| Model Number ESS305 |
| Device Problems
Break (1069); Biocompatibility (2886); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Pain (1994); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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| Event Date 01/01/2014 |
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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') and device breakage ('device in the right fallopian tube was removed with partial salpingectomy in two pieces') in a (b)(6) year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included nickel sensitivity.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2014, the patient experienced rash ("rash"), arthralgia ("joint pain in her hands and back") and myalgia ("muscle aches"), 11 months 27 days after insertion of essure.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("chronic fatigue"), coital bleeding ("post-coital bleeding"), dyspareunia ("dyspareunia"), bladder irritation ("irritable bladder"), hyperaesthesia teeth ("teeth sensitivity"), migraine ("migraines"), headache ("headaches") and dermatitis ("dermatitis returned").On (b)(6) 2015, the patient experienced device breakage (seriousness criterion medically significant) and complication of device removal ("device in the right fallopian tube was removed with partial salpingectomy in two pieces").On an unknown date, the patient was found to have blood pressure increased ("her blood pressure continued to rise") and experienced depression ("depression") and anxiety ("anxiety").The patient was treated with sertraline and surgery (laparoscopic removal of the essure on (b)(6) 2015/ hysterectomy on (b)(6) 2016).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, rash, fatigue, coital bleeding, dyspareunia, bladder irritation, hyperaesthesia teeth, migraine, headache, dermatitis, blood pressure increased and myalgia had resolved, the device breakage and complication of device removal outcome was unknown and the arthralgia, depression and anxiety had not resolved.The reporter considered anxiety, arthralgia, bladder irritation, blood pressure increased, coital bleeding, complication of device removal, depression, dermatitis, device breakage, dyspareunia, fatigue, headache, hyperaesthesia teeth, migraine, myalgia, pelvic pain and rash to be related to essure.The reporter commented: each month, her symptoms would be heightened during her period and although she had been told that they would pass, the pain never went away and eventually she was bedridden.During the laparoscopy on (b)(6) 2015, the device in the left fallopian tube was removed intact but the device in the right fallopian tube was removed with partial salpingectomy in two pieces.One month after the procedure, the patient was informed that the device had broken inside her and that the doctor was not sure whether he had retrieved the device in its entirety when he pieced the fragments together after the surgery and sent them to the lab.A year after the removal of the essure device, the patient was still suffering from pain and associated symptoms.An x-ray indicated that there were possibly fragments in the pelvic area although they were not clearly visible.Due to her ongoing gynaecological problems, the doctor then acceded to the patient's request for a hysterectomy.A laparoscopically assisted vaginal hysterectomy and bilateral salpingo-oophorectomy was performed on (b)(6) 2016.A subsequent histopathology report dated (b)(6) 2016 indicated that there was no evidence of any residual parts of the essure device remaining within the opening of the fallopian tubes or her uterus.Her symptoms improved following her hysterectomy.During summer 2017, she began to feel normal again although she still suffers from joint pain in her hands and back.She has also developed depression and anxiety since the essure device was provided and is currently being prescribed sertraline.Patient now has to take hrt due to her medically induced menopause.Diagnostic results (normal ranges are provided in parenthesis if available): red blood cell sedimentation rate increased - on an unknown date: high level of inflammation present.X-ray - on (b)(6) 2016: there were possibly fragments in the pelvic area although they were not clearly visible.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain worse when ovulates, only pain free between period and ovulation') and device breakage ('device in the right fallopian tube was removed with partial salpingectomy in two pieces') in a 42-year-old female patient who had essure (batch no.50697310) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included dysuria on (b)(6) 2013, uti (suspected by gp) on (b)(6) 2013, overweight (bmi 27.7) on (b)(6) 2011, uti in 2010, gravida ii in 2010, low mood (worse since birth of baby) in 2008, panic attacks from 2008 to 2010, vaginal delivery (girl) in 2008, genital warts in 2006, device insertion failed (unable to pass mirena inserter beyond internal cx os, spasm / tried 2 occasions, 1st mirena lot 42295b exp 04-2007, 2nd mirena lot 42295b exp 04-2007) in 2005, nickel sensitivity, iron deficiency anaemia (during pregnancy), parity 4 (all healthy, last delivery in 2011 (30 weeks pregnant in jun-2011)), penicillin allergy (urticaria, vomiting, diarrhea), smoker and surgery (loop electrical excision procedure (lletz)).Previously administered products included for low mood: prozac from 2010 to (b)(6) 2013 and citalopram on (b)(6) 2012; for iron deficiency anemia: iron on (b)(6) 2011; for panic attacks: fluoxetine in 2009 and diazepam in 2009; for heavy bleeding with clots, no flooding: norethisterone tabs 5 mg in 2007; for contraception: implanon in 2005 and mirena in 2005; for menorrhagia: progesterone.Past adverse reactions to the above products included complication of device insertion with mirena; and paraesthesia with implanon.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced procedural pain ("pain during essure insertion, procedure took around 30 minutes"), 1 day after insertion of essure.On (b)(6) 2014, the patient experienced skin candida ("candida rash both axillae"), arthralgia ("joint pain in her hands and back, no swelling, nil active synovitis") and myalgia ("muscle aches").On (b)(6) 2014, the patient was found to have red blood cell sedimentation rate increased ("raised esr").In 2014, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), dyspareunia ("dyspareunia"), hypersensitivity ("or possibility that there is some on-going hypersensitivity reaction, allergic reaction with "), polymenorrhoea ("periods increasing in frequency"), back pain ("few tender spots across upper back"), headache ("headaches"), fatigue ("chronic fatigue"), coital bleeding ("post-coital bleeding"), bladder irritation ("irritable bladder"), hyperaesthesia teeth ("teeth sensitivity"), migraine ("migraines"), dermatitis ("dermatitis returned"), sleep disorder ("unrefreshing sleep") and inflammation ("possibility that there is some on-going inflammation") and was found to have weight increased ("weight gain").In 2015, the patient experienced urinary tract infection ("recurrent uti").On (b)(6) 2015, the patient experienced device breakage (seriousness criterion medically significant) and complication of device removal ("device in the right fallopian tube was removed with partial salpingectomy in two pieces").On (b)(6) 2016, the patient experienced post procedural pain ("pain after hysterectomy").On an unknown date, the patient experienced allergy to metals ("allergic to nickel in essure"), menorrhagia ("menorrhagia"), genital haemorrhage ("abnormal bleeding"), hypertension ("blood pressure continued to rise / hypertension stage 1 160/110"), ovulation pain ("ovulation pain"), depression ("depression"), anxiety ("anxiety"), panic attack ("panic attack"), asthma ("asthma"), dyspepsia ("heartburn"), irritable bowel syndrome ("ibs"), arthritis ("arthritis left side of neck"), adenomyosis ("multiple foci of adenomyosis in subserosal region of uterine wall"), haemorrhagic ovarian cyst ("in left ovary haemorrhagic and cystic corpus luteum"), cervix inflammation ("cervix transformation zone is mildly inflamed"), alopecia ("hair loss") and palpitations ("palpitations").The patient was treated with amlodipine, cetirizine, chlorphenamine maleate (piriton), diclofenac, fluoxetine, fluoxetine hydrochloride (prozac), hydrocortisone;miconazole nitrate (daktacort), ibuprofen, ketorolac tromethamine (toradol), loratadine, miconazole, naproxen, paracetamol, ramipril, sertraline, tramadol, trimethoprim and surgery (laparoscopic bilat salpingectomy for essure on (b)(6) 2015, hysterectomy oophorectomy (b)(6) 2016).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, device breakage, dyspareunia, menorrhagia, genital haemorrhage, headache, skin candida, fatigue, coital bleeding, bladder irritation, hyperaesthesia teeth, migraine, dermatitis, hypertension, myalgia, procedural pain and post procedural pain had resolved, the allergy to metals, hypersensitivity, polymenorrhoea, complication of device removal, ovulation pain, sleep disorder, red blood cell sedimentation rate increased, inflammation, weight increased, panic attack, asthma, dyspepsia, irritable bowel syndrome, urinary tract infection, adenomyosis, haemorrhagic ovarian cyst, cervix inflammation, alopecia and palpitations outcome was unknown and the back pain, arthralgia, depression, anxiety and arthritis had not resolved.The reporter considered adenomyosis, allergy to metals, alopecia, anxiety, arthralgia, arthritis, asthma, back pain, bladder irritation, cervix inflammation, coital bleeding, complication of device removal, depression, dermatitis, device breakage, dyspareunia, dyspepsia, fatigue, genital haemorrhage, haemorrhagic ovarian cyst, headache, hyperaesthesia teeth, hypersensitivity, hypertension, inflammation, irritable bowel syndrome, menorrhagia, migraine, myalgia, ovulation pain, palpitations, panic attack, pelvic pain, polymenorrhoea, procedural pain, red blood cell sedimentation rate increased, skin candida, sleep disorder, urinary tract infection, weight increased and post procedural pain to be related to essure.The reporter commented: each month, symptoms would increase during period, the pain never went away and eventually she was bedridden.During the laparoscopy on (b)(6) 2015, device in left fallopian tube was removed intact, device in right tube was removed (partial salpingectomy) in two pieces.One month later, patient was told the device had broken inside her, doctor was unsure whether the device was removed entirely when he pieced the fragments together and he sent them to the lab.A year later, patient was still suffering from pain and associated symptoms.X-ray indicated possible fragments in pelvic area but not clearly visible.Due to ongoing gynaecological problems, doctor agreed to patient's request for hysterectomy.A laparoscopically assisted vaginal hysterectomy and bilateral salpingo-oophorectomy was performed on (b)(6) 2016.Histopathology report dated (b)(6) 2016 indicated no evidence of any residual parts of the essure device remaining within the opening of the fallopian tubes or her uterus/cornua.Allergic symptoms have improved dramatically since removal of her uterus (which did contain adenomyosis and endometriosis}.During summer 2017, she began to feel normal again, allergic symptoms improved (antihistamines were unsuccessful previously), although she still suffers from joint pain in her hands and back.Patient now has to take hrt due to her medically induced menopause.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.7 kg/sqm.Blood pressure measurement (mmhg) - on (b)(6) 2011: 140/90 (was initially 150/90); on (b)(6) 2014: 144/100 best of 3 readings; on (b)(6) 2015: 146/106; on (b)(6) 2015: 160/110.Blood test - on an unknown date: one marker raised at 38 due to inflammation in body.Hysteroscopy - on (b)(6) 2013: essure insertion lasted 30 minutes, it was completed without event.Left side 4 coils.Right side 8 coils.Pathology test - on (b)(6) 2015: left coil removed intact.Right coil removed with partial salpingectomy in 2 pieces.Is there a small metal fragment in the tubal specimen? - received 11 mm left of fallopian tube: on sectioning, there is no evidence of metal.Histology: fallopian tube appears unremarkable aside from cautery artefact.No endometriosis or malignancy; on (b)(6) 2016: contraceptive device not seen in either cornu.Histology: proliferative phase endometrial lining, multiple foci of adenomyosis and endometriosis in subserosal region of the uterine wall.In cervix transformation zone mildly inflamed.Sections of fallopian tube show markedly congested fimbrial end, in left ovary there is a haemorrhagic and cystic corpus luteum.Right ovary contains a follicular cyst but no endometriotic foci are seen.Uterus endometrioses.Red blood cell sedimentation rate increased - on (b)(6) 2014: high level of inflammation present; on (b)(6) 2014: 22.X-ray - on (b)(6) 2014: coils can be visualised within the tubes; on (b)(6) 2016: possibly fragments in pelvic area although not clearly visible.Quality-safety evaluation of ptc: unable to confirm complaint amendment: the report was amended for the following reason: report from lawyer was received on (b)(6) 2018 with med.Records (med.Confirmed): new: medical history, essure lot number.Event term "rash" specified to "skin candida", "blood pressure increased" to "hypertension".New events: endometriosis, haemorrhagic ovarian cyst, ovulation pain, cervix inflammation, metal allergy, hypersensitivity, back pain, palpitation, sleep disorder, inflammation, arthritis, polymenorrhea, weight gain, asthma, heartburn, ibs, uti, hair loss, procedural pain, post procedural pain, genital bleeding, menorrhagia.Remedial drugs and test data were added.-this record was also detected to have been posted from a consumer (later found to be from great britain, not from usa), it was a duplicate to record # (b)(4) which will be deleted from bayer safety database after all information was transferred to this duplicate record # (b)(4) (retained case).Social media reporter from usa was added.No new follow-up information was received from the reporter.We received a lot number in this case.A technical investigation will be conducted, including a batch review and review of complaint records and records of non-conformance's data; should any new and reportable information become available as a result, this 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 pain') and device breakage ('device in the right fallopian tube was removed with partial salpingectomy in two pieces') in a 43-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included nickel sensitivity.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2014, the patient experienced rash ("rash"), arthralgia ("joint pain in her hands and back") and myalgia ("muscle aches"), 11 months 27 days after insertion of essure.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("chronic fatigue"), coital bleeding ("post-coital bleeding"), dyspareunia ("dyspareunia"), bladder irritation ("irritable bladder"), hyperaesthesia teeth ("teeth sensitivity"), migraine ("migraines"), headache ("headaches") and dermatitis ("dermatitis returned").On (b)(6) 2015, the patient experienced device breakage (seriousness criterion medically significant) and complication of device removal ("device in the right fallopian tube was removed with partial salpingectomy in two pieces").On an unknown date, the patient was found to have blood pressure increased ("her blood pressure continued to rise") and experienced depression ("depression") and anxiety ("anxiety").The patient was treated with sertraline and surgery (laparoscopic removal of the essure on (b)(6) 2015, hysterectomy on (b)(6) 2016).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, rash, fatigue, coital bleeding, dyspareunia, bladder irritation, hyperaesthesia teeth, migraine, headache, dermatitis, blood pressure increased and myalgia had resolved, the device breakage and complication of device removal outcome was unknown and the arthralgia, depression and anxiety had not resolved.The reporter considered anxiety, arthralgia, bladder irritation, blood pressure increased, coital bleeding, complication of device removal, depression, dermatitis, device breakage, dyspareunia, fatigue, headache, hyperaesthesia teeth, migraine, myalgia, pelvic pain and rash to be related to essure.The reporter commented: each month, her symptoms would be heightened during her period and although she had been told that they would pass, the pain never went away and eventually she was bedridden.During the laparoscopy on (b)(6) 2015, the device in the left fallopian tube was removed intact but the device in the right fallopian tube was removed with partial salpingectomy in two pieces.One month after the procedure, the patient was informed that the device had broken inside her and that the doctor was not sure whether he had retrieved the device in its entirety when he pieced the fragments together after the surgery and sent them to the lab.A year after the removal of the essure device, the patient was still suffering from pain and associated symptoms.An x-ray indicated that there were possibly fragments in the pelvic area although they were not clearly visible.Due to her ongoing gynaecological problems, the doctor then acceded to the patient's request for a hysterectomy.A laparoscopically assisted vaginal hysterectomy and bilateral salpingo-oophorectomy was performed on (b)(6) 2016.A subsequent histopathology report dated (b)(6) of 2016 indicated that there was no evidence of any residual parts of the essure device remaining within the opening of the fallopian tubes or her uterus.Her symptoms improved following her hysterectomy.During summer 2017, she began to feel normal again although she still suffers from joint pain in her hands and back.She has also developed depression and anxiety since the essure device was provided and is currently being prescribed sertraline.Patient now has to take hrt due to her medically induced menopause.Diagnostic results (normal ranges are provided in parenthesis if available): red blood cell sedimentation rate increased - on an unknown date: high level of inflammation present.X-ray - on (b)(6) 2016: there were possibly fragments in the pelvic area although they were not clearly visible.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain worse when ovulates, only pain free between period and ovulation') and device breakage ('device in the right fallopian tube was removed with partial salpingectomy in two pieces') in a 42-year-old female patient who had essure (batch no.50697310) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included dysuria on (b)(6) 2013, uti (suspected by gp) on (b)(6) 2013, overweight (bmi 27.7) on (b)(6) 2011, uti in 2010, gravida in 2010, low mood (worse since birth of baby) in 2008, panic attacks from 2008 to 2010, vaginal delivery (girl) in 2008, genital warts in 2006, device insertion failed (unable to pass mirena inserter beyond internal cx os, spasm / tried 2 occasions, 1st mirena, lot 42295b, exp 04-2007, 2nd mirena lot 42295b exp 04-2007) in 2005, nickel sensitivity, iron deficiency anaemia (during pregnancy), parity 4 (all healthy, last delivery in 2011 (30 weeks pregnant in (b)(6) 2011)), penicillin allergy (urticaria, vomiting, diarrhea), smoker and loop electrosurgical excision procedure (loop electrical excision procedure (lletz)).Previously administered products included for low mood: prozac from 2010 to (b)(6) 2013 and citalopram on (b)(6) 2012; for iron deficiency anemia: iron on (b)(6) 2011; for panic attacks: fluoxetine in 2009 and diazepam in 2009; for heavy bleeding with clots, no flooding: norethisterone tabs 5 mg in 2007; for contraception: implanon in 2005 and mirena in 2005; for menorrhagia: progesterone.Past adverse reactions to the above products included complication of device insertion with mirena; and paraesthesia with implanon.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced procedural pain ("pain during essure insertion, procedure took around 30 minutes"), 1 day after insertion of essure.On (b)(6) 2014, the patient experienced skin candida ("candida rash both axillae"), arthralgia ("joint pain in her hands and back, no swelling, nil active synovitis") and myalgia ("muscle aches").On (b)(6) 2014, the patient was found to have red blood cell sedimentation rate increased ("raised esr").In 2014, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), dyspareunia ("dyspareunia"), hypersensitivity ("or possibility that there is some on-going hypersensitivity reaction, allergic reaction with "), polymenorrhoea ("periods increasing in frequency"), back pain ("few tender spots across upper back"), headache ("headaches"), fatigue ("chronic fatigue"), coital bleeding ("post-coital bleeding"), bladder irritation ("irritable bladder"), hyperaesthesia teeth ("teeth sensitivity"), migraine ("migraines"), dermatitis ("dermatitis returned"), sleep disorder ("unrefreshing sleep") and inflammation ("possibility that there is some on-going inflammation") and was found to have weight increased ("weight gain").In 2015, the patient experienced urinary tract infection ("recurrent uti").On (b)(6) 2015, the patient experienced device breakage (seriousness criterion medically significant) and complication of device removal ("device in the right fallopian tube was removed with partial salpingectomy in two pieces").On (b)(6) 2016, the patient experienced postoperative pain ("pain after hysterectomy").On an unknown date, the patient experienced allergy to metals ("allergic to nickel in essure"), menorrhagia ("menorrhagia"), genital haemorrhage ("abnormal bleeding"), hypertension ("blood pressure continued to rise / hypertension stage 1 160/110"), ovulation pain ("ovulation pain"), depression ("depression"), anxiety ("anxiety"), panic attack ("panic attack"), asthma ("asthma"), dyspepsia ("heartburn"), irritable bowel syndrome ("ibs"), spondylitis ("arthritis left side of neck"), adenomyosis ("multiple foci of adenomyosis in subserosal region of uterine wall"), haemorrhagic ovarian cyst ("in left ovary haemorrhagic and cystic corpus luteum"), cervix inflammation ("cervix transformation zone is mildly inflamed"), alopecia ("hair loss") and palpitations ("palpitations").The patient was treated with amlodipine, cetirizine, chlorphenamine maleate (piriton), diclofenac, fluoxetine, fluoxetine hydrochloride (prozac), hydrocortisone;miconazole nitrate (daktacort), ibuprofen, ketorolac tromethamine (toradol), loratadine, miconazole, naproxen, paracetamol, ramipril, sertraline, tramadol, trimethoprim and surgery (laparoscopic bilateral salpingectomy on (b)(6) 2015, hysterectomy and oophorectomy (b)(6) 2016).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, device breakage, dyspareunia, menorrhagia, genital haemorrhage, headache, skin candida, fatigue, coital bleeding, bladder irritation, hyperaesthesia teeth, migraine, dermatitis, hypertension, myalgia, procedural pain and postoperative pain had resolved, the allergy to metals, hypersensitivity, polymenorrhoea, complication of device removal, ovulation pain, sleep disorder, red blood cell sedimentation rate increased, inflammation, weight increased, panic attack, asthma, dyspepsia, irritable bowel syndrome, urinary tract infection, adenomyosis, haemorrhagic ovarian cyst, cervix inflammation, alopecia and palpitations outcome was unknown and the back pain, arthralgia, depression, anxiety and spondylitis had not resolved.The reporter considered adenomyosis, allergy to metals, alopecia, anxiety, arthralgia, asthma, back pain, bladder irritation, cervix inflammation, coital bleeding, complication of device removal, depression, dermatitis, device breakage, dyspareunia, dyspepsia, fatigue, genital haemorrhage, haemorrhagic ovarian cyst, headache, hyperaesthesia teeth, hypersensitivity, hypertension, inflammation, irritable bowel syndrome, menorrhagia, migraine, myalgia, ovulation pain, palpitations, panic attack, pelvic pain, polymenorrhoea, procedural pain, red blood cell sedimentation rate increased, skin candida, sleep disorder, spondylitis, urinary tract infection, weight increased and postoperative pain to be related to essure.The reporter commented: each month, symptoms would increase during period, the pain never went away and eventually she was bedridden.During the laparoscopy on (b)(6) 2015, device in left fallopian tube was removed intact, device in right tube was removed (partial salpingectomy) in two pieces.One month later, patient was told the device had broken inside her, doctor was unsure whether the device was removed entirely when he pieced the fragments together and he sent them to the lab.A year later, patient was still suffering from pain and associated symptoms.X-ray indicated possible fragments in pelvic area but not clearly visible.Due to ongoing gynaecological problems, doctor agreed to patient's request for hysterectomy.A laparoscopically assisted vaginal hysterectomy and bilateral salpingo-oophorectomy was performed on (b)(6) 2016.Histopathology report dated (b)(6) 2016 indicated no evidence of any residual parts of the essure device remaining within the opening of the fallopian tubes or her uterus/cornua.Allergic symptoms have improved dramatically since removal of her uterus (which did contain adenomyosis and endometriosis}.During (b)(6) 2017, she began to feel normal again, allergic symptoms improved (antihistamines were unsuccessful previously), although she still suffers from joint pain in her hands and back.Patient now has to take hrt due to her medically induced menopause.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.7 kg/sqm.Blood pressure measurement (mmhg) - on (b)(6) 2011: 140/90 (was initially 150/90); on (b)(6) 2014: 144/100 best of 3 readings; on (b)(6) 2015: 146/106; on (b)(6) 2015: 160/110.Blood test - on an unknown date: one marker raised at 38 due to inflammation in body.Hysteroscopy - on (b)(6) 2013: essure insertion lasted 30 minutes, it was completed without event.Left side 4 coils.Right side 8 coils.Pathology test - on (b)(6) 2015: left coil removed intact.Right coil removed with partial salpingectomy in 2 pieces.Is there a small metal fragment in the tubal specimen? - received 11 mm left of fallopian tube: on sectioning, there is no evidence of metal.Histology: fallopian tube appears unremarkable aside from cautery artefact.No endometriosis or malignancy; on (b)(6) 2016: contraceptive device not seen in either cornu.Histology: proliferative phase endometrial lining, multiple foci of adenomyosis and endometriosis in subserosal region of the uterine wall.In cervix transformation zone mildly inflamed.Sections of fallopian tube show markedly congested fimbrial end, in left ovary there is a haemorrhagic and cystic corpus luteum.Right ovary contains a follicular cyst but no endometriotic foci are seen.Uterus endometrioses.Red blood cell sedimentation rate increased - on (b)(6) 2014: high level of inflammation present; on (b)(6) 2014: 22.X-ray - on (b)(6) 2014: coils can be visualised within the tubes; on (b)(6) 2016: possibly fragments in pelvic area although not clearly visible.Lot number: 50697310, manufacturing date:2012-11, expiration date: 2015-11.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-aug-2020: quality-safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, this 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 ('chronic pelvic pain worse when ovulates, only pain free between period and ovulation') and device breakage ('device in the right fallopian tube was removed with partial salpingectomy in two pieces') in a 42-year-old female patient who had essure (batch no.50697310) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included dysuria on (b)(6) 2013, uti (suspected by gp) on (b)(6)2013, overweight (bmi 27.7) on (b)(6) 2011, uti in 2010, gravida in 2010, low mood (worse since birth of baby) in 2008, panic attacks from 2008 to 2010, vaginal delivery (girl) in 2008, genital warts in 2006, device insertion failed (unable to pass mirena inserter beyond internal cx os, spasm / tried 2 occasions, 1st mirena lot 42295b exp 04-2007, 2nd mirena lot 42295b exp 04-2007) in 2005, contact dermatitis (in 1990s), nickel sensitivity (according to patch test in 1990s.Very difficult to find evidence of this, patch test (b)(6) 2019 negative), iron deficiency anaemia (during pregnancy), parity 4 (all healthy, last delivery in 2011 (30 weeks pregnant in (b)(6) 2011)), penicillin allergy (urticaria, vomiting, diarrhea), smoker and loop electrosurgical excision procedure (loop electrical excision procedure (lletz)).Previously administered products included for low mood: prozac from 2010 to 25-jan-2013 and citalopram on (b)(6) 2012; for iron deficiency anemia: iron on (b)(6) 2011; for panic attacks: fluoxetine in 2009 and diazepam in 2009; for heavy bleeding with clots, no flooding: norethisterone tabs 5 mg in 2007; for contraception: implanon in 2005 and mirena in 2005; for menorrhagia: progesterone.Past adverse reactions to the above products included complication of device insertion with mirena; and paraesthesia with implanon.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced procedural pain ("pain during essure insertion, procedure took around 30 minutes"), 1 day after insertion of essure.On (b)(6) 2014, the patient experienced skin candida ("candida rash both axillae"), arthralgia ("joint pain in her hands and back, no swelling, nil active synovitis") and myalgia ("muscle aches").On (b)(6) 2014, the patient was found to have red blood cell sedimentation rate increased ("raised esr").In 2014, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), dyspareunia ("dyspareunia"), hypersensitivity ("possibility that there is some on-going hypersensitivity reaction, allergic reaction"), polymenorrhoea ("periods increasing in frequency"), back pain ("few tender spots across upper back"), headache ("headaches"), fatigue ("chronic fatigue"), coital bleeding ("post-coital bleeding"), bladder irritation ("irritable bladder"), hyperaesthesia teeth ("teeth sensitivity"), migraine ("migraines"), dermatitis ("dermatitis returned"), sleep disorder ("unrefreshing sleep") and inflammation ("possibility that there is some on-going inflammation") and was found to have weight increased ("weight gain").In 2015, the patient experienced urinary tract infection ("recurrent uti").On (b)(6)2015, the patient experienced device breakage (seriousness criterion medically significant) and complication of device removal ("device in the right fallopian tube was removed with partial salpingectomy in two pieces").On (b)(6) 2016, the patient experienced postoperative pain ("pain after hysterectomy").On an unknown date, the patient experienced allergy to metals ("allergic to nickel in essure"), menorrhagia ("menorrhagia"), genital haemorrhage ("abnormal bleeding"), hypertension ("blood pressure continued to rise / hypertension stage 1 160/110"), ovulation pain ("ovulation pain"), depression ("depression"), anxiety ("anxiety"), panic attack ("panic attack"), asthma ("asthma"), dyspepsia ("heartburn"), irritable bowel syndrome ("ibs"), spondylitis ("arthritis left side of neck"), adenomyosis ("multiple foci of adenomyosis in subserosal region of uterine wall"), haemorrhagic ovarian cyst ("in left ovary haemorrhagic and cystic corpus luteum"), cervix inflammation ("cervix transformation zone is mildly inflamed"), alopecia ("hair loss") and palpitations ("palpitations").The patient was treated with amlodipine, cetirizine, chlorphenamine maleate (piriton), diclofenac, fluoxetine, fluoxetine hydrochloride (prozac), hydrocortisone;miconazole nitrate (daktacort), ibuprofen, ketorolac tromethamine (toradol), loratadine, miconazole, naproxen, paracetamol, ramipril, sertraline, tramadol, trimethoprim and surgery (laparoscopic bilatateral salpingectomy on (b)(6) 2015, hysterectomy and oophorectomy (b)(6) 2016).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, device breakage, dyspareunia, menorrhagia, genital haemorrhage, headache, skin candida, fatigue, coital bleeding, bladder irritation, hyperaesthesia teeth, migraine, dermatitis, myalgia, haemorrhagic ovarian cyst, procedural pain and postoperative pain had resolved, the allergy to metals, hypersensitivity, polymenorrhoea, complication of device removal, ovulation pain, sleep disorder, red blood cell sedimentation rate increased, inflammation, weight increased, panic attack, asthma, dyspepsia, irritable bowel syndrome, urinary tract infection, adenomyosis, cervix inflammation, alopecia and palpitations outcome was unknown and the back pain, arthralgia, hypertension, depression, anxiety and spondylitis had not resolved.The reporter considered adenomyosis, allergy to metals, alopecia, anxiety, arthralgia, asthma, back pain, bladder irritation, cervix inflammation, coital bleeding, complication of device removal, depression, dermatitis, device breakage, dyspareunia, dyspepsia, fatigue, genital haemorrhage, haemorrhagic ovarian cyst, headache, hyperaesthesia teeth, hypersensitivity, hypertension, inflammation, irritable bowel syndrome, menorrhagia, migraine, myalgia, ovulation pain, palpitations, panic attack, pelvic pain, polymenorrhoea, procedural pain, red blood cell sedimentation rate increased, skin candida, sleep disorder, spondylitis, urinary tract infection, weight increased and postoperative pain to be related to essure.The reporter commented: each month, symptoms would increase during period, the pain never went away and eventually she was bedridden.During the laparoscopy on (b)(6) 2015, device in left fallopian tube was removed intact, device in right tube was removed (partial salpingectomy) in two pieces.One month later, patient was told the device had broken inside her, doctor was unsure whether the device was removed entirely when he pieced the fragments together and he sent them to the lab.A year later, patient was still suffering from pain and associated symptoms.X-ray indicated possible fragments in pelvic area but not clearly visible.Due to ongoing gynaecological problems, doctor agreed to patient's request for hysterectomy.A laparoscopically assisted vaginal hysterectomy and bilateral salpingo-oophorectomy was performed on (b)(6) 2016.Histopathology report dated (b)(6) 2016 indicated no evidence of any residual parts of the essure device remaining within the opening of the fallopian tubes or her uterus/cornua.Allergic symptoms have improved dramatically since removal of her uterus (which did contain adenomyosis and endometriosis}.During summer 2017, she began to feel normal again, allergic symptoms improved (antihistamines were unsuccessful previously), although she still suffers from joint pain in her hands and back.Patient now has to take hrt due to her medically induced menopause.Inquiry on (b)(6) 2019 about patient¿s nickel allergy.She had contact dermatitis in the 1990s and was patch tested at that time and was told she was nickel allergic.They are finding it very difficult to find evidence of this.She is hypertensive and suffers from depression and is on hrt, sertraline, and amlodipine.She has a penicillin allergy.Scheduled a patch test to the standard battery which has nickel in it.Patch test to the standard battery was negative.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.7 kg/sqm.Blood pressure measurement (mmhg) - on (b)(6) 2011: 140/90 (was initially 150/90); on (b)(6) 2014: 144/100 best of 3 readings; on (b)(6) 2015: 146/106; on (b)(6) 2015: 160/110.Blood test - on an unknown date: one marker raised at 38 due to inflammation in body.Hysteroscopy - on (b)(6) 2013: essure insertion lasted 30 minutes, it was completed without event.Left side 4 coils.Right side 8 coils.Pathology test - on (b)(6) 2015: left coil removed intact.Right coil removed with partial salpingectomy in 2 pieces.Is there a small metal fragment in the tubal specimen? - received 11 mm left of fallopian tube: on sectioning, there is no evidence of metal.Histology: fallopian tube appears unremarkable aside from cautery artefact.No endometriosis or malignancy; on (b)(6) 2016: contraceptive device not seen in either cornu.Histology: proliferative phase endometrial lining, multiple foci of adenomyosis and endometriosis in subserosal region of the uterine wall.In cervix transformation zone mildly inflamed.Sections of fallopian tube show markedly congested fimbrial end, in left ovary there is a haemorrhagic and cystic corpus luteum.Right ovary contains a follicular cyst but no endometriotic foci are seen.Uterus endometrioses.Red blood cell sedimentation rate increased - on (b)(6) 2014: high level of inflammation present; on (b)(6) 2014: 22.Skin test - on (b)(6) 2019: patch test to standard battery : negative.X-ray - on (b)(6) 2014: coils can be visualised within the tubes; on (b)(6) 2016: possibly fragments in pelvic area although not clearly visible.Lot number: 50697310, manufacturing date:2012-11, expiration date:2015-11.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: lawyer provided medical records: inquiry on (b)(6) 2019 about patient¿s nickel allergy.She had contact dermatitis in the 1990s (added to history) and was patch tested at that time and was told she was nickel allergic.They are finding it very difficult to find evidence of this.She is hypertensive (outcome: ongoing) and suffers from depression and is on hrt, sertraline, and amlodipine, she has a penicillin allergy (reported previously).Scheduled a patch test to the standard battery which has nickel in it.Patch test to the standard battery was negative (test results added) we received a lot number in this case.A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, this 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 ('chronic pelvic pain worse when ovulates, only pain free between period and ovulation'), embedded device ('aware they embed into the fallopian tubes so if removal was though to be an option by gynae would mean surgery to cut out tubes') and device breakage ('device in the right fallopian tube was removed with partial salpingectomy in two pieces') in a 42-year-old female patient who had essure (batch no.50697310) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "device in the right fallopian tube was removed with partial salpingectomy in two pieces" on (b)(6)2015.The patient's medical history included dysuria on (b)(6) 2013, uti (suspected by gp) on (b)(6)2013, overweight (bmi 27.7) on (b)(6) 2011, uti in 2010, gravida in 2010, low mood (worse since birth of baby) in 2008, panic attacks from 2008 to 2010, vaginal delivery (girl) in 2008, genital warts in 2006, device insertion failed (unable to pass mirena inserter beyond internal cx os, spasm / tried 2 occasions, 1st mirena lot 42295b exp 04-2007, 2nd mirena lot 42295b exp 04-2007) in 2005, contact dermatitis (in 1990s), nickel sensitivity (according to patch test in 1990s.Very difficult to find evidence of this, patch test (b)(6) 2019 negative), iron deficiency anaemia (during pregnancy), parity 4 (all healthy, last delivery in 2011 (30 weeks pregnant in (b)(6) 2011)), penicillin allergy (urticaria, vomiting, diarrhea), smoker, loop electrosurgical excision procedure (loop electrical excision procedure (lletz)), arthralgia and hand rash.Previously administered products included for low mood: prozac from 2010 to (b)(6) 2013 and citalopram on (b)(6) 2012; for iron deficiency anemia: iron on (b)(6) 2011; for panic attacks: fluoxetine in 2009 and diazepam in 2009; for heavy bleeding with clots, no flooding: norethisterone tabs 5 mg in 2007; for contraception: implanon in 2005 and mirena in 2005; for menorrhagia: progesterone.Past adverse reactions to the above products included complication of device insertion with mirena; and paraesthesia with implanon.Concomitant products included lactulose.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced procedural pain ("pain during essure insertion, procedure took around 30 minutes"), 1 day after insertion of essure.On (b)(6) 2014, the patient experienced skin candida ("candida rash both axillae"), arthralgia ("joint pain in her hands and back, no swelling, nil active synovitis") and myalgia ("muscle aches").On (b)(6) 2014, the patient was found to have red blood cell sedimentation rate increased ("raised esr").In 2014, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), dyspareunia ("dyspareunia"), hypersensitivity ("possibility that there is some on-going hypersensitivity reaction, allergic reaction"), polymenorrhoea ("periods increasing in frequency"), back pain ("few tender spots across upper back"), headache ("headaches"), fatigue ("chronic fatigue"), coital bleeding ("post-coital bleeding"), bladder irritation ("irritable bladder"), hyperaesthesia teeth ("teeth sensitivity"), migraine ("migraines"), dermatitis ("dermatitis returned"), sleep disorder ("unrefreshing sleep") and inflammation ("possibility that there is some on-going inflammation") and was found to have weight increased ("weight gain").In 2015, the patient experienced urinary tract infection ("recurrent uti").On (b)(6)2015, the patient experienced device breakage (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced postoperative pain ("pain after hysterectomy").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), allergy to metals ("allergic to nickel in essure"), heavy menstrual bleeding ("menorrhagia"), genital haemorrhage ("abnormal bleeding"), hypertension ("blood pressure continued to rise / hypertension stage 1 160/110"), ovulation pain ("ovulation pain"), depression ("depression"), anxiety ("anxiety"), panic attack ("panic attack"), asthma ("asthma"), dyspepsia ("heartburn"), irritable bowel syndrome ("ibs"), spondylitis ("arthritis left side of neck"), adenomyosis ("multiple foci of adenomyosis in subserosal region of uterine wall"), haemorrhagic ovarian cyst ("in left ovary haemorrhagic and cystic corpus luteum"), cervix inflammation ("cervix transformation zone is mildly inflamed"), alopecia ("hair loss") and palpitations ("palpitations").The patient was treated with amlodipine, cetirizine, chlorphenamine maleate (piriton), diclofenac, fluoxetine, fluoxetine hydrochloride (prozac), hydrocortisone;miconazole nitrate (daktacort), ibuprofen, ketorolac tromethamine (toradol), loratadine, miconazole, naproxen, paracetamol, ramipril, sertraline, tramadol, trimethoprim and surgery (laparoscopic bilatateral salpingectomy on (b)(6) 2015, hysterectomy and oophorectomy (b)(6) 2016).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, device breakage, dyspareunia, heavy menstrual bleeding, genital haemorrhage, headache, skin candida, fatigue, coital bleeding, bladder irritation, hyperaesthesia teeth, migraine, dermatitis, myalgia, haemorrhagic ovarian cyst, procedural pain and postoperative pain had resolved, the embedded device, allergy to metals, hypersensitivity, polymenorrhoea, ovulation pain, sleep disorder, red blood cell sedimentation rate increased, inflammation, weight increased, panic attack, asthma, dyspepsia, irritable bowel syndrome, urinary tract infection, adenomyosis, cervix inflammation, alopecia and palpitations outcome was unknown and the back pain, arthralgia, hypertension, depression, anxiety and spondylitis had not resolved.The reporter considered adenomyosis, allergy to metals, alopecia, anxiety, arthralgia, asthma, back pain, bladder irritation, cervix inflammation, coital bleeding, depression, dermatitis, device breakage, dyspareunia, dyspepsia, embedded device, fatigue, genital haemorrhage, haemorrhagic ovarian cyst, headache, heavy menstrual bleeding, hyperaesthesia teeth, hypersensitivity, hypertension, inflammation, irritable bowel syndrome, migraine, myalgia, ovulation pain, palpitations, panic attack, pelvic pain, polymenorrhoea, procedural pain, red blood cell sedimentation rate increased, skin candida, sleep disorder, spondylitis, urinary tract infection, weight increased and postoperative pain to be related to essure.The reporter commented: each month, symptoms would increase during period, the pain never went away and eventually she was bedridden.During the laparoscopy on (b)(6) 2015, device in left fallopian tube was removed intact, device in right tube was removed (partial salpingectomy) in two pieces.One month later, patient was told the device had broken inside her, doctor was unsure whether the device was removed entirely when he pieced the fragments together and he sent them to the lab.A year later, patient was still suffering from pain and associated symptoms.X-ray indicated possible fragments in pelvic area but not clearly visible.Due to ongoing gynaecological problems, doctor agreed to patient's request for hysterectomy.A laparoscopically assisted vaginal hysterectomy and bilateral salpingo-oophorectomy was performed on (b)(6) 2016.Histopathology report dated (b)(6) 2016 indicated no evidence of any residual parts of the essure device remaining within the opening of the fallopian tubes or her uterus/cornua.Allergic symptoms have improved dramatically since removal of her uterus (which did contain adenomyosis and endometriosis}.During summer 2017, she began to feel normal again, allergic symptoms improved (antihistamines were unsuccessful previously), although she still suffers from joint pain in her hands and back.Patient now has to take hrt due to her medically induced menopause.Inquiry on 31-jul-2019 about patient¿s nickel allergy.She had contact dermatitis in the 1990s and was patch tested at that time and was told she was nickel allergic.They are finding it very difficult to find evidence of this.She is hypertensive and suffers from depression and is on hrt, sertraline, and amlodipine.She has a penicillin allergy.Scheduled a patch test to the standard battery which has nickel in it.Patch test to the standard battery was negative.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.7 kg/sqm.Blood pressure measurement (mmhg) - on (b)(6) 2011: 140/90 (was initially 150/90); on (b)(6) 2014: 144/100 best of 3 readings; on (b)(6) 2015: 146/106; on (b)(6) 2015: 160/110.Blood test - on an unknown date: one marker raised at 38 due to inflammation in body.Hysteroscopy - on (b)(6) 2013: essure insertion lasted 30 minutes, it was completed without event.Left side 4 coils.Right side 8 coils.Pathology test - on (b)(6) 2015: left coil removed intact.Right coil removed with partial salpingectomy in 2 pieces.Is there a small metal fragment in the tubal specimen? - received 11 mm left of fallopian tube: on sectioning, there is no evidence of metal.Histology: fallopian tube appears unremarkable aside from cautery artefact.No endometriosis or malignancy; on (b)(6) 2016: contraceptive device not seen in either cornu.Histology: proliferative phase endometrial lining, multiple foci of adenomyosis and endometriosis in subserosal region of the uterine wall.In cervix transformation zone mildly inflamed.Sections of fallopian tube show markedly congested fimbrial end, in left ovary there is a haemorrhagic and cystic corpus luteum.Right ovary contains a follicular cyst but no endometriotic foci are seen.Uterus endometrioses.Red blood cell sedimentation rate increased - on (b)(6) 2014: high level of inflammation present; on (b)(6) 2014: 22.Skin test - on (b)(6) 2019: patch test to standard battery : negative.X-ray - on (b)(6) 2014: coils can be visualised within the tubes; on (b)(6) 2016: possibly fragments in pelvic area although not clearly visible.Lot number: 50697310; manufacturing date:2012-11; expiration date:2015-11.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2022: event embedded device was added.Concomitant conditions, drugs & historical conditions were added.Reporter information were updated.We received a lot number in this case.A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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