| Model Number ESS305 |
| Device Problems
Difficult to Remove (1528); Biocompatibility (2886)
|
| Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Foreign Body In Patient (2687)
|
| Event Date 01/01/2017 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pain') and allergy to metals ('nickel allergy diagnosed') in a (b)(6) female patient who had essure inserted for permanent contraceptive tubal implant.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "laparoscopic essure removal with suspected left essure plaque persistence" (seriousness criteria medically significant and intervention required).The patient's medical history included vertigo, wolff-parkinson-white syndrome, pollen allergy (rhino conjunctivitis allergy), inguinal herniorrhaphy, grass allergy, multi gravida and parity 3.Family history included hypertension.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2016, the patient experienced eye swelling ("eye swelling") and conjunctivitis ("conjunctivitis both eyes, different days"), 6 years 4 months after insertion of essure.In 2017, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2018, the patient experienced pruritus ("generalized itching").On 4-dec-2018, the patient experienced allergy to metals (seriousness criterion intervention required).On an unknown date, the patient experienced paraesthesia ("prickling sensation"), rash ("skin rash") and menstrual disorder ("menstrual disorder").The patient was treated with surgery (simple total laparoscopic hysterectomy, bilateral salpingectomy was performed using the usual laparoscopic technique and essures extraction, essure removal bilateral salpingectomy and hysterectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain and pruritus had resolved and the allergy to metals, paraesthesia, rash, eye swelling, conjunctivitis and menstrual disorder outcome was unknown.The reporter provided no causality assessment for conjunctivitis, eye swelling, menstrual disorder, paraesthesia and rash with essure.The reporter considered allergy to metals, pelvic pain and pruritus to be related to essure.The reporter commented: essure insertion details: surgical difficulty: easy.Comment: procedure is explained, and informed consent is collected.Vaginal asepsis with povidoneiodine.Endocervical canal and normal endometrial cavity.The essure device was placed in both tubes without complications, leaving 4 rings intracavitary in the right tube and 7 in the left tube.It has pain like menstruation.Removal information: bilateral salpingectomy was performed using the usual laparoscopic technique and essures extraction.Comments of the claim: "we understand that there has been a faulty operation of the health service, since she was not informed of the serious complications that she could suffer, nor was she informed that it contained titanium, nickel and metal fibers to which she turned out to be allergic, not even before implantation proceeded to check if it could test positive for these metals" pending removal of part of essure left from the removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.8 kg/sqm.Blood cholesterol (100 - 200 mg/dl) - on (b)(6) 2018: 205 mg/dl.Blood creatinine (0.60 - 1 mg/dl) - on (b)(6) 2018: 0.59 mg/dl.Blood iron (250 - 400 mcg/dl) - on (b)(6) 2016: 511 mcg/dl.C-reactive protein (0 - 3 mg/l) - on (b)(6) 2016: 3.5 mg/l.Cytology - in (b)(6) 2009: colpocytology: ascus.Echocardiogram - on (b)(6) 2019: echocardiogram (consultation): hr at 70 bpm.Pre-excitation, with a positive delta wave on the lower face and a narrow qrs.Echocardiogram (preanesthesia): similar to the previous one; on (b)(6) 2019: echocardiogram: 100 bpm, pre-excitation with a positive delta wave in the lower face and i.Narrow qrs.Echocardiography: non-dilated left ventricle without hypertrophy of its walls, non-dilated la.Right cavities of normal size and morphology.Normal sections of the aorta studied and without data ofcoarctation.Study of valves, ventricular function performed.Electrocardiogram ambulatory - on 07-oct-2019: ergometry performed.Conclusion: highly vibrated tracing to properly assess delta wave behavior.Based on the existing data, it is probable that the refractory period of the pathway was prolonged (no supraventricular arrhythmias, little apparent pre-excitation with effort and hr reached).Final result: negative.Holter: indicates performed in (b)(6) 2019, no report available.Exercise electrocardiogram - on (b)(6) 2019: ergometry performed on a treadmill with the bruce product and without pharmacological cardiovascular treatment.It starts from a baseline electrocardiogram with more visible pre-excitation in i, not so much in the lower face as what was stored in its previous digital records.The tracing during the effort is very vibrated and it cannot be affirmed that the pre-excitation disappears, but it is less apparent (probable prolonged refractory period of the pathway, maximum in a patient with no history of psvt).She has reached 103% of the predicted maximum theoretical heart rate for her age, with a total exercise time of 6:10 minutes, ending after reaching the predicted maximum heart rate and due to muscle fatigue/exhaustion.Functional capacity reached of 7.4 mets.Asymptomatic from the clinical point of view, not presenting significant alterations of the st segment.Adequate tension response.He has not presented any type of arrhythmia or conduction disorder.Highly vibrated tracing to properly assess delta wave behavior.With the existing data, a probable prolonged refractory period of the pathway (no supraventricular arrhythmias, little apparent preexcitation with effort and heart rate reached, etc.) final results: negative.Haematocrit (0.35 - 0.47 g/l) - on (b)(6) 2019: 0.33 g/l.Haemoglobin (11.8 - 15.7 g/dl) - on (b)(6) 2016: 11.7 g/dl; on (b)(6) 2018: 11.2 g/dl; on (b)(6) 2019: 9.9 g/dl.High density lipoprotein (35 - 45 mg/dl) - on (b)(6) 2018: 56 mg/dl; on (b)(6) 2019: 62 mg/dl.Low density lipoprotein (100 - 130 mg/dl) - on (b)(6) 2018: 137 mg/dl.Lymphocyte count (1.5 - 4 10*9/l) - on (b)(6) 2019: 1.2 10*9/l.Lymphocyte percentage (20 - 53 %) - on (b)(6) 2019: 10.8 %.Mean cell haemoglobin (27.5 - 33.2 pg) - on (b)(6) 2016: 24.8 pg; on (b)(6) 2018: 23.4 pg; on (b)(6) 2019: 23.1 pg; on (b)(6) 2019: 23.2 pg.Mean cell haemoglobin concentration (315 - 355 g/dl) - on (b)(6) 2016: 310 g/dl; on (b)(6) 2018: 308 g/dl; on (b)(6) 2019: 302 g/dl; on (b)(6) 2019: 298 g/dl.Mean cell volume (81 - 99 fl) - on (b)(6) 2016: 80.3 fl; on (b)(6) 2018: 76 fl; on (b)(6) 2019: 76.7 fl; on (b)(6) 2019: 77.9 fl.Monocyte count (0.2 - 0.8 10*9/l) - on (b)(6) 2019: 0.9 10*9/l.Neutrophil count (2.5 - 7.5 10*9/l) - on (b)(6) 2019: 9.1 10*9/l.Neutrophil percentage (25 - 65 %) - on (b)(6) 2019: 80.9 %.Pathology test - on (b)(6) 2019: finding: visualization of the minor pelvis: polymyomatous uterus and macroscopically normal uterine adnexa.Macroscopically normal abdominal cavity; on (b)(6) 2019: pathology report diagnosis: both oviducts (bilateral tubal blockage) -segments of both oviducts without notable histopathological alterations.Red blood cell analysis - on (b)(6) 2016: dispersion of red blood cells (volume) 15.1% [ 11.5-15]; on (b)(6) 2019: red cell dispersion 15.8%[11.5-15]; on (b)(6) 2019: erythrocyte distribution amplitude 15.3% [11.5-14.5].Red blood cell count (4 - 5.20 10*12/l) - on (b)(6) 019: 5.23 10*12/l.Serum ferritin (15 - 300 ng/ml) - on (b)(6) 2016: 6.2 ng/ml; on (b)(6) 2018: 6.4 ng/ml; on (b)(6) 2019: 6.4 ng/ml.Transferrin saturation (15 - 40 %) - on (b)(6) 2016: 7.4 %.Ultrasound scan vagina - on (b)(6) 2019: vaginal ultrasound: uterus in retroversion with 6 mm endometrium.Two intramural sub serosal uterine fibroids of 34 and 46x40 mm.Both essures devices are visualized as normal inserts, with their proximal portion in the interstitial portion of the tube and distal portion in the isthmic portion of the tube.It is explained what the intervention consists of, the possibility of breakage of the essure during extraction and the protocol that is followed, with the possibility of hysterectomy.; on (b)(6) 2019: vaginal ultrasound: uterus in retroversion with 6 mm endometrium.Two sub serosal-intramural uterine fibroids of 34 and 46x40 mm.Both essures devices are visualized as normally inserts, with their proximal portion in the interstitial portion of the tube and distal portion in the isthmic portion of the tube; on (b)(6) 2019: complementary tests: vaginal ultrasound: uterus in retroversion with 6 mm endometrium.Two subserosal-intramural uterine fibroids of 39x38 mm and 50x44 mm.10mm endometrium.A minimal linear refractive image seems to be visualized in the middle of the intramural portion of the left tube that could correspond to the left essure plate, although poor visualization due to acoustic shadowing of the fibroid.Normal ovaries, no free fluid, no pelvic collections.; on (b)(6) 2019: vaginal ultrasound: uterus in retroversion with 6 mm endometrium.Two subserosal-intramural uterine fibroids of 39x38 mm and 50x44 mm.10mm endometrium.A minimal linear refractive image seems to be visualized in the middle of the intramural portion of the left tube that could correspond to the left essure plate, although poor visualization due to acoustic shadowing of the fibroid.Normal ovaries, no free fluid, no pelvic collections.Clinical judgment: laparoscopic essure removal with suspected left essure plaque persistence.Uterine fibroids.; on (b)(6) 2019: vaginal ultrasound: retroverted uterus measuring 97 x 88 x 76 mm with a 16 mm endometrium.Two intramural subserous uterine fibroids of 45 x 36 mm and 47 x 46 mm.A minimal linear refractive image seems to be visualized in the middle of the intramural portion of the left tube that could correspond to the left essure plaque, although poor visualization due to the acoustic shadow of the myoma.Normal ovaries.Not free liquid.No pelvic collections.Weight (kg) - on (b)(6) 2019: 71 kg.X-ray - on (b)(6) 2019: pelvis x-ray: the 1.8 mm linear radiopaque image is displayed in the left iliac fossa compatible with the proximal left essure plate.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pain') and allergy to metals ('nickel allergy diagnosed') in a 31-year-old female patient who had essure inserted for permanent contraceptive tubal implant.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "laparoscopic essure removal with suspected left essure plaque persistence" (seriousness criteria medically significant and intervention required).The patient's medical history included vertigo, wolff-parkinson-white syndrome, pollen allergy (rhino conjunctivitis allergy), inguinal herniorrhaphy, grass allergy, multi gravida and parity 3.Family history included hypertension.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2016, the patient experienced eye swelling ("eye swelling") and conjunctivitis ("conjunctivitis both eyes, different days"), 6 years 4 months after insertion of essure.In 2017, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2018, the patient experienced pruritus ("generalized itching").On (b)(6) 2018, the patient experienced allergy to metals (seriousness criterion intervention required).On an unknown date, the patient experienced paraesthesia ("prickling sensation"), rash ("skin rash") and menstrual disorder ("menstrual disorder").The patient was treated with surgery (simple total laparoscopic hysterectomy, bilateral salpingectomy was performed using the usual laparoscopic technique and essures extraction, essure removal bilateral salpingectomy and hysterectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain and pruritus had resolved and the allergy to metals, paraesthesia, rash, eye swelling, conjunctivitis and menstrual disorder outcome was unknown.The reporter provided no causality assessment for conjunctivitis, eye swelling, menstrual disorder, paraesthesia and rash with essure.The reporter considered allergy to metals, pelvic pain and pruritus to be related to essure.The reporter commented: essure insertion details: surgical difficulty: easy.Comment: procedure is explained, and informed consent is collected.Vaginal asepsis with povidoneiodine.Endocervical canal and normal endometrial cavity.The essure device was placed in both tubes without complications, leaving 4 rings intracavitary in the right tube and 7 in the left tube.It has pain like menstruation.Removal information: bilateral salpingectomy was performed using the usual laparoscopic technique and essures extraction.Comments of the claim: "we understand that there has been a faulty operation of the health service, since she was not informed of the serious complications that she could suffer, nor was she informed that it contained titanium, nickel and metal fibers to which she turned out to be allergic, not even before implantation proceeded to check if it could test positive for these metals".Pending removal of part of essure left from the removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.8 kg/sqm.Blood cholesterol (100 - 200 mg/dl) - on (b)(6) 2018: 205 mg/dl.Blood creatinine (0.60 - 1 mg/dl) - on (b)(6) 2018: 0.59 mg/dl.Blood iron (250 - 400 mcg/dl) - on (b)(6) 2016: 511 mcg/dl.C-reactive protein (0 - 3 mg/l) - on (b)(6) 2016: 3.5 mg/l.Cytology - in (b)(6) 2009: colpocytology: ascus.Echocardiogram - on (b)(6) 2019: echocardiogram (consultation): hr at 70 bpm.Pre-excitation, with a positive delta wave on the lower face and a narrow qrs.Echocardiogram (preanesthesia): similar to the previous one; on (b)(6) 2019: echocardiogram: 100 bpm, pre-excitation with a positive delta wave in the lower face and i.Narrow qrs.Echocardiography: non-dilated left ventricle without hypertrophy of its walls, non-dilated la.Right cavities of normal size and morphology.Normal sections of the aorta studied and without data ofcoarctation.Study of valves, ventricular function performed.Electrocardiogram ambulatory - on (b)(6) 2019: ergometry performed.Conclusion: highly vibrated tracing to properly assess delta wave behavior.Based on the existing data, it is probable that the refractory period of the pathway was prolonged (no supraventricular arrhythmias, little apparent pre-excitation with effort and hr reached).Final result: negative.Holter: indicates performed in (b)(6) 2019, no report available.Exercise electrocardiogram - on (b)(6) 2019: ergometry performed on a treadmill with the bruce product and without pharmacological cardiovascular treatment.It starts from a baseline electrocardiogram with more visible pre-excitation in i, not so much in the lower face as what was stored in its previous digital records.The tracing during the effort is very vibrated and it cannot be affirmed that the pre-excitation disappears, but it is less apparent (probable prolonged refractory period of the pathway, maximum in a patient with no history of psvt).She has reached 103% of the predicted maximum theoretical heart rate for her age, with a total exercise time of 6:10 minutes, ending after reaching the predicted maximum heart rate and due to muscle fatigue/exhaustion.Functional capacity reached of 7.4 mets.Asymptomatic from the clinical point of view, not presenting significant alterations of the st segment.Adequate tension response.He has not presented any type of arrhythmia or conduction disorder.Highly vibrated tracing to properly assess delta wave behavior.With the existing data, a probable prolonged refractory period of the pathway (no supraventricular arrhythmias, little apparent preexcitation with effort and heart rate reached, etc.) final results: negative.Haematocrit (0.35 - 0.47 g/l) - on (b)(6) 2019: 0.33 g/l.Haemoglobin (11.8 - 15.7 g/dl) - on (b)(6) 2016: 11.7 g/dl; on (b)(6) 2018: 11.2 g/dl; on (b)(6) 2019: 9.9 g/dl.High density lipoprotein (35 - 45 mg/dl) - on (b)(6) 2018: 56 mg/dl; on (b)(6) 2019: 62 mg/dl.Low density lipoprotein (100 - 130 mg/dl) - on (b)(6) 2018: 137 mg/dl.Lymphocyte count (1.5 - 4 10*9/l) - on (b)(6) 2019: 1.2 10*9/l.Lymphocyte percentage (20 - 53 %) - on (b)(6) 2019: 10.8 %.Mean cell haemoglobin (27.5 - 33.2 pg) - on (b)(6) 2016: 24.8 pg; on (b)(6) 2018: 23.4 pg; on (b)(6) 2019: 23.1 pg; on (b)(6) 2019: 23.2 pg.Mean cell haemoglobin concentration (315 - 355 g/dl) - on (b)(6) 2016: 310 g/dl; on (b)(6) 2018: 308 g/dl; on (b)(6) 2019: 302 g/dl; on (b)(6) 2019: 298 g/dl.Mean cell volume (81 - 99 fl) - on (b)(6) 2016: 80.3 fl; on (b)(6) 2018: 76 fl; on (b)(6) 2019: 76.7 fl; on (b)(6) 2019: 77.9 fl.Monocyte count (0.2 - 0.8 10*9/l) - on (b)(6) 2019: 0.9 10*9/l.Neutrophil count (2.5 - 7.5 10*9/l) - on (b)(6) 2019: 9.1 10*9/l.Neutrophil percentage (25 - 65 %) - on (b)(6) 2019: 80.9 %.Pathology test - on (b)(6) 2019: finding: visualization of the minor pelvis: polymyomatous uterus and macroscopically normal uterine adnexa.Macroscopically normal abdominal cavity; on (b)(6) 2019: pathology report diagnosis: both oviducts (bilateral tubal blockage) -segments of both oviducts without notable histopathological alterations.Red blood cell analysis - on (b)(6) 2016: dispersion of red blood cells (volume) 15.1% [ 11.5-15]; on (b)(6) 2019: red cell dispersion 15.8%[11.5-15]; on (b)(6) 2019: erythrocyte distribution amplitude 15.3% [11.5-14.5].Red blood cell count (4 - 5.20 10*12/l) - on (b)(6) 2019: 5.23 10*12/l.Serum ferritin (15 - 300 ng/ml) - on (b)(6) 2016: 6.2 ng/ml; on (b)(6) 2018: 6.4 ng/ml; on (b)(6) 2019: 6.4 ng/ml.Transferrin saturation (15 - 40 %) - on (b)(6) 2016: 7.4 %.Ultrasound scan vagina - on (b)(6) 2019: vaginal ultrasound: uterus in retroversion with 6 mm endometrium.Two intramural sub serosal uterine fibroids of 34 and 46x40 mm.Both essures devices are visualized as normal inserts, with their proximal portion in the interstitial portion of the tube and distal portion in the isthmic portion of the tube.It is explained what the intervention consists of, the possibility of breakage of the essure during extraction and the protocol that is followed, with the possibility of hysterectomy.; on (b)(6) 2019: vaginal ultrasound: uterus in retroversion with 6 mm endometrium.Two sub serosal-intramural uterine fibroids of 34 and 46x40 mm.Both essures devices are visualized as normally inserts, with their proximal portion in the interstitial portion of the tube and distal portion in the isthmic portion of the tube; on (b)(6) 2019: complementary tests: vaginal ultrasound: uterus in retroversion with 6 mm endometrium.Two subserosal-intramural uterine fibroids of 39x38 mm and 50x44 mm.10mm endometrium.A minimal linear refractive image seems to be visualized in the middle of the intramural portion of the left tube that could correspond to the left essure plate, although poor visualization due to acoustic shadowing of the fibroid.Normal ovaries, no free fluid, no pelvic collections.; on (b)(6) 2019: vaginal ultrasound: uterus in retroversion with 6 mm endometrium.Two subserosal-intramural uterine fibroids of 39x38 mm and 50x44 mm.10mm endometrium.A minimal linear refractive image seems to be visualized in the middle of the intramural portion of the left tube that could correspond to the left essure plate, although poor visualization due to acoustic shadowing of the fibroid.Normal ovaries, no free fluid, no pelvic collections.Clinical judgment: laparoscopic essure removal with suspected left essure plaque persistence.Uterine fibroids.; on (b)(6) 2019: vaginal ultrasound: retroverted uterus measuring 97 x 88 x 76 mm with a 16 mm endometrium.Two intramural subserous uterine fibroids of 45 x 36 mm and 47 x 46 mm.A minimal linear refractive image seems to be visualized in the middle of the intramural portion of the left tube that could correspond to the left essure plaque, although poor visualization due to the acoustic shadow of the myoma.Normal ovaries.Not free liquid.No pelvic collections.Weight (kg) - on (b)(6) 2019: 71 kg.X-ray - on (b)(6) 2019: pelvis x-ray: the 1.8 mm linear radiopaque image is displayed in the left iliac fossa compatible with the proximal left essure plate.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 19-apr-2022: 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.
|
| |
|
Search Alerts/Recalls
|
|
