cm.Cervical canal of 3.5 cm and endometrial canal of 2.5 cm.Externally, a small fragment of wire is observed in relation to the left tube, which when cut penetrates the uterine wall by 0.4 mm.At the opening and the section, no relevant findings are found.Cs: a1-4 cervix.A5: endometrium - myometrium.A6: myometrium in relation to the metallic structure.The metal structure is removed and left in a jar next to the one found in the left tube.Microscopic description: a.In the histological sections evaluated, the fragments of the blister and the infundibulum of normal appearance with epithelium of ciliated cylindrical cells surrounded by muscle layer and normal serosa are observed.At the level of the isthmus, a fibrous obliteration of the lumen is observed, accompanied by giant cells of the foreign body type, or that form granulomas.B.In the histological sections evaluated, fragments of the ampulla, infundibulum and isthmus of normal appearance with epithelium of ciliated cylindrical cells surrounded by muscle layer and normal serosa are observed.C.In the histological sections evaluated, it is observed at the level of the cervix: mature squamous metaplastic changes with keratinization and focally papillomatous acanthosis.A focus of epithelial erosion.The stroma shows a nonspecific inflammatory infiltrate.The sections made at the level of the endometrium show this with an initial secretory pattern, made up of glands with elongated lights with few infranuclear vacuoles and with an edematous stroma.The myometrium does not show histological abnormalities, minimal fibrous changes are observed in relation to the removed device.Diagnosis: a.Uterine annex (excisional biopsy, left tube): inflammatory reaction to foreign body (essure) with fibrosis and obliteration of the lumen.B.Uterine annex (excisional biopsy, right tube): within histological normality.C.Uterus (simple hysterectomy piece): cervix: squamous metaplasis, endometrium: initial secretory type, myometrium: minimal fibrous changes in relation to the device [pregnancy test] on (b)(6) 2014: negative; on (b)(6) 2016: positive [smear test] in (b)(6) 2017: previous morphological alterations: no.Cytological report:morphologic: squamous cell abnormalities: ascus atypical (squamous cells asc-us).Microbiological: microorganisms with morphologies compatible with: actinomyces.Cytology result: positive [specialist consultation] on (b)(6) 2014: gynecological consultation, the patient is well.Hysterosalpingography is requested at 3 months; (date unknown): neurology consultation report: "refers headache for about 12 years, occipital headache for 6 months, bilateral frontal headache, oppressive throbbing, sometimes occipital [ultrasound abdomen] on (b)(6) 2017: complete abdominal ultrasound (includes renal).Findings: liver of normal echogenicity and structure.No focal lesions are observed.Thin-walled gallbladder, without stones inside.Intra and extra hepatic bile duct with normal characteristics.Both kidneys are of normal structure and echogenicity.There is no dilation of the excretory tract or evidence of stone images.Empty bladder.Spleen and pancreatic area visualized without alterations.Abdominal aorta of normal caliber.No evidence of free fluid [ultrasound breast] on (b)(6) 2014: clinical information: left mastalgia.Findings: no solid or cystic nodules or other significant ultrasound abnormalities are demonstrated.Bilateral reactive-appearing axillary lymphadenopathies.Conclusion: ultrasound birads 1 [ultrasound doppler] in (b)(6) 2017: doppler not suspicious in the left adnexa.Right adnexa without specific images [ultrasound pelvis] on (b)(6) 2014: uterus of normal size and morphology; on (b)(6) 2016: the essures are seen at the bottom of the cavity and "impress slightly lowered, with no other finding; on (b)(6) 2017: uterus av.Endometrium 10,3 mm proliferative.Ovaries not visible; on (b)(6) 2017: high resolution ultrasound: anteverted uterus, regular.Hypoechoic endometrium (menstruation), left ovary: adnexal image, bilobed cystic 4.4 x 2.7, right ovary: poorly defined, without specific images 2.3 x 1 cm.Left essure is not seen in the interstitial section.Echogenic foci are observed that correspond to the device without being able to visualize it in its entirety between the uterine horn and the adnexal image.Ultrasound: cystic left adnexal.Probable left hydrosalpinx.Essure partially migrated.Uterus av ovary d normal, left ovary, bilobed cyst with doppler not suspicious in left horn.Uterus no visible intrauterine tract [weight] on (b)(6) 2017: 90.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 08-apr-2022: plaintiff fact sheet received and the follow information were include other's, other health professional's, physician's reporters, pregnancy updated to yes, pregnancy information, medical record, lab data, dyspareunia, urinary incontinence, menstruation frequent, menstrual disorders, dysmenorrhea, discomfort nos, pregnancy with contraceptive device, device insertion failed.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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