| Model Number ESS305 |
| Device Problems
Break (1069); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Arrhythmia (1721); Bruise/Contusion (1754); Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Fatigue (1849); Micturition Urgency (1871); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Muscle Weakness (1967); Pain (1994); Rash (2033); Skin Irritation (2076); Tinnitus (2103); Visual Impairment (2138); Hypoesthesia (2352); Arthralgia (2355); Malaise (2359); Sensitivity of Teeth (2427); Weight Changes (2607); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/20/2017 |
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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 genital haemorrhage ("heavy bleeding") and ovarian mass ("left ovarian mass") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included nickel sensitivity.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), ovarian mass (seriousness criteria medically significant and intervention required), abdominal pain ("severe abdominal pain"), back pain ("severe back pain"), dysmenorrhoea ("severe menstrual pain"), fatigue, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, rash, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, temperature intolerance, temperature intolerance, haemorrhage, increased tendency to bruise and malaise.The patient was treated with surgery (on (b)(6) 2015, underwent hysteroscopy, endometrial ablation and laparoscopy left salpingoophorectomy) and surgery (on (b)(6) 2015, underwent hysteroscopy,endometrial ablation and laparoscopy left salpingoophorectomy).At the time of the report, the genital haemorrhage, ovarian mass, abdominal pain lower, back pain, dysmenorrhoea, fatigue, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, rash, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, temperature intolerance, temperature intolerance, haemorrhage, increased tendency to bruise and malaise outcome was unknown.The reporter considered abdominal pain lower, fatigue, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, rash, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, temperature intolerance, temperature intolerance, haemorrhage, increased tendency to bruise and malaise, back pain, dysmenorrhoea, genital haemorrhage and ovarian mass to be related to essure.The reporter commented: her abdominal pain had at times been so severe that it has sent her to the emergency room.She may have to undergo a hysterectomy to remove the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: complete occlusion of the fallopian tubes.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 genital haemorrhage ("heavy bleeding") and ovarian mass ("left ovarian mass") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included nickel sensitivity, gravida ii, parity 2, on (b)(6) delivery and on (b)(6) delivery.The patient's concomitant disease included overweight and gestational diabetes.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), ovarian mass (seriousness criteria medically significant and intervention required), abdominal pain ("severe abdominal pain"), back pain ("severe back pain"), dysmenorrhoea ("severe menstrual pain"),fatigue, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, rash, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, temperature intolerance, temperature intolerance, haemorrhage, increased tendency to bruise, malaise, autoimmune disorder (seriousness criteria medically significant), allergy to metals, basedow's disease (seriousness criteria medically significant), hypersensitivity, abdominal pain lower, eye pain, pruritus, abdominal distension and device breakage.The patient was treated with surgery (on (b)(6) 2015, underwent hysteroscopy, endometrial ablation and laparoscopy left salpingoophorectomy) and surgery (on (b)(6) 2015, underwent hysteroscopy, endometrial ablation and laparoscopy left salpingoophorectomy).At the time of the report, the genital haemorrhage, ovarian mass, abdominal pain lower, back pain, dysmenorrhoea, fatigue, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, rash, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, temperature intolerance, temperature intolerance, haemorrhage, increased tendency to bruise, malaise, auto-immune disorder, allergy to metals, basedow's disease, hypersensitivity, abdominal pain lower, eye pain, pruritus, abdominal distension and device breakage outcome was unknown.The reporter considered abdominal pain lower, fatigue, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, rash, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, temperature intolerance, temperature intolerance, haemorrhage, increased tendency to bruise and malaise, back pain, dysmenorrhoea, genital haemorrhage, ovarian mass, auto-immune disorder, allergy to metals, basedow's disease, hypersensitivity, abdominal pain lower, eye pain, pruritus, abdominal distension and device defective to be related to essure.The reporter commented: her abdominal pain had at times been so severe that it has sent her to the emergency room.She may have to undergo a hysterectomy to remove the essure device diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: complete occlusion of the fallopian tubes.On 11-jan-2018: most recent follow-up information incorporated above includes: new events autoimmune disorder, allergy to metals, basedow's disease, hypersensitivity, abdominal pain lower, eye pain, pruritus, abdominal distension and device breakage were added.Reporter information, patient details, other relevant history, product information, concomitant drugs and treatment drugs were added 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 breakage ("shattered coil identified"), genital haemorrhage ("heavy bleeding/easy bleeding/heavy bleeding"), ovarian mass ("left ovarian mass"), ovarian germ cell teratoma benign ("ovary with mature teratoma"), uterine haemorrhage ("abnormal uterine bleeding"), autoimmune disorder ("auto immune disease"), basedow's disease ("graves disease/recurring thyroid eye disease"), allergy to metals ("nickel allergies/systemic/titanium allergies") and device allergy ("allergy/hypersensitivity reaction to nickel or any other component of essure") in a (b)(6) year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included nickel sensitivity, gravida ii, parity 2, delivery in 2000, delivery in 2006, enlarged thyroid and painful intercourse.Concurrent conditions included overweight, gestational diabetes, vaginal discharge, vaginal itching and yeast infection (with antibiotic use).Concomitant products included pantoprazole from 2015 to 2017 for acid reflux (oesophageal), sumatriptan (imitrex) since 2015 for migraine as well as antibiotics.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2012, the patient experienced basedow's disease (seriousness criterion medically significant).In 2013, the patient experienced eye pain ("eye pain (feels as if eyes being pushed out)").On (b)(6) 2017, 7 years 4 months after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), ovarian mass (seriousness criteria medically significant) with abdominal pain, back pain and abdominal pain lower, ovarian germ cell teratoma benign (seriousness criteria medically significant), uterine haemorrhage (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), dysmenorrhoea ("severe menstrual pain"), fatigue ("fatigue"), weight increased ("weight gain"), visual impairment ("vision changes"), tooth disorder ("dental problem"), ear pain ("earaches"), tinnitus ("ringing in ears"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), heart rate irregular ("irregular heart beats"), dyspnoea ("shortness of breath"), diarrhoea ("frequent diarrhea"), micturition urgency ("urgency to urinate,"), pollakiuria ("frequent urination"), rash ("rashes"), dry skin ("skin dryness"), pain ("sores"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain/arthritis pain"), myalgia ("muscle pain"), muscular weakness ("muscular weaknes"), alopecia ("loss of hair"), the first episode of temperature intolerance ("cold intolerance"), the second episode of temperature intolerance ("heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), allergy to metals (seriousness criteria medically significant and intervention required), device allergy (seriousness criteria medically significant and intervention required), pruritus ("itchy skin/itchy scalp"), abdominal distension ("bloating") and treatment noncompliance ("did not use contraceptive after confirmation test").The patient was treated with ibuprofen (motrin), levothyroxine, surgery ((b)(6) 2015 had a partial hysterectomy removing left ovary and fallopian tube, hysterectomy scheduled on (b)(6) 2017), surgery (hysteroscopy;d&c;novasure endometrial ablation;laparoscopic left salpingo-oophorectomy on (b)(6) 2015) and surgery (hysterectomy scheduled on (b)(6) 2017).At the time of the report, the device breakage, genital haemorrhage, ovarian mass, ovarian germ cell teratoma benign, uterine haemorrhage, autoimmune disorder, basedow's disease, dysmenorrhoea, fatigue, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, rash, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, the last episode of temperature intolerance, increased tendency to bruise, malaise, device allergy, eye pain, pruritus, abdominal distension and treatment noncompliance outcome was unknown.The reporter considered abdominal distension, allergy to metals, alopecia, arthralgia, auditory disorder, autoimmune disorder, basedow's disease, chest pain, device allergy, device breakage, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, eye pain, fatigue, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, malaise, memory impairment, micturition urgency, muscular weakness, myalgia, ovarian mass, pain, paraesthesia, pollakiuria, pruritus, rash, sinus disorder, stomatitis, tinnitus, tooth disorder, treatment noncompliance, visual impairment, weight increased, the first episode of temperature intolerance and the second episode of temperature intolerance, ovarian germ cell teratoma benign and uterine haemorrhage to be related to essure.The reporter commented: patient had no complication during essure placement procedure.Her abdominal pain had at times been so severe that it has sent her to the emergency room.Hysterectomy ((b)(6) 2017) scheduled to remove essure device.Patient had post operative visit on (b)(6) 2015, she had improved and reports no pain.On (b)(6) 2015, patient presents for post operative bleeding, she had an ablation on (b)(6) 2015 and was then complaining of bleeding (clotting) times 3 days.She had a left salpingoophorectomy for a cyst in 2015 and was uncertain if the left essure coil was removed at that surgery.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.On (b)(6) 2009, after patient had essure placement bilaterally.There were 3 coils noted outside of the os which was considered to be good placement.Findings: normal appearing endometrial cavity.On (b)(6) 2010, hsg (hysterosalpingogram test) done.Finding: bilateral obstruction found to the fallopian tubes caused by the essure devices.Normal appearance to the endometrial lining.On (b)(6) 2015, pathology report uterine curettings: proliferative endometrium.Negative for malignancy.Left fallopian tube and ovary, salpingo-oophorectomy: ovary with mature teratoma.Fallopian tube with no significant pathology received in formalin in a plastic container labeled with the patient's name and marked as "left tube and ovary" and consist with two fragments of fallopian tube measuring 4.5 cm in length x 0.6 cm in diameter and two fragments of ovarian tissue measuring 3.5 x 3,2 x 1.8 cm.Sectioning of one of the fragments of ovary shows thin walled ovarian cyst containing gelatinous fluid and measuring 2.5 x 2 x 2 cm.The inner surface of the fallopian tube shows area of slightly elevated surface.The rest of the inner surface was tan-pink and smooth.The rest of the ovarian tissue shows a few corpora albicantia.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: uterine haemorrhage (confirming genital haemorrhage), ovarian germ cell teratoma benign (confirming ovarian mass).Most recent follow-up information incorporated above includes: on 5-feb-2018: medical record received.Reporter's added.Patient¿s relevant history, concomitant drug antibiotics and lab data updated.Abnormal uterine bleeding and ovary with mature teratoma added as events.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 breakage ("shattered coil identified"), genital haemorrhage ("heavy bleeding/easy bleeding/heavy bleeding"), device allergy ("allergy/hypersensitivity reaction to nickel or any other component of essure"), allergy to metals ("nickel allergies/systemic/titanium allergies"), uterine haemorrhage ("abnormal uterine bleeding"), ovarian germ cell teratoma benign ("ovary with mature teratoma"), ovarian mass ("left ovarian mass"), autoimmune disorder ("auto immune disease") and basedow's disease ("graves disease/recurring thyroid eye disease") in a 38-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included nickel sensitivity, gravida ii, parity 2, delivery in 2000, delivery in 2006, enlarged thyroid, painful intercourse, joint pain, migraine, neuropathy, eye pain, orbital decompression (first orbital decompression (2014)), eyelid operation, urethral repair, radiation therapy (radioactive thyroid treatment) and carpal tunnel syndrome (right (2010) and let).Concurrent conditions included overweight, gestational diabetes, vaginal discharge, vaginal itching and yeast infection (with antibiotic use).Concomitant products included pantoprazole from 2015 to 2017 for acid reflux (oesophageal), sumatriptan (imitrex) since 2015 for migraine as well as antibiotics.On (b)(6) 2009, the patient had essure inserted.In october 2012, the patient experienced basedow's disease (seriousness criterion medically significant).In 2013, the patient experienced eye pain ("eye pain (feels as if eyes being pushed out)"), eye disorder ("eye disease") and thyroid disorder ("thyroid disease").On 3-mar-2017, 7 years 4 months after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), device allergy (seriousness criteria medically significant and intervention required), allergy to metals (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), ovarian germ cell teratoma benign (seriousness criterion medically significant), ovarian mass (seriousness criterion medically significant) with abdominal pain, back pain and abdominal pain lower, autoimmune disorder (seriousness criterion medically significant), tinnitus ("ringing in ears"), dysmenorrhoea ("severe menstrual pain"), fatigue ("fatigue"), weight increased ("weight gain"), visual impairment ("vision changes"), tooth disorder ("dental problem"), ear pain ("earaches"), diarrhoea ("frequent diarrhea"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), heart rate irregular ("irregular heart beats"), dyspnoea ("shortness of breath"), rash ("rashes"), micturition urgency ("urgency to urinate,"), pollakiuria ("frequent urination"), dry skin ("skin dryness"), pain ("sores"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain/arthritis pain"), myalgia ("muscle pain"), muscular weakness ("muscular weaknes"), alopecia ("loss of hair"), the first episode of temperature intolerance ("cold intolerance"), the second episode of temperature intolerance ("heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), pruritus ("itchy skin/itchy scalp"), abdominal distension ("bloating") and treatment noncompliance ("did not use contraceptive after confirmation test").The patient was treated with ibuprofen (motrin), levothyroxine, surgery (jul2015 had a partial hysterectomy removing left ovary and fallopian tube, scheduled on 05-dec-2017), surgery (on 21-jul-2015, underwent hysteroscopy,endometrial ablation and laparoscopy left salpingoophorectomy), surgery (hysterectomy scheduled on 05-dec-2017), surgery (hysterectomy scheduled on 05-dec-2017), surgery (on 21-jul-2015, underwent hysteroscopy,endometrial ablation and laparoscopy left salpingoophorectomy), surgery (on 21-jul-2015, laparoscopy left salpingoophorectomy) and surgery (on 21-jul-2015, laparoscopy left salpingoophorectomy).Essure was removed on 5-dec-2017.At the time of the report, the device breakage, genital haemorrhage, device allergy, uterine haemorrhage, ovarian mass, autoimmune disorder, basedow's disease, tinnitus, dysmenorrhoea, fatigue, weight increased, visual impairment, tooth disorder, ear pain, diarrhoea, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, rash, micturition urgency, pollakiuria, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, the last episode of temperature intolerance, increased tendency to bruise, malaise, eye pain, pruritus, abdominal distension, treatment noncompliance, eye disorder and thyroid disorder outcome was unknown.The reporter considered abdominal distension, allergy to metals, alopecia, arthralgia, auditory disorder, autoimmune disorder, basedow's disease, chest pain, device allergy, device breakage, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, eye disorder, eye pain, fatigue, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, malaise, memory impairment, micturition urgency, muscular weakness, myalgia, ovarian germ cell teratoma benign, ovarian mass, pain, paraesthesia, pollakiuria, pruritus, rash, sinus disorder, stomatitis, thyroid disorder, tinnitus, tooth disorder, treatment noncompliance, uterine haemorrhage, visual impairment, weight increased, the first episode of temperature intolerance and the second episode of temperature intolerance to be related to essure.The reporter commented: patient had no complication during essure placement procedure.Her abdominal pain had at times been so severe that it has sent her to the emergency room.Hysterectomy (05-dec-2017) scheduled to remove essure device.Patient had post operative visit on 27-jul-2015, she had improved and reports no pain.On 05-aug-2015, patient presents for post operative bleeding, she had an ablation on 21-jul-2015 and was then complaining of bleeding (clotting) times 3 days.She had a left salpingoophorectomy for a cyst in 2015 and was uncertain if the left essure coil was removed at that surgery.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Hysterosalpingogram - on 17-mar-2010: bilateral obstruction found to the fallopian tubes on 03-nov-2009, after patient had essure placement bilaterally.There were 3 coils noted outside of the os which was considered to be good placement.Findings: normal appearing endometrial cavity.Finding: 1.Bilateral obstruction found to the fallopian tubes caused by the essure devices.2.Normal appearance to the endometrial lining.On 21-jul-2015, pathology report uterine curettings: proliferative endometrium.Negative for malignancy.Left fallopian tube and ovary, salpingo-oophorectomy: ovary with mature teratoma.Fallopian tube with no significant pathology received in formalin in a plastic container labeled with the patient's name and marked as "left tube and ovary" and consist with two fragments of fallopian tube measuring 4.5 cm in length x 0.6 cm in diameter and two fragments of ovarian tissue measuring 3.5 x 3,2 x 1.8 cm.Sectioning of one of the fragments of ovary shows thin walled ovarian cyst containing gelatinous fluid and measuring 2.5 x 2 x 2 cm.The inner surface of the fallopian tube shows area of slightly elevated surface.The rest of the inner surface was tan-pink and smooth.The rest of the ovarian tissue shows a few corpora albicantia.Melsa test to diagnose allergy.Nickel and titanium allergy skin test done and the results were positive.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: uterine haemorrhage (confirming genital haemorrhage), ovarian germ cell teratoma benign (confirming ovarian mass).Most recent follow-up information incorporated above includes: on 27-mar-2018: reporter information was added.Her historical conditions were added.Lab data was added.Event: eye disease and thyroid disease were added.She had recovered for abdominal pain.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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Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("shattered coil identified/ my left coils was broken during a surgery"), genital haemorrhage ("heavy bleeding/easy bleeding/heavy bleeding"), uterine haemorrhage ("abnormal uterine bleeding"), device allergy ("allergy/hypersensitivity reaction to nickel or any other component of essure"), allergy to metals ("nickel allergies/systemic/titanium allergies/allergic to latex"), ovarian germ cell teratoma benign ("ovary with mature teratoma/ my left ovary was removed 2years ago."), ovarian mass ("left ovarian mass"), autoimmune disorder ("auto immune disease") and basedow's disease ("graves disease/recurring thyroid eye disease") in a 38-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: treatment noncompliance "did not use contraceptive after confirmation test".The patient's past medical history included nickel sensitivity, gravida ii, parity 2, delivery in 2000, delivery in 2006, enlarged thyroid, painful intercourse, joint pain, migraine, neuropathy, eye pain, orbital decompression (first orbital decompression (2014), eyelid operation, urethral repair, radiation therapy (radioactive thyroid treatment), carpal tunnel syndrome (right (2010) and let) and rubber sensitivity.Concurrent conditions included overweight, gestational diabetes, vaginal discharge, vaginal itching, yeast infection (with antibiotic use), vision abnormal, ringing in ears, sores mouth, chest pain, shortness of breath, foreign body in genitourinary tract and diarrhea.Concomitant products included pantoprazole from 2015 to 2017 for acid reflux (oesophageal), sumatriptan (imitrex) since 2015 for migraine as well as antibiotics.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2012, the patient experienced basedow's disease (seriousness criterion medically significant).In 2013, the patient experienced eye pain ("eye pain (feels as if eyes being pushed out)", eye disorder ("eye disease") and thyroid disorder ("thyroid disease").On (b)(6) 2017, 7 years 4 months after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), device allergy (seriousness criteria medically significant and intervention required), allergy to metals (seriousness criteria medically significant and intervention required), ovarian germ cell teratoma benign (seriousness criterion medically significant), ovarian mass (seriousness criterion medically significant) with abdominal pain, back pain and abdominal pain lower, autoimmune disorder (seriousness criterion medically significant), tinnitus ("ringing in ears"), dysmenorrhoea ("severe menstrual pain"), fatigue ("fatigue"), weight increased ("weight gain"), visual impairment ("vision changes"), tooth disorder ("dental problem"), ear pain ("earaches"), diarrhoea ("frequent diarrhea"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), heart rate irregular ("irregular heart beats"), dyspnoea ("shortness of breath"), rash ("rashes"), micturition urgency ("urgency to urinate,"), pollakiuria ("frequent urination"), dry skin ("skin dryness"), pain ("sores"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain/arthritis pain"), myalgia ("muscle pain"), muscular weakness ("muscular weakens"), alopecia ("loss of hair"), the first episode of temperature intolerance ("cold intolerance"), the second episode of temperature intolerance ("heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), pruritus ("itchy skin/itchy scalp"), abdominal distension ("bloating"), rheumatoid arthritis ("rheumatoid arthritis"), pigmentation disorder ("dark pigment spots on my head and upper lip"), neuropathy peripheral ("peripheral neuropathy") and gastrointestinal disorder ("gastrointestinal issues").The patient was treated with ibuprofen (motrin), levothyroxine, surgery (on (b)(6) 2015 had a partial hysterectomy removing left ovary and fallopian tube, scheduled on (b)(6) 2017), surgery (on (b)(6) 2015, underwent hysteroscopy,endometrial ablation and laparoscopy left salpingoophorectomy), surgery (on (b)(6) 2015, underwent hysteroscopy,endometrial ablation and laparoscopy left salpingoophorectomy), surgery (hysterectomy scheduled on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, genital haemorrhage, uterine haemorrhage, device allergy, ovarian germ cell teratoma benign, ovarian mass, autoimmune disorder, tinnitus, dysmenorrhoea, fatigue, weight increased, visual impairment, tooth disorder, ear pain, diarrhoea, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, rash, micturition urgency, pollakiuria, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, the last episode of temperature intolerance, increased tendency to bruise, malaise, eye pain, pruritus, abdominal distension, eye disorder, thyroid disorder, rheumatoid arthritis, pigmentation disorder, neuropathy peripheral and gastrointestinal disorder outcome was unknown and the basedow's disease had resolved.The reporter considered abdominal distension, allergy to metals, alopecia, arthralgia, auditory disorder, autoimmune disorder, basedow's disease, chest pain, device allergy, device breakage, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, eye disorder, eye pain, fatigue, gastrointestinal disorder, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, malaise, memory impairment, micturition urgency, muscular weakness, myalgia, neuropathy peripheral, ovarian germ cell teratoma benign, ovarian mass, pain, paraesthesia, pigmentation disorder, pollakiuria, pruritus, rash, rheumatoid arthritis, sinus disorder, stomatitis, thyroid disorder, tinnitus, tooth disorder, uterine haemorrhage, visual impairment, weight increased, the first episode of temperature intolerance and the second episode of temperature intolerance to be related to essure.The reporter commented: patient had no complication during essure placement procedure.Her abdominal pain had at times been so severe that it has sent her to the emergency room.Hysterectomy (on (b)(6) 2017) scheduled to remove essure device.Patient had post operative visit on (b)(6) 2015, she had improved and reports no pain.On (b)(6) 2015, patient presents for post operative bleeding, she had an ablation on (b)(6) 2015 and was then complaining of bleeding (clotting) times 3 days.She had a left salpingoophorectomy for a cyst in 2015 and was uncertain if the left essure coil was removed at that surgery.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Hysterosalpingogram: on (b)(6) 2010: bilateral obstruction found to the fallopian tubes; on (b)(6) 2017: two essure wires are present on (b)(6) 2009, after patient had essure placement bilaterally.There were 3 coils noted outside of the os which was considered to be good placement.Findings: normal appearing endometrial cavity.Finding: 1.Bilateral obstruction found to the fallopian tubes caused by the essure devices.2.Normal appearance to the endometrial lining.On (b)(6) 2015, pathology report.Uterine curettings: proliferative endometrium.Negative for malignancy.Left fallopian tube and ovary, salpingo-oophorectomy: ovary with mature teratoma.Fallopian tube with no significant pathology received in formalin in a plastic container labeled with the patient's name and marked as "left tube and ovary" and consist with two fragments of fallopian tube measuring 4.5 cm in length x 0.6 cm in diameter and two fragments of ovarian tissue measuring 3.5 x 3,2 x 1.8 cm.Sectioning of one of the fragments of ovary shows thin walled ovarian cyst containing gelatinous fluid and measuring 2.5 x 2 x 2 cm.The inner surface of the fallopian tube shows area of slightly elevated surface.The rest of the inner surface was tan-pink and smooth.The rest of the ovarian tissue shows a few corpora albicantia.(b)(6) test to diagnose allergy.Nickel and titanium allergy skin test done and the results were positive.On (b)(6) 2015 surgical pathology report: clinical history: menorrhagia and ovarian cysts.Specimens received: a.Uterine curettings.B.Left tube and ovary.Final pathologic diagnosis: a.Uterine curettings: proliferative endometrium, negative for malignancy.B.Left fallopian tube and ovary, salpingectomy-oophorectomy: ovary with mature teratoma, fallopian tube with no significant pathology.On (b)(6) 2017 surgical pathology report.Preoperative diagnosis: pelvic pain.Subtotal hysterectomy.Specimen submitted: uterus + right fallopian tube.Diagnosis: uterus; right fallopian tube, subtotal hysterectomy and right salpingectomy: leiomyomas, largest measuring 1.3 cm unremarkable f:ssurc device in the right cornu, extending into right fallopian tube (gross exam only).Portion of metallic coils consistent with portion of essure device in the left cornu inactive endometrium right fallopian tube with reactive change.(b)(6) blood test done.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: uterine haemorrhage (confirming genital haemorrhage), ovarian germ cell teratoma benign (confirming ovarian mass).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-oct-2018: new pfs + mr received- new event rheumatoid arthritis and dark pigment spots on my head and upper lip, peripheral neuropathy, gastrointestinal issues were added.Outcome of event thyroid eye disease from unknown to recovered/resolved was updated.New reports were added.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 breakage ('shattered coil identified/ my left coils was broken during a surgery.'), genital haemorrhage ('heavy bleeding/easy bleeding/heavy bleeding'), uterine haemorrhage ('abnormal uterine bleeding'), device allergy ('allergy/hypersensitivity reaction to nickel or any other component of essure'), allergy to metals ('nickel allergies/systemic/titanium allergies/allergic to latex'), ovarian germ cell teratoma benign ('ovary with mature teratoma/ my leftovary was removed 2years ago.'), ovarian mass ('left ovarian mass'), autoimmune disorder ('auto immune disease') and basedow's disease ('graves disease/recurring thyroid eye disease') in a 38-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: treatment noncompliance "did not use contraceptive after confirmation test".The patient's medical history included nickel sensitivity, gravida ii, parity 2, delivery in 2000, delivery in 2006, enlarged thyroid, painful intercourse, joint pain, migraine, neuropathy, eye pain, orbital decompression (first orbital decompression (2014)), eyelid operation, urethral repair, radiation therapy (radioactive thyroid treatment), carpal tunnel syndrome (right (2010) and let) and rubber sensitivity.On (b)(6) 2009, after patient had essure placement bilaterally.There were 3 coils noted outside of the os which was considered to be good placement.Findings: normal appearing endometrial cavity.Finding: 1.Bilateral obstruction found to the fallopian tubes caused by the essure devices.2.Normal appearance to the endometrial lining.On (b)(6) 2015, pathology report uterine curettings: proliferative endometrium.Negative for malignancy.Left fallopian tube and ovary, salpingo-oophorectomy: ovary with mature teratoma.Fallopian tube with no significant pathology received in formalin in a plastic container labeled with the patient's name and marked as "left tube and ovary" and consist with two fragments of fallopian tube measuring 4.5 cm in length x 0.6 cm in diameter and two fragments of ovarian tissue measuring 3.5 x 3,2 x 1.8 cm.Sectioning of one of the fragments of ovary shows thin walled ovarian cyst containing gelatinous fluid and measuring 2.5 x 2 x 2 cm.The inner surface of the fallopian tube shows area of slightly elevated surface.The rest of the inner surface was tan-pink and smooth.The rest of the ovarian tissue shows a few corpora albicantia.Melsa test to diagnose allergy.Nickel and titanium allergy skin test done and the results were positive.(b)(6) 2015 surgical pathology report: clinical history: menorrhagia and ovarian cysts specimens received: a.Uterine curettings b.Left tube and ovary final pathologic diagnosis: a.Uterine curettings: proliferative endometrium, negative for malignancy b.Left fallopian tube and ovary, salpingectomy-oophorectomy: ovary with mature teratoma, fallopian tube with no significant pathology (b)(6) 2017 surgical pathology report preoperative diagnosis: pelvic pain.Subtotal hysterectomy.Specimen submitted: uterus + right fallopian tube diagnosis: uterus; right fallopian tube, subtotal hysterectomy and right salpingectomy: leiomyomas, largest measuring 1.3 cm unremarkable f:ssurc device in the right cornu, extending into right fallopian tube (gross exam only) portion of metallic coils consistent with portion of essure device in the left cornu inactive endometrium right fallopian tube with reactive change.Melisa blood test done,.Concurrent conditions included overweight, gestational diabetes, vaginal discharge, vaginal itching, yeast infection (with antibiotic use), vision abnormal, ringing in ears, sores mouth, chest pain, shortness of breath, foreign body in genitourinary tract, diarrhea and pelvic pain.Concomitant products included pantoprazole from 2015 to 2017 for acid reflux (oesophageal), sumatriptan (imitrex) since 2015 for migraine as well as antibiotics.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2012, the patient experienced basedow's disease (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced thyroid disorder ("thyroid disease").In 2013, the patient experienced eye pain ("eye pain (feels as if eyes being pushed out)") and eye disorder ("eye disease").On (b)(6) 2017, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), 7 years 2 months after insertion of essure.On (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), device allergy (seriousness criteria medically significant and intervention required), ovarian mass (seriousness criterion medically significant) with abdominal pain, back pain and abdominal pain lower, autoimmune disorder (seriousness criterion medically significant), tinnitus ("ringing in ears"), dysmenorrhoea ("severe menstrual pain / cramping"), fatigue ("fatigue"), visual impairment ("vision changes"), tooth disorder ("dental problem"), ear pain ("earaches"), diarrhoea ("frequent diarrhea"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), dyspnoea ("shortness of breath"), rash ("rashes"), micturition urgency ("urgency to urinate,"), pollakiuria ("frequent urination"), dry skin ("skin dryness"), pain ("sores"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain/arthritis pain"), myalgia ("muscle pain"), muscular weakness ("muscular weaknes"), alopecia ("loss of hair"), cold intolerance ("cold intolerance"), heat intolerance ("heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), pruritus ("itchy skin/itchy scalp"), abdominal distension ("bloating"), rheumatoid arthritis ("rheumatoid arthritis"), pigmentation disorder ("dark pigment spots on my head and upper lip"), neuropathy peripheral ("peripheral neropathy"), gastrointestinal disorder ("gastrointestinal issues") and menstruation irregular ("unusual periods") and was found to have ovarian germ cell teratoma benign (seriousness criterion medically significant), weight increased ("weight gain") and heart rate irregular ("irregular heart beats").The patient was treated with levothyroxine, and surgery (on (b)(6) 2015, laparoscopy left salpingoophorectomy, on (b)(6) 2015, underwent hysteroscopy,endometrial ablation and laparoscopy left salpingoophorectomy and subtotal abdominal hysterectomy, right salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, genital haemorrhage, uterine haemorrhage, device allergy, ovarian germ cell teratoma benign, ovarian mass, autoimmune disorder, tinnitus, dysmenorrhoea, fatigue, weight increased, visual impairment, tooth disorder, ear pain, diarrhoea, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, rash, micturition urgency, pollakiuria, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, cold intolerance, heat intolerance, increased tendency to bruise, malaise, eye pain, pruritus, abdominal distension, eye disorder, thyroid disorder, rheumatoid arthritis, pigmentation disorder, neuropathy peripheral, gastrointestinal disorder and menstruation irregular outcome was unknown and the basedow's disease had resolved.The reporter considered abdominal distension, allergy to metals, alopecia, arthralgia, auditory disorder, autoimmune disorder, basedow's disease, chest pain, cold intolerance, device allergy, device breakage, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, eye disorder, eye pain, fatigue, gastrointestinal disorder, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, malaise, memory impairment, menstruation irregular, micturition urgency, muscular weakness, myalgia, neuropathy peripheral, ovarian germ cell teratoma benign, ovarian mass, pain, paraesthesia, pigmentation disorder, pollakiuria, pruritus, rash, rheumatoid arthritis, sinus disorder, stomatitis, thyroid disorder, tinnitus, tooth disorder, uterine haemorrhage, visual impairment, weight increased and heat intolerance to be related to essure.The reporter commented: patient had no complication during essure placement procedure.Her abdominal pain had at times been so severe that it has sent her to the emergency room.Hysterectomy ((b)(6) 2017) scheduled to remove essure device.Patient had post operative visit on (b)(6) 2015, she had improved and reports no pain.On (b)(6) 2015, patient presents for post operative bleeding, she had an ablation on (b)(6) 2015 and was then complaining of bleeding (clotting) times 3 days.She had a left salpingoophorectomy for a cyst in 2015 and was uncertain if the left essure coil was removed at that surgery.Insertion details: there were 3 coils noted outside of the os.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: bilateral obstruction found to the fallopian tubes; on (b)(6) 2017: results: two essure wires are present.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: uterine haemorrhage (confirming genital haemorrhage), ovarian germ cell teratoma benign (confirming ovarian mass).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-oct-2020: pif received: events: unusual periods was added.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 breakage ('shattered coil identified/ my left coils was broken during a surgery.'), genital haemorrhage ('heavy bleeding/easy bleeding/heavy bleeding'), uterine haemorrhage ('abnormal uterine bleeding'), device allergy ('allergy/hypersensitivity reaction to nickel or any other component of essure'), allergy to metals ('nickel allergies/systemic/titanium allergies/allergic to latex'), ovarian germ cell teratoma benign ('ovary with mature teratoma/ my left ovary was removed 2years ago.'), ovarian mass ('left ovarian mass'), autoimmune disorder ('auto immune disease') and basedow's disease ('graves disease/recurring thyroid eye disease') in a 38-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: treatment noncompliance "did not use contraceptive after confirmation test".The patient's medical history included nickel sensitivity, gravida ii, parity 2, delivery in 2000, delivery in 2006, enlarged thyroid, painful intercourse, joint pain, migraine, neuropathy, eye pain, orbital decompression (first orbital decompression (2014)), eyelid operation, urethral repair, radiation therapy (radioactive thyroid treatment), carpal tunnel syndrome (right (2010) and let) and rubber sensitivity.*on (b)(6) 2009, after patient had essure placement bilaterally.There were 3 coils noted outside of the os which was considered to be good placement.Findings: normal appearing endometrial cavity.Finding: 1.Bilateral obstruction found to the fallopian tubes caused by the essure devices.2.Normal appearance to the endometrial lining.On (b)(6) 2015, pathology report uterine curettings: proliferative endometrium.Negative for malignancy.Left fallopian tube and ovary, salpingo-oophorectomy: ovary with mature teratoma.Fallopian tube with no significant pathology received in formalin in a plastic container labeled with the patient's name and marked as "left tube and ovary" and consist with two fragments of fallopian tube measuring 4.5 cm in length x 0.6 cm in diameter and two fragments of ovarian tissue measuring 3.5 x 3,2 x 1.8 cm.Sectioning of one of the fragments of ovary shows thin walled ovarian cyst containing gelatinous fluid and measuring 2.5 x 2 x 2 cm.The inner surface of the fallopian tube shows area of slightly elevated surface.The rest of the inner surface was tan-pink and smooth.The rest of the ovarian tissue shows a few corpora albicantia.Melsa test to diagnose allergy.Nickel and titanium allergy skin test done and the results were positive.(b)(6) 2015 surgical pathology report: clinical history: menorrhagia and ovarian cysts specimens received: a.Uterine curettings b.Left tube and ovary final pathologic diagnosis: a.Uterine curettings: proliferative endometrium, negative for malignancy b.Left fallopian tube and ovary, salpingectomy-oophorectomy: ovary with mature teratoma, fallopian tube with no significant pathology.(b)(6) 2017 surgical pathology report preoperative diagnosis: pelvic pain.Subtotal hysterectomy.Specimen submitted: uterus + right fallopian tube diagnosis: uterus; right fallopian tube, subtotal hysterectomy and right salpingectomy: leiomyomas, largest measuring 1.3 cm.Unremarkable f:ssurc device in the right cornu, extending into right fallopian tube (gross exam only).Portion of metallic coils consistent with portion of essure device in the left cornu inactive endometrium right fallopian tube with reactive change.Melisa blood test done,.Concurrent conditions included overweight, gestational diabetes, vaginal discharge, vaginal itching, yeast infection (with antibiotic use), vision abnormal, ringing in ears, sores mouth, chest pain, shortness of breath, foreign body in genitourinary tract, diarrhea and pelvic pain.Concomitant products included pantoprazole from 2015 to 2017 for acid reflux (oesophageal), sumatriptan (imitrex) since 2015 for migraine as well as antibiotics.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2012, the patient experienced basedow's disease (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced thyroid disorder ("thyroid disease").In 2013, the patient experienced eye pain ("eye pain (feels as if eyes being pushed out)") and eye disorder ("eye disease").On (b)(6) 2017, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), 7 years 2 months after insertion of essure.On (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), device allergy (seriousness criteria medically significant and intervention required), ovarian mass (seriousness criterion medically significant) with abdominal pain, back pain and abdominal pain lower, autoimmune disorder (seriousness criterion medically significant), tinnitus ("ringing in ears"), dysmenorrhoea ("severe menstrual pain / cramping"), fatigue ("fatigue"), visual impairment ("vision changes"), tooth disorder ("dental problem"), ear pain ("earaches"), diarrhoea ("frequent diarrhea"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), dyspnoea ("shortness of breath"), rash ("rashes"), micturition urgency ("urgency to urinate,"), pollakiuria ("frequent urination"), dry skin ("skin dryness"), pain ("sores"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain/arthritis pain"), myalgia ("muscle pain"), muscular weakness ("muscular weakness"), alopecia ("loss of hair"), cold intolerance ("cold intolerance"), heat intolerance ("heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), pruritus ("itchy skin/itchy scalp"), abdominal distension ("bloating"), rheumatoid arthritis ("rheumatoid arthritis"), pigmentation disorder ("dark pigment spots on my head and upper lip"), neuropathy peripheral ("peripheral neuropathy"), gastrointestinal disorder ("gastrointestinal issues") and menstruation irregular ("unusual periods") and was found to have ovarian germ cell teratoma benign (seriousness criterion medically significant), weight increased ("weight gain") and heart rate irregular ("irregular heart beats").The patient was treated with levothyroxine, and surgery (on (b)(6) 2015, laparoscopy left salpingoophorectomy, on (b)(6) 2015, underwent hysteroscopy,endometrial ablation and laparoscopy left salpingoophorectomy and subtotal abdominal hysterectomy, right salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, genital haemorrhage, uterine haemorrhage, device allergy, ovarian germ cell teratoma benign, ovarian mass, autoimmune disorder, tinnitus, dysmenorrhoea, fatigue, weight increased, visual impairment, tooth disorder, ear pain, diarrhoea, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, rash, micturition urgency, pollakiuria, dry skin, pain, hypoaesthesia, paraesthesia, memory impairment, headache, arthralgia, myalgia, muscular weakness, alopecia, cold intolerance, heat intolerance, increased tendency to bruise, malaise, eye pain, pruritus, abdominal distension, eye disorder, thyroid disorder, rheumatoid arthritis, pigmentation disorder, neuropathy peripheral, gastrointestinal disorder and menstruation irregular outcome was unknown and the basedow's disease had resolved.The reporter considered abdominal distension, allergy to metals, alopecia, arthralgia, auditory disorder, autoimmune disorder, basedow's disease, chest pain, cold intolerance, device allergy, device breakage, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, eye disorder, eye pain, fatigue, gastrointestinal disorder, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, malaise, memory impairment, menstruation irregular, micturition urgency, muscular weakness, myalgia, neuropathy peripheral, ovarian germ cell teratoma benign, ovarian mass, pain, paraesthesia, pigmentation disorder, pollakiuria, pruritus, rash, rheumatoid arthritis, sinus disorder, stomatitis, thyroid disorder, tinnitus, tooth disorder, uterine haemorrhage, visual impairment, weight increased and heat intolerance to be related to essure.No further causality assessment were provided for the product.The reporter commented: patient had no complication during essure placement procedure.Her abdominal pain had at times been so severe that it has sent her to the emergency room.Hysterectomy (b)(6) 2017) scheduled to remove essure device.Patient had post operative visit on (b)(6) 2015, she had improved and reports no pain.On (b)(6) 2015, patient presents for post operative bleeding, she had an ablation on (b)(6) 2015 and was then complaining of bleeding (clotting) times 3 days.She had a left salpingoophorectomy for a cyst in 2015 and was uncertain if the left essure coil was removed at that surgery.Insertion details: there were 3 coils noted outside of the os.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: bilateral obstruction found to the fallopian tubes; on (b)(6) 2017: results: two essure wires are present.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: uterine haemorrhage (confirming genital haemorrhage), ovarian germ cell teratoma benign (confirming ovarian mass).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-oct-2020: quality safety evaluation of ptc(product technical complaint).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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