| Model Number ESS305 |
| Device Problems
Bent (1059); Break (1069); Patient-Device Incompatibility (2682); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Expulsion (2933)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Fever (1858); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Pelvic Inflammatory Disease (2000); Perforation (2001); Seizures (2063); Vomiting (2144); Malaise (2359); Sweating (2444); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2010 |
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5032620) on 13-jan-2014.The most recent information was received on 28-feb-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("pid pelvic inflammatory disease"), device breakage ("device breakage"), device dislocation ("right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("autoimmune disorder") in a (b)(6) female patient who had essure (batch no.740668) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle" (seriousness criteria medically significant and intervention required) in 2010, patient-device incompatibility "got really sick, body was trying to reject the coil" and device monitoring procedure not performed "no she did not undergo essure confirmation test".The patient's past medical history included gravida in 2003.Concurrent conditions included body mass index normal.On (b)(6) 2010, the patient had essure inserted.In 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), uterine inflammation ("chronic inflammation"), general physical health deterioration ("so sick her body was shutting down"), weight decreased ("losing weight"), pyrexia ("running fevers"), vomiting ("vomiting"), diarrhoea ("chronic diarrhea") and device expulsion ("right coil had fallen into uterus / malposition of essure device location of device: uterine cavity").On the same day, the patient experienced pelvic pain ("prolonged chronic pain").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), menopause ("hormonal changes describe: put in complete menopause"), genital haemorrhage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), allergy to metals ("cobalt allergy / nickel"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), autoimmune disorder (seriousness criterion medically significant), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines"), headache ("headaches"), epilepsy ("epilepsy"), seizure ("seizures"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), night sweats ("night sweats"), loss of libido ("diminished sex drive"), abdominal pain lower ("right lower quadrant pain"), pain in extremity ("right leg pain"), arthralgia ("hip pain"), abdominal pain ("abdominal pain") and mental disorder ("psychological or psychiatric problems").The patient was treated with oxycocet (percocet), surgery (surgical removal of coil(s) / hysterectomy with unilateral salpingectomy), and surgery (in (b)(6) 2010 underwent ablation).Essure was removed on (b)(6) 2010.In 2010, the device dislocation had resolved.On (b)(6) 2010, the device expulsion had resolved.At the time of the report, the pelvic inflammatory disease, device breakage, general physical health deterioration, weight decreased, pyrexia, vomiting, diarrhoea, menopause, genital haemorrhage, vaginal haemorrhage, menorrhagia, allergy to metals, female sexual dysfunction, autoimmune disorder, bladder disorder, urinary tract disorder, migraine, headache, epilepsy, seizure, dysmenorrhoea, dyspareunia, fatigue, alopecia, night sweats, loss of libido, abdominal pain lower, pain in extremity, arthralgia, abdominal pain and mental disorder outcome was unknown and the pelvic pain and uterine inflammation had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, autoimmune disorder, bladder disorder, device breakage, device dislocation, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, epilepsy, fatigue, female sexual dysfunction, general physical health deterioration, genital haemorrhage, headache, loss of libido, menopause, menorrhagia, mental disorder, migraine, night sweats, pain in extremity, pelvic inflammatory disease, pelvic pain, pyrexia, seizure, urinary tract disorder, uterine inflammation, vaginal haemorrhage, vomiting and weight decreased to be related to essure.The reporter commented: current weight (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Most recent follow-up information incorporated above includes: on (b)(6) 2018: events- "hormonal changes describe: put in complete menopause, abnormal bleeding (general), abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), cobalt allergy / nickel, apareunia (inability to have sexual intercourse), autoimmune disorder, bladder problems, urinary problems or changes, migraines, headaches, epilepsy, seizures, device breakage, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, pid pelvic inflammatory disease, hair loss, night sweats, diminished sex drive, right lower quadrant pain, right leg pain, hip pain, abdominal pain, psychological or psychiatric problems, no she did not undergo essure confirmation test", lot number added from pfs.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, 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 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 case was initially received via regulatory authority (food and drug administration, reference number: mw5032620) on (b)(6)2014.The most recent information was received on (b)(6)2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("pid pelvic inflammatory disease"), device breakage ("device breakage"), device dislocation ("right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle / malposition of essure location of device: uterine cavity"), systemic inflammatory response syndrome ("autoimmune disorder : primary inflammatory response") and genital haemorrhage ("abnormal bleeding (general)") in a 47-year-old female patient who had essure (batch no.740668) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle" (seriousness criteria medically significant and intervention required) in 2010, patient-device incompatibility "got really sick, body was trying to reject the coil" and device monitoring procedure not performed "no she did not undergo essure confirmation test".The patient's past medical history included gravida in 2003, cesarean section in 2003, irritable bowel syndrome, nonsmoker and hip surgery.Patient was a nonsmoker and no alcohol abuse.Previously administered products included for birth control: loestrin.Concurrent conditions included body mass index normal.Concomitant products included progesterone (progesteron), trazodone and vicodin.On (b)(6)2010, the patient had essure inserted.In 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), uterine inflammation ("chronic inflammation"), general physical health deterioration ("so sick her body was shutting down"), pyrexia ("running fevers"), vomiting ("vomiting") and diarrhoea ("chronic diarrhea").On the same day, the patient experienced pelvic pain ("prolonged chronic pain / pain").In(b)(6)2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6)2010, the patient experienced weight decreased ("losing weight"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), abdominal pain ("abdominal pain"), depression ("psychological or psychiatric problems : depression"), nausea ("nausea") and pain ("chronic pain syndrome").On (b)(6)2010, the patient experienced device expulsion ("right coil had fallen into uterus / malposition of essure device location of device: uterine cavity").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), systemic inflammatory response syndrome (seriousness criterion medically significant), menopausal symptoms ("hormonal changes describe: put in complete menopause"), genital haemorrhage (seriousness criteria medically significant and intervention required), allergy to metals ("cobalt allergy / nickel"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines"), headache ("headaches"), epilepsy ("epilepsy"), seizure ("seizures"), night sweats ("night sweats"), loss of libido ("diminished sex drive"), abdominal pain lower ("right lower quadrant pain"), pain in extremity ("right leg pain"), arthralgia ("hip pain") and mood altered ("mood changes").The patient was treated with oxycocet (percocet), surgery (surgical removal of coil(s) / hysterectomy with unilateral salpingectomy), surgery (surgical removal of coil(s) / hysterectomy with unilateral salpingectomy) and surgery (in (b)(6)2010 underwent novasure endometrial ablation).Essure was removed on (b)(6)2010.In 2010, the device dislocation had resolved.At the time of the report, the pelvic inflammatory disease, device breakage, systemic inflammatory response syndrome, general physical health deterioration, weight decreased, pyrexia, vomiting, diarrhoea, menopausal symptoms, allergy to metals, female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, headache, epilepsy, seizure, dyspareunia, fatigue, alopecia, night sweats, loss of libido, abdominal pain lower, pain in extremity, arthralgia, abdominal pain, depression, mood altered, nausea and pain outcome was unknown, the pelvic pain, device expulsion, genital haemorrhage, vaginal haemorrhage, menorrhagia and dysmenorrhoea had resolved and the uterine inflammation had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, bladder disorder, depression, device breakage, device dislocation, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, epilepsy, fatigue, female sexual dysfunction, general physical health deterioration, genital haemorrhage, headache, loss of libido, menopausal symptoms, menorrhagia, migraine, mood altered, nausea, night sweats, pain, pain in extremity, pelvic inflammatory disease, pelvic pain, pyrexia, seizure, systemic inflammatory response syndrome, urinary tract disorder, uterine inflammation, vaginal haemorrhage, vomiting and weight decreased to be related to essure.The reporter commented: removal date provided as (b)(6)2010, (b)(6)2010.Three tailing coils on the right side and four trailing coils on the left.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 17.5 kg/sqm.Ultrasound - one coil had fallen into her uterus repeat ultrasound - left coil in the uterus, right side coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent into uterus at 90 degree angle ct (computed tomography) scan before hysterectomy - showed severe inflammation on (b)(6)2010, both tubal ostia were identified.The essure device was deployed in each tubal ostia with three trailing coils on the right side and four trailing coils on the left.On (b)(6)2010, ultrasound exam, the uterus was anteverted.Essure coil identified in both cornua, however, trailing coils noted within the endometrial cavity as well.Hysteroscopic exam performed in the office today after cervix prepped with technicare.The patient was noted to have essure coil within the fundus of the uterine cavity on her left side.The coil was removed.Impression-failed essure coil placement on the left side.On (b)(6)2010, examination: cat abdomen/pelvis with contrast, impression: 1.Findings suggesting cecitis with adjacent reactive adenopathy.2.Otherwise, negative ct scan of the abdomen and pelvis.No pathologic change.On (b)(6)2010, procedure performed: total laparoscopic hysterectomy with right salpingo-oophorectomy and cystoscopy.Findings: slightly enlarged boggy uterus, surgically absent left adnexa, unremarkable right adnexa, normal cystoscopy, essure noted to be tenting the tubal peritoneum on the left side.Impression: pelvic pain, abnormal uterine bleeding, failed endometrial ablation.Final pathologic diagnosis uterus: inactive type endometrium.Superficial adenomyosis.Leiomyomas.Cervix: no pathologic change.Right ovary and fallopian tube: no pathologic change.On (b)(6)2010, exam: pelviscopic incisions all healing well.Impression: normal postop exam.Exam: bilateral digital mammogram with implant views mammographic findings: digital mammographic views of both breasts show the breast tissue to be heterogeneously dense.Microlobulated nodule, 1 cm within the left lateral breast is noted on the implant displaced views without associated microcalcifications or architectural distortion.The right breast was negative for suspicious mass, microcalcification, or architectural distortion.Presence of bilateral retropectoral implants were noted.Impression: bi-rads 0.Incomplete: need additional imaging evaluation.On (b)(6)2010, exam: bilateral digital mammogram with implant views mammographic findings: the breast tissue was heterogeneously dense.This may lower the sensitivity of mammography.Bilateral breast implants are noted.There are no suspicious masses, clustered microcalcifications, architectural distortion, or secondary signs of malignancy.There has been no significant interval change.Impression: negative examination.Bi-rads 1 findings: the background pattern of fibroglandular enhancement was mild.Right breast: there are no suspicious enhancing mass or non-mass like areas identified in the right breast.The right axilla is unremarkable.Left breast: there are no suspicious enhancing mass or non-mass like areas identified in the left breast.The left axilla was unremarkable.Impression: 1.No suspicious areas of enhancement seen in either breast.2.The right implant has developed an intra-and extracapsular rupture with migration of silicone superiorly and medially behind the pectoralis muscle.On (b)(6)2011, ct abdomen and pelvis w contrast impression: 1.Status post hysterectomy, without definite ct evidence of complication.2.Constipation without obstruction.3.Slightly enlarged liver with suggestion of mild fatty infiltration.4.Degenerative disc disease in the lumbar spine.On (b)(6)2011, exam: mri of the lumbar spine without contrast.Impression: mild degenerative disc changes at l5-s1.Degenerative disc and facet changes at l4-5 with mild narrowing of the inferior aspect of the right neural foramen as above.On (b)(6)2011, patient presents ten days following total laparoscopic hysterectomy with right salpingooophorectomy.Postoperatively, she has done well.Scant amount of dark fever.No discharge noted.No odor.Exam: pelviscopic incisions all healing well.Impression: normal postop exam.(b)(6)2010 : transvaginal ultrasound : unilateral occlusion (right tube occluded), right side was in place and the left side was in the uterine cavity and removed concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, genital haemorrhage.Most recent follow-up information incorporated above includes: on(b)(6)2018: events- "mood changes, nausea, chronic pain syndrome", concomittant drug added from pfs.On (b)(6)2018: no new information added.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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E was initially received via regulatory authority (food and drug administration, reference number: mw5032620) on 13-jan-2014.The most recent information was received on 21-aug-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("pid pelvic inflammatory disease"), device breakage ("device breakage"), device dislocation ("right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle / malposition of essure location of device: uterine cavity"), genital haemorrhage ("abnormal bleeding (general)") and systemic inflammatory response syndrome ("autoimmune disorder : primary inflammatory response") in a 47-year-old female patient who had essure (batch no.740668) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle" (seriousness criteria medically significant and intervention required) in 2010, device monitoring procedure not performed "no she did not undergo essure confirmation test" and patient-device incompatibility "got really sick, body was trying to reject the coil".The patient's past medical history included gravida in 2003, cesarean section in 2003, irritable bowel syndrome, nonsmoker and hip surgery.Patient was a nonsmoker and no alcohol abuse.Previously administered products included for birth control: loestrin.Concurrent conditions included body mass index normal and uterine bleeding.Concomitant products included progesterone (progesteron), trazodone and vicodin.In 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), uterine inflammation ("chronic inflammation"), general physical health deterioration ("so sick her body was shutting down"), pyrexia ("running fevers"), vomiting ("vomiting") and diarrhoea ("chronic diarrhea").On 4-aug-2010, the patient had essure inserted.On the same day, the patient experienced pelvic pain ("prolonged chronic pain / pain").In august 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and dysmenorrhoea ("dysmenorrhea (cramping)").In september 2010, the patient experienced weight decreased ("losing weight"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), abdominal pain ("abdominal pain"), depression ("psychological or psychiatric problems : depression"), nausea ("nausea") and pain ("chronic pain syndrome").On 28-oct-2010, the patient experienced device expulsion ("right coil had fallen into uterus / malposition of essure device location of device: uterine cavity/intrauterine device is identified that is grossly embedded into the myometrium").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), systemic inflammatory response syndrome (seriousness criterion medically significant), menopausal symptoms ("hormonal changes describe: put in complete menopause"), allergy to metals ("cobalt allergy / nickel"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines"), headache ("headaches"), epilepsy ("epilepsy"), seizure ("seizures"), night sweats ("night sweats"), loss of libido ("diminished sex drive"), abdominal pain lower ("right lower quadrant pain"), pain in extremity ("right leg pain"), arthralgia ("hip pain") and mood altered ("mood changes").The patient was treated with oxycocet (percocet), surgery (surgical removal of coil(s) / hysterectomy with unilateral salpingectomy), surgery (surgical removal of coil(s) / hysterectomy with unilateral salpingectomy) and surgery (in aug-2010 underwent novasure endometrial ablation).Essure was removed on 6-dec-2010.In 2010, the device dislocation had resolved.At the time of the report, the pelvic inflammatory disease, device breakage, systemic inflammatory response syndrome, general physical health deterioration, weight decreased, pyrexia, vomiting, diarrhoea, menopausal symptoms, allergy to metals, female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, headache, epilepsy, seizure, dyspareunia, fatigue, alopecia, night sweats, loss of libido, abdominal pain lower, pain in extremity, arthralgia, abdominal pain, depression, mood altered, nausea and pain outcome was unknown, the genital haemorrhage, pelvic pain, device expulsion, vaginal haemorrhage, menorrhagia and dysmenorrhoea had resolved and the uterine inflammation had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, bladder disorder, depression, device breakage, device dislocation, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, epilepsy, fatigue, female sexual dysfunction, general physical health deterioration, genital haemorrhage, headache, loss of libido, menopausal symptoms, menorrhagia, migraine, mood altered, nausea, night sweats, pain, pain in extremity, pelvic inflammatory disease, pelvic pain, pyrexia, seizure, systemic inflammatory response syndrome, urinary tract disorder, uterine inflammation, vaginal haemorrhage, vomiting and weight decreased to be related to essure.The reporter commented: removal date provided as 28oct2010, 06dec2010.Three tailing coils on the right side and four trailing coils on the left.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 17.5 kg/sqm.Ultrasound - one coil had fallen into her uterus repeat ultrasound - left coil in the uterus, right side coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent into uterus at 90 degree angle ct (computed tomography) scan before hysterectomy - showed severe inflammation on 04-aug-2010, both tubal ostia were identified.The essure device was deployed in each tubal ostia with three trailing coils on the right side and four trailing coils on the left.On 28-oct-2010, ultrasound exam, the uterus was anteverted.Essure coil identified in both cornua, however, trailing coils noted within the endometrial cavity as well.Hysteroscopic exam performed in the office today after cervix prepped with technicare.The patient was noted to have essure coil within the fundus of the uterine cavity on her left side.The coil was removed.Impression-failed essure coil placement on the left side.On 01-dec-2010, examination: cat abdomen/pelvis with contrast, impression: 1.Findings suggesting cecitis with adjacent reactive adenopathy.2.Otherwise, negative ct scan of the abdomen and pelvis.No pathologic change.On 06-dec-2010, procedure performed: total laparoscopic hysterectomy with right salpingo-oophorectomy and cystoscopy.Findings: slightly enlarged boggy uterus, surgically absent left adnexa, unremarkable right adnexa, normal cystoscopy, essure noted to be tenting the tubal peritoneum on the left side.Impression: pelvic pain, abnormal uterine bleeding, failed endometrial ablation.Final pathologic diagnosis uterus: inactive type endometrium.Superficial adenomyosis.Leiomyomas.Cervix: no pathologic change.Right ovary and fallopian tube: no pathologic change.On 16-dec-2010, exam: pelviscopic incisions all healing well.Impression: normal postop exam.Exam: bilateral digital mammogram with implant views mammographic findings: digital mammographic views of both breasts show the breast tissue to be heterogeneously dense.Microlobulated nodule, 1 cm within the left lateral breast is noted on the implant displaced views without associated microcalcifications or architectural distortion.The right breast was negative for suspicious mass, microcalcification, or architectural distortion.Presence of bilateral retropectoral implants were noted.Impression: bi-rads 0.Incomplete: need additional imaging evaluation.On 30-dec-2010, exam: bilateral digital mammogram with implant views mammographic findings: the breast tissue was heterogeneously dense.This may lower the sensitivity of mammography.Bilateral breast implants are noted.There are no suspicious masses, clustered microcalcifications, architectural distortion, or secondary signs of malignancy.There has been no significant interval change.Impression: negative examination.Bi-rads 1 findings: the background pattern of fibroglandular enhancement was mild.Right breast: there are no suspicious enhancing mass or non-mass like areas identified in the right breast.The right axilla is unremarkable.Left breast: there are no suspicious enhancing mass or non-mass like areas identified in the left breast.The left axilla was unremarkable.Impression: 1.No suspicious areas of enhancement seen in either breast.2.The right implant has developed an intra-and extracapsular rupture with migration of silicone superiorly and medially behind the pectoralis muscle.On 09-feb-2011, ct abdomen and pelvis w contrast impression: 1.Status post hysterectomy, without definite ct evidence of complication.2.Constipation without obstruction.3.Slightly enlarged liver with suggestion of mild fatty infiltration.4.Degenerative disc disease in the lumbar spine.On 17-feb-2011, exam: mri of the lumbar spine without contrast.Impression: mild degenerative disc changes at l5-s1.Degenerative disc and facet changes at l4-5 with mild narrowing of the inferior aspect of the right neural foramen as above.On 20-may-2011, patient presents ten days following total laparoscopic hysterectomy with right salpingooophorectomy.Postoperatively, she has done well.Scant amount of dark fever.No discharge noted.No odor.Exam: pelviscopic incisions all healing well.Impression: normal postop exam.28-oct-2010 : transvaginal ultrasound : unilateral occlusion (right tube occluded), right side was in place and the left side was in the uterine cavity and removed concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, genital haemorrhage, device expulsion quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6)2018: unable to confirm complaint 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 case was initially received via regulatory authority (food and drug administration, reference number: mw5032620) on 13-jan-2014.The most recent information was received on 21-aug-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('pid pelvic inflammatory disease'), device breakage ('device breakage/ failure to occlude (close) fallopain tube'), perforation ('perforation'), device dislocation ('right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle / malposition of essure location of device: uterine cavity'), genital haemorrhage ('abnormal bleeding (general)') and systemic inflammatory response syndrome ('autoimmune disorder : primary inflammatory response, but triggering immune response and deterioration') in a 47-year-old female patient who had essure (batch no.740668) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle" (seriousness criteria medically significant and intervention required) in 2010, patient-device incompatibility "got really sick, body was trying to reject the coil" and device monitoring procedure not performed "no she did not undergo essure confirmation test".The patient's medical history included cesarean section in 2003, gravida in 2003, irritable bowel syndrome, nonsmoker and hip surgery.Patient was a nonsmoker and no alcohol abuse.Previously administered products included for birth control: loestrin.Concurrent conditions included body mass index normal and uterine bleeding.Concomitant products included hydrocodone bitartrate;paracetamol (vicodin), progesterone (progesteron) and trazodone.In 2010, the patient experienced uterine inflammation ("chronic inflammation"), general physical health deterioration ("so sick her body was shutting down"), pyrexia ("running fevers"), vomiting ("vomiting") and diarrhoea ("chronic diarrhea").On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain ("prolonged chronic pain / pain").In (b)(6) 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2010, the patient was found to have weight decreased ("losing weight") and experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), abdominal pain ("abdominal pain"), depression ("psychological or psychiatric problems: depression"), nausea ("nausea") and pain ("chronic pain syndrome").On (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and device expulsion ("right coil had fallen into uterus / malposition of essure device location of device: uterine cavity/intrauterine device is identified that is grossly embedded into the myometrium").On (b)(6) 2011, the patient experienced allergy to metals ("cobalt allergy / nickel/ nickel allergy ").In (b)(6) 2012, the patient experienced menopausal symptoms ("hormonal changes describe: put in complete menopause").In 2013, the patient experienced systemic inflammatory response syndrome (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced epilepsy ("epilepsy") and seizure ("seizures").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), perforation (seriousness criterion medically significant), genital haemorrhage (seriousness criteria medically significant and intervention required), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems or changes"), night sweats ("night sweats"), loss of libido ("diminished sex drive"), abdominal pain lower ("right lower quadrant pain/ abdominal pain"), pain in extremity ("right leg pain"), arthralgia ("hip pain") and mood altered ("mood changes").The patient was treated with oxycodone hydrochloride;paracetamol (percocet) and surgery ((b)(6) 2010 underwent novasure endometrial ablation, ablation, ablation , surgical removal of coil(s) / hysterectomy with unilateral salpingectomy and surgical removal of coil(s), hysterectomy with bilateral salpingo- oopherectomy).Essure was removed on (b)(6) 2010.In 2010, the device dislocation had resolved.At the time of the report, the pelvic inflammatory disease, device breakage, perforation, systemic inflammatory response syndrome, general physical health deterioration, weight decreased, pyrexia, vomiting, diarrhoea, menopausal symptoms, allergy to metals, female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, headache, epilepsy, seizure, dyspareunia, fatigue, alopecia, night sweats, loss of libido, abdominal pain lower, pain in extremity, arthralgia, abdominal pain, depression, mood altered, nausea and pain outcome was unknown, the genital haemorrhage, pelvic pain, device expulsion, vaginal haemorrhage, menorrhagia and dysmenorrhoea had resolved and the uterine inflammation had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, bladder disorder, depression, device breakage, device dislocation, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, epilepsy, fatigue, female sexual dysfunction, general physical health deterioration, genital haemorrhage, headache, loss of libido, menopausal symptoms, menorrhagia, migraine, mood altered, nausea, night sweats, pain, pain in extremity, pelvic inflammatory disease, pelvic pain, perforation, pyrexia, seizure, systemic inflammatory response syndrome, urinary tract disorder, uterine inflammation, vaginal haemorrhage, vomiting and weight decreased to be related to essure.The reporter commented: removal date provided as (b)(6) 2010, (b)(6) 2010.Three tailing coils on the right side and four trailing coils on the left.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 17.5 kg/sqm.Ultrasound - one coil had fallen into her uterus.Repeat ultrasound - left coil in the uterus, right side coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent into uterus at 90 degree angle ct (computed tomography) scan before hysterectomy - showed severe inflammation on (b)(6) 2010, both tubal ostia were identified.The essure device was deployed in each tubal ostia with three trailing coils on the right side and four trailing coils on the left.On (b)(6) 2010, ultrasound exam, the uterus was anteverted.Essure coil identified in both cornua, however, trailing coils noted within the endometrial cavity as well.Hysteroscopic exam performed in the office today after cervix prepped with technicare.The patient was noted to have essure coil within the fundus of the uterine cavity on her left side.The coil was removed.Impression-failed essure coil placement on the left side.On (b)(6) 2010, examination: cat abdomen/pelvis with contrast, impression: 1.Findings suggesting cecitis with adjacent reactive adenopathy.2.Otherwise, negative ct scan of the abdomen and pelvis.No pathologic change.On (b)(6) 2010, procedure performed: total laparoscopic hysterectomy with right salpingo-oophorectomy and cystoscopy.Findings: slightly enlarged boggy uterus, surgically absent left adnexa, unremarkable right adnexa, normal cystoscopy, essure noted to be tenting the tubal peritoneum on the left side.Impression: pelvic pain, abnormal uterine bleeding, failed endometrial ablation.Final pathologic diagnosis, uterus: inactive type endometrium.Superficial adenomyosis.Leiomyomas.Cervix: no pathologic change.Right ovary and fallopian tube: no pathologic change.On (b)(6) 2010, exam: pelviscopic incisions all healing well.Impression: normal postop exam.Exam: bilateral digital mammogram with implant views mammographic findings: digital mammographic views of both breasts show the breast tissue to be heterogeneously dense.Microlobulated nodule, 1 cm within the left lateral breast is noted on the implant displaced views without associated microcalcifications or architectural distortion.The right breast was negative for suspicious mass, microcalcification, or architectural distortion.Presence of bilateral retropectoral implants were noted.Impression: bi-rads 0.Incomplete: need additional imaging evaluation.On (b)(6) 2010, exam: bilateral digital mammogram with implant views mammographic findings: the breast tissue was heterogeneously dense.This may lower the sensitivity of mammography.Bilateral breast implants are noted.There are no suspicious masses, clustered microcalcifications, architectural distortion, or secondary signs of malignancy.There has been no significant interval change.Impression: negative examination.Bi-rads 1.Findings: the background pattern of fibroglandular enhancement was mild.Right breast: there are no suspicious enhancing mass or non-mass like areas identified in the right breast.The right axilla is unremarkable.Left breast: there are no suspicious enhancing mass or non-mass like areas identified in the left breast.The left axilla was unremarkable.Impression: 1.No suspicious areas of enhancement seen in either breast.2.The right implant has developed an intra-and extracapsular rupture with migration of silicone superiorly and medially behind the pectoralis muscle.On (b)(6) 2011, ct abdomen and pelvis w contrast impression: 1.Status post hysterectomy, without definite ct evidence of complication.2.Constipation without obstruction.3.Slightly enlarged liver with suggestion of mild fatty infiltration.4.Degenerative disc disease in the lumbar spine.On (b)(6) 2011, exam: mri of the lumbar spine without contrast.Impression: mild degenerative disc changes at l5-s1.Degenerative disc and facet changes at l4-5 with mild narrowing of the inferior aspect of the right neural foramen as above.On (b)(6) 2011, patient presents ten days following total laparoscopic hysterectomy with right salpingooophorectomy.Postoperatively, she has done well.Scant amount of dark fever.No discharge noted.No odor.Exam: pelviscopic incisions all healing well.Impression: normal postop exam.(b)(6) 2010: transvaginal ultrasound : unilateral occlusion (right tube occluded), right side was in place and the left side was in the uterine cavity and removed concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, genital haemorrhage, device expulsion and autoimmune deficiency, primary autoimmune disease.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-feb-2020: pif received- new event perforation was added.Surgery ablation was added.Incident.We received a lot number in this case.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 case was initially received via regulatory authority (food and drug administration, reference number: mw5032620 on 13-jan-2014.The most recent information was received on 15-jul-2020.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('pid pelvic inflammatory disease'), device breakage ('device breakage/ failure to occlude (close) fallopian tube'), perforation ('perforation'), device dislocation ('right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle / malposition of essure location of device: uterine cavity'), genital haemorrhage ('abnormal bleeding (general)') and systemic inflammatory response syndrome ('autoimmune disorder : primary inflammatory response, but triggering immune response and deterioration') in a 47-year-old female patient who had essure (batch no.740668) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent at 90 degrees angle" (seriousness criteria medically significant and intervention required) in 2010, patient-device incompatibility "got really sick, body was trying to reject the coil" and device monitoring procedure not performed "no she did not undergo essure confirmation test".The patient's medical history included cesarean section in 2003, gravida in 2003, irritable bowel syndrome, nonsmoker and hip surgery.Patient was a nonsmoker and no alcohol abuse.Previously administered products included for birth control: loestrin.Concurrent conditions included body mass index normal and uterine bleeding.Concomitant products included hydrocodone bitartrate;paracetamol (vicodin), progesterone (progesterone) and trazodone.In 2010, the patient experienced uterine inflammation ("chronic inflammation"), general physical health deterioration ("so sick her body was shutting down"), pyrexia ("running fevers"), vomiting ("vomiting") and diarrhoea ("chronic diarrhea").On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain ("prolonged chronic pain / pain").In (b)(6) 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2010, the patient was found to have weight decreased ("losing weight") and experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), abdominal pain ("abdominal pain"), depression ("psychological or psychiatric problems : depression"), nausea ("nausea") and pain ("chronic pain syndrome").On (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and device expulsion ("right coil had fallen into uterus / malposition of essure device location of device: uterine cavity/intrauterine device is identified that is grossly embedded into the myometrium").On (b)(6) 2011, the patient experienced allergy to metals ("cobalt allergy / nickel/ nickel allergy ").In (b)(6) 2012, the patient experienced menopausal symptoms ("hormonal changes describe: put in complete menopause").In 2013, the patient experienced systemic inflammatory response syndrome (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced epilepsy ("epilepsy") and seizure ("seizures").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), perforation (seriousness criterion medically significant), genital haemorrhage (seriousness criteria medically significant and intervention required), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems or changes"), night sweats ("night sweats"), loss of libido ("diminished sex drive"), abdominal pain lower ("right lower quadrant pain/ abdominal pain"), pain in extremity ("right leg pain"), arthralgia ("hip pain") and mood altered ("mood changes").The patient was treated with oxycodone hydrochloride;paracetamol (percocet) and surgery ( (b)(6) 2010 underwent novasure endometrial ablation, ablation, ablation , surgical removal of coil(s) / hysterectomy with unilateral salpingectomy and surgical removal of coil(s), hysterectomy with bilateral salpingo- oopherectomy).Essure was removed on (b)(6) 2010.In 2010, the device dislocation had resolved.At the time of the report, the pelvic inflammatory disease, device breakage, perforation, systemic inflammatory response syndrome, general physical health deterioration, weight decreased, pyrexia, vomiting, diarrhoea, menopausal symptoms, allergy to metals, female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, headache, epilepsy, seizure, dyspareunia, fatigue, alopecia, night sweats, loss of libido, abdominal pain lower, pain in extremity, arthralgia, abdominal pain, depression, mood altered, nausea and pain outcome was unknown, the genital haemorrhage, pelvic pain, device expulsion, vaginal haemorrhage, menorrhagia and dysmenorrhoea had resolved and the uterine inflammation had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, bladder disorder, depression, device breakage, device dislocation, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, epilepsy, fatigue, female sexual dysfunction, general physical health deterioration, genital haemorrhage, headache, loss of libido, menopausal symptoms, menorrhagia, migraine, mood altered, nausea, night sweats, pain, pain in extremity, pelvic inflammatory disease, pelvic pain, perforation, pyrexia, seizure, systemic inflammatory response syndrome, urinary tract disorder, uterine inflammation, vaginal haemorrhage, vomiting and weight decreased to be related to essure.The reporter commented: removal date provided as (b)(6) 2010, (b)(6) 2010.Three tailing coils on the right side and four trailing coils on the left.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 17.5 kg/sqm.Ultrasound - one coil had fallen into her uterus repeat ultrasound - left coil in the uterus, right side coil was stuck 15 percent in the tube and 85 percent in the uterus and was bent into uterus at 90 degree angle ct (computed tomography) scan before hysterectomy - showed severe inflammation on (b)(6) 2010, both tubal ostia were identified.The essure device was deployed in each tubal ostia with three trailing coils on the right side and four trailing coils on the left.On (b)(6) 2010, ultrasound exam, the uterus was anteverted.Essure coil identified in both cornua, however, trailing coils noted within the endometrial cavity as well.Hysteroscopic exam performed in the office today after cervix prepped with technicare.The patient was noted to have essure coil within the fundus of the uterine cavity on her left side.The coil was removed.Impression-failed essure coil placement on the left side.On (b)(6) 2010, examination: cat abdomen/pelvis with contrast, impression: findings suggesting cecitis with adjacent reactive adenopathy.Otherwise, negative ct scan of the abdomen and pelvis.No pathologic change.On (b)(6) 2010, procedure performed: total laparoscopic hysterectomy with right salpingo-oophorectomy and cystoscopy.Findings: slightly enlarged boggy uterus, surgically absent left adnexa, unremarkable right adnexa, normal cystoscopy, essure noted to be tenting the tubal peritoneum on the left side.Impression: pelvic pain, abnormal uterine bleeding, failed endometrial ablation.Final pathologic diagnosis uterus: inactive type endometrium.Superficial adenomyosis.Leiomyomas.Cervix: no pathologic change.Right ovary and fallopian tube: no pathologic change.On (b)(6) 2010, exam: pelviscopic incisions all healing well.Impression: normal postop exam.Exam: bilateral digital mammogram with implant views mammographic findings: digital mammographic views of both breasts show the breast tissue to be heterogeneously dense.Microlobulated nodule, 1 cm within the left lateral breast is noted on the implant displaced views without associated microcalcifications or architectural distortion.The right breast was negative for suspicious mass, microcalcification, or architectural distortion.Presence of bilateral retropectoral implants were noted.Impression: bi-rads 0.Incomplete: need additional imaging evaluation.On (b)(6) 2010, exam: bilateral digital mammogram with implant views mammographic findings: the breast tissue was heterogeneously dense.This may lower the sensitivity of mammography.Bilateral breast implants are noted.There are no suspicious masses, clustered microcalcifications, architectural distortion, or secondary signs of malignancy.There has been no significant interval change.Impression: negative examination.Bi-rads 1 findings: the background pattern of fibroglandular enhancement was mild.Right breast: there are no suspicious enhancing mass or non-mass like areas identified in the right breast.The right axilla is unremarkable.Left breast: there are no suspicious enhancing mass or non-mass like areas identified in the left breast.The left axilla was unremarkable.Impression: no suspicious areas of enhancement seen in either breast.The right implant has developed an intra-and extracapsular rupture with migration of silicone superiorly and medially behind the pectoralis muscle.On (b)(6) 2011, ct abdomen and pelvis w contrast impression: status post hysterectomy, without definite ct evidence of complication.Constipation without obstruction.Slightly enlarged liver with suggestion of mild fatty infiltration.Degenerative disc disease in the lumbar spine.On (b)(6) 2011, exam: mri of the lumbar spine without contrast.Impression: mild degenerative disc changes at l5-s1.Degenerative disc and facet changes at l4-5 with mild narrowing of the inferior aspect of the right neural foramen as above.On (b)(6) 2011, patient presents ten days following total laparoscopic hysterectomy with right salpingooophorectomy.Postoperatively, she has done well.Scant amount of dark fever.No discharge noted.No odor.Exam: pelviscopic incisions all healing well.Impression: normal postop exam.(b)(6) 2010 : transvaginal ultrasound : unilateral occlusion (right tube occluded), right side was in place and the left side was in the uterine cavity and removed concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, genital haemorrhage, device expulsion and autoimmune deficiency, primary autoimmune disease.Lot number: 740668.Manufacture date: 2010-05.Expiration date: 2013-05.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-jul-2020: quality-safety evaluation of ptc.We received a lot number in this case.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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