| Model Number ESS305 |
| Device Problems
Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Pelvic Inflammatory Disease (2000); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2015 |
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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 breakage ('device breakage') and uterine inflammation ('uterine inflammation') in a (b)(6) female patient who had essure (batch no.B02267) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and parity 2.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced procedural pain ("pain on the right side on same day of essure procedure").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criterion medically significant), device dislocation ("èssure not well positioned in fallopian tubes"), pelvic pain ("pelvic pain"), the first episode of dyspareunia ("pain during sex"), vaginal discharge ("heavy vaginal discharge with odor"), abdominal pain ("abdominal cramps"), breast pain ("breast pain"), breast swelling ("breast distention"), breast oedema ("breast edema"), menorrhagia ("heavy prolonged menstrual bleeding with clots"), headache ("strong headaches"), pain in extremity ("pain in legs"), peripheral swelling ("swelling legs"), paraesthesia ("tingling"), tremor ("tremors"), back pain ("lumbar pain"), uterine pain ("sensation of uterine perforation (pain)"), fatigue ("fatigue"), loss of libido ("loss of libido"), the second episode of dyspareunia ("pain during and after sex"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen"), pain ("generalized pain"), dysmenorrhoea ("pain during menses") and anxiety ("anxiety").At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, procedural pain, vaginal discharge, abdominal pain, breast pain, breast swelling, breast oedema, menorrhagia, headache, pain in extremity, peripheral swelling, paraesthesia, tremor, back pain, uterine pain, fatigue, loss of libido, the last episode of dyspareunia, coital bleeding, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, dysmenorrhoea and anxiety outcome was unknown.The reporter considered abdominal pain, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast oedema, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, dysmenorrhoea, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, procedural pain, tremor, uterine inflammation, uterine pain, vaginal discharge, the first episode of dyspareunia and the second episode of dyspareunia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test (0.6 - 7.5 mcg/l) - on (b)(6) -2019: 1.87 mcg/l.X-ray - on (b)(6) 2019: essure in pelvis; fragments were noted.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage'), uterine inflammation ('uterine inflammation') and device dislocation ('essure not well positioned in fallopian tubes/ essure in pelvis') in a 44-year-old female patient who had essure (batch no.B02267) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and parity 2.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced procedural pain ("pain on the right side on same day of essure procedure").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal cramps"), dyspareunia ("pain during and after sex"), menorrhagia ("heavy prolonged menstrual bleeding with clots"), dysmenorrhoea ("pain during menses"), back pain ("lumbar pain"), uterine pain ("sensation of uterine perforation (pain)"), vaginal discharge ("heavy vaginal discharge with odor"), headache ("strong headaches"), pain ("generalized pain"), coital bleeding ("bleeding during and after sexual intercourse"), adenomyosis ("suspicion of adenomyosis"), breast pain ("breast pain"), breast swelling ("breast distention"), breast oedema ("breast edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling legs"), paraesthesia ("tingling"), arthralgia ("joint pain"), tremor ("tremors"), fatigue ("fatigue"), loss of libido ("loss of libido"), mood swings ("mood swings"), anxiety ("anxiety"), alopecia ("hair loss") and intra-abdominal fluid collection ("liquid in abdomen").At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, abdominal pain, dyspareunia, menorrhagia, dysmenorrhoea, back pain, uterine pain, procedural pain, vaginal discharge, headache, pain, coital bleeding, adenomyosis, breast pain, breast swelling, breast oedema, pain in extremity, peripheral swelling, paraesthesia, arthralgia, tremor, fatigue, loss of libido, mood swings, anxiety, alopecia and intra-abdominal fluid collection outcome was unknown.The reporter considered abdominal pain, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast oedema, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, procedural pain, tremor, uterine inflammation, uterine pain and vaginal discharge to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available):
allergy test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 1.87 mcg/l.X-ray - on (b)(6) 2019: essure in pelvis; fragments were noted.Lot number: b02267, manufacturing date: 2013-02, expiration date: 2016-02.Quality-safety evaluation of ptc:
unable to confirm complaint.Most recent follow-up information incorporated above includes:
on 26-jun-2020: 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 breakage ('device breakage'), uterine inflammation ('uterine inflammation') and device dislocation ('essure not well positioned in fallopian tubes/ essure in pelvis') in a 44-year-old female patient who had essure (batch no.B02267) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and parity 2.On (b)(6)2014, the patient had essure inserted.In (b)(6)2014, the patient experienced procedural pain ("pain on the right side on same day of essure procedure").In 2017, the patient experienced vulvovaginal pruritus ("vaginal pruritus").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal cramps"), dyspareunia ("pain during and after sex"), menorrhagia ("heavy prolonged menstrual bleeding with clots"), dysmenorrhoea ("pain during menses"), back pain ("lumbar pain"), uterine pain ("sensation of uterine perforation (pain)"), vaginal discharge ("heavy vaginal discharge with odor"), headache ("strong headaches"), pain ("generalized pain"), coital bleeding ("bleeding during and after sexual intercourse"), adenomyosis ("suspicion of adenomyosis"), breast pain ("breast pain"), breast swelling ("breast distention"), breast oedema ("breast edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling legs"), paraesthesia ("tingling"), arthralgia ("joint pain"), tremor ("tremors"), fatigue ("fatigue"), loss of libido ("loss of libido"), mood swings ("mood swings"), anxiety ("anxiety"), alopecia ("hair loss") and intra-abdominal fluid collection ("liquid in abdomen").At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, abdominal pain, dyspareunia, menorrhagia, dysmenorrhoea, back pain, uterine pain, procedural pain, vaginal discharge, headache, pain, coital bleeding, adenomyosis, breast pain, breast swelling, breast oedema, pain in extremity, peripheral swelling, paraesthesia, arthralgia, tremor, fatigue, loss of libido, mood swings, anxiety, alopecia and intra-abdominal fluid collection outcome was unknown and the vulvovaginal pruritus had not resolved.The reporter considered abdominal pain, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast oedema, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, procedural pain, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal pruritus to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test (0.6 - 7.5 mcg/l) - on (b)(6)2019: 1.87 mcg/l.X-ray - on (b)(6)2019: essure in pelvis; fragments were noted.Lot number: b02267 manufacturing date: 2013-02 expiration date: 2016-02.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-jul-2020: new event added (vaginal pruritus).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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of device breakage ("device breakage/ device is bet"), uterine inflammation ("uterine inflammation"), device dislocation ("essure not well positioned in fallopian tubes/ essure in pelvis") and pelvic pain ("pain on the right side for 6 years") in a 44 year-old female patient who had essure inserted (lot no.B02267) for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: device shape alteration ("essure was bent on the right side").The patient had a medical history of amenorrhoea, multiple cesarean sections, parity 2 and gravida ii.Previously administered products included: desogestrel.Concurrent conditions were listed as epigastric pain, vomiting and vomiting.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014 she experienced procedural pain ("pain on the right side on same day of essure procedure").In 2015 she experienced pelvic pain (seriousness criteria medically important and intervention required).In 2017 she experienced vulvovaginal pruritus ("vaginal pruritus").At an unknown time she experienced device breakage (seriousness criterion intervention required), uterine inflammation (seriousness criteria medically important and intervention required), device dislocation (seriousness criterion medically important), abdominal pain ("abdominal cramps"), dyspareunia ("pain during and after sex"), heavy menstrual bleeding ("heavy prolonged menstrual bleeding with clots"), dysmenorrhoea ("pain during menses"), back pain ("lumbar pain"), uterine pain ("sensation of uterine perforation (pain)"), vaginal discharge ("heavy vaginal discharge with odor"), headache ("strong headaches"), pain ("generalized pain"), coital bleeding ("bleeding during and after sexual intercourse"), adenomyosis ("suspicion of adenomyosis"), breast pain ("breast pain"), breast swelling ("breast distention"), breast oedema ("breast edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling legs"), paraesthesia ("tingling"), arthralgia ("joint pain"), tremor ("tremors"), fatigue ("fatigue"), loss of libido ("loss of libido"), mood swings ("mood swings"), anxiety ("anxiety"), alopecia ("hair loss"), intra-abdominal fluid collection ("liquid in abdomen"), abdominal pain lower ("severe pain in and right iliac fossa") and affect lability ("emotional lability").The patient was treated with surgery (abdominal hysterectomy + bilateral salpingectomy (with essure removal)).At the time of the report, the vulvovaginal pruritus had not resolved.The outcomes for device breakage, uterine inflammation, device dislocation, pelvic pain, abdominal pain, dyspareunia, heavy menstrual bleeding, dysmenorrhoea, back pain, uterine pain, procedural pain, vaginal discharge, headache, pain, coital bleeding, adenomyosis, breast pain, breast swelling, breast oedema, pain in extremity, peripheral swelling, paraesthesia, arthralgia, tremor, fatigue, loss of libido, mood swings, anxiety, alopecia, intra-abdominal fluid collection, abdominal pain lower and affect lability were unknown.Essure was removed on (b)(6) 2021.The reporter considered abdominal pain, abdominal pain lower, adenomyosis, affect lability, alopecia, anxiety, arthralgia, back pain, breast oedema, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, procedural pain, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal pruritus to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 67 kg.[allergy test ( 0.6- 7.5 mcg/l)] on (b)(6) 2019: 1.87 mcg/l [ultrasound scan] on (b)(6) 2021: examination performed in a state-of-the-art ultrasound machine, voluson s6, 4d/4d, high resolution, color doppler, shows: uterus with hysterectomy scar on the anterior wall of normal shape, volume, contours, topography and echotexture, with echogenic, homogeneous, centred endometrium, measuring 3.6 mm in thickness.Essure in pelvis on the right and left.The largest uterine diameters measure 70 mm x 40 mm x 29 mm, respectively longitudinal, transverse and anteroposterior diameters, with a volume of 43 cm³ (normal up to 120 cm³ for secundipara).Right ovary with normal volume, measuring 25 mm x 24 mm x 23 mm with a volume of 7.6 cm³, with an anechoic nodule (cyst) with septum, with homogeneous content, measuring 21 mm x 19 mm x 14 mm with a volume of 3.2 cm³.The left ovary has a normal volume, measuring 22 mm x 19 mm x 18 mm with a volume of 4.1 cm³, with an anechoic nodule (cyst) with regular smooth walls, with homogeneous content, measuring 16 mm x 14 mm x 12 mm with a volume of 1.5 cm³.Empty bladder.Vagina of normal contours, shape and position.Free peritoneal sac fundus; (date unknown): material: uterus and fallopian tubes macroscopy: uterus with cervix measuring 8.0 x 5.0 x 4.0 cm.The cervix measures 5.0 x 3.0 x 3.0 cm, with an external orifice in the form of a slit and a channel of the usual appearance.The body is globose, with smooth, brownish serosa.When cut, the endometrium and myometrium do not exhibit particularities.They accompany right and left tubes, 10.0 cm long each, showing brownish serous surface and both with essure device in the light (8b/vf/cr) conclusion - chronic cervicitis; - endometrium with findings of hypotrophy; - myometrium without particularities; - congested tubes, with paratubal cysts.[x-ray] on (b)(6) 2019: essure in pelvis; fragments were noted; (date unknown): appears that the device was folded in the patient's body.Lot number: b02267, manufacturing date: 2013-02, and expiration date: 2016-02.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: 04-jul-2023: 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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of device breakage ("device breakage/ device is bet"), uterine inflammation ("uterine inflammation") and device dislocation ("essure not well positioned in fallopian tubes/ essure in pelvis") in a 44 year-old female patient who had essure inserted (lot no.B02267) for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: device shape alteration ("appears that the device was folded in the patient's body").The patient had a medical history of amenorrhoea, c-section, parity 2 and gravida ii.Previously administered products included: desogestrel.Concurrent conditions were listed as epigastric pain, vomiting and vomiting.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014 she experienced procedural pain ("pain on the right side on same day of essure procedure").In 2017 she experienced vulvovaginal pruritus ("vaginal pruritus").Essure was removed on (b)(6) 2021.An unknown time later she experienced device breakage (seriousness criterion intervention required), uterine inflammation (seriousness criteria medically important and intervention required), device dislocation (seriousness criterion medically important), pelvic pain ("pelvic pain"), abdominal pain ("abdominal cramps"), dyspareunia ("pain during and after sex"), heavy menstrual bleeding ("heavy prolonged menstrual bleeding with clots"), dysmenorrhoea ("pain during menses"), back pain ("lumbar pain"), uterine pain ("sensation of uterine perforation (pain)"), vaginal discharge ("heavy vaginal discharge with odor"), headache ("strong headaches"), pain ("generalized pain"), coital bleeding ("bleeding during and after sexual intercourse"), adenomyosis ("suspicion of adenomyosis"), breast pain ("breast pain"), breast swelling ("breast distention"), breast oedema ("breast edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling legs"), paraesthesia ("tingling"), arthralgia ("joint pain"), tremor ("tremors"), fatigue ("fatigue"), loss of libido ("loss of libido"), mood swings ("mood swings"), anxiety ("anxiety"), alopecia ("hair loss"), intra-abdominal fluid collection ("liquid in abdomen"), abdominal pain lower ("severe pain in and right iliac fossa") and affect lability ("emotional lability").The patient was treated with surgery (abdominal hysterectomy + bilateral salpingectomy (with essure removal)).At the time of the report, the vulvovaginal pruritus had not resolved.The outcomes for device breakage, uterine inflammation, device dislocation, pelvic pain, abdominal pain, dyspareunia, heavy menstrual bleeding, dysmenorrhoea, back pain, uterine pain, procedural pain, vaginal discharge, headache, pain, coital bleeding, adenomyosis, breast pain, breast swelling, breast oedema, pain in extremity, peripheral swelling, paraesthesia, arthralgia, tremor, fatigue, loss of libido, mood swings, anxiety, alopecia, intra-abdominal fluid collection, abdominal pain lower and affect lability were unknown.The reporter considered abdominal pain, abdominal pain lower, adenomyosis, affect lability, alopecia, anxiety, arthralgia, back pain, breast oedema, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, procedural pain, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal pruritus to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 67 kg.[allergy test ( 0.6- 7.5 mcg/l)] on (b)(6) 2019: 1.87 mcg/l [ultrasound scan] on (b)(6) 2021: examination performed in a state-of-the-art ultrasound machine, voluson s6, 4d/4d, high resolution, color doppler, shows: uterus with hysterectomy scar on the anterior wall of normal shape, volume, contours, topography and echotexture, with echogenic, homogeneous, centred endometrium, measuring 3.6 mm in thickness.Essure in pelvis on the right and left.The largest uterine diameters measure 70 mm x 40 mm x 29 mm, respectively longitudinal, transverse and anteroposterior diameters, with a volume of 43 cm³ (normal up to 120 cm³ for secundipara).Right ovary with normal volume, measuring 25 mm x 24 mm x 23 mm with a volume of 7.6 cm³, with an anechoic nodule (cyst) with septum, with homogeneous content, measuring 21 mm x 19 mm x 14 mm with a volume of 3.2 cm³.The left ovary has a normal volume, measuring 22 mm x 19 mm x 18 mm with a volume of 4.1 cm³, with an anechoic nodule (cyst) with regular smooth walls, with homogeneous content, measuring 16 mm x 14 mm x 12 mm with a volume of 1.5 cm³.Empty bladder.Vagina of normal contours, shape and position.Free peritoneal sac fundus; (date unknown): material: uterus and fallopian tubes macroscopy: uterus with cervix measuring 8.0 x 5.0 x 4.0 cm.The cervix measures 5.0 x 3.0 x 3.0 cm, with an external orifice in the form of a slit and a channel of the usual appearance.The body is globose, with smooth, brownish serosa.When cut, the endometrium and myometrium do not exhibit particularities.They accompany right and left tubes, 10.0 cm long each, showing brownish serous surface and both with essure device in the light (8b/vf/cr) conclusion - chronic cervicitis; - endometrium with findings of hypotrophy; - myometrium without particularities; - congested tubes, with paratubal cysts.[x-ray] on 10-oct-2019: essure in pelvis; fragments were noted; (date unknown): appears that the device was folded in the patient's body.Lot number: b02267, manufacturing date: 2013-02 & expiration date: 2016-02.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 14-jun-2023: medical record received.Event emotional liability, abdominal pain lower, device physical property issue essure removal date updated.Concomitant conditions added.Lab data updated.Treatment drug updated.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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