| Model Number ESS305 |
| Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Pain (1994); Pelvic Inflammatory Disease (2000)
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| Event Date 01/01/2018 |
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Event Type
Injury
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Event Description
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain in the region pelvic") in a 36 year-old female patient who had essure inserted.Additional non-serious events are detailed below.Medical conditions: denies nausea and vomiting no complaints spontaneous diuresis walking.On (b)(6)2014, the patient had essure inserted.In 2018 she experienced pelvic pain (seriousness criterion intervention required), abdominal pain lower ("severe cramps"), heavy menstrual bleeding ("intense increase in menstrual flow, up to 15 days in menstrual period"), uterine pain ("uterine stitches"), dyspareunia (" pain during and after intercourse"), back pain ("lower back pain"), pain ("generalized pain"), vaginal discharge ("strong odor from vaginal fluid"), headache ("severe headaches"), pain in extremity ("pain in the legs"), peripheral swelling ("swelling in the legs"), paraesthesia ("tingling too much"), tremor ("tremors"), uterine tenderness ("sensation of perforation in the uterus"), fatigue ("fatigue"), loss of libido ("lack of libido"), coital bleeding ("bleeding during and after intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("constant mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis") and intra-abdominal fluid collection ("fluid in the abdomen").On (b)(6)2022 she experienced hypertension ("arterial hypertension").An unknown time later she experienced abdominal pain ("abdominal pain"), post procedural haemorrhage ("discrete vaginal bleeding"), abnormal uterine bleeding ("abnormal uterine bleeding"), dysuria ("she feels pain when urinating"), proctalgia ("pain in the rectum"), irritability ("she feels a lot of irritation"), anxiety ("anxiety"), depressed mood ("sadness"), depression ("depression"), premenstrual syndrome ("premenstrual tension"), urinary tract infection bacterial ("bacterial urinary infection") and polyuria ("diuresis") and was found to have uterine leiomyoma ("fibroids").The patient was treated with surgery (vaginal hysterectomy and bilateral salpingectomy).At the time of the report, the outcomes for pelvic pain, abdominal pain lower, heavy menstrual bleeding, uterine pain, dyspareunia, back pain, pain, vaginal discharge, headache, pain in extremity, peripheral swelling, paraesthesia, tremor, uterine tenderness, fatigue, loss of libido, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, dysuria, proctalgia, irritability, anxiety, depressed mood and depression were unknown.The reporter considered abdominal pain, abdominal pain lower, abnormal uterine bleeding, adenomyosis, alopecia, anxiety, arthralgia, back pain, coital bleeding, depressed mood, depression, dyspareunia, dysuria, fatigue, headache, heavy menstrual bleeding, hypertension, intra-abdominal fluid collection, irritability, loss of libido, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polyuria, post procedural haemorrhage, proctalgia, tremor, urinary tract infection bacterial, uterine inflammation, uterine leiomyoma, uterine pain, uterine tenderness and vaginal discharge to be related to essure administration.No causality assessment was received for essure with regard to premenstrual syndrome.The reporter commented: the medical record adds little, describing only the peri-procedure hospitalisation for removal of the device and one pre-procedure and one post-procedure consultation.There is a lack of important information/examinations, such as the anatomopathological examination of the surgical specimen.Procedure for removal was total hysterectomy + bilateral salpingectomy, it is not the standard procedure and indicates the possibility of a cause other than essure.Medical consultation performed on (b)(6)2022 (post procedure review consultation), shows the diagnostic hypothesis ¿with essure + adenomyosis medical consultation carried out on (b)(6)2022 (pre-procedure consultation) shows a diagnosis of adenomyosis (uterus with an increased volume of 124 cm3 is one of the signs of adenomyosis/fibroids).Adenomyosis explains symptoms such as abdominal pain and dyspareunia.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 31.25 kg/sqm.[allergy test ( 0.6- 7.5 mcg/l)] on (b)(6)2020: 1.01 mcg/l.[blood bilirubin] on (b)(6)2020: negative.[blood creatinine ( 0.53- 1.0 mg/dl)] on (b)(6)2020: 0.59 mg/dl.[glucose urine] on (b)(6)2020: unremarkable.[haemoglobin urine] on (b)(6)2020: negative.[nitrite urine] on (b)(6)2020: positive.[occult blood] on (b)(6)2020: negative.[protein urine] on (b)(6)2020: negative.[ultrasound scan vagina] in 2020: diffusely heterogeneous uterus ¿ suggestive of adenomyosis, which can cause pain and increased bleeding.Essures apparently well positioned; on (b)(6)2020: urethra and bladder without abnormalities, vaginal wall without changes, uterus in antiversoflexion, with normal volume and normal shape, regular contour, homogeneous myometrium, secreted endometrium, 8.3 mm thick.Presence of linear echogenic images located in the interstitial region of the fallopian tubes suggestive of essure, normoposisional.Parauterine right ovary of normal volume, normal shape and echotexture, parauterine left ovary of normal volume, normal shape and echotexture, absence of collection of pathological liquids on the pelves.Uterus 9x5x6 cm, 140.4 cm3, right ovary 3.3x1.7x2.6 cm, 7.6 cm3, left ovary 2.2x3.0x2.5 cm 8.6 cm3 and no abnormalities, essure well positioned (according to the report).[urine analysis] on (b)(6)2020: density 1016, ph 6.0.[urine ketone body] on (b)(6)2020: negative.[urobilinogen urine] on (b)(6)2020: unremarkable.[x-ray] on (b)(6)2014: x-ray pelvis, integral articular surfaces with conserved spaces, normal-looking bone structure, bilateral tubal microdevice.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 17-jul-2023: case became serious incident: event pelvic pain (pain in the region pelvic) updated to serious incident due to surgical intervention (vaginal hysterectomy and bilateral salpingectomy).Premenstrual pain, diuresis, post procedural bleeding, hypertension, fibroids, abnormal uterine bleeding, and bacterial urinary tract infection added as events.19-jul-2023: event abdominal pain & reporter causality comment 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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain in the region pelvic") in a 36 year-old female patient who had essure inserted.Additional non-serious events are detailed below.Medical conditions: denies nausea and vomiting no complaints spontaneous diuresis walking.On (b)(6) 2014, the patient had essure inserted.In 2018, she experienced pelvic pain (seriousness criterion intervention required), abdominal pain lower ("severe cramps"), heavy menstrual bleeding ("intense increase in menstrual flow, up to 15 days in menstrual period"), uterine pain ("uterine stitches"), dyspareunia (" pain during and after intercourse"), back pain ("lower back pain"), pain ("generalized pain"), vaginal discharge ("strong odor from vaginal fluid"), headache ("severe headaches"), pain in extremity ("pain in the legs"), peripheral swelling ("swelling in the legs"), paraesthesia ("tingling too much"), tremor ("tremors"), uterine tenderness ("sensation of perforation in the uterus"), fatigue ("fatigue"), loss of libido ("lack of libido"), coital bleeding ("bleeding during and after intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("constant mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis") and intra-abdominal fluid collection ("fluid in the abdomen").On (b)(6) 2022, she experienced hypertension ("arterial hypertension").An unknown time later she experienced abdominal pain ("abdominal pain"), post procedural haemorrhage ("discrete vaginal bleeding"), abnormal uterine bleeding ("abnormal uterine bleeding"), dysuria ("she feels pain when urinating"), proctalgia ("pain in the rectum"), irritability ("she feels a lot of irritation"), anxiety ("anxiety"), depressed mood ("sadness"), depression ("depression"), premenstrual syndrome ("premenstrual tension"), urinary tract infection bacterial ("bacterial urinary infection") and polyuria ("diuresis") and was found to have uterine leiomyoma ("fibroids").The patient was treated with surgery (vaginal hysterectomy and bilateral salpingectomy).At the time of the report, the outcomes for pelvic pain, abdominal pain lower, heavy menstrual bleeding, uterine pain, dyspareunia, back pain, pain, vaginal discharge, headache, pain in extremity, peripheral swelling, paraesthesia, tremor, uterine tenderness, fatigue, loss of libido, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, dysuria, proctalgia, irritability, anxiety, depressed mood and depression were unknown.The reporter considered abdominal pain, abdominal pain lower, abnormal uterine bleeding, adenomyosis, alopecia, anxiety, arthralgia, back pain, coital bleeding, depressed mood, depression, dyspareunia, dysuria, fatigue, headache, heavy menstrual bleeding, hypertension, intra-abdominal fluid collection, irritability, loss of libido, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polyuria, post procedural haemorrhage, proctalgia, tremor, urinary tract infection bacterial, uterine inflammation, uterine leiomyoma, uterine pain, uterine tenderness and vaginal discharge to be related to essure administration.No causality assessment was received for essure with regard to premenstrual syndrome.The reporter commented: the medical record adds little, describing only the peri-procedure hospitalisation for removal of the device and one pre-procedure and one post-procedure consultation.There is a lack of important information/examinations, such as the anatomopathological examination of the surgical specimen.Procedure for removal was total hysterectomy + bilateral salpingectomy, it is not the standard procedure and indicates the possibility of a cause other than essure.Medical consultation performed on (b)(6) 2022 (post procedure review consultation), shows the diagnostic hypothesis ¿with essure + adenomyosis.Medical consultation carried out on (b)(6) 2022 (pre-procedure consultation) shows a diagnosis of adenomyosis (uterus with an increased volume of 124 cm3 is one of the signs of adenomyosis/fibroids).Adenomyosis explains symptoms such as abdominal pain and dyspareunia.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 31.25 kg/sqm.[allergy test ( 0.6- 7.5 mcg/l)] on (b)(6) 2020: 1.01 mcg/l.[blood bilirubin] on (b)(6) 2020: negative.[blood creatinine ( 0.53- 1.0 mg/dl)] on (b)(6) 2020: 0.59 mg/dl.[glucose urine] on (b)(6) 2020: unremarkable.[haemoglobin urine] on (b)(6) 2020: negative.[nitrite urine] on (b)(6) 2020: positive.[occult blood] on (b)(6) 2020: negative.[protein urine] on (b)(6) 2020: negative.[ultrasound scan vagina] in 2020: diffusely heterogeneous uterus ¿ suggestive of adenomyosis, which can cause pain and increased bleeding.Essures apparently well positioned; on (b)(6) 2020: urethra and bladder without abnormalities, vaginal wall without changes, uterus in antiversoflexion, with normal volume and normal shape, regular contour, homogeneous myometrium, secreted endometrium, 8.3 mm thick.Presence of linear echogenic images located in the interstitial region of the fallopian tubes suggestive of essure, normoposisional.Parauterine right ovary of normal volume, normal shape and echotexture, parauterine left ovary of normal volume, normal shape and echotexture, absence of collection of pathological liquids on the pelves.Uterus 9x5x6 cm, 140.4 cm3, right ovary 3.3x1.7x2.6 cm, 7.6 cm3, left ovary 2.2x3.0x2.5 cm 8.6 cm3 and no abnormalities, essure well positioned (according to the report).[urine analysis] on (b)(6) 2020: density 1016, ph 6.0.[urine ketone body] on (b)(6) 2020: negative.[urobilinogen urine] on (b)(6) 2020: unremarkable.[x-ray] on (b)(6) 2014: x-ray pelvis, integral articular surfaces with conserved spaces, normal-looking bone structure, bilateral tubal microdevice.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 27-jul-2023: 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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain in the region pelvic") and salpingitis ("fallopian tube - chronic inflammatory process with foreign body-type gigantocytic reaction") in a 36 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of uterine cervical squamous metaplasia and uterine anteflexion.Denies nausea and vomiting no complaints spontaneous diuresis walking.On (b)(6) 2014, the patient had essure inserted.In 2018, she experienced pelvic pain (seriousness criterion intervention required), abdominal pain lower ("severe cramps"), heavy menstrual bleeding ("intense increase in menstrual flow, up to 15 days in menstrual period"), uterine pain ("uterine stitches"), dyspareunia (" pain during and after intercourse"), back pain ("lower back pain"), pain ("generalized pain"), vaginal discharge ("strong odor from vaginal fluid"), headache ("severe headaches"), pain in extremity ("pain in the legs"), peripheral swelling ("swelling in the legs"), paraesthesia ("tingling too much"), tremor ("tremors"), uterine tenderness ("sensation of perforation in the uterus"), fatigue ("fatigue"), loss of libido ("lack of libido"), coital bleeding ("bleeding during and after intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("constant mood swings"), alopecia ("hair loss"), adenomyosis ("adenomyosis in rare foci") and intra-abdominal fluid collection ("fluid in the abdomen").On (b)(6) 2022, she experienced hypertension ("arterial hypertension").An unknown time later she experienced salpingitis (seriousness criterion intervention required), abdominal pain ("abdominal pain"), post procedural haemorrhage ("discrete vaginal bleeding"), abnormal uterine bleeding ("abnormal uterine bleeding"), dysuria ("she feels pain when urinating"), proctalgia ("pain in the rectum"), irritability ("she feels a lot of irritation"), anxiety ("anxiety"), depressed mood ("sadness"), depression ("depression"), premenstrual syndrome ("premenstrual tension"), urinary tract infection bacterial ("bacterial urinary infection") and polyuria ("diuresis") and was found to have uterine leiomyoma ("fibroids").The patient was treated with surgery (vaginal hysterectomy and bilateral salpingectomy).At the time of the report, the outcomes for pelvic pain, abdominal pain lower, heavy menstrual bleeding, uterine pain, dyspareunia, back pain, pain, vaginal discharge, headache, pain in extremity, peripheral swelling, paraesthesia, tremor, uterine tenderness, fatigue, loss of libido, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, dysuria, proctalgia, irritability, anxiety, depressed mood and depression were unknown.The reporter considered abdominal pain, abdominal pain lower, abnormal uterine bleeding, adenomyosis, alopecia, anxiety, arthralgia, back pain, coital bleeding, depressed mood, depression, dyspareunia, dysuria, fatigue, headache, heavy menstrual bleeding, hypertension, intra-abdominal fluid collection, irritability, loss of libido, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polyuria, post procedural haemorrhage, proctalgia, salpingitis, tremor, urinary tract infection bacterial, uterine inflammation, uterine leiomyoma, uterine pain, uterine tenderness and vaginal discharge to be related to essure administration.No causality assessment was received for essure with regard to premenstrual syndrome.The reporter commented: the medical record adds little, describing only the peri-procedure hospitalisation for removal of the device and one pre-procedure and one post-procedure consultation.There is a lack of important information/examinations, such as the anatomopathological examination of the surgical specimen.Procedure for removal was total hysterectomy + bilateral salpingectomy, it is not the standard procedure and indicates the possibility of a cause other than essure.Medical consultation performed on (b)(6) 2022 (post procedure review consultation), shows the diagnostic hypothesis ¿with essure + adenomyosis.Medical consultation carried out on (b)(6) 2022 (pre-procedure consultation) shows a diagnosis of adenomyosis (uterus with an increased volume of 124 cm3 is one of the signs of adenomyosis/fibroids).Adenomyosis explains symptoms such as abdominal pain and dyspareunia.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 31.25 kg/sqm.[allergy test (0.6- 7.5 mcg/l)] on (b)(6) 2020: 1.01 mcg/l.[blood bilirubin] on (b)(6) 2020: negative.[blood creatinine (0.53- 1.0 mg/dl)] on (b)(6) 2020: 0.59 mg/dl.[glucose urine] on (b)(6) 2020: unremarkable.[haemoglobin urine] on (b)(6) 2020: negative.[nitrite urine] on (b)(6) 2020: positive.[occult blood] on (b)(6) 2020: negative.[pathology test] on (b)(6) 2022: material: uterus and fallopian tubes, surgical specimens.Macroscopy: items a and b were received as a monoblock and items c and d were received separately: pyriform uterine body, weighing 9.0 grams and measuring 7.0 x 6.0 x 4.5 cm.The serosa is smooth and congested.The myometrium is brown and heterogeneous, 2.0 cm thick.The endometrium is brownish and has a maximum thickness of 2.0 cm.The topography of the tubal insertion shows metallic devices bilaterally.Cervix weighs 28.0 grams, measures 4.5 x 2.8 cm, with a smooth ectovertex.The external cervical orifice is slit-like.When cut, the endocervical canal is dilated and the endovertex is yellow and fasciculate.Uterine tube of unspecified laterality, measures 5.5 x 1.0 cm, with congested serosa.The wall is thick, and the lumen is virtual.Uterine tube of unspecified laterality, measures 4.5 x 8.0 cm, with congested serosa.The wall is thick, and the lumen is virtual.Block labelling: blocks total: 8, fragments total: several, a4 and a5 = tubal insertion topography conclusion: product of total hysterectomy and bilateral salpingectomy: uterine body: adenomyosis in rare foci.Secretory endometrium.Uterine cervix: mature squamous metaplasia.Fallopian tubes: fibrosis.Chronic inflammatory process with foreign body-type gigantocytic reaction metallic medical devices were found bilaterally in the topography of the tubal insertion.Correlate with clinical data and other complementary tests.[protein urine] on (b)(6) 2020: negative.[ultrasound scan vagina] in 2020: diffusely heterogeneous uterus ¿ suggestive of adenomyosis, which can cause pain and increased.Bleeding.Essures apparently well positioned; on (b)(6) 2020: urethra and bladder without abnormalities, vaginal wall without changes, uterus in antiversoflexion, with normal volume and normal shape, regular contour, homogeneous myometrium, secreted endometrium, 8.3 mm thick.Presence of linear echogenic images located in the interstitial region of the fallopian tubes suggestive of essure, normoposisional.Parauterine right ovary of normal volume, normal shape and echotexture, parauterine left ovary of normal volume, normal shape and echotexture, absence of collection of pathological liquids on the pelves.Uterus 9x5x6 cm, 140.4 cm3, right ovary 3.3x1.7x2.6 cm, 7.6 cm3, left ovary 2.2x3.0x2.5 cm 8.6 cm3 and no abnormalities, essure well positioned (according to the report).[urine analysis] on (b)(6) 2020: density 1016, ph 6.0.[urine ketone body] on (b)(6) 2020: negative.[urobilinogen urine] on (b)(6) 2020: unremarkable.[x-ray of pelvis and hip] on (b)(6) 2014: integral articular surfaces with conserved spaces, normal-looking bone structure, bilateral tubal microdevice.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 03-oct-2023: pathology test result was provided.Event 'salpingitis' was added.Medical history added (none reported previously).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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain in the region pelvic") and salpingitis ("fallopian tube - chronic inflammatory process with foreign body-type gigantocytic reaction") in a 36 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of uterine cervical squamous metaplasia and uterine anteflexion.Denies nausea and vomiting no complaints spontaneous diuresis walking.On (b)(6) 2014, the patient had essure inserted.In 2018 she experienced pelvic pain (seriousness criterion intervention required), abdominal pain lower ("severe cramps"), heavy menstrual bleeding ("intense increase in menstrual flow, up to 15 days in menstrual period"), uterine pain ("uterine stitches"), dyspareunia (" pain during and after intercourse"), back pain ("lower back pain"), pain ("generalized pain"), vaginal discharge ("strong odor from vaginal fluid"), headache ("severe headaches"), pain in extremity ("pain in the legs"), peripheral swelling ("swelling in the legs"), paraesthesia ("tingling too much"), tremor ("tremors"), uterine tenderness ("sensation of perforation in the uterus"), fatigue ("fatigue"), loss of libido ("lack of libido"), coital bleeding ("bleeding during and after intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("constant mood swings"), alopecia ("hair loss"), adenomyosis ("adenomyosis in rare foci") and intra-abdominal fluid collection ("fluid in the abdomen").On (b)(6) 2022 she experienced hypertension ("arterial hypertension").An unknown time later she experienced salpingitis (seriousness criterion intervention required), abdominal pain ("abdominal pain"), post procedural haemorrhage ("discrete vaginal bleeding"), abnormal uterine bleeding ("abnormal uterine bleeding"), dysuria ("she feels pain when urinating"), proctalgia ("pain in the rectum"), irritability ("she feels a lot of irritation"), anxiety ("anxiety"), depressed mood ("sadness"), depression ("depression"), premenstrual syndrome ("premenstrual tension"), urinary tract infection bacterial ("bacterial urinary infection") and polyuria ("diuresis") and was found to have uterine leiomyoma ("fibroids").The patient was treated with surgery (vaginal hysterectomy and bilateral salpingectomy).At the time of the report, the outcomes for pelvic pain, abdominal pain lower, heavy menstrual bleeding, uterine pain, dyspareunia, back pain, pain, vaginal discharge, headache, pain in extremity, peripheral swelling, paraesthesia, tremor, uterine tenderness, fatigue, loss of libido, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, dysuria, proctalgia, irritability, anxiety, depressed mood and depression were unknown.The reporter considered abdominal pain, abdominal pain lower, abnormal uterine bleeding, adenomyosis, alopecia, anxiety, arthralgia, back pain, coital bleeding, depressed mood, depression, dyspareunia, dysuria, fatigue, headache, heavy menstrual bleeding, hypertension, intra-abdominal fluid collection, irritability, loss of libido, mood swings, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polyuria, post procedural haemorrhage, proctalgia, salpingitis, tremor, urinary tract infection bacterial, uterine inflammation, uterine leiomyoma, uterine pain, uterine tenderness and vaginal discharge to be related to essure administration.No causality assessment was received for essure with regard to premenstrual syndrome.The reporter commented: the medical record adds little, describing only the peri-procedure hospitalisation for removal of the device and one pre-procedure and one post-procedure consultation.There is a lack of important information/examinations, such as the anatomopathological examination of the surgical specimen.Procedure for removal was total hysterectomy + bilateral salpingectomy, it is not the standard procedure and indicates the possibility of a cause other than essure.Medical consultation performed on (b)(6) 2022 (post procedure review consultation), shows the diagnostic hypothesis ¿with essure + adenomyosis medical consultation carried out on (b)(6) 2022 (pre-procedure consultation) shows a diagnosis of adenomyosis (uterus with an increased volume of 124 cm3 is one of the signs of adenomyosis/fibroids).Adenomyosis explains symptoms such as abdominal pain and dyspareunia.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 31.25 kg/sqm.[allergy test ( 0.6- 7.5 mcg/l)] on (b)(6) 2020: 1.01 mcg/l [blood bilirubin] on (b)(6) 2020: negative [blood creatinine ( 0.53- 1.0 mg/dl)] on (b)(6) 2020: 0.59 mg/dl [glucose urine] on (b)(6)2020: unremarkable [haemoglobin urine] on (b)(6) 2020: negative [nitrite urine] on (b)(6) 2020: positive [occult blood] on (b)(6) 2020: negative [pathology test] on (b)(6)2022: material: uterus and fallopian tubes, surgical specimens macroscopy: items a and b were received as a monoblock and items c and d were received separately: a) pyriform uterine body, weighing 9.0 grams and measuring 7.0 x 6.0 x 4.5 cm.The serosa is smooth and congested.The myometrium is brown and heterogeneous, 2.0 cm thick.The endometrium is brownish and has a maximum thickness of 2.0 cm.The topography of the tubal insertion shows metallic devices bilaterally.B) cervix weighs 28.0 grams, measures 4.5 x 2.8 cm, with a smooth ectovertex.The external cervical orifice is slit-like.When cut, the endocervical canal is dilated and the endovertex is yellow and fasciculate.C) uterine tube of unspecified laterality, measures 5.5 x 1.0 cm, with congested serosa.The wall is thick, and the lumen is virtual.D) uterine tube of unspecified laterality, measures 4.5 x 8.0 cm, with congested serosa.The wall is thick, and the lumen is virtual.Block labelling: blocks total: 8, />fragments total: several, />a4 and a5 = tubal insertion topography conclusion: product of total hysterectomy and bilateral salpingectomy: a) uterine body: adenomyosis in rare foci.Secretory endometrium.B) uterine cervix: mature squamous metaplasia.C/d) fallopian tubes: fibrosis.Chronic inflammatory process with foreign body-type gigantocytic reaction metallic medical devices were found bilaterally in the topography of the tubal insertion.Correlate with clinical data and other complementary tests.[protein urine] on (b)(6) 2020: negative [ultrasound scan vagina] in 2020: diffusely heterogeneous uterus ¿ suggestive of adenomyosis, which can cause pain and increased bleeding.Essures apparently well positioned; on (b)(6) 2020: urethra and bladder without abnormalities, vaginal wall without changes, uterus in antiversoflexion, with normal volume and normal shape, regular contour, homogeneous myometrium, secreted endometrium, 8.3 mm thick.Presence of linear echogenic images located in the interstitial region of the fallopian tubes suggestive of essure, normoposisional.Parauterine right ovary of normal volume, normal shape and echotexture, parauterine left ovary of normal volume, normal shape and echotexture, absence of collection of pathological liquids on the pelves.Uterus 9x5x6 cm, 140.4 cm3, right ovary 3.3x1.7x2.6 cm, 7.6 cm3, left ovary 2.2x3.0x2.5 cm 8.6 cm3 and no abnormalities, essure well positioned (according to the report).[urine analysis] on (b)(6) 2020: density 1016, ph 6.0 [urine ketone body] on (b)(6) 2020: negative [urobilinogen urine] on (b)(6) 2020: unremarkable [x-ray of pelvis and hip] on (b)(6) 2014: integral articular surfaces with conserved spaces, normal-looking bone structure, bilateral tubal microdevice quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 25-oct-2023: 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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