| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
|
| Patient Problems
Abdominal Pain (1685); Arthritis (1723); Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Pain (1994); Sjogren's Syndrome (2073); Skin Irritation (2076); Swelling (2091); Vertigo (2134); Hot Flashes/Flushes (2153); Tingling (2171); Urticaria (2278); Anxiety (2328); Arthralgia (2355); Depression (2361); Inadequate Pain Relief (2388); Numbness (2415); Sleep Dysfunction (2517); Abdominal Cramps (2543); Weight Changes (2607)
|
| Event Date 01/01/2010 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("sharp pelvic pain (sharp pain)/ pain and suffering") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included c-section (for childbirth) in 2004, gravida ii, parity 1 in 2004, miscarriage in 2000 and nephrotic syndrome.Essure did not caused birth defects.Essure did not worsened a previously existing injury/condition.Previously administered products included for contraception: condoms from 2004 to 2008.Concomitant products included medroxyprogesterone (depo provera) in (b)(6) 2008 for birth control.On (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced migraine ("severe migraines"), vertigo ("vertigo"), weight increased ("weight gain"), abdominal pain ("abdominal pain/ abdomen pain (severe sharp pain)"), tooth fracture ("teeth breakage"), hypertension ("high blood pressure"), skin irritation ("skin irritations"), diarrhoea ("constant diarrhea"), arthralgia ("joint pain (sharp)/ elbow pain (sharp)/ hips pains/ ankles pains (sharp)") and musculoskeletal pain ("shoulders pains (sharp)").In 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), hypoaesthesia ("numbness of hands and feet"), paraesthesia ("tingling of hands and feet"), dysgeusia ("metallic taste in mouth") and back pain ("back (constant throbbing and sharp pain, feel at times my hips are breaking)").In 2011, the patient experienced dyspnoea ("shortness of breath"), alopecia ("hair loss") and depression ("essure caused or aggravated any psychiatric and/or psychological condition /depression").In 2012, the patient experienced chest pain ("chest pains"), osteoarthritis ("degenerative joint disorder"), vitamin d deficiency ("vitamin d deficiency"), peripheral swelling ("swelling of hands and legs") and feeling abnormal ("brain fogs").In 2013, the patient experienced fibromyalgia ("fibromyalgia"), sjogren's syndrome ("sjogren's syndrome"), sleep apnoea syndrome ("sleep apnea"), hot flush ("hot flashes"), anxiety ("anxiety attacks"), uterine polyp ("ovarian polyps"), multiple allergies ("heightened allergies"), loss of libido ("loss of libido"), rectal haemorrhage ("rectal bleeding") and joint injury ("knee injury (sharp)").On an unknown date, the patient experienced allergy to metals ("allergic to nickel or any other component of essure/ i was allergic to a bunch of things including nickel and other metals/ hypersensitivity reaction to nickel or any other component of essure") with urticaria, pruritus and dry skin and abdominal pain lower ("cramping").The patient was treated with gabapentin, zaleplon (sonata), escitalopram oxalate (lexapro), hydroxyzine, fluoxetine hydrochloride (prozac), tramadol, axotal (fioricet), meclozine (meclizine), alprazolam (xanax), metoprolol, dicycloverine (dicyclomine), vicodin (norco), novicort, muscle relaxants, gliclazide (diamitex), thomapyrin n (excedrin migraine) and surgery (abdominal hysterectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, fibromyalgia, sjogren's syndrome, sleep apnoea syndrome, migraine, vertigo, weight increased, chest pain, abdominal pain, dyspnoea, tooth fracture, osteoarthritis, hot flush, anxiety, hypoaesthesia, paraesthesia, vitamin d deficiency, hypertension, alopecia, uterine polyp, dysgeusia, skin irritation, multiple allergies, peripheral swelling, diarrhoea, feeling abnormal, loss of libido, rectal haemorrhage, allergy to metals, depression, arthralgia, joint injury, musculoskeletal pain, back pain and abdominal pain lower had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, chest pain, depression, diarrhoea, dysgeusia, dyspnoea, feeling abnormal, fibromyalgia, hot flush, hypertension, hypoaesthesia, joint injury, loss of libido, migraine, multiple allergies, musculoskeletal pain, osteoarthritis, paraesthesia, pelvic pain, peripheral swelling, rectal haemorrhage, sjogren's syndrome, skin irritation, sleep apnoea syndrome, tooth fracture, uterine polyp, vertigo, vitamin d deficiency and weight increased to be related to essure.The reporter commented: patient was not advised of any complications or problems that occurred at the time of essure placement procedure.She did retain the essure or any portion of it after essure removed.Diagnostic results: in (b)(6) 2008, patient had essure confirmation test: hsg (hysterosalpingogram).Approximate weight at the time of essure placement: (b)(6) (unit unspecified).Current weight as of (b)(6) 2017: (b)(6) (unit unspecified).Physician did an allergy test in 2014.Pathology report on (b)(6) 2015, gross description: the uterus body and cervix have a combined weight of 63 grams.The cervix measures 4.6 x 3.7 x 2.7 cm.The uterine body measures 6.0 x 5.8 x 3.5 cm.The ectocervix is yellowhite, smooth and glistening with a centrally located patent 0.4 x 0.2 cm ectocervical os.The cervix has a firm, yellow-white cut surface.The endocervical canal is finely trabeculated.The uterine body serosa is pink tan.Noted in the fundic region, there is a 6 mm dome shaped red brown nodule.The uterine cavity is triangular shaped measuring 3.3 x 2.0 cm.The endometrium is yellow-tan and grossly flattened.The myometrium is pink tan with a maximum thickness of 1.8 cm.Located in the posterior wall there is a small 6 mm intramural fibroid.Noted in the bilateral cornu region are silver metal coils (essure coils).The aforementioned coils are in place without obvious gross complication.The fibriated fallopian tube segments average 3.5 cm in length (diameter ranges from 0.5 to 0.7 cm).Transection reveals pinpoint to slightly dilated luminal spaces.Final diagnosis: uterus/bilateral fallopian tubes, hysterectomy/ bilateral salpingectomy: chronic cervicitis/endocervicitis with mucinous cysts and focal microglandular endocervical hyperplasia most recent follow-up information incorporated above includes: on (b)(6) 2017: plaintiff fact sheet received.Reporter information updated, case became medically confirmed.Patient demographic information, relevant history and lab data added.Essure indication, stop date (b)(6) 2015 added and start date updated from (b)(6) 2008.Event severe and permanent injuries was replaced with sharp pelvic pain (sharp pain)/ pain and suffering, fibromyalgia, sjogren's syndrome, sleep apnea, severe migraines, vertigo, weight gain, chest pains, abdominal pain/ abdomen pain (severe sharp pain), shortness of breath, teeth breakage, degenerative joint disorder, hot flashes, anxiety attacks, numbness of hands and feet, tingling of hands and feet, vitamin d deficiency, high blood pressure, hair loss, ovarian polyps, metallic taste in mouth, skin irritations, heightened allergies, swelling of hands and legs, constant diarrhea, brain fogs, loss of libido, rectal bleeding, allergic to nickel or any other component of essure/ i was allergic to a bunch of things including nickel and other metals/ hypersensitivity reaction to nickel or any other component of essure, essure caused or aggravated any psychiatric and/or psychological condition /depression, joint pain (sharp)/ elbow pain (sharp)/ hips pains/ ankles pains (sharp), knee injury (sharp), shoulders pains (sharp), back (constant throbbing and sharp pain, feel at times my hips are breaking) and cramping.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("sharp pelvic pain (sharp pain)/ pain and suffering") and ovarian neoplasm ("ovarian polyps /tumors on ovaries") in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section (for childbirth) in 2004, gravida ii, parity 1 (multiparty) in 2004, miscarriage in 2000 and nephrotic syndrome.Essure did not caused birth defects.Essure did not worsened a previously existing injury/condition.Previously administered products included for contraception: condoms from 2004 to 2008.Concurrent conditions included knee operation since (b)(6) 2013, arthritis, dysmenorrhea, morbid obesity, breast lump (benign), stress urinary incontinence, normal delivery (live child), arthritis and bone disorder.Concomitant products included medroxyprogesterone acetate (depo provera) from march 2008 to june 2008 for birth control as well as levocetirizine dihydrochloride (xyzal) since 2014, lisinopril, sumatriptan since 2009 and topiramate (topamax) since 2009.On (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced migraine ("severe migraines"), vertigo ("vertigo"), abdominal pain ("abdominal pain/ abdomen pain (severe sharp pain)"), tooth fracture ("teeth breakage"), hypertension ("high blood pressure"), skin irritation ("skin irritations"), diarrhoea ("constant diarrhea"), arthralgia ("joint pain (sharp)/ elbow pain (sharp)/ hips pains/ ankles pains (sharp)") and musculoskeletal pain ("shoulders pains (sharp)") and was found to have weight increased ("weight gain").In 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), hypoaesthesia ("numbness of hands and feet"), paraesthesia ("tingling of hands and feet") and back pain ("back (constant throbbing and sharp pain, feel at times my hips are breaking)").In 2011, the patient experienced dyspnoea ("shortness of breath"), alopecia ("hair loss") and depression ("essure caused or aggravated any psychiatric and/or psychological condition /depression").In 2012, the patient experienced chest pain ("chest pains"), osteoarthritis ("degenerative joint disorder"), vitamin d deficiency ("vitamin d deficiency"), peripheral swelling ("swelling of hands and legs") and feeling abnormal ("brain fogs").In 2013, the patient was found to have ovarian neoplasm (seriousness criterion medically significant) and experienced fibromyalgia ("fibromyalgia"), sjogren's syndrome ("sjogren's syndrome"), sleep apnoea syndrome ("sleep apnea"), hot flush ("hot flashes"), anxiety ("anxiety attacks"), multiple allergies ("heightened allergies"), loss of libido ("loss of libido"), rectal haemorrhage ("rectal bleeding") and joint injury ("knee injury (sharp)").In 2015, the patient experienced dysgeusia ("metallic taste in mouth").On an unknown date, the patient experienced allergy to metals ("allergic to nickel or any other component of essure/ i was allergic to a bunch of things including nickel and other metals/ hypersensitivity reaction to nickel or any other component of essure") with urticaria, pruritus and dry skin, abdominal pain lower ("cramping"), abdominal rigidity ("abdominal spasm"), abdominal distension ("severe bloating") and pain in extremity ("leg pain").The patient was treated with acetylsalicylic acid;caffeine;paracetamol (excedrin migraine), alprazolam (xanax), amphotericin b;fludrocortisone acetate;gramicidin;neomycin sulfate (novicort), butalbital;caffeine;paracetamol (fioricet), dicycloverine (dicyclomine), escitalopram oxalate (lexapro), fluoxetine hydrochloride (prozac), gabapentin, gliclazide (diamitex), hydrocodone bitartrate;paracetamol (norco), hydroxyzine, meclozine (meclizine), metoprolol, muscle relaxants, tramadol, zaleplon (sonata) and surgery (abdominal hysterectomy/ bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, ovarian neoplasm, fibromyalgia, sjogren's syndrome, sleep apnoea syndrome, migraine, vertigo, weight increased, chest pain, abdominal pain, dyspnoea, tooth fracture, osteoarthritis, hot flush, anxiety, hypoaesthesia, paraesthesia, vitamin d deficiency, hypertension, alopecia, dysgeusia, skin irritation, multiple allergies, peripheral swelling, diarrhoea, feeling abnormal, loss of libido, rectal haemorrhage, allergy to metals, depression, arthralgia, joint injury, musculoskeletal pain, back pain and abdominal pain lower had not resolved and the abdominal rigidity and abdominal distension outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, alopecia, anxiety, arthralgia, back pain, chest pain, depression, diarrhoea, dysgeusia, dyspnoea, feeling abnormal, fibromyalgia, hot flush, hypertension, hypoaesthesia, joint injury, loss of libido, migraine, multiple allergies, musculoskeletal pain, osteoarthritis, ovarian neoplasm, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, rectal haemorrhage, sjogren's syndrome, skin irritation, sleep apnoea syndrome, tooth fracture, vertigo, vitamin d deficiency and weight increased to be related to essure.The reporter commented: patient was not advised of any complications or problems that occurred at the time of essure placement procedure.She did retain the essure or any portion of it after essure removed.Diagnostic results: in (b)(6) 2008, patient had essure confirmation test: hsg (hysterosalpingogram).Approximate weight at the time of essure placement: 230 (unit unspecified).Current weight as of (b)(6)2017: 302 (unit unspecified).Physician did an allergy test in 2014.Pathology report on (b)(6) 2015, gross description: the uterus body and cervix have a combined weight of 63 grams.The cervix measures 4.6 x 3.7 x 2.7 cm.The uterine body measures 6.0 x 5.8 x 3.5 cm.The ectocervix is yellowhite, smooth and glistening with a centrally located patent 0.4 x 0.2 cm ectcervical os.The cervix has a firm, yellow-white cut surface.The endocervical canal is finely trabeculated.The uterine body serosa is pink tan.Noted in the fundic region, there is a 6 mm dome shaped red brown nodule.The uterine cavity is triangular shaped measuring 3.3 x 2.0 cm.The endometrium is yellow-tan and grossly flattened.The myometrium is pink tan with a maximum thickness of 1.8 cm.Located in the posterior wall there is a small 6 mm intramural fibroid.Noted in the bilateral cornu region are silver metal coils (essure coils).The aforementioned coils are in place without obvious gross complication.The fibriated fallopian tube segments average 3.5 cm in length (diameter ranges from 0.5 to 0.7 cm).Transection reveals pinpoint to slightly dilated luminal spaces.Final diagnosis: uterus/bilateral fallopian tubes, hysterectomy/ bilateral salpingectomy: chronic cervicitis/endocervicitis with mucinous cysts and focal microglandular endocervical hyperplasia went in for pain, did a ct scan and vaginal ultrasound and found two tumors.I have an appointment scheduled dec2017 for removal.On (b)(6) 2015: clinical history: pelvic pain gross description: received in one container of formalin, labeled properly with the patient's name and labeled uterus , cervix, tubes" is a hysterectomy specimen cons is ting of the uterine body, attached bilateral fabricated fallopian tube segments, and free-floating (detached) cervix.Noted in the bilateral cornu region are silver metal coils (essure coils).The aforementioned coils are in place without obvious gross complication.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, hypertension.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received.Reporter's information was added.Added event abdominal spasm, severe bloating, leg pain.Historical condition,concomitant condition, concomitant drug were added.Incident no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('sharp pelvic pain (sharp pain)/ pain and suffering') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included delayed period on (b)(6) 2015, c-section (for childbirth) in 2004, parity 1 (multiparty) in 2004, miscarriage in 2000, gravida ii, nephrotic syndrome, sjoegren's syndrome, hyperlipidemia, sinusitis, phlegm, angioedema, irritable bowel syndrome and sneezing.Essure did not caused birth defects.Essure did not worsened a previously existing injury/condition.In (b)(6) 2008, patient had essure confirmation test: hsg (hysterosalpingogram).Approximate weight at the time of essure placement: 230 (unit unspecified).Current weight as of (b)(6) 2017: 230 (unit unspecified).Physician did an allergy test in 2014.Pathology report on (b)(6) 2015, gross description: the uterus body and cervix have a combined weight of 63 grams.The cervix measures 4.6 x 3.7 x 2.7 cm.The uterine body measures 6.0 x 5.8 x 3.5 cm.The ectocervix is yellowhite, smooth and glistening with a centrally located patent 0.4 x 0.2 cm ectcervical os.The cervix has a firm, yellow-white cut surface.The endocervical canal is finely trabeculated.The uterine body serosa is pink tan.Noted in the fundic region, there is a 6 mm dome shaped red brown nodule.The uterine cavity is triangular shaped measuring 3.3 x 2.0 cm.The endometrium is yellow-tan and grossly flattened.The myometrium is pink tan with a maximum thickness of 1.8 cm.Located in the posterior wall there is a small 6 mm intramural fibroid.Noted in the bilateral cornu region are silver metal coils (essure coils).The aforementioned coils are in place without obvious gross complication.The fibriated fallopian tube segments average 3.5 cm in length (diameter ranges from 0.5 to 0.7 cm).Transection reveals pinpoint to slightly dilated luminal spaces.Final diagnosis: uterus/bilateral fallopian tubes, hysterectomy/ bilateral salpingectomy: chronic cervicitis/endocervicitis with mucinous cysts and focal microglandular endocervical hyperplasia went in for pain, did a ct scan and vaginal ultrasound and found two tumors.I have an appointment scheduled (b)(6) 2017 for removal.On (b)(6) 2015: clinical history: pelvic pain gross description: received in one container of formalin, labeled properly with the patient's name and labeled uterus , cervix, tubes" is a hysterectomy specimen cons is ting of the uterine body, attached bilateral fabricated fallopian tube segments, and free-floating (detached) cervix.Noted in the bilateral cornu region are silver metal coils (essure coils).The aforementioned coils are in place without obvious gross complication.Previously administered products included for contraception: condoms from 2004 to 2008.Concurrent conditions included knee operation since (b)(6) 2013, arthritis, dysmenorrhea, morbid obesity, breast lump (benign), stress urinary incontinence, normal delivery (live child), arthritis, degenerative bone disease, heart murmur, diverticulosis, hemorrhoids and anesthesia.Concomitant products included medroxyprogesterone acetate (depo provera) from (b)(6) 2008 to (b)(6) 2008 for birth control as well as levocetirizine dihydrochloride (xyzal) since 2014, lisinopril, sumatriptan since 2009 and topiramate (topamax) since 2009.On (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced migraine ("severe migraines"), vertigo ("vertigo"), abdominal pain ("abdominal pain/ abdomen pain (severe sharp pain)"), tooth fracture ("teeth breakage"), hypertension ("high blood pressure"), skin irritation ("skin irritations"), diarrhoea ("constant diarrhea"), arthralgia ("joint pain (sharp)/ elbow pain (sharp)/ hips pains/ ankles pains (sharp)") and musculoskeletal pain ("shoulders pains (sharp)") and was found to have weight increased ("weight gain").In 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), hypoaesthesia ("numbness of hands and feet"), paraesthesia ("tingling of hands and feet") and back pain ("back (constant throbbing and sharp pain, feel at times my hips are breaking)").In 2011, the patient experienced dyspnoea ("shortness of breath"), alopecia ("hair loss") and depression ("essure caused or aggravated any psychiatric and/or psychological condition /depression").In 2012, the patient experienced chest pain ("chest pains"), osteoarthritis ("degenerative joint disorder"), vitamin d deficiency ("vitamin d deficiency"), peripheral swelling ("swelling of hands and legs") and feeling abnormal ("brain fogs").In 2013, the patient was found to have ovarian neoplasm ("ovarian polyps /tumors on ovaries") and experienced fibromyalgia ("fibromyalgia"), sjogren's syndrome ("sjogren's syndrome"), sleep apnoea syndrome ("sleep apnea"), hot flush ("hot flashes"), anxiety ("anxiety attacks"), multiple allergies ("heightened allergies"), loss of libido ("loss of libido"), rectal haemorrhage ("rectal bleeding") and joint injury ("knee injury (sharp)").In 2015, the patient experienced dysgeusia ("metallic taste in mouth").On an unknown date, the patient experienced allergy to metals ("allergic to nickel or any other component of essure/ i was allergic to a bunch of things including nickel and other metals/ hypersensitivity reaction to nickel or any other component of essure") with urticaria, pruritus and dry skin, abdominal pain lower ("cramping"), abdominal rigidity ("abdominal spasm"), abdominal distension ("severe bloating"), pain in extremity ("leg pain"), malaise ("sickness"), genital haemorrhage ("severe bleeding"), dental caries ("tooth decay"), rash ("rash"), visual impairment ("vision problems"), dry mouth ("cotton mouth") and urticaria ("hives").The patient was treated with acetylsalicylic acid; caffeine; paracetamol (excedrin migraine), alprazolam (xanax), amphotericin b;fludrocortisone acetate;gramicidin; neomycin sulfate (novicort), butalbital; caffeine; paracetamol (fioricet), dicycloverine (dicyclomine), escitalopram oxalate (lexapro), fluoxetine hydrochloride (prozac), gabapentin, gliclazide (diamitex), hydrocodone bitartrate; paracetamol (norco), hydroxyzine, meclozine (meclizine), metoprolol, muscle relaxants, tramadol, and surgery (abdominal hysterectomy/ bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, ovarian neoplasm, fibromyalgia, sjogren's syndrome, sleep apnoea syndrome, migraine, vertigo, weight increased, chest pain, abdominal pain, dyspnoea, tooth fracture, osteoarthritis, hot flush, anxiety, hypoaesthesia, paraesthesia, vitamin d deficiency, hypertension, alopecia, dysgeusia, skin irritation, multiple allergies, peripheral swelling, diarrhoea, feeling abnormal, loss of libido, rectal haemorrhage, allergy to metals, depression, arthralgia, joint injury, musculoskeletal pain, back pain and abdominal pain lower had not resolved and the abdominal rigidity, abdominal distension, malaise, genital haemorrhage, dental caries, rash, visual impairment, dry mouth and urticaria outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, alopecia, anxiety, arthralgia, back pain, chest pain, dental caries, depression, diarrhoea, dry mouth, dysgeusia, dyspnoea, feeling abnormal, fibromyalgia, genital haemorrhage, hot flush, hypertension, hypoaesthesia, joint injury, loss of libido, malaise, migraine, multiple allergies, musculoskeletal pain, osteoarthritis, ovarian neoplasm, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, rash, rectal haemorrhage, sjogren's syndrome, skin irritation, sleep apnoea syndrome, tooth fracture, urticaria, vertigo, visual impairment, vitamin d deficiency and weight increased to be related to essure.The reporter commented: patient was not advised of any complications or problems that occurred at the time of essure placement procedure.She did retain the essure or any portion of it after essure removed.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, hypertension, migraine, back pain, arthralgia, urticaria, abdominal pain concerning the injuries reported in this case, the following ones were described in patient¿s medical records: angioedema.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media content received: reporter added.Events: sick, severe bleeding, tooth decay, rash, hives, vision problems, cotton mouth.Fu 21 and 22 processed together.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('sharp pelvic pain (sharp pain)/ pain and suffering') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included delayed period on (b)(6) 2015, c-section (for childbirth) in 2004, parity 1 (multiparty) in 2004, miscarriage in 2000, gravida ii, nephrotic syndrome, sjoegren's syndrome, hyperlipidemia, sinusitis, phlegm, angioedema, irritable bowel syndrome and sneezing.Essure did not caused birth defects.Essure did not worsened a previously existing injury/condition.In (b)(6) 2008, patient had essure confirmation test: hsg (hysterosalpingogram).Approximate weight at the time of essure placement: 230 (unit unspecified).Current weight as of (b)(6) 2017: 302 (unit unspecified).Physician did an allergy test in 2014.Pathology report on (b)(6) 2015, gross description: the uterus body and cervix have a combined weight of 63 grams.The cervix measures 4.6 x 3.7 x 2.7 cm.The uterine body measures 6.0 x 5.8 x 3.5 cm.The ectocervix is yellowhite, smooth and glistening with a centrally located patent 0.4 x 0.2 cm ectcervical os.The cervix has a firm, yellow-white cut surface.The endocervical canal is finely trabeculated.The uterine body serosa is pink tan.Noted in the fundic region, there is a 6 mm dome shaped red brown nodule.The uterine cavity is triangular shaped measuring 3.3 x 2.0 cm.The endometrium is yellow-tan and grossly flattened.The myometrium is pink tan with a maximum thickness of 1.8 cm.Located in the posterior wall there is a small 6 mm intramural fibroid.Noted in the bilateral cornu region are silver metal coils (essure coils).The aforementioned coils are in place without obvious gross complication.The fibriated fallopian tube segments average 3.5 cm in length (diameter ranges from 0.5 to 0.7 cm).Transection reveals pinpoint to slightly dilated luminal spaces.Final diagnosis: uterus/bilateral fallopian tubes, hysterectomy/ bilateral salpingectomy: chronic cervicitis/endocervicitis with mucinous cysts and focal microglandular endocervical hyperplasia went in for pain, did a ct scan and vaginal ultrasound and found two tumors.I have an appointment scheduled (b)(6) 2017 for removal.On (b)(6) 2015: clinical history: pelvic pain gross description: received in one container of formalin, labeled properly with the patient's name and labeled uterus , cervix, tubes" is a hysterectomy specimen cons is ting of the uterine body, attached bilateral fabricated fallopian tube segments, and free-floating (detached) cervix.Noted in the bilateral cornu region are silver metal coils (essure coils).The aforementioned coils are in place without obvious gross complication.Previously administered products included for contraception: condoms from 2004 to 2008.Concurrent conditions included knee operation since (b)(6) 2013, arthritis, dysmenorrhea, morbid obesity, breast lump (benign), stress urinary incontinence, normal delivery (live child), arthritis, degenerative bone disease, heart murmur, diverticulosis, hemorrhoids and anesthesia.Concomitant products included medroxyprogesterone acetate (depo provera) from (b)(6) 2008 to (b)(6) 2008 for birth control as well as levocetirizine dihydrochloride (xyzal) since 2014, lisinopril, sumatriptan since 2009 and topiramate (topamax) since 2009.On (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced migraine ("severe migraines"), vertigo ("vertigo"), abdominal pain ("abdominal pain/ abdomen pain (severe sharp pain)"), tooth fracture ("teeth breakage"), hypertension ("high blood pressure"), skin irritation ("skin irritations"), diarrhoea ("constant diarrhea"), arthralgia ("joint pain (sharp)/ elbow pain (sharp)/ hips pains/ ankles pains (sharp)") and musculoskeletal pain ("shoulders pains (sharp)") and was found to have weight increased ("weight gain").In 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), hypoaesthesia ("numbness of hands and feet"), paraesthesia ("tingling of hands and feet") and back pain ("back (constant throbbing and sharp pain, feel at times my hips are breaking)").In 2011, the patient experienced dyspnoea ("shortness of breath"), alopecia ("hair loss") and depression ("essure caused or aggravated any psychiatric and/or psychological condition /depression").In 2012, the patient experienced chest pain ("chest pains"), osteoarthritis ("degenerative joint disorder"), vitamin d deficiency ("vitamin d deficiency"), peripheral swelling ("swelling of hands and legs") and feeling abnormal ("brain fogs").In 2013, the patient was found to have ovarian neoplasm ("ovarian polyps /tumors on ovaries") and experienced fibromyalgia ("fibromyalgia"), sjogren's syndrome ("sjogren's syndrome"), sleep apnoea syndrome ("sleep apnea"), hot flush ("hot flashes"), anxiety ("anxiety attacks"), multiple allergies ("heightened allergies"), loss of libido ("loss of libido"), rectal haemorrhage ("rectal bleeding") and joint injury ("knee injury (sharp)").In 2015, the patient experienced dysgeusia ("metallic taste in mouth").On an unknown date, the patient experienced allergy to metals ("allergic to nickel or any other component of essure/ i was allergic to a bunch of things including nickel and other metals/ hypersensitivity reaction to nickel or any other component of essure") with urticaria, pruritus and dry skin, abdominal pain lower ("cramping"), abdominal rigidity ("abdominal spasm"), abdominal distension ("severe bloating"), pain in extremity ("leg pain"), malaise ("sickness"), genital haemorrhage ("severe bleeding"), dental caries ("tooth decay"), rash ("rash"), visual impairment ("vision problems"), dry mouth ("cotton mouth") and urticaria ("hives").The patient was treated with acetylsalicylic acid;caffeine;paracetamol (excedrin migraine), alprazolam (xanax), amphotericin b;fludrocortisone acetate;gramicidin;neomycin sulfate (novicort), butalbital;caffeine;paracetamol (fioricet), dicycloverine (dicyclomine), escitalopram oxalate (lexapro), fluoxetine hydrochloride (prozac), gabapentin, gliclazide (diamitex), hydrocodone bitartrate;paracetamol (norco), hydroxyzine, meclozine (meclizine), metoprolol, muscle relaxants, tramadol, and surgery (abdominal hysterectomy/ bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, ovarian neoplasm, fibromyalgia, sjogren's syndrome, sleep apnoea syndrome, migraine, vertigo, weight increased, chest pain, abdominal pain, dyspnoea, tooth fracture, osteoarthritis, hot flush, anxiety, hypoaesthesia, paraesthesia, vitamin d deficiency, hypertension, alopecia, dysgeusia, skin irritation, multiple allergies, peripheral swelling, diarrhoea, feeling abnormal, loss of libido, rectal haemorrhage, allergy to metals, depression, arthralgia, joint injury, musculoskeletal pain, back pain and abdominal pain lower had not resolved and the abdominal rigidity, abdominal distension, malaise, genital haemorrhage, dental caries, rash, visual impairment, dry mouth and urticaria outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, alopecia, anxiety, arthralgia, back pain, chest pain, dental caries, depression, diarrhoea, dry mouth, dysgeusia, dyspnoea, feeling abnormal, fibromyalgia, genital haemorrhage, hot flush, hypertension, hypoaesthesia, joint injury, loss of libido, malaise, migraine, multiple allergies, musculoskeletal pain, osteoarthritis, ovarian neoplasm, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, rash, rectal haemorrhage, sjogren's syndrome, skin irritation, sleep apnoea syndrome, tooth fracture, urticaria, vertigo, visual impairment, vitamin d deficiency and weight increased to be related to essure.The reporter commented: patient was not advised of any complications or problems that occurred at the time of essure placement procedure.She did retain the essure or any portion of it after essure removed.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, hypertension, migraine, back pain, arthralgia, urticaria, abdominal pain.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: angioedema.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-may-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.
|
| |
|
Search Alerts/Recalls
|
|
