| Model Number ESS305 |
| Device Problems
Break (1069); Device Appears to Trigger Rejection (1524); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Migration (4003)
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| Patient Problems
Cyst(s) (1800); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Gastritis (1874); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Menstrual Irregularities (1959); Nausea (1970); Neuropathy (1983); Pain (1994); Pelvic Inflammatory Disease (2000); Rash (2033); Urinary Tract Infection (2120); Uterine Perforation (2121); Blurred Vision (2137); Hot Flashes/Flushes (2153); Hernia (2240); Anxiety (2328); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2008 |
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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 pains / increasingly intense pain/pain"), genital haemorrhage ("abnormal bleeding (general)") and device breakage ("device breakage") in a (b)(6) -year-old female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo an essure confirmation test".The patient's past medical history included multigravida, parity 4 (((b)(6) 1989, (b)(6) 1996, (b)(6) 1990 and (b)(6) 2004)) and c-section in 2004.Concomitant products included medroxyprogesterone (depo provera).On (b)(6) 2007, the patient had essure (ess205) inserted.In 2008, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required).In 2009, the patient experienced menorrhagia ("increased bleeding during menstruation/continues to experience bleeding/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)") and ovarian cyst ("cyst on ovary").In 2010, the patient experienced gastritis ("gastritis") and hiatus hernia ("hiatal hernia").In (b)(6) 2011, the patient experienced vision blurred ("blurry vision").In 2012, the patient experienced dermal cyst ("cysts on face").On (b)(6) 2013, 5 years 11 months after insertion of essure (ess205), the patient experienced gastrooesophageal reflux disease ("gerd"), anxiety ("anxiety"), bipolar disorder ("bipolar") and neuropathy peripheral ("neuropathy").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), hypersensitivity ("skin sensitive to everything") with rash, bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), blood disorder ("blood or heart disorder/condition"), cardiac disorder ("blood or heart disorder/condition"), tooth disorder ("dental problems"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), mood swings ("mood swings"), hot flush ("hot flashes"), urinary tract infection ("uti"), bacterial vaginosis ("bacterial vaginosis"), pelvic infection ("pelvic infection"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), nervous system disorder ("neurological conditions or problems"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge"), rectal haemorrhage ("rectal bleeding"), diarrhoea ("diarrhea"), polyp ("hyperplastic polyp"), adenoma benign ("tubular adenoma"), back pain ("lower back pain") and neck pain ("neck radiating down arms to forearms, wrist, and hands").The patient was treated with surgery (bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes) and surgery (ablation on (b)(6) 2011).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage and mood swings had resolved, the device breakage, vaginal haemorrhage, hypersensitivity, bladder disorder, urinary tract disorder, blood disorder, cardiac disorder, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, hot flush, urinary tract infection, bacterial vaginosis, pelvic infection, migraine, headache, nausea, nervous system disorder, allergy to metals, anxiety, bipolar disorder, dermal cyst, vaginal discharge, vision blurred, rectal haemorrhage, diarrhoea, gastritis, polyp, adenoma benign, neuropathy peripheral, hiatus hernia, ovarian cyst, back pain and neck pain outcome was unknown and the menorrhagia had not resolved.The reporter considered adenoma benign, allergy to metals, anxiety, back pain, bacterial vaginosis, bipolar disorder, bladder disorder, blood disorder, cardiac disorder, dermal cyst, device breakage, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, gastritis, gastrooesophageal reflux disease, genital haemorrhage, headache, hiatus hernia, hot flush, hypersensitivity, menorrhagia, migraine, mood swings, nausea, neck pain, nervous system disorder, neuropathy peripheral, ovarian cyst, pelvic infection, pelvic pain, polyp, rectal haemorrhage, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure (ess205).The reporter commented: as a result of the coils remaining in her body, she continues to experience the increasingly intense pain and bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: not provided quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no med dra llt can be provided.Most recent follow-up information incorporated above includes: on 27-feb-2018: essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer (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.New events added- abnormal bleeding (vaginal, menorrhagia), skin sensitive to everything, bladder or urinary problems or changes, bladder or urinary problems or changes, blood or heart disorder/condition, dental problems, device breakage, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, gerd, mood swings, hot flashes, uti, bacterial vaginosis, pelvic infection, migraines, headaches, nausea, neurological conditions or problems, nickel allergy, anxiety, bipolar, cysts on face, vaginal discharge, blurry vision, rectal bleeding, diarrhea, gastritis, hyperplastic polyp, tubular adenoma, neuropathy, hiatal hernia, cyst on ovary, lower back pain, neck radiating down arms to forearms, wrist, and hands, rashes and did not undergo an essure confirmation test.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 pelvic pain ("pelvic pains / increasingly intense pain/pain"), uterine haemorrhage ("abnormal bleeding (general) / abnormal uterine bleeding") and device breakage ("device breakage") in a 42-year-old female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo an essure confirmation test".The patient's past medical history included multigravida, parity 4 ((b)(6)1989, (b)(6)1996, (b)(6)1990 and (b)(6)2004)), c-section in 2004 and uterine dilation and curettage.Concurrent conditions included menometrorrhagia.Concomitant products included medroxyprogesterone (depo provera) and medroxyprogesterone acetate (provera).On (b)(6)2007, the patient had essure (ess205) inserted.In 2008, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required).In 2009, the patient experienced menorrhagia ("increased bleeding during menstruation/continues to experience bleeding/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)") and ovarian cyst ("cyst on ovary").In 2010, the patient experienced gastritis ("gastritis") and hiatus hernia ("hiatal hernia").In june 2011, the patient experienced vision blurred ("blurry vision").In 2012, the patient experienced dermal cyst ("cysts on face").On (b)(6)2013, 5 years 11 months after insertion of essure (ess205), the patient experienced gastrooesophageal reflux disease ("gerd"), anxiety ("anxiety"), bipolar disorder ("bipoloar") and neuropathy peripheral ("neuropathy").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), dermatitis allergic ("skin sensitive to everything") with rash, bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), blood disorder ("blood or heart disorder/condition"), cardiac disorder ("blood or heart disorder/condition"), tooth disorder ("dental problems"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), mood swings ("mood swings"), hot flush ("hot flashes"), urinary tract infection ("uti"), bacterial vaginosis ("bacterial vaginosis"), pelvic infection ("pelvic infection"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), nervous system disorder ("neurological conditions or problems"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge"), rectal haemorrhage ("rectal bleeding"), diarrhoea ("diarrhea"), polyp ("hyperplastic polyp"), adenoma benign ("tubular adenoma"), back pain ("lower back pain") and neck pain ("neck radiating down arms to forearms, wrist, and hands").The patient was treated with surgery (bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes)), surgery (ablation on (b)(6)2011) and surgery (bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes)).Essure (ess205) was removed on (b)(6)2016.At the time of the report, the pelvic pain, uterine haemorrhage and mood swings had resolved, the device breakage, vaginal haemorrhage, dermatitis allergic, bladder disorder, urinary tract disorder, blood disorder, cardiac disorder, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, hot flush, urinary tract infection, bacterial vaginosis, pelvic infection, migraine, headache, nausea, nervous system disorder, allergy to metals, anxiety, bipolar disorder, dermal cyst, vaginal discharge, vision blurred, rectal haemorrhage, diarrhoea, gastritis, polyp, adenoma benign, neuropathy peripheral, hiatus hernia, ovarian cyst, back pain and neck pain outcome was unknown and the menorrhagia had not resolved.The reporter considered adenoma benign, allergy to metals, anxiety, back pain, bacterial vaginosis, bipolar disorder, bladder disorder, blood disorder, cardiac disorder, dermal cyst, dermatitis allergic, device breakage, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, gastritis, gastrooesophageal reflux disease, headache, hiatus hernia, hot flush, menorrhagia, migraine, mood swings, nausea, neck pain, nervous system disorder, neuropathy peripheral, ovarian cyst, pelvic infection, pelvic pain, polyp, rectal haemorrhage, tooth disorder, urinary tract disorder, urinary tract infection, uterine haemorrhage, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure (ess205).The reporter commented: as a result of the coils remaining in her body, she continues to experience the increasingly intense pain and bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: not provided thickened endometrial stripe measuring 10 mm on ultrasound, enlarged uterus on ultrasound.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, she has been experiencing heavier menstrual flow for 1+yr and described uterine haemorrhage.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no med dra llt can be provided.Most recent follow-up information incorporated above includes: on(b)(6)2018: medical records received.Patient's medical history, concomintant medication was added, laboratory data was updated.Event abnormal uterine bleeding clubbed with abnormal bleeding (general).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 pelvic pain ("pelvic pains / increasingly intense pain/pain"), uterine haemorrhage ("abnormal bleeding (general) / abnormal uterine bleeding"), device breakage ("device breakage") and rectal haemorrhage ("rectal bleeding") in a 42-year-old female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo an essure confirmation test".The patient's past medical history included multigravida, parity 4 (((b)(6) 1989, (b)(6) 1996, (b)(6) 1990 and (b)(6) 2004)), c-section in 2004, uterine dilation and curettage, anogenital warts and appendectomy.Previously administered products included for an unreported indication: xanax, vicodin, metrogel, geodon, flagyl, zantac, bactrim, prilosec and loratadin.Concurrent conditions included menometrorrhagia.Concomitant products included cannabis sativa (marijuana), medroxyprogesterone (depo provera) and medroxyprogesterone acetate (provera).On (b)(6) 2007, the patient had essure (ess205) inserted.In 2008, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required).In 2009, the patient experienced menorrhagia ("increased bleeding during menstruation/continues to experience bleeding/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)"), rectal haemorrhage (seriousness criterion medically significant), diarrhoea ("diarrhea") and ovarian cyst ("cyst on ovary").In 2010, the patient experienced gastritis ("gastritis") and hiatus hernia ("hiatal hernia").In (b)(6) 2011, the patient experienced vision blurred ("blurry vision").In 2012, the patient experienced dermal cyst ("cysts on face").On (b)(6) 2013, 5 years 11 months after insertion of essure (ess205), the patient experienced gastrooesophageal reflux disease ("gerd"), anxiety ("anxiety"), bipolar disorder ("bipoloar") and neuropathy peripheral ("neuropathy").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), dermatitis allergic ("skin sensitive to everything") with rash, bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), blood disorder ("blood or heart disorder/condition"), cardiac disorder ("blood or heart disorder/condition"), tooth disorder ("dental problems"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), mood swings ("mood swings"), hot flush ("hot flashes"), urinary tract infection ("uti"), bacterial vaginosis ("bacterial vaginosis"), pelvic infection ("pelvic infection"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), nervous system disorder ("neurological conditions or problems"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge"), polyp ("hyperplastic polyp"), adenoma benign ("tubular adenoma"), back pain ("lower back pain"), neck pain ("neck radiating down arms to forearms, wrist, and hands") and autoimmune arthritis ("autoimmune disorder- type of disorder: arthritis").The patient was treated with surgery (bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes)), surgery (ablation on (b)(6) 2011).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage and mood swings had resolved, the device breakage, vaginal haemorrhage, dermatitis allergic, bladder disorder, urinary tract disorder, blood disorder, cardiac disorder, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, hot flush, urinary tract infection, bacterial vaginosis, pelvic infection, migraine, headache, nausea, nervous system disorder, allergy to metals, anxiety, bipolar disorder, dermal cyst, vaginal discharge, vision blurred, rectal haemorrhage, diarrhoea, gastritis, polyp, adenoma benign, neuropathy peripheral, hiatus hernia, ovarian cyst, back pain, neck pain and autoimmune arthritis outcome was unknown and the menorrhagia had not resolved.The reporter considered adenoma benign, allergy to metals, anxiety, autoimmune arthritis, back pain, bacterial vaginosis, bipolar disorder, bladder disorder, blood disorder, cardiac disorder, dermal cyst, dermatitis allergic, device breakage, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, gastritis, gastrooesophageal reflux disease, headache, hiatus hernia, hot flush, menorrhagia, migraine, mood swings, nausea, neck pain, nervous system disorder, neuropathy peripheral, ovarian cyst, pelvic infection, pelvic pain, polyp, rectal haemorrhage, tooth disorder, urinary tract disorder, urinary tract infection, uterine haemorrhage, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure (ess205).The reporter commented: as a result of the coils remaining in her body, she continues to experience the increasingly intense pain and bleeding.After deploying the first essure device, there were a total of 8 coils noted to be extending into the endometrial cavity.And upon performing the left insertion, there were a total of 3 coils noted to be extending into the endometrial cavity.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: not provided.Thickened endometrial stripe measuring 10 mm on ultrasound, enlarged uterus on ultrasound.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, she has been experiencing heavier menstrual flow for 1+yr and described uterine haemorrhage, back pain, anxiety, neck pain, depression, vaginal discharge, ovarian cyst, abdominal pain.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no med dra llt can be provided.Most recent follow-up information incorporated above includes: on 5-apr-2018: plaintiff fact sheet received:event arthritis was added.Product, patient & reporter information updated.On 12-mar-2018: medical records received.Concomitant condition added.Product, patient & reporter information updated.Processed with fu 05.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 pelvic pain ("pelvic pains / increasingly intense pain/pain"), uterine haemorrhage ("abnormal bleeding (general) / abnormal uterine bleeding"), device breakage ("device breakage"), fallopian tube perforation ("fallopian tube perforation"), device dislocation ("migration of essure device"), pelvic infection ("pelvic infection"), ovarian cyst ("cyst on ovary") and rectal haemorrhage ("rectal bleeding") in a 45-year-old female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo an essure confirmation test".The patient's past medical history included multigravida, parity 4 (((b)(6) 1989, (b)(6) 1996, (b)(6)1990 and (b)(6) 2004)), c-section in 2004, uterine dilation and curettage, anogenital warts, appendectomy, polycystic ovary, ovarian cystectomy in 2004 and tooth disorder in 1983.Previously administered products included for an unreported indication: xanax, vicodin, metrogel, geodon, flagyl, zantac, bactrim, prilosec and loratadin.Concurrent conditions included menometrorrhagia, acid reflux (oesophageal), gerd, anxiety, depression and bipolar disorder.Concomitant products included cannabis sativa (marijuana), medroxyprogesterone (depo provera) and medroxyprogesterone acetate (provera).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and vaginal discharge ("vaginal discharge").In (b)(6) 2008, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required) and nausea ("nausea").In (b)(6) 2008, the patient experienced mood swings ("mood swings") and hot flush ("hot flashes").In 2008, 5 years 11 months after insertion of essure (ess205), the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), nocturia ("incomplete emptying, nocturia, urgency"), bladder disorder ("bladder problems or changes"), urinary retention ("incomplete emptying, nocturia, urgency"), micturition urgency ("incomplete emptying, nocturia, urgency") and fatigue ("fatigue").In 2008, the patient experienced neuropathy peripheral ("neuropathy").In (b)(6) 2008, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), urinary tract infection ("uti"), bacterial vaginosis ("bacterial vaginosis") and female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2009, the patient experienced ovarian cyst (seriousness criterion medically significant), rectal haemorrhage (seriousness criterion medically significant), menorrhagia ("increased bleeding during menstruation/continues to experience bleeding/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), tooth disorder ("dental problems"), migraine ("migraines"), headache ("headaches"), diarrhoea ("diarrhea") and irritable bowel syndrome ("ibs").In (b)(6) 2009, the patient experienced dermatitis allergic ("skin sensitive to everything") with rash.In 2010, the patient experienced metal poisoning ("nickel in blood"), gastritis ("gastritis") and hiatus hernia ("hiatal hernia").In june 2011, the patient experienced vision blurred ("blurry vision").In 2012, the patient experienced dermal cyst ("cysts on face").On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), nervous system disorder ("neurological conditions or problems"), allergy to metals ("nickel allergy"), polyp ("hyperplastic polyp"), adenoma benign ("tubular adenoma"), back pain ("lower back pain"), neck pain ("neck radiating down arms to forearms, wrist, and hands"), autoimmune arthritis ("autoimmune disorder- type of disorder: arthritis in neck, back, knees and hands"), depression ("depression") and urticaria ("hives").On an unknown date, the patient experienced gastrooesophageal reflux disease ("gerd"), anxiety ("anxiety") and bipolar disorder ("bipoloar").The patient was treated with surgery (bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes)), surgery (ablation on 21-jun-2011/uterine dilation and curettage (2011/2013)), and surgery (ovarian cyst surgery in 2013).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage and mood swings had resolved, the device breakage, fallopian tube perforation, device dislocation, pelvic infection, ovarian cyst, rectal haemorrhage, nocturia, vaginal haemorrhage, dermatitis allergic, bladder disorder, urinary retention, micturition urgency, metal poisoning, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, hot flush, urinary tract infection, bacterial vaginosis, migraine, headache, nausea, nervous system disorder, allergy to metals, anxiety, bipolar disorder, dermal cyst, vaginal discharge, vision blurred, diarrhoea, gastritis, polyp, adenoma benign, neuropathy peripheral, hiatus hernia, back pain, neck pain, autoimmune arthritis, depression, irritable bowel syndrome, female sexual dysfunction and urticaria outcome was unknown and the menorrhagia had not resolved.The reporter considered adenoma benign, allergy to metals, anxiety, autoimmune arthritis, back pain, bacterial vaginosis, bipolar disorder, bladder disorder, depression, dermal cyst, dermatitis allergic, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, gastritis, gastrooesophageal reflux disease, headache, hiatus hernia, hot flush, irritable bowel syndrome, menorrhagia, metal poisoning, micturition urgency, migraine, mood swings, nausea, neck pain, nervous system disorder, neuropathy peripheral, nocturia, ovarian cyst, pelvic infection, pelvic pain, polyp, rectal haemorrhage, tooth disorder, urinary retention, urinary tract infection, urticaria, uterine haemorrhage, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure (ess205).The reporter commented: as a result of the coils remaining in her body, she continues to experience the increasingly intense pain and bleeding.After deploying the first essure device, there were a total of 8 coils noted to be extending into the endometrial cavity.And upon performing the left insertion, there were a total of 3 coils noted to be extending into the endometrial cavity.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: not provided thickened endometrial stripe measuring 10 mm on ultrasound, enlarged uterus on ultrasound.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, she has been experiencing heavier menstrual flow for 1+yr and described uterine haemorrhage, back pain, anxiety, neck pain, depression, vaginal discharge, ovarian cyst, abdominal pain.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no med dra llt can be provided.Most recent follow-up information incorporated above includes: on 23-may-2018: plaintiff fact sheet was received and the following information was provided: event onset date; urinary problems or changes was updated to incomplete emptying, nocturia, urgency; blood or heart disorder/condition updated to nickel in blood, depression, ibs, apareunia (inability to have sexual intercourse), hives, migration of essure device, and fallopian tube perforation were added as event; historical and concomitant condition added.On 11-jun-2018: coding correction.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 pelvic pain ("pelvic pains / increasingly intense pain/pain"), uterine haemorrhage ("abnormal bleeding (general) / abnormal uterine bleeding"), device breakage ("device breakage"), fallopian tube perforation ("fallopian tube perforation"), device dislocation ("migration of essure device"), pelvic infection ("pelvic infection"), ovarian cyst ("cyst on ovary"), rectal haemorrhage ("rectal bleeding") and autoimmune arthritis ("autoimmune disorder- type of disorder: arthritis in neck, back, knees and hands") in a 45-year-old female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo an essure confirmation test".The patient's past medical history included multigravida, parity 4 (((b)(6) 1989, (b)(6) 1996, (b)(6) 1990 and (b)(6) 2004)), c-section in 2004, uterine dilation and curettage, anogenital warts, appendectomy, polycystic ovary, ovarian cystectomy in 2004 and tooth disorder in 1983.Previously administered products included for an unreported indication: xanax, vicodin, metrogel, geodon, flagyl, zantac, bactrim, prilosec and loratadin.Concurrent conditions included menometrorrhagia, acid reflux (oesophageal), gerd, anxiety, depression and bipolar disorder.Concomitant products included cannabis sativa (marijuana), medroxyprogesterone (depo provera) and medroxyprogesterone acetate (provera).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and vaginal discharge ("vaginal discharge").In (b)(6) 2008, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required) and nausea ("nausea").In (b)(6) 2008, the patient experienced mood swings ("mood swings") and hot flush ("hot flashes").In 2008, 5 years 11 months after insertion of essure (ess205), the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), nocturia ("incomplete emptying, nocturia, urgency"), bladder disorder ("bladder problems or changes"), urinary retention ("incomplete emptying, nocturia, urgency"), micturition urgency ("incomplete emptying, nocturia, urgency") and fatigue ("fatigue").In 2008, the patient experienced neuropathy peripheral ("neuropathy").In (b)(6) 2008, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), urinary tract infection ("uti"), bacterial vaginosis ("bacterial vaginosis") and female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2009, the patient experienced ovarian cyst (seriousness criterion medically significant), rectal haemorrhage (seriousness criterion medically significant), menorrhagia ("increased bleeding during menstruation/continues to experience bleeding/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), tooth disorder ("dental problems"), migraine ("migraines"), headache ("headaches"), diarrhoea ("diarrhea") and irritable bowel syndrome ("ibs").In (b)(6) 2009, the patient experienced dermatitis allergic ("skin sensitive to everything") with rash.In 2010, the patient experienced blood test abnormal ("nickel in blood"), gastritis ("gastritis") and hiatus hernia ("hiatal hernia").In (b)(6) 2011, the patient experienced vision blurred ("blurry vision").In 2012, the patient experienced dermal cyst ("cysts on face").On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), nervous system disorder ("neurological conditions or problems"), allergy to metals ("nickel allergy"), polyp ("hyperplastic polyp"), adenoma benign ("tubular adenoma"), back pain ("lower back pain"), neck pain ("neck radiating down arms to forearms, wrist, and hands"), autoimmune arthritis (seriousness criterion medically significant), depression ("depression") and urticaria ("hives").On an unknown date, the patient experienced gastrooesophageal reflux disease ("gerd"), anxiety ("anxiety") and bipolar disorder ("bipoloar").The patient was treated with surgery (bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes)), surgery (ablation on (b)(6) 2011/uterine dilation and curettage ((b)(6) 2013)), and surgery (ovarian cyst surgery in 2013).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage and mood swings had resolved, the device breakage, fallopian tube perforation, device dislocation, pelvic infection, ovarian cyst, rectal haemorrhage, nocturia, vaginal haemorrhage, dermatitis allergic, bladder disorder, urinary retention, micturition urgency, blood test abnormal, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, hot flush, urinary tract infection, bacterial vaginosis, migraine, headache, nausea, nervous system disorder, allergy to metals, anxiety, bipolar disorder, dermal cyst, vaginal discharge, vision blurred, diarrhoea, gastritis, polyp, adenoma benign, neuropathy peripheral, hiatus hernia, back pain, neck pain, autoimmune arthritis, depression, irritable bowel syndrome, female sexual dysfunction and urticaria outcome was unknown and the menorrhagia had not resolved.The reporter considered adenoma benign, allergy to metals, anxiety, autoimmune arthritis, back pain, bacterial vaginosis, bipolar disorder, bladder disorder, blood test abnormal, depression, dermal cyst, dermatitis allergic, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, gastritis, gastrooesophageal reflux disease, headache, hiatus hernia, hot flush, irritable bowel syndrome, menorrhagia, micturition urgency, migraine, mood swings, nausea, neck pain, nervous system disorder, neuropathy peripheral, nocturia, ovarian cyst, pelvic infection, pelvic pain, polyp, rectal haemorrhage, tooth disorder, urinary retention, urinary tract infection, urticaria, uterine haemorrhage, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure (ess205).The reporter commented: as a result of the coils remaining in her body, she continues to experience the increasingly intense pain and bleeding.After deploying the first essure device, there were a total of 8 coils noted to be extending into the endometrial cavity.And upon performing the left insertion, there were a total of 3 coils noted to be extending into the endometrial cavity diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: not provided thickened endometrial stripe measuring 10 mm on ultrasound, enlarged uterus on ultrasound.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, she has been experiencing heavier menstrual flow for 1+yr and described uterine haemorrhage, back pain, anxiety, neck pain, depression, vaginal discharge, ovarian cyst, abdominal pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-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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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pains / increasingly intense pain/pain"), uterine haemorrhage ("abnormal bleeding (general) / abnormal uterine bleeding"), device breakage ("device breakage"), fallopian tube perforation ("fallopian tube perforation"), device dislocation ("migration of essure device"), pelvic infection ("pelvic infection"), ovarian cyst ("cyst on ovary"), rectal haemorrhage ("rectal bleeding") and autoimmune arthritis ("autoimmune disorder- type of disorder: arthritis in neck, back, knees and hands") in a 45-year-old female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo an essure confirmation test".The patient's past medical history included multigravida, parity 4 (((b)(6) 1989, (b)(6) 1996, (b)(6) 1990 and (b)(6) 2004)), c-section in 2004, uterine dilation and curettage, anogenital warts, appendectomy, polycystic ovary, ovarian cystectomy in 2004 and tooth disorder in 1983.Previously administered products included for an unreported indication: xanax, vicodin, metrogel, geodon, flagyl, zantac, bactrim, prilosec and loratadin.Concurrent conditions included menometrorrhagia, acid reflux (oesophageal), gerd, anxiety, depression and bipolar disorder.Concomitant products included cannabis sativa (marijuana), medroxyprogesterone (depo provera) and medroxyprogesterone acetate (provera).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and vaginal discharge ("vaginal discharge").In (b)(6) 2008, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required) and nausea ("nausea").In (b)(6) 2008, the patient experienced mood swings ("mood swings") and hot flush ("hot flashes").In 2008, 5 years 11 months after insertion of essure (ess205), the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), nocturia ("incomplete emptying, nocturia, urgency"), bladder disorder ("bladder problems or changes"), urinary retention ("incomplete emptying, nocturia, urgency"), micturition urgency ("incomplete emptying, nocturia, urgency") and fatigue ("fatigue").In 2008, the patient experienced neuropathy peripheral ("neuropathy").In (b)(6) 2008, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), urinary tract infection ("uti"), bacterial vaginosis ("bacterial vaginosis") and female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2009, the patient experienced ovarian cyst (seriousness criterion medically significant), rectal haemorrhage (seriousness criterion medically significant), menorrhagia ("increased bleeding during menstruation/continues to experience bleeding/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), tooth disorder ("dental problems"), migraine ("migraines"), headache ("headaches"), diarrhoea ("diarrhea") and irritable bowel syndrome ("ibs").In (b)(6) 2009, the patient experienced dermatitis allergic ("skin sensitive to everything") with rash.In 2010, the patient experienced blood test abnormal ("nickel in blood"), gastritis ("gastritis") and hiatus hernia ("hiatal hernia").In (b)(6) 2011, the patient experienced vision blurred ("blurry vision").In 2012, the patient experienced dermal cyst ("cysts on face").On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), nervous system disorder ("neurological conditions or problems"), allergy to metals ("nickel allergy"), polyp ("hyperplastic polyp"), adenoma benign ("tubular adenoma"), back pain ("lower back pain"), neck pain ("neck radiating down arms to forearms, wrist, and hands"), autoimmune arthritis (seriousness criterion medically significant), depression ("depression") and urticaria ("hives").On an unknown date, the patient experienced gastrooesophageal reflux disease ("gerd"), anxiety ("anxiety") and bipolar disorder ("bipoloar").The patient was treated with surgery (bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes)), surgery (ablation on (b)(6) 2011/uterine dilation and curettage (2011/2013)), surgery (bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes)) and surgery (ovarian cyst surgery in 2013).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage and mood swings had resolved, the device breakage, fallopian tube perforation, device dislocation, pelvic infection, ovarian cyst, rectal haemorrhage, nocturia, vaginal haemorrhage, dermatitis allergic, bladder disorder, urinary retention, micturition urgency, blood test abnormal, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, hot flush, urinary tract infection, bacterial vaginosis, migraine, headache, nausea, nervous system disorder, allergy to metals, anxiety, bipolar disorder, dermal cyst, vaginal discharge, vision blurred, diarrhoea, gastritis, polyp, adenoma benign, neuropathy peripheral, hiatus hernia, back pain, neck pain, autoimmune arthritis, depression, irritable bowel syndrome, female sexual dysfunction and urticaria outcome was unknown and the menorrhagia had not resolved.The reporter considered adenoma benign, allergy to metals, anxiety, autoimmune arthritis, back pain, bacterial vaginosis, bipolar disorder, bladder disorder, blood test abnormal, depression, dermal cyst, dermatitis allergic, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, gastritis, gastrooesophageal reflux disease, headache, hiatus hernia, hot flush, irritable bowel syndrome, menorrhagia, micturition urgency, migraine, mood swings, nausea, neck pain, nervous system disorder, neuropathy peripheral, nocturia, ovarian cyst, pelvic infection, pelvic pain, polyp, rectal haemorrhage, tooth disorder, urinary retention, urinary tract infection, urticaria, uterine haemorrhage, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure (ess205).The reporter commented: as a result of the coils remaining in her body, she continues to experience the increasingly intense pain and bleeding.After deploying the first essure device, there were a total of 8 coils noted to be extending into the endometrial cavity.And upon performing the left insertion, there were a total of 3 coils noted to be extending into the endometrial cavity diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: not provided thickened endometrial stripe measuring 10 mm on ultrasound, enlarged uterus on ultrasound.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, she has been experiencing heavier menstrual flow for 1+yr and described uterine haemorrhage, back pain, anxiety, neck pain, depression, vaginal discharge, ovarian cyst, abdominal pain.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 1-aug-2018: quality safety evaluation of product technical complaint 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 pelvic pain ('pelvic pains / increasingly intense pain/pain'), uterine haemorrhage ('abnormal bleeding (general) / abnormal uterine bleeding'), device breakage ('device breakage'), fallopian tube perforation ('fallopian tube perforation'), pelvic infection ('pelvic infection'), bipolar disorder ('bipoloar') and autoimmune arthritis ('autoimmune disorder- type of disorder: arthritis in neck, back, knees and hands') in a 45-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: device monitoring procedure not performed "did not undergo an essure confirmation test".The patient's medical history included c-section in 2004, ovarian cystectomy in 2004, multigravida, parity 4 (((b)(6) 1989, (b)(6) 1996, (b)(6) 1990 and (b)(6) 2004)), uterine dilation and curettage, anogenital warts, appendectomy, polycystic ovary and tooth disorder in 1983.Previously administered products included for an unreported indication: xanax, vicodin, metrogel, geodon, flagyl, zantac, bactrim, prilosec and loratadin.Concurrent conditions included menometrorrhagia, acid reflux (oesophageal), gerd, anxiety, depression, bipolar disorder and appendicitis.Concomitant products included anti allergic agents, aripiprazole (abilify), buspirone hydrochloride (buspar), cannabis sativa (marijuana), corticosteroid nos, medroxyprogesterone acetate (depo provera) and medroxyprogesterone acetate (provera).On (b)(6) 2007, the patient had essure inserted.In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and vaginal discharge ("vaginal discharge").In (b)(6) 2008, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required) and nausea ("nausea").In (b)(6) 2008, the patient experienced mood swings ("mood swings") and hot flush ("hot flashes").In 2008, the patient experienced neuropathy peripheral ("neuropathy"), 5 years 11 months after insertion of essure.In 2008, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), nocturia ("incomplete emptying, nocturia, urgency"), bladder disorder ("bladder problems or changes"), urinary retention ("incomplete emptying, nocturia, urgency"), micturition urgency ("incomplete emptying, nocturia, urgency") and fatigue ("fatigue").In (b)(6) 2008, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), urinary tract infection ("uti"), bacterial vaginosis ("bacterial vaginosis") and female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2009, the patient experienced ovarian cyst ("cyst on ovary"), tooth disorder ("dental problems"), rectal haemorrhage ("rectal bleeding"), menorrhagia ("increased bleeding during menstruation/continues to experience bleeding/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("headaches"), diarrhoea ("diarrhea") and irritable bowel syndrome ("ibs").In (b)(6) 2009, the patient experienced dermatitis allergic ("skin sensitive to everything") with rash.In 2010, the patient was found to have blood test abnormal ("nickel in blood") and experienced gastritis ("gastritis") and hiatus hernia ("hiatal hernia").In (b)(6) 2011, the patient experienced vision blurred ("blurry vision").In 2012, the patient experienced dermal cyst ("cysts on face").On (b)(6) 2016, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required).On an unknown date, the patient experienced gastrooesophageal reflux disease ("gerd"), anxiety ("anxiety") and bipolar disorder (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), device dislocation ("migration of essure device"), nervous system disorder ("neurological conditions or problems"), allergy to metals ("nickel allergy"), polyp ("hyperplastic polyp"), back pain ("lower back pain"), neck pain ("neck radiating down arms to forearms, wrist, and hands"), autoimmune arthritis (seriousness criterion medically significant), depression ("depression") and urticaria ("hives") and was found to have adenoma benign ("tubular adenoma").The patient was treated with 13 teeth extractions and surgery (ablation on (b)(6) 2011/uterine dilation and curettage (2011/2013), bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes) and ovarian cyst surgery in 2013).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage and mood swings had resolved, the device breakage, fallopian tube perforation, pelvic infection, device dislocation, ovarian cyst, tooth disorder, rectal haemorrhage, nocturia, vaginal haemorrhage, dermatitis allergic, bladder disorder, urinary retention, micturition urgency, blood test abnormal, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, hot flush, urinary tract infection, bacterial vaginosis, migraine, headache, nausea, nervous system disorder, allergy to metals, anxiety, bipolar disorder, dermal cyst, vaginal discharge, vision blurred, diarrhoea, gastritis, polyp, adenoma benign, neuropathy peripheral, hiatus hernia, back pain, neck pain, autoimmune arthritis, depression, irritable bowel syndrome, female sexual dysfunction and urticaria outcome was unknown and the menorrhagia had not resolved.The reporter considered adenoma benign, allergy to metals, anxiety, autoimmune arthritis, back pain, bacterial vaginosis, bipolar disorder, bladder disorder, blood test abnormal, depression, dermal cyst, dermatitis allergic, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, gastritis, gastrooesophageal reflux disease, headache, hiatus hernia, hot flush, irritable bowel syndrome, menorrhagia, micturition urgency, migraine, mood swings, nausea, neck pain, nervous system disorder, neuropathy peripheral, nocturia, ovarian cyst, pelvic infection, pelvic pain, polyp, rectal haemorrhage, tooth disorder, urinary retention, urinary tract infection, urticaria, uterine haemorrhage, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure.The reporter commented: as a result of the coils remaining in her body, she continues to experience the increasingly intense pain and bleeding.After deploying the first essure device, there were a total of 8 coils noted to be extending into the endometrial cavity.And upon performing the left insertion, there were a total of 3 coils noted to be extending into the endometrial cavity diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: results: not provided.Diagnostic results: thickened endometrial stripe measuring 10 mm on ultrasound, enlarged uterus on ultrasound.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, she has been experiencing heavier menstrual flow for 1+yr and described uterine haemorrhage, back pain, anxiety, neck pain, depression, vaginal discharge, ovarian cyst, abdominal pain.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: essure model number was changed from e205 to e305.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 pelvic pain ('pelvic pains / increasingly intense pain/pain'), uterine haemorrhage ('abnormal bleeding (general) / abnormal uterine bleeding'), device breakage ('device breakage'), fallopian tube perforation ('fallopian tube perforation'), pelvic infection ('pelvic infection'), bipolar disorder ('bipolar') and autoimmune arthritis ('autoimmune disorder- type of disorder: arthritis in neck, back, knees and hands') in a 45-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: device monitoring procedure not performed "did not undergo an essure confirmation test." the patient's medical history included c-section in 2004, ovarian cystectomy in 2004, multigravida, parity 4 (b)(6) 1989, (b)(6) 1996, (b)(6) 1990 and (b)(6) 2004, uterine dilation and curettage, anogenital warts, appendectomy, polycystic ovary and tooth disorder in 1983.Previously administered products included for an unreported indication: xanax, vicodin, metrogel, geodon, flagyl, zantac, bactrim, prilosec and loratadin.Concurrent conditions included menometrorrhagia, acid reflux (oesophageal), gerd, anxiety, depression, bipolar disorder and appendicitis.Concomitant products included anti allergic agents, aripiprazole (abilify), buspirone hydrochloride (buspar), cannabis sativa (marijuana), corticosteroid nos, medroxyprogesterone acetate (depo provera) and medroxyprogesterone acetate (provera).On (b)(6) 2007, the patient had essure inserted.In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea cramping") and vaginal discharge ("vaginal discharge").In (b)(6) 2008, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required) and nausea ("nausea").In (b)(6) 2008, the patient experienced mood swings ("mood swings") and hot flush ("hot flashes").In 2008, the patient experienced neuropathy peripheral ("neuropathy"), 5 years 11 months after insertion of essure.In 2008, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), nocturia ("incomplete emptying, nocturia, urgency"), bladder disorder ("bladder problems or changes"), urinary retention ("incomplete emptying, nocturia, urgency"), micturition urgency ("incomplete emptying, nocturia, urgency") and fatigue ("fatigue").In (b)(6) 2008, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), urinary tract infection ("uti"), bacterial vaginosis ("bacterial vaginosis") and female sexual dysfunction ("apareunia inability to have sexual intercourse").In 2009, the patient experienced ovarian cyst ("cyst on ovary"), tooth disorder ("dental problems"), rectal haemorrhage ("rectal bleeding"), menorrhagia ("increased bleeding during menstruation/continues to experience bleeding/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding vaginal, menorrhagia"), migraine ("migraines"), headache ("headaches"), diarrhoea ("diarrhea") and irritable bowel syndrome ("ibs").In (b)(6) 2009, the patient experienced dermatitis allergic ("skin sensitive to everything") with rash.In 2010, the patient was found to have blood test abnormal ("nickel in blood") and experienced gastritis ("gastritis") and hiatus hernia ("hiatal hernia").In (b)(6) (b)(6) 2011, the patient experienced vision blurred ("blurry vision").In 2012, the patient experienced dermal cyst ("cysts on face").On (b)(6) 2016, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required).On an unknown date, the patient experienced gastrooesophageal reflux disease ("gerd"), anxiety ("anxiety") and bipolar disorder (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), device dislocation ("migration of essure device"), nervous system disorder ("neurological conditions or problems"), allergy to metals ("nickel allergy"), polyp ("hyperplastic polyp"), back pain ("lower back pain"), neck pain ("neck radiating down arms to forearms, wrist, and hands"), autoimmune arthritis (seriousness criterion medically significant), depression ("depression") and urticaria ("hives") and was found to have adenoma benign ("tubular adenoma").The patient was treated with 13 teeth extractions and surgery (ablation on (b)(6) 2011/uterine dilation and curettage (2011/2013), bilateral salpingectomy and partial hysterectomy (uterus, cervix, fallopian tubes) and ovarian cyst surgery in 2013).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage and mood swings had resolved, the device breakage, fallopian tube perforation, pelvic infection, device dislocation, ovarian cyst, tooth disorder, rectal haemorrhage, nocturia, vaginal haemorrhage, dermatitis allergic, bladder disorder, urinary retention, micturition urgency, blood test abnormal, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, hot flush, urinary tract infection, bacterial vaginosis, migraine, headache, nausea, nervous system disorder, allergy to metals, anxiety, bipolar disorder, dermal cyst, vaginal discharge, vision blurred, diarrhoea, gastritis, polyp, adenoma benign, neuropathy peripheral, hiatus hernia, back pain, neck pain, autoimmune arthritis, depression, irritable bowel syndrome, female sexual dysfunction and urticaria outcome was unknown and the menorrhagia had not resolved.The reporter considered adenoma benign, allergy to metals, anxiety, autoimmune arthritis, back pain, bacterial vaginosis, bipolar disorder, bladder disorder, blood test abnormal, depression, dermal cyst, dermatitis allergic, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, gastritis, gastrooesophageal reflux disease, headache, hiatus hernia, hot flush, irritable bowel syndrome, menorrhagia, micturition urgency, migraine, mood swings, nausea, neck pain, nervous system disorder, neuropathy peripheral, nocturia, ovarian cyst, pelvic infection, pelvic pain, polyp, rectal haemorrhage, tooth disorder, urinary retention, urinary tract infection, urticaria, uterine haemorrhage, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure.The reporter commented: as a result of the coils remaining in her body, she continues to experience the increasingly intense pain and bleeding.After deploying the first essure device, there were a total of 8 coils noted to be extending into the endometrial cavity.And upon performing the left insertion, there were a total of 3 coils noted to be extending into the endometrial cavity.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram on an unknown date: results: not provided.Diagnostic results: thickened endometrial stripe measuring 10 mm on ultrasound, enlarged uterus on ultrasound.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, she has been experiencing heavier menstrual flow for 1+yr and described uterine haemorrhage, back pain, anxiety, neck pain, depression, vaginal discharge, ovarian cyst, abdominal pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-jul-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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