| Model Number ESS205 |
| Device Problems
Break (1069); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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| Patient Problems
Autoimmune Disorder (1732); Cervical Changes (1773); Diarrhea (1811); Fall (1848); Fatigue (1849); Granuloma (1876); Hair Loss (1877); Pyrosis/Heartburn (1883); Inflammation (1932); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Pain (1994); Perforation (2001); Raynauds Phenomenon (2034); Swollen Glands (2092); Arthralgia (2355); Malaise (2359); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Constipation (3274)
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| Event Date 01/01/2005 |
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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 device dislocation ("essure dissected from anterior rectal serosa and serosal surface og lower portion of cervix and posterior vaginal canal"), device breakage ("this was removed in several segments"), pelvic pain ("sharp/stabbing pelvic pain"), optic neuritis ("optic neuritis") and autoimmune disorder ("unidentified autoimmune issue") in a female patient who had essure (ess205) (batch no.12267945) inserted for birth control.The occurrence of additional non-serious events is detailed below.The patient's past medical history included deep vein thrombosis (due to birth control pill) on (b)(6) 2004.She is not allergic to nickle.On (b)(6) 2004, the patient had essure (ess205) inserted.In 2004, the patient experienced endometriosis ("endometriosis"), adenomyosis ("adenomyosis"), weight increased ("weight gain"), alopecia ("hair loss-worsened") and the first episode of arthralgia ("knees pain (locking clicking, unstable, pain bending)").In 2005, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal menses/"), dysmenorrhoea (" painful periods"), histamine intolerance ("histamine sensitivity"), rosacea ("rosacea"), lymphadenopathy ("swollen glands-worsened") and joint stiffness ("nonspecific joints (stiffness in fingers wrists and elbows) ").In (b)(6) 2005, the patient experienced granuloma annulare ("granuloma annular").In 2006, the patient experienced loss of libido ("loss of libido"), pain ("all over body aches/pain") and inflammation ("acute inflammation").In 2007, the patient experienced cervical dysplasia ("cervical dysplasia"), cervicitis ("cervicitis") with cervix oedema and cervix inflammation, muscle spasms ("abdominal spasm / twitching / fluttering / muscle spasms"), mental impairment ("diminished brain function") with feeling abnormal, confusional state, memory impairment and amnesia and musculoskeletal pain ("shoulders pain (tightness, aching, pain moving arms, weakness)").In 2008, the patient experienced dysgeusia ("metallic taste in mouth").In 2009, the patient experienced urinary tract infection ("uti (urinary tract infection"), mood swings ("mood disorder/swings") and disturbance in attention ("inability to concentrate").In 2010, the patient experienced varicose vein ("varicose veins"), chronic fatigue syndrome ("suspected chronic fatigue syndrome"), raynaud's phenomenon ("suspected raynaud's syndrome"), malaise ("malaise"), the first episode of unevaluable event ("exhaustion unidentified autonomic issue"), sleep apnoea syndrome ("sleep apnea") and adrenal disorder ("adrenal like issues").In 2011, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea"), abdominal distension ("bloating"), dyspepsia ("heartburn") and gastrointestinal disorder ("bowel issues").In 2012, the patient experienced incontinence ("incontinence"), the first episode of neuralgia ("nerve pain"), the second episode of unevaluable event ("hyper sensitive nerve reactions ") and fall ("unexplained falls").In 2013, the patient experienced ovarian cyst ("ovarian cysts"), vitamin d deficiency ("vitamin d deficiency"), increased tendency to bruise ("unexplained/easily bruising") and vitamin b12 deficiency ("vitamin b-12 deficiency").In 2014, the patient experienced fatigue ("tired") and hypersensitivity ("nonspecific allergic reactions").In (b)(6) 2015, the patient experienced hypohidrosis ("inability to sweat"), hyposmia ("diminished sense of smell") and hypogeusia ("diminished sense of taste").In 2015, the patient experienced paraesthesia ("random tingling sensations"), meralgia paraesthetica ("meralgia parenthetical"), the second episode of neuralgia ("nerve pain"), hypoglycaemia ("inability to maintain blood sugar (hypoglycemia)"), hypotension ("low blood pressure"), feeling cold ("always cold") and autoimmune disorder (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced optic neuritis (seriousness criterion medically significant), the first episode of visual impairment ("vision problems") and the second episode of visual impairment ("decreased vision").In 2016, the patient experienced peripheral swelling ("swelling of legs and feet") and pruritus ("skin irritation / itching").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criteria medically significant and intervention required), abdominal adhesions ("adhesion - scar tissue in abdomen"), hypoaesthesia ("random numbness hands, feet, legs"), limb discomfort ("heavy legs"), neuropathy peripheral ("undiagnosed neuropathy"), tooth fracture (" cracked tooth"), the second episode of arthralgia ("hips pain"), pelvic adhesions ("significant adhesions of right ovarian complex on the right ureter and right internal iliac vessels") and complication of device removal ("this was removed in several segments").The patient was treated with surgery (laparoscopic bilateral salpingo- oophorectomy), alternative therapy (chiropractor), alternative therapy (nerve biopsy) and alternative therapy (root canals).Essure (ess205) was removed on (b)(6) 2014.At the time of the report, the device dislocation, device breakage, endometriosis, menstrual disorder, dysmenorrhoea, ovarian cyst, adenomyosis, cervical dysplasia, incontinence, cervicitis, muscle spasms, abdominal adhesions, inflammation, constipation, diarrhoea, abdominal distension, dysgeusia, dyspepsia, optic neuritis, the last episode of visual impairment, paraesthesia, hypoaesthesia, the last episode of unevaluable event, disturbance in attention, fall, the last episode of neuralgia, vitamin d deficiency, increased tendency to bruise, vitamin b12 deficiency, hypoglycaemia, peripheral swelling, fatigue, limb discomfort, varicose vein, chronic fatigue syndrome, raynaud's phenomenon, malaise, neuropathy peripheral, feeling cold, hypohidrosis, histamine intolerance, rosacea, granuloma annulare, hypersensitivity, pruritus, tooth fracture, sleep apnoea syndrome, weight increased, alopecia, adrenal disorder, autoimmune disorder, hyposmia, hypogeusia, the last episode of arthralgia, musculoskeletal pain, joint stiffness, pelvic adhesions and complication of device removal outcome was unknown, the pelvic pain, gastrointestinal disorder and mood swings had resolved and the loss of libido, pain and mental impairment was resolving.The reporter considered abdominal adhesions, abdominal distension, adenomyosis, adrenal disorder, alopecia, autoimmune disorder, cervical dysplasia, cervicitis, chronic fatigue syndrome, complication of device removal, constipation, device breakage, device dislocation, diarrhoea, disturbance in attention, dysgeusia, dysmenorrhoea, dyspepsia, endometriosis, fall, fatigue, feeling cold, gastrointestinal disorder, granuloma annulare, histamine intolerance, hypersensitivity, hypoaesthesia, hypogeusia, hypoglycaemia, hypohidrosis, hyposmia, hypotension, incontinence, increased tendency to bruise, inflammation, joint stiffness, limb discomfort, loss of libido, lymphadenopathy, malaise, menstrual disorder, mental impairment, meralgia paraesthetica, mood swings, muscle spasms, musculoskeletal pain, neuropathy peripheral, optic neuritis, ovarian cyst, pain, paraesthesia, pelvic adhesions, pelvic pain, peripheral swelling, pruritus, raynaud's phenomenon, rosacea, sleep apnoea syndrome, tooth fracture, urinary tract infection, varicose vein, vitamin b12 deficiency, vitamin d deficiency, weight increased, the first episode of arthralgia, the first episode of neuralgia, the first episode of unevaluable event, the first episode of visual impairment, the second episode of arthralgia, the second episode of neuralgia, the second episode of unevaluable event and the second episode of visual impairment to be related to essure (ess205).The reporter commented: she mentioned that back, joint, leg, neck, spine, hip have worsened in 2005 but she has had since 1999 she have been tested for many suspected disorders but have not received positive confirmations; including ms, addison¿s disease, peripheral neuropathy, lyme disease.She stated she had pet acute inflammation all over body that she believe was made worse after essure was implanted.After doctor attempted to locate essure to remove and could not find in tube.Tube perforation, and migrated to rectovaginal septum.She was having ongoing problems so she wanted to look into have essure removed.She do not remember the exact date (b)(6) 2012- (b)(6) 2013 and then (b)(6) 2014 but spoke with both doctors.He said he would not do the surgery to remove it.On (b)(6) 2014.She was scheduled to have a cyst removed from her ovary/tube and asked to have the essure removed at the same time if they were going to be operating.She was then scheduled to have it removed.She had a laparoscopic bilateral salpingo- oophorectomy, bilateral uterotual corneal.During surgery, the ectopic essure tubal implant was then dissected from the anterior rectal serosa and serosal surface the lower portion of the cervix and posterior vaginal canal.This was removed in several segments.Then the right adnexa attempts at dissection and mobilization were carried out there was significant adhesions of the right tubo-ovarian complex on the right ureter and right internal iliac vessels.Diagnostic results: on unspecified date, an allergy testing was performed and nothing reacted.On (b)(6) 2005, hysterosalpingography with fluoroscope was done and confirmed blockage/occlusion on (b)(6) 2014, the surgical pathology report showed that the fallopian tub has na unremarkable purple-pink serosa and lumen.Inside the lumen there is a coiled wire extending along the entire length of the fallopian tube.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: peripheral swelling; varicose vein; sleep apnoea syndrome; pelvic pain; endometriosis; device migration; optic neuritis; pelvic adhesions; and device breakage.Further company follow-up with the lawyer is not possible.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("essure dissected from anterior rectal serosa and serosal surface og lower portion of cervix and posterior vaginal canal"), device breakage ("this was removed in several segments"), pelvic pain ("sharp/stabbing pelvic pain"), autoimmune disorder ("unidentified autoimmune issue"), optic neuritis ("optic neuritis") and mental impairment ("diminished brain function") in a female patient who had essure (ess205) (batch no.12267945) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included deep vein thrombosis (due to birth control pill) on (b)(6) 2004.She is not allergic to nickle.On (b)(6) 2004, the patient had essure (ess205) inserted.In 2004, the patient experienced endometriosis ("endometriosis"), adenomyosis ("adenomyosis"), weight increased ("weight gain"), alopecia ("hair loss-worsened") and the first episode of arthralgia ("knees pain (locking clicking, unstable, pain bending)").In (b)(6) 2005, the patient experienced granuloma annulare ("granuloma annular").In 2005, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal menses"), dysmenorrhoea ("painful periods"), histamine intolerance ("histamine sensitivity"), rosacea ("rosacea"), lymphadenopathy ("swollen glands-worsened") and joint stiffness ("nonspecific joints (stiffness in fingers wrists and elbows)").In 2006, the patient experienced loss of libido ("loss of libido"), pain ("all over body aches/pain") and inflammation ("acute inflammation").In 2007, the patient experienced mental impairment (seriousness criterion medically significant) with memory impairment, confusional state, amnesia and feeling abnormal, cervical dysplasia ("cervical dysplasia"), cervicitis ("cervicitis") with cervix oedema and cervix inflammation, muscle spasms ("abdominal spasm / twitching / fluttering / muscle spasms") and musculoskeletal pain ("shoulders pain (tightness, aching, pain moving arms, weakness)").In 2008, the patient experienced dysgeusia ("metallic taste in mouth").In 2009, the patient experienced urinary tract infection ("uti (urinary tract infection"), mood swings ("mood disorder/swings") and disturbance in attention ("inability to concentrate").In 2010, the patient experienced varicose vein ("varicose veins"), chronic fatigue syndrome ("suspected chronic fatigue syndrome"), raynaud's phenomenon ("suspected raynaud's syndrome"), malaise ("malaise"), autonomic nervous system imbalance ("exhaustion unidentified autonomic issue"), sleep apnoea syndrome ("sleep apnea") and adrenal disorder ("adrenal like issues").In 2011, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea"), abdominal distension ("bloating"), dyspepsia ("heartburn") and gastrointestinal disorder ("bowel issues").In 2012, the patient experienced incontinence ("incontinence"), the first episode of neuralgia ("nerve pain"), hyperreflexia ("hyper sensitive nerve reactions") and fall ("unexplained falls").In 2013, the patient experienced ovarian cyst ("ovarian cysts"), vitamin d deficiency ("vitamin d deficiency"), increased tendency to bruise ("unexplained/easily bruising") and vitamin b12 deficiency ("vitamin b-12 deficiency").In 2014, the patient experienced fatigue ("tired") and hypersensitivity ("nonspecific allergic reactions").In (b)(6) 2015, the patient experienced hypohidrosis ("inability to sweat"), hyposmia ("diminished sense of smell") and hypogeusia ("diminished sense of taste").In 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant), paraesthesia ("random tingling sensations"), meralgia paraesthetica ("meralgia parenthetical"), the second episode of neuralgia ("nerve pain"), hypoglycaemia ("inability to maintain blood sugar (hypoglycemia)"), hypotension ("low blood pressure") and feeling cold ("always cold").In (b)(6) 2015, the patient experienced optic neuritis (seriousness criterion medically significant), the first episode of visual impairment ("vision problems") and the second episode of visual impairment ("decreased vision").In 2016, the patient experienced peripheral swelling ("swelling of legs and feet") and pruritus ("skin irritation / itching").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal adhesions ("adhesion - scar tissue in abdomen"), hypoaesthesia ("random numbness hands, feet, legs"), limb discomfort ("heavy legs"), neuropathy peripheral ("undiagnosed neuropathy"), tooth fracture ("craked tooth"), the second episode of arthralgia ("hips pain"), pelvic adhesions ("significant adhesions of right ovarian complex on the right ureter and right internal iliac vessels") and complication of device removal ("this was removed in several segments").The patient was treated with surgery, surgery, surgery (laparoscopic bilateral salpingo- oophorectomy), alternative therapy (chiropractor), alternative therapy (nerve biopsy) and alternative therapy (root canals).Essure (ess205) was removed on (b)(6) 2014.At the time of the report, the device dislocation, device breakage, autoimmune disorder, optic neuritis, endometriosis, menstrual disorder, dysmenorrhoea, ovarian cyst, adenomyosis, cervical dysplasia, incontinence, urinary tract infection, cervicitis, muscle spasms, abdominal adhesions, inflammation, constipation, diarrhoea, abdominal distension, dysgeusia, dyspepsia, the last episode of visual impairment, paraesthesia, hypoaesthesia, hyperreflexia, disturbance in attention, fall, meralgia paraesthetica, the last episode of neuralgia, vitamin d deficiency, increased tendency to bruise, vitamin b12 deficiency, hypoglycaemia, peripheral swelling, fatigue, limb discomfort, varicose vein, chronic fatigue syndrome, raynaud's phenomenon, malaise, autonomic nervous system imbalance, hypotension, neuropathy peripheral, feeling cold, hypohidrosis, histamine intolerance, rosacea, granuloma annulare, hypersensitivity, pruritus, tooth fracture, sleep apnoea syndrome, lymphadenopathy, weight increased, alopecia, adrenal disorder, hyposmia, hypogeusia, the last episode of arthralgia, musculoskeletal pain, joint stiffness, pelvic adhesions and complication of device removal outcome was unknown, the pelvic pain, gastrointestinal disorder and mood swings had resolved and the mental impairment, loss of libido and pain was resolving.The reporter considered abdominal adhesions, abdominal distension, adenomyosis, adrenal disorder, alopecia, autoimmune disorder, autonomic nervous system imbalance, cervical dysplasia, cervicitis, chronic fatigue syndrome, complication of device removal, constipation, device breakage, device dislocation, diarrhoea, disturbance in attention, dysgeusia, dysmenorrhoea, dyspepsia, endometriosis, fall, fatigue, feeling cold, gastrointestinal disorder, granuloma annulare, histamine intolerance, hyperreflexia, hypersensitivity, hypoaesthesia, hypogeusia, hypoglycaemia, hypohidrosis, hyposmia, hypotension, incontinence, increased tendency to bruise, inflammation, joint stiffness, limb discomfort, loss of libido, lymphadenopathy, malaise, menstrual disorder, mental impairment, meralgia paraesthetica, mood swings, muscle spasms, musculoskeletal pain, neuropathy peripheral, optic neuritis, ovarian cyst, pain, paraesthesia, pelvic adhesions, pelvic pain, peripheral swelling, pruritus, raynaud's phenomenon, rosacea, sleep apnoea syndrome, tooth fracture, urinary tract infection, varicose vein, vitamin b12 deficiency, vitamin d deficiency, weight increased, the first episode of arthralgia, the first episode of neuralgia, the first episode of visual impairment, the second episode of arthralgia, the second episode of neuralgia and the second episode of visual impairment to be related to essure (ess205).The reporter commented: she mentioned that back, joint, leg, neck, spine, hip have worsened in 2005 but she has had since 1999.She have been tested for many suspected disorders but have not received positive confirmations; including ms, addison¿s disease, peripheral neuropathy, lyme disease.She stated she had pet acute inflammation all over body that she believe was made worse after essure was implanted.After doctor attempted to locate essure to remove and could not find in tube.Tube perforation, and migrated to rectovaginal septum.She was having ongoing problems so she wanted to look into have essure removed.She do not remember the exact date (b)(6) 2012-(b)(6) 2013 and then (b)(6) 2014 but spoke with both doctors.He said he would not do the surgery to remove it.Feb2014.She was scheduled to have a cyst removed from her ovary/tube and asked to have the essure removed at the same time if they were going to be operating.She was then scheduled to have it removed.She had a laparoscopic bilateral salpingo- oophorectomy, bilateral uterotual corneal.During surgery, the ectopic essure tubal implant was then dissected from the anterior rectal serosa and serosal surface the lower portion of the cervix and posterior vaginal canal.This was removed in several segments.Then the right adnexa attempts at dissection and mobilization were carried out there was significant adhesions of the right tubo-ovarian complex on the right ureter and right internal iliac vessels.Diagnostic results: on unspecified date, an allergy testing was performed and nothing reacted.On (b)(6) 2005, hysterosalpingography with fluoroscope was done and confirmed blockage/occlusion on (b)(6) 2014, the surgical pathology report showed that the fallopian tub has na unremarkable purple-pink serosa and lumen.Inside the lumen there is a coiled wire extending along the entire length of the fallopian tube.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: peripheral swelling; varicose vein; sleep apnoea syndrome; pelvic pain; endometriosis; device migration; optic neuritis; pelvic adhesions; and device breakage.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 5-jul-2018: quality-safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dissected from anterior rectal serosa and serosal surface og lower portion of cervix and posterior vaginal canal/ migration'), perforation ('perforation'), device breakage ('this was removed in several segments'), pelvic pain ('sharp/stabbing pelvic pain'), autoimmune disorder ('unidentified autoimmune issue'), optic neuritis ('optic neuritis') and mental impairment ('diminished brain function') in a 46-year-old female patient who had essure (ess205) (batch no.12267945) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included deep vein thrombosis (due to birth control pill) on (b)(6) 2004.She is not allergic to nickle.In 2004, the patient experienced endometriosis ("endometriosis"), adenomyosis ("adenomyosis"), alopecia ("hair loss-worsened") and knee pain ("knees pain (locking clicking, unstable, pain bending)") and was found to have weight increased ("weight gain").On (b)(6) 2004, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced granuloma annulare ("granuloma annular").In 2005, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal menses"), dysmenorrhoea ("painful periods"), histamine intolerance ("histamine sensitivity"), rosacea ("rosacea"), lymphadenopathy ("swollen glands-worsened") and joint stiffness ("nonspecific joints (stiffness in fingers wrists and elbows)").In 2006, the patient experienced loss of libido ("loss of libido"), pain ("all over body aches/pain") and inflammation ("acute inflammation").In 2007, the patient experienced mental impairment (seriousness criterion medically significant) with memory impairment, confusional state, amnesia and feeling abnormal, cervical dysplasia ("cervical dysplasia"), cervicitis ("cervicitis") with cervix oedema and cervix inflammation, muscle spasms ("abdominal spasm / twitching / fluttering / muscle spasms") and musculoskeletal pain ("shoulders pain (tightness, aching, pain moving arms, weakness)").In 2008, the patient experienced dysgeusia ("metallic taste in mouth").In 2009, the patient experienced urinary tract infection ("uti (urinary tract infection"), mood swings ("mood disorder/swings") and disturbance in attention ("inability to concentrate").In 2010, the patient experienced varicose vein ("varicose veins"), chronic fatigue syndrome ("suspected chronic fatigue syndrome"), raynaud's phenomenon ("suspected raynaud's syndrome"), malaise ("malaise"), autonomic nervous system imbalance ("exhaustion unidentified autonomic issue"), sleep apnoea syndrome ("sleep apnea") and adrenal disorder ("adrenal like issues").In 2011, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea"), abdominal distension ("bloating"), dyspepsia ("heartburn") and gastrointestinal disorder ("bowel issues").In 2012, the patient experienced incontinence ("incontinence"), the first episode of neuralgia ("nerve pain"), hyperreflexia ("hyper sensitive nerve reactions") and fall ("unexplained falls").In 2013, the patient experienced ovarian cyst ("ovarian cysts"), vitamin d deficiency ("vitamin d deficiency"), increased tendency to bruise ("unexplained/easily bruising") and vitamin b12 deficiency ("vitamin b-12 deficiency").In 2014, the patient experienced fatigue ("tired") and hypersensitivity ("nonspecific allergic reactions").In (b)(6) 2015, the patient experienced hypohidrosis ("inability to sweat"), hyposmia ("diminished sense of smell") and hypogeusia ("diminished sense of taste").In 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant), paraesthesia ("random tingling sensations"), meralgia paraesthetica ("meralgia parenthetical"), the second episode of neuralgia ("nerve pain"), hypoglycaemia ("inability to maintain blood sugar (hypoglycemia)"), hypotension ("low blood pressure") and feeling cold ("always cold").In (b)(6) 2015, the patient experienced optic neuritis (seriousness criterion medically significant), visual disturbances ("vision problems") and vision decreased ("decreased vision").In 2016, the patient experienced peripheral swelling ("swelling of legs and feet") and pruritus ("skin irritation / itching").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal adhesions ("adhesion - scar tissue in abdomen"), hypoaesthesia ("random numbness hands, feet, legs"), limb discomfort ("heavy legs"), neuropathy peripheral ("undiagnosed neuropathy"), tooth fracture ("craked tooth"), painful hips ("hips pain"), pelvic adhesions ("significant adhesions of right ovarian complex on the right ureter and right internal iliac vessels") and complication of device removal ("this was removed in several segments").The patient was treated with cpap, root canals, surgery (laparoscopic bilateral salpingo- oophorectomy), chiropractor and nerve biopsy.Essure (ess205) was removed on (b)(6) 2014.At the time of the report, the device dislocation, perforation, device breakage, autoimmune disorder, optic neuritis, endometriosis, menstrual disorder, dysmenorrhoea, ovarian cyst, adenomyosis, cervical dysplasia, incontinence, urinary tract infection, cervicitis, muscle spasms, abdominal adhesions, inflammation, constipation, diarrhoea, abdominal distension, dysgeusia, dyspepsia, visual disturbances, vision decreased, paraesthesia, hypoaesthesia, hyperreflexia, disturbance in attention, fall, meralgia paraesthetica, the last episode of neuralgia, vitamin d deficiency, increased tendency to bruise, vitamin b12 deficiency, hypoglycaemia, peripheral swelling, fatigue, limb discomfort, varicose vein, chronic fatigue syndrome, raynaud's phenomenon, malaise, autonomic nervous system imbalance, hypotension, neuropathy peripheral, feeling cold, hypohidrosis, histamine intolerance, rosacea, granuloma annulare, hypersensitivity, pruritus, tooth fracture, sleep apnoea syndrome, lymphadenopathy, weight increased, alopecia, adrenal disorder, hyposmia, hypogeusia, painful hips, knee pain, musculoskeletal pain, joint stiffness, pelvic adhesions and complication of device removal outcome was unknown, the pelvic pain, gastrointestinal disorder and mood swings had resolved and the mental impairment, loss of libido and pain was resolving.The reporter considered abdominal adhesions, abdominal distension, adenomyosis, adrenal disorder, alopecia, autoimmune disorder, autonomic nervous system imbalance, cervical dysplasia, cervicitis, chronic fatigue syndrome, complication of device removal, constipation, device breakage, device dislocation, diarrhoea, disturbance in attention, dysgeusia, dysmenorrhoea, dyspepsia, endometriosis, fall, fatigue, feeling cold, gastrointestinal disorder, granuloma annulare, histamine intolerance, hyperreflexia, hypersensitivity, hypoaesthesia, hypogeusia, hypoglycaemia, hypohidrosis, hyposmia, hypotension, incontinence, increased tendency to bruise, inflammation, joint stiffness, knee pain, limb discomfort, loss of libido, lymphadenopathy, malaise, menstrual disorder, mental impairment, meralgia paraesthetica, mood swings, muscle spasms, musculoskeletal pain, neuropathy peripheral, optic neuritis, ovarian cyst, pain, paraesthesia, pelvic adhesions, pelvic pain, perforation, peripheral swelling, pruritus, raynaud's phenomenon, rosacea, sleep apnoea syndrome, tooth fracture, urinary tract infection, varicose vein, visual disturbances, vitamin b12 deficiency, vitamin d deficiency, weight increased, the first episode of neuralgia, painful hips, vision decreased and the second episode of neuralgia to be related to essure (ess205).The reporter commented: she mentioned that back, joint, leg, neck, spine, hip have worsened in 2005 but she has had since 1999 she have been tested for many suspected disorders but have not received positive confirmations; including ms, addison¿s disease, peripheral neuropathy, lyme disease.She stated she had pet acute inflammation all over body that she believe was made worse after essure was implanted.After doctor attempted to locate essure to remove and could not find in tube.Tube perforation, and migrated to rectovaginal septum.She was having ongoing problems so she wanted to look into have essure removed.She do not remember the exact date (b)(6) 2012 (b)(6) 2013 and then (b)(6) 2014 but spoke with both doctors.He said he would not do the surgery to remove it.(b)(6) 2014.She was scheduled to have a cyst removed from her ovary/tube and asked to have the essure removed at the same time if they were going to be operating.She was then scheduled to have it removed.She had a laparoscopic bilateral salpingo- oophorectomy, bilateral uterotual corneal.During surgery, the ectopic essure tubal implant was then dissected from the anterior rectal serosa and serosal surface the lower portion of the cervix and posterior vaginal canal.This was removed in several segments.Then the right adnexa attempts at dissection and mobilization were carried out there was significant adhesions of the right tubo-ovarian complex on the right ureter and right internal iliac vessels.Diagnostic results: on unspecified date, an allergy testing was performed and nothing reacted.On (b)(6) 2005, hysterosalpingography with fluoroscope was done and confirmed blockage/occlusion on (b)(6) 2014, the surgical pathology report showed that the fallopian tub has na unremarkable purple-pink serosa and lumen.Inside the lumen there is a coiled wire extending along the entire length of the fallopian tube.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 28-jan-2020: pif received: newly added events- perforation, reporter was added.Incident a technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, 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 device dislocation ('essure dissected from anterior rectal serosa and serosal surface og lower portion of cervix and posterior vaginal canal/ migration'), perforation ('perforation'), device breakage ('this was removed in several segments'), pelvic pain ('sharp/stabbing pelvic pain'), autoimmune disorder ('unidentified autoimmune issue'), optic neuritis ('optic neuritis') and mental impairment ('diminished brain function') in a (b)(6) female patient who had essure (ess205) (batch no.12267945) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included deep vein thrombosis (due to birth control pill) on (b)(6) 2004.She is not allergic to nickle.On (b)(6) 2004, the patient had essure (ess205) inserted.In 2004, the patient experienced endometriosis ("endometriosis"), adenomyosis ("adenomyosis"), alopecia ("hair loss-worsened") and knee pain ("knees pain (locking clicking, unstable, pain bending)") and was found to have weight increased ("weight gain").In (b)(6) 2005, the patient experienced granuloma annulare ("granuloma annular").In 2005, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal menses"), dysmenorrhoea ("painful periods"), histamine intolerance ("histamine sensitivity"), rosacea ("rosacea"), lymphadenopathy ("swollen glands-worsened") and joint stiffness ("nonspecific joints (stiffness in fingers wrists and elbows)").In 2006, the patient experienced loss of libido ("loss of libido"), pain ("all over body aches/pain") and inflammation ("acute inflammation").In 2007, the patient experienced mental impairment (seriousness criterion medically significant) with memory impairment, confusional state, amnesia and feeling abnormal, cervical dysplasia ("cervical dysplasia"), cervicitis ("cervicitis") with cervix oedema and cervix inflammation, muscle spasms ("abdominal spasm / twitching / fluttering / muscle spasms") and musculoskeletal pain ("shoulders pain (tightness, aching, pain moving arms, weakness)").In 2008, the patient experienced dysgeusia ("metallic taste in mouth").In 2009, the patient experienced urinary tract infection ("uti (urinary tract infection"), mood swings ("mood disorder/swings") and disturbance in attention ("inability to concentrate").In 2010, the patient experienced varicose vein ("varicose veins"), chronic fatigue syndrome ("suspected chronic fatigue syndrome"), raynaud's phenomenon ("suspected raynaud's syndrome"), malaise ("malaise"), autonomic nervous system imbalance ("exhaustion unidentified autonomic issue"), sleep apnoea syndrome ("sleep apnea") and adrenal disorder ("adrenal like issues").In 2011, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea"), abdominal distension ("bloating"), dyspepsia ("heartburn") and gastrointestinal disorder ("bowel issues").In 2012, the patient experienced incontinence ("incontinence"), the first episode of neuralgia ("nerve pain"), hyperreflexia ("hyper sensitive nerve reactions") and fall ("unexplained falls").In 2013, the patient experienced ovarian cyst ("ovarian cysts"), vitamin d deficiency ("vitamin d deficiency"), increased tendency to bruise ("unexplained/easily bruising") and vitamin b12 deficiency ("vitamin b-12 deficiency").In 2014, the patient experienced fatigue ("tired") and hypersensitivity ("nonspecific allergic reactions").In (b)(6) 2015, the patient experienced hypohidrosis ("inability to sweat"), hyposmia ("diminished sense of smell") and hypogeusia ("diminished sense of taste").In 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant), paraesthesia ("random tingling sensations"), meralgia paraesthetica ("meralgia parenthetical"), the second episode of neuralgia ("nerve pain"), hypoglycaemia ("inability to maintain blood sugar (hypoglycemia)"), hypotension ("low blood pressure") and feeling cold ("always cold").In (b)(6) 2015, the patient experienced optic neuritis (seriousness criterion medically significant), visual disturbances ("vision problems") and vision decreased ("decreased vision").In 2016, the patient experienced peripheral swelling ("swelling of legs and feet") and pruritus ("skin irritation / itching").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal adhesions ("adhesion - scar tissue in abdomen"), hypoaesthesia ("random numbness hands, feet, legs"), limb discomfort ("heavy legs"), neuropathy peripheral ("undiagnosed neuropathy"), tooth fracture ("craked tooth"), painful hips ("hips pain"), pelvic adhesions ("significant adhesions of right ovarian complex on the right ureter and right internal iliac vessels") and complication of device removal ("this was removed in several segments").The patient was treated with cpap, root canals, surgery (laparoscopic bilateral salpingo- oophorectomy), chiropractor and nerve biopsy.Essure (ess205) was removed on (b)(6) 2014.At the time of the report, the device dislocation, perforation, device breakage, autoimmune disorder, optic neuritis, endometriosis, menstrual disorder, dysmenorrhoea, ovarian cyst, adenomyosis, cervical dysplasia, incontinence, urinary tract infection, cervicitis, muscle spasms, abdominal adhesions, inflammation, constipation, diarrhoea, abdominal distension, dysgeusia, dyspepsia, visual disturbances, vision decreased, paraesthesia, hypoaesthesia, hyperreflexia, disturbance in attention, fall, meralgia paraesthetica, the last episode of neuralgia, vitamin d deficiency, increased tendency to bruise, vitamin b12 deficiency, hypoglycaemia, peripheral swelling, fatigue, limb discomfort, varicose vein, chronic fatigue syndrome, raynaud's phenomenon, malaise, autonomic nervous system imbalance, hypotension, neuropathy peripheral, feeling cold, hypohidrosis, histamine intolerance, rosacea, granuloma annulare, hypersensitivity, pruritus, tooth fracture, sleep apnoea syndrome, lymphadenopathy, weight increased, alopecia, adrenal disorder, hyposmia, hypogeusia, painful hips, knee pain, musculoskeletal pain, joint stiffness, pelvic adhesions and complication of device removal outcome was unknown, the pelvic pain, gastrointestinal disorder and mood swings had resolved and the mental impairment, loss of libido and pain was resolving.The reporter considered abdominal adhesions, abdominal distension, adenomyosis, adrenal disorder, alopecia, autoimmune disorder, autonomic nervous system imbalance, cervical dysplasia, cervicitis, chronic fatigue syndrome, complication of device removal, constipation, device breakage, device dislocation, diarrhoea, disturbance in attention, dysgeusia, dysmenorrhoea, dyspepsia, endometriosis, fall, fatigue, feeling cold, gastrointestinal disorder, granuloma annulare, histamine intolerance, hyperreflexia, hypersensitivity, hypoaesthesia, hypogeusia, hypoglycaemia, hypohidrosis, hyposmia, hypotension, incontinence, increased tendency to bruise, inflammation, joint stiffness, knee pain, limb discomfort, loss of libido, lymphadenopathy, malaise, menstrual disorder, mental impairment, meralgia paraesthetica, mood swings, muscle spasms, musculoskeletal pain, neuropathy peripheral, optic neuritis, ovarian cyst, pain, paraesthesia, pelvic adhesions, pelvic pain, perforation, peripheral swelling, pruritus, raynaud's phenomenon, rosacea, sleep apnoea syndrome, tooth fracture, urinary tract infection, varicose vein, visual disturbances, vitamin b12 deficiency, vitamin d deficiency, weight increased, the first episode of neuralgia, painful hips, vision decreased and the second episode of neuralgia to be related to essure (ess205).The reporter commented: she mentioned that back, joint, leg, neck, spine, hip have worsened in 2005 but she has had since 1999 she have been tested for many suspected disorders but have not received positive confirmations; including ms, addison¿s disease, peripheral neuropathy, lyme disease.She stated she had pet acute inflammation all over body that she believe was made worse after essure was implanted.After doctor attempted to locate essure to remove and could not find in tube.Tube perforation, and migrated to rectovaginal septum.She was having ongoing problems so she wanted to look into have essure removed.She do not remember the exact date (b)(6) 2012-(b)(6) 2013 and then (b)(6) 2014 but spoke with both doctors.He said he would not do the surgery to remove it.(b)(6) 2014.She was scheduled to have a cyst removed from her ovary/tube and asked to have the essure removed at the same time if they were going to be operating.She was then scheduled to have it removed.She had a laparoscopic bilateral salpingo- oophorectomy, bilateral uterotual corneal.During surgery, the ectopic essure tubal implant was then dissected from the anterior rectal serosa and serosal surface the lower portion of the cervix and posterior vaginal canal.This was removed in several segments.Then the right adnexa attempts at dissection and mobilization were carried out there was significant adhesions of the right tubo-ovarian complex on the right ureter and right internal iliac vessels.Diagnostic results: on unspecified date, an allergy testing was performed and nothing reacted.On (b)(6) 2005, hysterosalpingography with fluoroscope was done and confirmed blockage/occlusion on (b)(6) 2014, the surgical pathology report showed that the fallopian tub has na unremarkable purple-pink serosa and lumen.Inside the lumen there is a coiled wire extending along the entire length of the fallopian tube.Lot number: 12267945 manufacturing date: 2004-11 expiration date: 2006-01 quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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