| Model Number ESS205 |
| Device Problems
Patient-Device Incompatibility (2682); Biocompatibility (2886); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Cyst(s) (1800); Dry Eye(s) (1814); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Vertigo (2134); Urticaria (2278); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); No Code Available (3191)
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| Event Date 08/09/2007 |
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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 pelvic pain ("pelvic pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), colitis ulcerative ("autoimmune disorder type of disorder: ulcerative colitis"), seizure ("neurological conditions or problems type: seizures") and genital haemorrhage ("abnormal bleeding (general)") in a (b)(6) female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included loop electrosurgical excision procedure since 2007, seasonal allergy, anemia, kidney stone, fracture of spine and back pain.On (b)(6) 2006, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced mood swings ("mood swings"), abdominal distension ("bloating"), abdominal pain lower ("cramps pinching on the right side") and depression ("depression").In 2007, the patient experienced seizure (seriousness criterion medically significant) and tooth disorder ("dental problems").On (b)(6) 2007, 7 months 27 days after insertion of essure (ess205), the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain ("stabbing abdominal pain").On (b)(6) 2008, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2010, the patient experienced fatigue ("fatigue").In (b)(6) 2012, the patient experienced colitis ulcerative (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), allergy to metals ("nickel allergy") with rash and urticaria, infection ("infection (other) describe: not sure"), headache ("headaches"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), nausea ("nausea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), alopecia ("hair loss"), ovarian cyst ("ovarian cysts"), weight increased ("weight gain"), dry eye ("dry eyes"), vaginal discharge ("vaginal discharge"), acne ("acne"), balance disorder ("balance issue") and vertigo ("vertigo").The patient was treated with cetirizine hydrochloride (zyrtec), midrid (midrin), iron, normensal (ortho-novum 7/7/7), dicycloverin hydrochloride (bentyl), amitriptyline hydrochloride (elavil), cyclobenzaprine hydrochloride (flexeril), mesalazine (mesalamine), omeprazole (prilosec), eletriptan hydrobromide (relpax), ibuprofen, thomapyrin n (excedrin migraine), prednisone, diphenhydramine hydrochloride (benadryl), meclozine (meclizine), methocarbamol, surgery (hysterectomy with bilateral salpingectomy) and surgery (endometrial ablation and laproscopy d&c done on (b)(6) 2008).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, migraine, abdominal distension, alopecia, ovarian cyst, abdominal pain, acne, balance disorder and vertigo had resolved and the menorrhagia, colitis ulcerative, seizure, genital haemorrhage, vaginal haemorrhage, allergy to metals, infection, mood swings, headache, female sexual dysfunction, abdominal pain lower, nausea, tooth disorder, dyspareunia, depression, dysmenorrhoea, weight increased, dry eye, fatigue and vaginal discharge outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, allergy to metals, alopecia, balance disorder, colitis ulcerative, depression, dry eye, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, infection, menorrhagia, migraine, mood swings, nausea, ovarian cyst, pelvic pain, seizure, tooth disorder, vaginal discharge, vaginal haemorrhage, vertigo and weight increased to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received: reporters, historical and concomitant conditions were updated.Previously reported ¿severe physical injuries¿ was replaced by: pelvic pain, abnormal bleeding (general), ulcerative colitis, seizures, abnormal bleeding (vaginal, menorrhagia), nickel allergy, rash, hives, apareunia, infection, migraines / headaches, bloating, cramps pinching on the right side, nausea, dental problems, depression, dysmenorrhea (cramping), dyspareunia, abdominal pain, vaginal discharge, dry eyes, fatigue, mood swings, weight gain, hair loss, ovarian cyst, acne, balance issue and vertigo.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device"), pelvic pain ("pelvic pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), colitis ulcerative ("autoimmune disorder type of disorder: ulcerative colitis"), seizure ("neurological conditions or problems type: seizures") and genital haemorrhage ("abnormal bleeding (general)") in a 34-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included ovarian cystectomy and loop electrosurgical excision procedure.Concurrent conditions included loop electrosurgical excision procedure since 2007, seasonal allergy, anemia, kidney stone, fracture of spine, back pain, hot flashes and fatigue.Concomitant products included bupropion hydrochloride (zyban), cephalosporins and related substances, codeine, levofloxacin (levaquin), prochlorperazine edisylate (compazine) and vicodin.On (b)(6) 2006, the patient had essure (ess205) inserted.In 2006, the patient experienced alopecia ("hair loss").In (b)(6) 2007, the patient experienced mood swings ("mood swings"), abdominal distension ("bloating"), abdominal pain lower ("cramps pinching on the right side") and depression ("depression").In 2007, the patient experienced seizure (seriousness criterion medically significant), allergy to metals ("nickel allergy") with rash and urticaria, headache ("headaches"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), tooth disorder ("dental problems"), weight increased ("weight gain"), dry eye ("dry eyes") and vaginal discharge ("vaginal discharge").On (b)(6) 2007, 7 months 27 days after insertion of essure (ess205), the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain ("stabbing abdominal pain").On (b)(6) 2008, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2010, the patient experienced fatigue ("fatigue").On (b)(6) 2012, the patient experienced colitis ulcerative (seriousness criterion medically significant) and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2016, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On an unknown date, the patient experienced infection ("infection (other) describe: not sure"), nausea ("nausea"), ovarian cyst ("ovarian cysts"), acne ("acne"), balance disorder ("balance issue") and vertigo ("vertigo").The patient was treated with cetirizine hydrochloride (zyrtec), midrid (midrin), iron, normensal (ortho-novum 7/7/7), dicycloverine hydrochloride (bentyl), amitriptyline hydrochloride (elavil), cyclobenzaprine hydrochloride (flexeril), mesalazine (mesalamine), omeprazole (prilosec), eletriptan hydrobromide (relpax), ibuprofen, thomapyrin n (excedrin migraine), prednisone, diphenhydramine hydrochloride (benadryl), meclozine (meclizine), methocarbamol, surgery (robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy.Right ovarian cystectomy ), surgery (hysterectomy with bilateral salpingectomy on (b)(6) 2016(bilateral removal of fallopian tube)) and surgery (endometrial ablation and laproscopy d&c done on (b)(6) 2008,another ablation in 2011).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device dislocation, menorrhagia, colitis ulcerative, seizure, genital haemorrhage, vaginal haemorrhage, allergy to metals, infection, mood swings, headache, female sexual dysfunction, abdominal pain lower, nausea, tooth disorder, dyspareunia, depression, dysmenorrhoea, weight increased, dry eye, fatigue and vaginal discharge outcome was unknown and the pelvic pain, migraine, abdominal distension, alopecia, ovarian cyst, abdominal pain, acne, balance disorder and vertigo had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, allergy to metals, alopecia, balance disorder, colitis ulcerative, depression, device dislocation, dry eye, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, infection, menorrhagia, migraine, mood swings, nausea, ovarian cyst, pelvic pain, seizure, tooth disorder, vaginal discharge, vaginal haemorrhage, vertigo and weight increased to be related to essure (ess205).The reporter commented: on (b)(6) 2006 (discrepancy noted) essure device was placed without difficulty under direct visualization release, and there were probably 8 to 10 coilseen in the patient's right tubal ostia and prior 3 to 5 coil seen in the patient's left tubal ostia.On (b)(6) 2016 (discrepancy noted) pre and post-op diagnosis: pelvic pain.Dyspareunia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion.Concerning all the injuries reported in this case,the following ones were confirmed in patients's medical record: pelvic pain, dyspareunia, depression, fatigue, migraine.Most recent follow-up information incorporated above includes: on 12-jun-2018: plaintiff fact sheet and medical record received.Event added: migration of essure device.Concomitant and historical conditions 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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Spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device"), pelvic pain ("pelvic pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), colitis ulcerative ("autoimmune disorder type of disorder: ulcerative colitis"), seizure ("neurological conditions or problems type: seizures") and genital haemorrhage ("abnormal bleeding (general)") in a 34-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included ovarian cystectomy and loop electrosurgical excision procedure.Concurrent conditions included loop electrosurgical excision procedure since 2007, seasonal allergy, anemia, kidney stone, fracture of spine, back pain, hot flashes and fatigue.Concomitant products included bupropion hydrochloride (zyban), cephalosporins and related substances, codeine, levofloxacin (levaquin), prochlorperazine edisylate (compazine) and vicodin.In 2006, the patient experienced alopecia ("hair loss").On (b)(6) 2006, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced mood swings ("mood swings"), abdominal distension ("bloating"), abdominal pain lower ("cramps pinching on the right side") and depression ("depression").In 2007, the patient experienced seizure (seriousness criterion medically significant), allergy to metals ("nickel allergy") with rash and urticaria, headache ("headaches"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), tooth disorder ("dental problems"), weight increased ("weight gain"), dry eye ("dry eyes") and vaginal discharge ("vaginal discharge").On (b)(6) 2007, 7 months 27 days after insertion of essure (ess205), the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain ("stabbing abdominal pain").On (b)(6) 2008, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2010, the patient experienced fatigue ("fatigue").On (b)(6) 2012, the patient experienced colitis ulcerative (seriousness criterion medically significant) and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2016, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On an unknown date, the patient experienced infection ("infection (other) describe: not sure"), nausea ("nausea"), ovarian cyst ("ovarian cysts"), acne ("acne"), balance disorder ("balance issue") and vertigo ("vertigo").The patient was treated with cetirizine hydrochloride (zyrtec), midrid (midrin), iron, normensal (ortho-novum 7/7/7), dicycloverine hydrochloride (bentyl), amitriptyline hydrochloride (elavil), cyclobenzaprine hydrochloride (flexeril), mesalazine (mesalamine), omeprazole (prilosec), eletriptan hydrobromide (relpax), ibuprofen, thomapyrin n (excedrin migraine), prednisone, diphenhydramine hydrochloride (benadryl), meclozine (meclizine), methocarbamol, surgery (robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy.Right ovarian cystectomy), surgery (hysterectomy with bilateral salpingectomy on (b)(6) 2016 (bilateral removal of fallopian tube)) and surgery (endometrial ablation and laproscopy d&c done on (b)(6) 2008, another ablation in 2011).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device dislocation, menorrhagia, colitis ulcerative, seizure, genital haemorrhage, vaginal haemorrhage, allergy to metals, infection, mood swings, headache, female sexual dysfunction, abdominal pain lower, nausea, tooth disorder, dyspareunia, depression, dysmenorrhoea, weight increased, dry eye, fatigue and vaginal discharge outcome was unknown and the pelvic pain, migraine, abdominal distension, alopecia, ovarian cyst, abdominal pain, acne, balance disorder and vertigo had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, allergy to metals, alopecia, balance disorder, colitis ulcerative, depression, device dislocation, dry eye, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, infection, menorrhagia, migraine, mood swings, nausea, ovarian cyst, pelvic pain, seizure, tooth disorder, vaginal discharge, vaginal haemorrhage, vertigo and weight increased to be related to essure (ess205).The reporter commented: on (b)(6) 2006 (discrepancy noted) essure device was placed without difficulty under direct visualization release, and there were probably 8 to 10 coilseen in the patient's right tubal ostia and prior 3 to 5 coil seen in the patient's left tubal ostia.On (b)(6) 2016 (discrepancy noted) pre and post-op diagnosis: pelvic pain.Dyspareunia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion.Concerning all the injuries reported in this case,the following ones were confirmed in patients's medical record: pelvic pain, dyspareunia, depression, fatigue, migraine.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-jul-2018: quality safety evaluation of ptc.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 expulsion ("migration of essure device / migration of essure device location of device: uterus"), pelvic pain ("pelvic pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), colitis ulcerative ("autoimmune disorder type of disorder: ulcerative colitis"), seizure ("neurological conditions or problems type: seizures") and genital haemorrhage ("abnormal bleeding (general)") in a 34-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included ovarian cystectomy and loop electrosurgical excision procedure.Concurrent conditions included loop electrosurgical excision procedure since 2007, seasonal allergy, anemia, kidney stone, fracture of spine, back pain, hot flashes, fatigue, cervical dysplasia and fracture of spine.Concomitant products included bupropion hydrochloride (zyban), cephalosporins and related substances, codeine, levofloxacin (levaquin), prochlorperazine edisylate (compazine) and vicodin.In 2006, the patient experienced alopecia ("hair loss").On (b)(6) 2006, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced mood swings ("mood swings"), abdominal distension ("bloating"), abdominal pain lower ("cramps pinching on the right side") and depression ("depression").In 2007, the patient experienced seizure (seriousness criterion medically significant), allergy to metals ("nickel allergy") with rash and urticaria, headache ("headaches"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), tooth disorder ("dental problems"), weight increased ("weight gain"), dry eye ("dry eyes") and vaginal discharge ("vaginal discharge").On (b)(6) 2007, 7 months 27 days after insertion of essure (ess205), the patient experienced device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain ("stabbing abdominal pain").On (b)(6) 2008, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2010, the patient experienced fatigue ("fatigue").On (b)(6) 2012, the patient experienced colitis ulcerative (seriousness criterion medically significant) and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2016, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On an unknown date, the patient experienced infection ("infection (other) describe: not sure"), nausea ("nausea"), ovarian cyst ("ovarian cysts"), acne ("acne"), balance disorder ("balance issue") and vertigo ("vertigo").The patient was treated with cetirizine hydrochloride (zyrtec), midrid (midrin), iron, normensal (ortho-novum 7/7/7), dicycloverine hydrochloride (bentyl), amitriptyline hydrochloride (elavil), cyclobenzaprine hydrochloride (flexeril), mesalazine (mesalamine), omeprazole (prilosec), eletriptan hydrobromide (relpax), ibuprofen, thomapyrin n (excedrin migraine), prednisone, diphenhydramine hydrochloride (benadryl), meclozine (meclizine), methocarbamol, surgery (robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy.Right ovarian cystectomy), surgery (hysterectomy with bilateral salpingectomy on (b)(6) 2016 (bilateral removal of fallopian tube)) and surgery (endometrial ablation and laproscopy d&c done on (b)(6) 2008,another ablation in 2011).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device expulsion, menorrhagia, colitis ulcerative, seizure, genital haemorrhage, vaginal haemorrhage, allergy to metals, infection, mood swings, headache, female sexual dysfunction, abdominal pain lower, nausea, tooth disorder, dyspareunia, depression, dysmenorrhoea, weight increased, dry eye, fatigue and vaginal discharge outcome was unknown and the pelvic pain, migraine, abdominal distension, alopecia, ovarian cyst, abdominal pain, acne, balance disorder and vertigo had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, allergy to metals, alopecia, balance disorder, colitis ulcerative, depression, device expulsion, dry eye, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, infection, menorrhagia, migraine, mood swings, nausea, ovarian cyst, pelvic pain, seizure, tooth disorder, vaginal discharge, vaginal haemorrhage, vertigo and weight increased to be related to essure (ess205).The reporter commented: on (b)(6) 2006 (discrepancy noted) essure device was placed without difficulty under direct visualization release, and there were probably 8 to 10 coilseen in the patient's right tubal ostia and prior 3 to 5 coil seen in the patient's left tubal ostia.On (b)(6) 2016 (discrepancy noted).Pre and post-op diagnosis: pelvic pain.Dyspareunia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion.Concerning all the injuries reported in this case,the following ones were confirmed in patients's medical record: pelvic pain, dyspareunia, depression, fatigue, migraine.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-sep-2018: pfs received.Pt updated for event devise dislocation to device expulsion.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 expulsion ('migration of essure device / migration of essure device location of device: uterus'), pelvic pain ('pelvic pain/pain is unreal/stabbing pain'), menorrhagia ('abnormal bleeding (menorrhagia)'), colitis ulcerative ('autoimmune disorder type of disorder: ulcerative colitis'), seizure ('neurological conditions or problems type: seizures'), genital haemorrhage ('abnormal bleeding (general)'), tooth abscess ('dental problems/abscessed tooth'), crohn's disease ('crohn's disease'), cerebrovascular accident ('stroke'), paralysis ('left sided tongue/facial paralysis, left arm/drip paralysis'), adrenocortical insufficiency acute ('adrenal crisis'), transient ischaemic attack ('tia (post removal)') and addison's disease ('addison's disease (post removal)') in a 34-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included ovarian cystectomy, loop electrosurgical excision procedure and cholecystectomy.Pathology report: pre and post-operative diagnosis right ovarian cyst; pelvic pain; dyspareunia final diagnosis: uterus with cervix, bilateral fallopian tubes.And right ovarian cyst : mild chronic cervicitis.Fibrotic endometrial canal with calcification, suggestive of prior ablation effect.No pathologic diagnosis of myometrium or serosa.Bilateral fallopian tubes with benign paratubal cysts and intratubal devices.Hemorrhagic corpus luteum right ovary.Concurrent conditions included loop electrosurgical excision procedure since 2007, seasonal allergy, anemia, kidney stone, fracture of spine, back pain, hot flashes, fatigue, cervical dysplasia and fracture of spine.Concomitant products included bupropion hydrochloride (zyban), cephalosporin nos, codeine, hydrocodone bitartrate;paracetamol (vicodin), levofloxacin (levaquin) and prochlorperazine.On (b)(6) 2006, the patient had essure (ess205) inserted.In 2006, the patient experienced alopecia ("hair loss").In (b)(6) 2007, the patient experienced mood swings ("mood swings"), abdominal distension ("bloating"), abdominal pain lower ("cramps pinching on the right side") and depression ("depression").In 2007, the patient experienced seizure (seriousness criterion medically significant), allergy to metals ("nickel allergy") with rash and urticaria, headache ("headaches"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), tooth abscess (seriousness criterion medically significant), dry eye ("dry eyes") and vaginal discharge ("vaginal discharge") and was found to have weight increased ("weight gain").On (b)(6) 2007, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain ("stabbing abdominal pain"), 7 months 27 days after insertion of essure (ess205).On (b)(6) 2008, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2010, the patient experienced fatigue ("fatigue").In 2012, the patient experienced crohn's disease (seriousness criterion medically significant).On(b)(6) 2012, the patient experienced colitis ulcerative (seriousness criterion medically significant) and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2016, the patient experienced cerebrovascular accident (seriousness criterion medically significant) and cardiac disorder ("cardiac disorder").On (b)(6) 2016, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On an unknown date, the patient experienced infection ("infection (other) describe: not sure"), nausea ("nausea"), ovarian cyst ("ovarian cysts"), acne ("acne"), balance disorder ("balance issue"), the first episode of vertigo ("vertigo"), inflammation ("inflammation leaving my body"), peripheral swelling ("swelling in my arms and legs"), sinusitis ("sinus infection"), abdominal pain upper ("stomach pain/stomach is turning"), back pain ("back hurts"), insomnia ("can't sleep"), swelling face ("face was swelled up"), hypersensitivity ("allergies/allergy to some stuff"), hot flush ("hot flashes"), rash ("skin rash"), anxiety ("anxious"), stress ("stressed"), the second episode of vertigo ("vertigo"), urticaria ("hives"), erythema ("forehead is flaming out"), procedural pain ("pain from surgery"), dermatitis allergic ("itching from nickel allergy"), joint swelling ("achy swollen ankles and feet"), dysgeusia ("metallic taste in mouth"), feeling abnormal ("brain fog"), gastrooesophageal reflux disease ("gastric reflux"), paralysis (seriousness criterion medically significant), adrenocortical insufficiency acute (seriousness criterion medically significant), nerve injury ("nerve damage"), transient ischaemic attack (seriousness criterion medically significant), addison's disease (seriousness criterion medically significant), pain ("pain that shot through my body and took me to my knees"), oropharyngeal pain ("sore throat"), incision site complication ("upper left side was most uncomfortable") and constipation ("constipation").The patient was treated with acetylsalicylic acid;caffeine;paracetamol (excedrin migraine), anti allergic agents, dichloralphenazone;isometheptene;paracetamol (midrin), dicycloverine hydrochloride (bentyl), diphenhydramine hydrochloride, eletriptan hydrobromide (relpax), ethinylestradiol;norethisterone (ortho-novum 7/7/7), ibuprofen, iron, meclozine (meclizine), mesalazine (mesalamine), methocarbamol, omeprazole (prilosec), prednisone, and surgery (hysterectomy with bilateral salpingectomy on (b)(6) 2016(bilateral removal of fallopian tube), robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy.Right ovarian cystectomy, ablation, endometrial ablation and laproscopy d&c done on (b)(6) 2008,another ablation in 2011 and root canal).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device expulsion, colitis ulcerative, seizure, allergy to metals, infection, mood swings, female sexual dysfunction, abdominal pain lower, nausea, tooth abscess, dyspareunia, dysmenorrhoea, weight increased, dry eye, fatigue, vaginal discharge, sinusitis, abdominal pain upper, back pain, insomnia, swelling face, crohn's disease, hypersensitivity, hot flush, rash, stress, urticaria, erythema, procedural pain, feeling abnormal, cerebrovascular accident, cardiac disorder, paralysis, adrenocortical insufficiency acute, nerve injury, transient ischaemic attack, addison's disease, pain, oropharyngeal pain and incision site complication outcome was unknown, the pelvic pain, menorrhagia, genital haemorrhage, vaginal haemorrhage, headache, migraine, abdominal distension, depression, alopecia, ovarian cyst, abdominal pain, acne, balance disorder, inflammation, peripheral swelling, anxiety, the last episode of vertigo, dermatitis allergic, joint swelling, dysgeusia and constipation had resolved and the gastrooesophageal reflux disease had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abdominal pain upper, acne, addison's disease, adrenocortical insufficiency acute, allergy to metals, alopecia, anxiety, back pain, balance disorder, cardiac disorder, cerebrovascular accident, colitis ulcerative, constipation, crohn's disease, depression, dermatitis allergic, device expulsion, dry eye, dysgeusia, dysmenorrhoea, dyspareunia, erythema, fatigue, feeling abnormal, female sexual dysfunction, gastrooesophageal reflux disease, genital haemorrhage, headache, hot flush, hypersensitivity, incision site complication, infection, inflammation, insomnia, joint swelling, menorrhagia, migraine, mood swings, nausea, nerve injury, oropharyngeal pain, ovarian cyst, pain, paralysis, pelvic pain, peripheral swelling, procedural pain, rash, seizure, sinusitis, stress, swelling face, tooth abscess, transient ischaemic attack, urticaria, vaginal discharge, vaginal haemorrhage, weight increased, the first episode of vertigo and the second episode of vertigo to be related to essure (ess205).The reporter commented: on (b)(6) 2006 (discrepancy noted) essure device was placed without difficulty under direct visualization release, and there were probably 8 to 10 coilseen in the patient's right tubal ostia and prior 3 to 5 coil seen in the patient's left tubal ostia.On (b)(6) 2016 (discrepancy noted) pre and post-op diagnosis: pelvic pain.Dyspareunia.Many of the symptoms are gone.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: results: total bilateral occlusion.Concerning all the injuries reported in this case,the following ones were confirmed in patients's medical record: pelvic pain, dyspareunia, depression, fatigue, migraine.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: inflammation leaving my body, swelling in my arms and legs, sinus infection, stomach pain/stomach is turning, back hurts, can't sleep, face was swelled up, crohn's disease, (allergies/allergy to some stuff), skin rash, anxious, stressed, vertigo, hives, forehead is flaming out, pain from surgery, itching from nickel allergy, achy swollen ankles and feet, metallic taste in mouth, brain fog, gastric reflux, stroke, cardiac disorder, left sided tongue/facial paralysis, left arm/drip paralysis, adrenal crisis, nerve damage, tia, addison's disease (post removal), pain that shot through my body and took me to my knees), sore throat, upper left side was most uncomfortable, constipation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2019: content from social media received.Events: inflammation leaving my body, swelling in my arms and legs, sinus infection, stomach pain/stomach is turning, back hurts, can't sleep, face was swelled up, crohn's disease, (allergies/allergy to some stuff), skin rash, anxious, stressed, vertigo, hives, forehead is flaming out, pain from surgery, itching from nickel allergy, achy swollen ankles and feet, metallic taste in mouth, brain fog, gastric reflux, stroke, cardiac disorder, left sided tongue/facial paralysis, left arm/drip paralysis, adrenal crisis, nerve damage, tia, addison's disease (post removal), pain that shot through my body and took me to my knees), sore throat, upper left side was most uncomfortable, constipation were added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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