| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Arthritis (1723); Diarrhea (1811); Emotional Changes (1831); Fall (1848); Fatigue (1849); Hair Loss (1877); Headache (1880); Pyrosis/Heartburn (1883); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Rash (2033); Staphylococcus Aureus (2058); Swelling (2091); Vertigo (2134); Blurred Vision (2137); Vomiting (2144); Dizziness (2194); Myalgia (2238); Anxiety (2328); Toxicity (2333); Arthralgia (2355); Malaise (2359); Depression (2361); Numbness (2415); Skin Inflammation (2443); Sweating (2444); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607); Alteration In Body Temperature (2682); Test Result (2695)
|
| Event Date 11/01/2009 |
|
Event Type
Injury
|
|
Event Description
|
|
Other event.This spontaneous case report was received from a female consumer of unspecified age via regulatory authority (case# mw5031938) in united states on 25-oct-2013 referring to herself.The consumer had essure (fallopian tube occlusion insert) inserted and experienced joint pain, muscle pain, migraines, headaches, hair loss, severe skin itchiness, painful intercourse, irregular periods, fatigue, always overheated, sweating, diarrhea, vomiting, dermatitis, staph folliculitis, extreme and quick weight gain, vertigo, dizziness, general daily 'sick' feeling, body aches, crawling on skin sensation, mouth sores, sharp stabbing and shooting pains in the abdomen, ear itching, anal itching, vaginal itching, anxiety, depression, back pain, blurred vision, floaters, forgetfulness, confusion, heartburn, coughing up mucus, cramping, ear pain/swelling shut, loss of appetite, inability to maintain sugar level, insomnia, mood swings, muscle spasms, nausea, nerve pain, metal taste, night sweats, numbness in hands/feet, painful ovulation, pelvic pain, pressure/pain on bottom while sitting, swelling on hands/feet, vitamin d deficiency, lumps in armpits, clumsiness, tripping (falling down) and bleeding during intercourse.No information given on consumer's history, past drugs, concurrent conditions and concomitant drugs.On (b)(6) 2009 the consumer had essure (fallopian tube occlusion insert) implanted.Lot number was not reported.Consumer stated that since essure placement on (b)(6) 2009 she developed the following side effects: joint pain, muscle pain, migraines, headaches, hair loss, severe skin itchiness, painful intercourse, irregular periods, fatigue, always overheated, sweating, diarrhea, vomiting, dermatitis, staph folliculitis, extreme and quick weight gain, vertigo, dizziness, general daily 'sick' feeling, body aches, crawling on skin sensation, mouth sores, sharp stabbing and shooting pains in the abdomen, ear itching, anal itching, vaginal itching, anxiety, depression, back pain, blurred vision, floaters, forgetfulness, confusion, heartburn, coughing up mucus, cramping, ear pain/swelling shut, loss of appetite, inability to maintain sugar level, insomnia, mood swings, muscle spasms, nausea, nerve pain, metal taste, night sweats, numbness in hands/feet, painful ovulation, pelvic pain, pressure/pain on bottom while sitting, swelling on hands/feet, vitamin d deficiency, lumps in armpits, clumsiness, tripping (falling down) and bleeding during intercourse.It was reported that the consumer required intervention, not specified.It was not informed if essure was explanted or remained in place.Consumer's outcome was not reported.The local health authority did not provide the relationship between events and essure.**fup information received on 27-nov-2013: no new clinical information.**follow-up received on 23-jan-2014: product technical complaint investigation and final assessment received.This adverse event report is related to a product technical complaint (ptc) ¿ request for confirmation of quality.(b)(4).If the outcome of the ptc investigation confirms a quality defect or a counterfeit, this will be communicated in a follow-up report.Final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in (b)(4).Medical assessment: the reported medical events are not indicative for a quality deficit per se.The medical events were reported with an occurrence over a period of 3 years and are of broad nature.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At the time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.Follow up 13-jul-2016: legal claim was received from lawyer on behalf of plaintiff.Essure was inserted in (b)(6) 2009.After being implanted with essure, this plaintiff suffered from severe and permanent injuries.Follow up information received on 04-dec-2017 via plaintiff fact sheet and medical record.A (b)(6) patient¿s demographic information updated.Patient¿s historical condition included heart surgery, wolff-parkinson-white, gravida 4, parity 1 and miscarriage.Patient¿s used condoms from 2004 to 2009.Patient's concomitant condition included obese.Patient¿s concomitant medication included meloxicam, biotin, lorazepam, atorvastatin, propranolol, omeprazole, terazosin, duloxetine, metformin, vitamin d and geodan.In (b)(6) 2009, patient inserted essure for female sterilization.On an unspecified date, patient experienced rash (¿skin rashes/ rashes¿), metal poisoning (¿nickel blood toxicity¿), staphylococcal infection (¿staph infection¿), uterine haemorrhage (¿abnormal uterine bleeding¿), genital haemorrhage (¿bleeding¿) and allergy to metals (¿allergic to nickel¿).In (b)(6) 2015, patient was diagnosed with diabetes mellitus (¿diabetes¿) and osteoarthritis (¿osteoarthritis¿).In (b)(6) 2017, patient was diagnosed with fibromyalgia (¿fibromyalgia¿).Patient was treated with sumatriptan.Essure was removed on (b)(6) 2014 by laparoscopic bilateral salpingectomy.Reporter causality between reported events and essure was related.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.9 kg/sqm.Current weight as of 04-dec-2017: (b)(6).Approximate weight at the time of essure placement: (b)(6).She underwent essure confirmation test in (b)(6) 2009, type of test was hysterosalpingogram.Pathology/ tissue specimen on (b)(6) 2014, clinical information: pelvic pain.Status post essure specimen description: left fallopian tube with coil is a 7 cm long, 0.4 cm diameter fimbriated fallopian tube.Sections show focally hemorrhagic tan mucosa.A coil was seen in the proximal 3 cm of the tube.Sections submitted in cassette a.Right fallopian tube with coil is a 7 cm long, 0.4 cm diameter fimbriated fallopian tube.The mucosa was gray and focally hemorrhagic.A coil was seen in the proximal 2.8 cm of the tube.Sections submitted in cassette b.Final diagnosis: bilateral salpingectomy: two fallopian tubes with essure inserts in place, no significant histologic changes seen.Comment: the specimens are not appropriate for serum nickel testing.Essure legal manufacture has changed from bayer healthcare, llc, (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 case was initially received via regulatory authority (reference number: mw5031938) on 25-oct-2013.The most recent information was received on 28-jan-2020.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in (b)(4), ¿processing essure cases in (b)(6).¿ medical assessment: the reported medical events are not indicative for a quality deficit per se.The medical events were reported with an occurrence over a period of 3 years and are of broad nature.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At the time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain/ pain and suffering/ severe and persistent pelvic pain (severe and persistent)/ pain'), diabetes mellitus ('diabetes'), metal poisoning ('nickel blood toxicity'), staphylococcal infection ('staph infection'), uterine haemorrhage ('abnormal uterine bleeding') and genital haemorrhage ('bleeding') in a 38-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 parity 1 in 1995, cardiac operation, wolff-parkinson-white syndrome, multi gravida and miscarriage.She did not use birth control or contraception following her essure placement procedure.Previously administered products included for an unreported indication: condoms from 2004 to 2009.Concurrent conditions included obesity.Concomitant products included biotin since 2015 and lorazepam since 2015 for alopecia, anxiety and osteoarthritis, duloxetine and metformin since 2015 for depression and diabetes, omeprazole since 2015 and terazosin since 2015 for heartburn and excess sweating, atorvastatin since 2015 and propranolol since 2015 for high cholesterol and anxiety, meloxicam since 2014 for joint pain, alopecia, osteoarthritis and anxiety and vitamin d nos (vitamin d) since 2014 and ziprasidone hydrochloride (geodon) since 2017 for vitamin d deficiency and depression.In (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pain abdominal ("sharp stabbing and shooting pains in the abdomen"), arthralgia ("joint pain/ joint pain (severe and persistent)"), myalgia ("muscle pain"), migraine ("migraines/ migraines/head pain (severe and persistent)"), headache ("headaches"), alopecia ("hair loss/ alopecia"), pruritus ("severe skin itchiness"), dyspareunia ("painful intercourse"), menstruation irregular ("irregular periods"), fatigue ("fatigue"), feeling hot ("i am always overheated"), hyperhidrosis ("sweating"), diarrhoea ("diarrhea"), vomiting ("vomiting"), dermatitis ("dermatitis"), folliculitis ("staph folliculitis/ folliculitis/folliculitis occurred all over her body"), abnormal weight gain ("extreme and quick weight gain/ extreme weight gain"), vertigo ("vertigo"), dizziness ("dizziness"), malaise ("general daily 'sick' feeling"), pain ("body aches"), formication ("crawling on skin sensation"), stomatitis ("mouth sores"), ear pruritus ("ear itching"), anal pruritus ("anal itching"), vulvovaginal pruritus ("vaginal itching"), anxiety ("anxiety/ mental anguish"), depression ("depression"), back pain ("back pain"), vision blurred ("blurred vision"), vitreous floaters ("floaters"), memory impairment ("forgetfulness"), confusional state ("confusion"), dyspepsia ("heartburn"), productive cough ("coughing up mucus"), cramp abdominal ("cramping"), ear swelling ("ear pain/swelling shut"), decreased appetite ("loss of appetite"), insomnia ("insomnia"), mood swings ("mood swings"), muscle spasms ("muscle spasms"), nausea ("nausea"), neuralgia ("nerve pain"), dysgeusia ("metal taste"), night sweats ("night sweats"), hypoaesthesia ("numbness in hands/feet"), ovulation pain ("painful ovulation"), musculoskeletal pain ("pressure/pain on bottom while sitting"), peripheral swelling ("swelling on hands/feet"), vitamin d deficiency ("vitamin d deficiency"), axillary mass ("lumps in armpits"), clumsiness ("clumsiness"), fall ("tripping (falling down)"), coital bleeding ("bleeding during intercourse") and ear pain ("ear pain/swelling shut") and was found to have blood glucose fluctuation ("inability to maintain sugar level").In (b)(6) 2015, the patient experienced diabetes mellitus (seriousness criterion medically significant) and osteoarthritis ("osteoarthritis").In (b)(6) 2017, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced rash ("skin rashes/ rashes"), metal poisoning (seriousness criterion medically significant), staphylococcal infection (seriousness criterion medically significant), uterine haemorrhage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant) and allergy to metals ("allergic to nickel").The patient was treated with sumatriptan and surgery (laparoscopic bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, arthralgia, migraine, alopecia, fatigue, folliculitis, abnormal weight gain, anxiety, depression, rash, diabetes mellitus, metal poisoning, osteoarthritis, staphylococcal infection, fibromyalgia, uterine haemorrhage, genital haemorrhage and allergy to metals had not resolved, the pain abdominal, headache, pruritus, hyperhidrosis, vertigo, dizziness, malaise, pain, formication, stomatitis, anal pruritus, back pain, vitreous floaters, blood glucose fluctuation, insomnia and coital bleeding outcome was unknown and the myalgia, dyspareunia, menstruation irregular, feeling hot, diarrhoea, vomiting, dermatitis, ear pruritus, vulvovaginal pruritus, vision blurred, memory impairment, confusional state, dyspepsia, productive cough, cramp abdominal, ear swelling, decreased appetite, mood swings, muscle spasms, nausea, neuralgia, dysgeusia, night sweats, hypoaesthesia, ovulation pain, musculoskeletal pain, peripheral swelling, vitamin d deficiency, axillary mass, clumsiness, fall and ear pain outcome was unknown.The reporter provided no causality assessment for anal pruritus, axillary mass, back pain, blood glucose fluctuation, clumsiness, coital bleeding, confusional state, decreased appetite, dermatitis, diarrhoea, dizziness, dysgeusia, dyspareunia, dyspepsia, ear pain, ear pruritus, ear swelling, fall, feeling hot, formication, headache, hyperhidrosis, hypoaesthesia, insomnia, malaise, memory impairment, menstruation irregular, mood swings, muscle spasms, musculoskeletal pain, myalgia, nausea, neuralgia, night sweats, ovulation pain, pain, pain abdominal, peripheral swelling, productive cough, pruritus, stomatitis, vertigo, vision blurred, vitamin d deficiency, vitreous floaters, vomiting, vulvovaginal pruritus and cramp abdominal with essure.The reporter considered abnormal weight gain, allergy to metals, alopecia, anxiety, arthralgia, depression, diabetes mellitus, fatigue, fibromyalgia, folliculitis, genital haemorrhage, metal poisoning, migraine, osteoarthritis, pelvic pain, rash, staphylococcal infection and uterine haemorrhage to be related to essure.The reporter commented: patient retained the essure or any portion of it in her home, after removal.Discrepancy noted: date of insertion: (b)(6) 2009.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.9 kg/sqm.Current weight as of (b)(6) 2017: 278 lbs.Approximate weight at the time of essure placement: 180 lbs she underwent essure confirmation test in (b)(6) 2009, type of test was hysterosalpingogram.Pathology/ tissue specimen on (b)(6) 2014, clinical information: pelvic pain.Status post essure specimen description: left fallopian tube with coil is a 7 cm long, 0.4 cm diameter fimbriated fallopian tube.Sections show focally hemorrhagic tan mucosa.A coil was seen in the proximal 3 cm of the tube.Sections submitted in cassette a.Right fallopian tube with coil is a 7 cm long, 0.4 cm diameter fimbriated fallopian tube.The mucosa was gray and focally hemorrhagic.A coil was seen in the proximal 2.8 cm of the tube.Sections submitted in cassette b.Final diagnosis: bilateral salpingectomy: two fallopian tubes with essure inserts in place, no significant histologic changes seen.Comment: the specimens are not appropriate for serum nickle testing.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in wi-(b)(4), ¿processing essure cases in (b)(6).¿ medical assessment: the reported medical events are not indicative for a quality deficit per se.The medical events were reported with an occurrence over a period of 3 years and are of broad nature.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At the time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.Most recent follow-up information incorporated above includes: on 28-jan-2020: pif received: company causality of events myalgia, numbness in hands/feet, swelling on hands/feet was amended due to routing error.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.
|
| |
|
Manufacturer Narrative
|
|
This case was initially received via regulatory authority (reference number: mw5031938 on 25-oct-2013.The most recent information was received on 17-jul-2020.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain/ pain and suffering/ severe and persistent pelvic pain (severe and persistent)/ pain') in a 38-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "essure bilateral tubal occlusion and thermochoice endometrial ablation".The patient's medical history included parity 1 in 1995, cardiac operation, wolff-parkinson-white syndrome, multi gravida and miscarriage.She did not use birth control or contraception following her essure placement procedure.Previously administered products included for an unreported indication: condoms from 2004 to 2009.Concurrent conditions included obesity.Concomitant products included biotin since 2015 and lorazepam since 2015 for alopecia, anxiety and osteoarthritis, duloxetine and metformin since 2015 for depression and diabetes, omeprazole since 2015 and terazosin since 2015 for heartburn and excess sweating, atorvastatin since 2015 and propranolol since 2015 for high cholesterol and anxiety, meloxicam since 2014 for joint pain, alopecia, osteoarthritis and anxiety and vitamin d nos (vitamin d) since 2014 and ziprasidone hydrochloride (geodon) since 2017 for vitamin d deficiency and depression.On (b)(6) 2009, the patient had essure inserted.On (b)(6)2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pain abdominal ("sharp stabbing and shooting pains in the abdomen"), arthralgia ("joint pain/ joint pain (severe and persistent)"), myalgia ("muscle pain"), migraine ("migraines/ migraines/head pain (severe and persistent)"), headache ("headaches"), alopecia ("hair loss/ alopecia"), pruritus ("severe skin itchiness"), dyspareunia ("painful intercourse"), menstruation irregular ("irregular periods"), fatigue ("fatigue"), feeling hot ("i am always overheated"), hyperhidrosis ("sweating"), diarrhoea ("diarrhea"), vomiting ("vomiting"), dermatitis ("dermatitis"), folliculitis ("staph folliculitis/ folliculitis/folliculitis occurred all over her body"), abnormal weight gain ("extreme and quick weight gain/ extreme weight gain"), vertigo ("vertigo"), dizziness ("dizziness"), malaise ("general daily 'sick' feeling"), pain ("body aches"), formication ("crawling on skin sensation"), stomatitis ("mouth sores"), ear pruritus ("ear itching"), anal pruritus ("anal itching"), vulvovaginal pruritus ("vaginal itching"), anxiety ("anxiety/ mental anguish"), depression ("depression"), back pain ("back pain"), vision blurred ("blurred vision"), vitreous floaters ("floaters"), memory impairment ("forgetfulness"), confusional state ("confusion"), dyspepsia ("heartburn"), productive cough ("coughing up mucus"), cramp abdominal ("cramping"), ear swelling ("ear pain/swelling shut"), decreased appetite ("loss of appetite"), insomnia ("insomnia"), mood swings ("mood swings"), muscle spasms ("muscle spasms"), nausea ("nausea"), neuralgia ("nerve pain"), dysgeusia ("metal taste"), night sweats ("night sweats"), hypoaesthesia ("numbness in hands/feet"), ovulation pain ("painful ovulation"), musculoskeletal pain ("pressure/pain on bottom while sitting"), peripheral swelling ("swelling on hands/feet"), vitamin d deficiency ("vitamin d deficiency"), axillary mass ("lumps in armpits"), clumsiness ("clumsiness"), fall ("tripping (falling down)"), coital bleeding ("bleeding during intercourse") and ear pain ("ear pain/swelling shut") and was found to have blood glucose fluctuation ("inability to maintain sugar level"), 8 months 16 days after insertion of essure.In (b)(6) 2015, the patient experienced diabetes mellitus ("diabetes") and osteoarthritis ("osteoarthritis").In (b)(6)2017, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced rash ("skin rashes/ rashes"), metal poisoning ("nickel blood toxicity"), staphylococcal infection ("staph infection"), uterine haemorrhage ("abnormal uterine bleeding"), genital haemorrhage ("bleeding") and allergy to metals ("allergic to nickel/ allergies").The patient was treated with sumatriptan and surgery (laparoscopic bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, arthralgia, migraine, alopecia, fatigue, folliculitis, abnormal weight gain, anxiety, depression, rash, diabetes mellitus, metal poisoning, osteoarthritis, staphylococcal infection, fibromyalgia, uterine haemorrhage, genital haemorrhage and allergy to metals had not resolved, the pain abdominal, headache, pruritus, hyperhidrosis, diarrhoea, vertigo, dizziness, malaise, pain, formication, stomatitis, anal pruritus, back pain, vitreous floaters, blood glucose fluctuation, insomnia and coital bleeding outcome was unknown and the myalgia, dyspareunia, menstruation irregular, feeling hot, vomiting, dermatitis, ear pruritus, vulvovaginal pruritus, vision blurred, memory impairment, confusional state, dyspepsia, productive cough, cramp abdominal, ear swelling, decreased appetite, mood swings, muscle spasms, nausea, neuralgia, dysgeusia, night sweats, hypoaesthesia, ovulation pain, musculoskeletal pain, peripheral swelling, vitamin d deficiency, axillary mass, clumsiness, fall and ear pain outcome was unknown.The reporter provided no causality assessment for anal pruritus, axillary mass, back pain, blood glucose fluctuation, clumsiness, coital bleeding, confusional state, decreased appetite, dermatitis, diarrhoea, dizziness, dysgeusia, dyspareunia, dyspepsia, ear pain, ear pruritus, ear swelling, fall, feeling hot, formication, headache, hyperhidrosis, hypoaesthesia, insomnia, malaise, memory impairment, menstruation irregular, mood swings, muscle spasms, musculoskeletal pain, myalgia, nausea, neuralgia, night sweats, ovulation pain, pain, pain abdominal, peripheral swelling, productive cough, pruritus, stomatitis, vertigo, vision blurred, vitamin d deficiency, vitreous floaters, vomiting, vulvovaginal pruritus and cramp abdominal with essure.The reporter considered abnormal weight gain, allergy to metals, alopecia, anxiety, arthralgia, depression, diabetes mellitus, fatigue, fibromyalgia, folliculitis, genital haemorrhage, metal poisoning, migraine, osteoarthritis, pelvic pain, rash, staphylococcal infection and uterine haemorrhage to be related to essure.The reporter commented: patient retained the essure or any portion of it in her home, after removal.Discrepancy noted: date of insertion: (b)(6) 2009.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: spillage into the peritoneal cavity is demonstrated beyond the right fallopian tube implant.Current weight as of (b)(6) 2017: 278 lbs.Approximate weight at the time of essure placement: 180 lbs she underwent essure confirmation test in (b)(6) 2009, type of test was hysterosalpingogram.Impression: spillage into the peritoneal cavity is demonstrated beyond the right fallopian tube implant.Pathology/ tissue specimen on (b)(6)2014, clinical information: pelvic pain.Status post essure specimen description: left fallopian tube with coil is a 7 cm long, 0.4 cm diameter fimbriated fallopian tube.Sections show focally hemorrhagic tan mucosa.A coil was seen in the proximal 3 cm of the tube.Sections submitted in cassette a.Right fallopian tube with coil is a 7 cm long, 0.4 cm diameter fimbriated fallopian tube.The mucosa was gray and focally hemorrhagic.A coil was seen in the proximal 2.8 cm of the tube.Sections submitted in cassette b.Final diagnosis: bilateral salpingectomy: two fallopian tubes with essure inserts in place, no significant histologic changes seen.Comment: the specimens are not appropriate for serum nickle testing.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-jul-2020: mr received: reporter was added.Medical device monitoring error was added as a event.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.
|
| |
|
Manufacturer Narrative
|
|
This case was initially received via regulatory authority (reference number: mw5031938) on 25-oct-2013.The most recent information was received on 23-jun-2020.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain/ pain and suffering/ severe and persistent pelvic pain (severe and persistent)/ pain'), diabetes mellitus ('diabetes'), metal poisoning ('nickel blood toxicity'), staphylococcal infection ('staph infection'), uterine haemorrhage ('abnormal uterine bleeding') and genital haemorrhage ('bleeding') in a 38-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 parity 1 in 1995, cardiac operation, wolff-parkinson-white syndrome, multi gravida and miscarriage.She did not use birth control or contraception following her essure placement procedure.Previously administered products included for an unreported indication: condoms from 2004 to 2009.Concurrent conditions included obesity.Concomitant products included biotin since 2015 and lorazepam since 2015 for alopecia, anxiety and osteoarthritis, duloxetine and metformin since 2015 for depression and diabetes, omeprazole since 2015 and terazosin since 2015 for heartburn and excess sweating, atorvastatin since 2015 and propranolol since 2015 for high cholesterol and anxiety, meloxicam since 2014 for joint pain, alopecia, osteoarthritis and anxiety and vitamin d nos (vitamin d) since 2014 and ziprasidone hydrochloride (geodon) since 2017 for vitamin d deficiency and depression.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pain abdominal ("sharp stabbing and shooting pains in the abdomen"), arthralgia ("joint pain/ joint pain (severe and persistent)"), myalgia ("muscle pain"), migraine ("migraines/ migraines/head pain (severe and persistent)"), headache ("headaches"), alopecia ("hair loss/ alopecia"), pruritus ("severe skin itchiness"), dyspareunia ("painful intercourse"), menstruation irregular ("irregular periods"), fatigue ("fatigue"), feeling hot ("i am always overheated"), hyperhidrosis ("sweating"), diarrhoea ("diarrhea"), vomiting ("vomiting"), dermatitis ("dermatitis"), folliculitis ("staph folliculitis/ folliculitis/folliculitis occurred all over her body"), abnormal weight gain ("extreme and quick weight gain/ extreme weight gain"), vertigo ("vertigo"), dizziness ("dizziness"), malaise ("general daily 'sick' feeling"), pain ("body aches"), formication ("crawling on skin sensation"), stomatitis ("mouth sores"), ear pruritus ("ear itching"), anal pruritus ("anal itching"), vulvovaginal pruritus ("vaginal itching"), anxiety ("anxiety/ mental anguish"), depression ("depression"), back pain ("back pain"), vision blurred ("blurred vision"), vitreous floaters ("floaters"), memory impairment ("forgetfulness"), confusional state ("confusion"), dyspepsia ("heartburn"), productive cough ("coughing up mucus"), cramp abdominal ("cramping"), ear swelling ("ear pain/swelling shut"), decreased appetite ("loss of appetite"), insomnia ("insomnia"), mood swings ("mood swings"), muscle spasms ("muscle spasms"), nausea ("nausea"), neuralgia ("nerve pain"), dysgeusia ("metal taste"), night sweats ("night sweats"), hypoaesthesia ("numbness in hands/feet"), ovulation pain ("painful ovulation"), musculoskeletal pain ("pressure/pain on bottom while sitting"), peripheral swelling ("swelling on hands/feet"), vitamin d deficiency ("vitamin d deficiency"), axillary mass ("lumps in armpits"), clumsiness ("clumsiness"), fall ("tripping (falling down)"), coital bleeding ("bleeding during intercourse") and ear pain ("ear pain/swelling shut") and was found to have blood glucose fluctuation ("inability to maintain sugar level"), 8 months 16 days after insertion of essure.In (b)(6) 2015, the patient experienced diabetes mellitus (seriousness criterion medically significant) and osteoarthritis ("osteoarthritis").In (b)(6) 2017, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced rash ("skin rashes/ rashes"), metal poisoning (seriousness criterion medically significant), staphylococcal infection (seriousness criterion medically significant), uterine haemorrhage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant) and allergy to metals ("allergic to nickel/ allergies").The patient was treated with sumatriptan and surgery (laparoscopic bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, arthralgia, migraine, alopecia, fatigue, folliculitis, abnormal weight gain, anxiety, depression, rash, diabetes mellitus, metal poisoning, osteoarthritis, staphylococcal infection, fibromyalgia, uterine haemorrhage, genital haemorrhage and allergy to metals had not resolved, the pain abdominal, headache, pruritus, hyperhidrosis, diarrhoea, vertigo, dizziness, malaise, pain, formication, stomatitis, anal pruritus, back pain, vitreous floaters, blood glucose fluctuation, insomnia and coital bleeding outcome was unknown and the myalgia, dyspareunia, menstruation irregular, feeling hot, vomiting, dermatitis, ear pruritus, vulvovaginal pruritus, vision blurred, memory impairment, confusional state, dyspepsia, productive cough, cramp abdominal, ear swelling, decreased appetite, mood swings, muscle spasms, nausea, neuralgia, dysgeusia, night sweats, hypoaesthesia, ovulation pain, musculoskeletal pain, peripheral swelling, vitamin d deficiency, axillary mass, clumsiness, fall and ear pain outcome was unknown.The reporter provided no causality assessment for anal pruritus, axillary mass, back pain, blood glucose fluctuation, clumsiness, coital bleeding, confusional state, decreased appetite, dermatitis, diarrhoea, dizziness, dysgeusia, dyspareunia, dyspepsia, ear pain, ear pruritus, ear swelling, fall, feeling hot, formication, headache, hyperhidrosis, hypoaesthesia, insomnia, malaise, memory impairment, menstruation irregular, mood swings, muscle spasms, musculoskeletal pain, myalgia, nausea, neuralgia, night sweats, ovulation pain, pain, pain abdominal, peripheral swelling, productive cough, pruritus, stomatitis, vertigo, vision blurred, vitamin d deficiency, vitreous floaters, vomiting, vulvovaginal pruritus and cramp abdominal with essure.The reporter considered abnormal weight gain, allergy to metals, alopecia, anxiety, arthralgia, depression, diabetes mellitus, fatigue, fibromyalgia, folliculitis, genital haemorrhage, metal poisoning, migraine, osteoarthritis, pelvic pain, rash, staphylococcal infection and uterine haemorrhage to be related to essure.The reporter commented: patient retained the essure or any portion of it in her home, after removal.Discrepancy noted: date of insertion: (b)(6) 2009.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.9 kg/sqm.Current weight as of (b)(6) 2017: 278 lbs.Approximate weight at the time of essure placement: 180 lbs.She underwent essure confirmation test in (b)(6) 2009, type of test was hysterosalpingogram.Impression: spillage into the peritoneal cavity is demonstrated beyond the right fallopian tube implant.Pathology/ tissue specimen on (b)(6) 2014, clinical information: pelvic pain.Status post essure.Specimen description: left fallopian tube with coil is a 7 cm long, 0.4 cm diameter fimbriated fallopian tube.Sections show focally hemorrhagic tan mucosa.A coil was seen in the proximal 3 cm of the tube.Sections submitted in cassette a.Right fallopian tube with coil is a 7 cm long, 0.4 cm diameter fimbriated fallopian tube.The mucosa was gray and focally hemorrhagic.A coil was seen in the proximal 2.8 cm of the tube.Sections submitted in cassette b.Final diagnosis: bilateral salpingectomy: two fallopian tubes with essure inserts in place, no significant histologic changes seen.Comment: the specimens are not appropriate for serum nickle testing.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-jun-2020: quality-safety evaluation of product technical complaint.On 18-jun-2020: plaintiff fact sheet received.Reporter added.On (b)(6) 2009, she implanted essure (previously reported as (b)(6) 2009).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
|
|
