| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Edema (1820); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Uterine Perforation (2121); Cramp(s) (2193); Arthralgia (2355); Sleep Dysfunction (2517); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Menorrhagia (4508)
|
| Event Date 01/01/2013 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("left essure coil was seen medially abutting the endometrium/ left essure coil protruding into the endometrial cavity/ uterine foreign body"), pelvic pain ("pelvic pain") and menorrhagia ("menorrhagia with regular cycles") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure placement, plaintiff menstrual cycle was normal and regular, and she did not rely on oral contraceptives or other forms of birth control to manage her menstrual cycle.Concurrent conditions included general anesthesia (underwent the essure procedure under general anesthesia.) since 2007.On (b)(6) 2007, the patient had essure inserted.In 2013, 8 years 4 months after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), back pain ("back pain"), insomnia ("insomnia"), dysmenorrhoea ("dysmenorrhea"), oedema peripheral ("lower extremity edema") and headache ("headaches").On (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced abdominal distension ("bloating"), abdominal pain lower ("cramps"), diarrhoea ("diarrhea"), nausea ("nausea") and memory impairment ("forgetfulness").In (b)(6) 2016, the patient experienced device expulsion ("the right essure coil was not visualized/ the right essure coil could not be located within the right fallopian tube/ radiology could not identify any retained coils").On an unknown date, the patient experienced fatigue ("fatigue"), menometrorrhagia ("menometrorrhagia"), arthralgia ("joint pain"), alopecia ("hair loss") and weight increased ("weight gain").The patient was treated with surgery (robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, pelvic pain, menorrhagia, device expulsion, back pain, fatigue, insomnia, dysmenorrhoea, menometrorrhagia, oedema peripheral, headache, arthralgia, alopecia, weight increased, abdominal distension, abdominal pain lower, nausea and memory impairment outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, arthralgia, back pain, device dislocation, device expulsion, diarrhoea, dysmenorrhoea, fatigue, headache, insomnia, memory impairment, menometrorrhagia, menorrhagia, nausea, oedema peripheral, pelvic pain and weight increased to be related to essure.Diagnostic results: on (b)(6) 2016, patient underwent an ultrasound of the pelvis in which the left essure coil was seen medially abutting the endometrium and the right essure coil was not visualized.On (b)(6) 2016, patient underwent an hsg test which showed that bilateral fallopian tube occlusion and noted bilateral fallopian tube occlusion devices.The operative report noted the left essure coil protruding into the endometrial cavity, but stated that the right essure coil could not be located within the right fallopian tube.On (b)(6) 2016, patient was evaluated for a possible retained right essure coil.Radiology could not identify any retained coils, despite the fact that on (b)(6) 2016 both coils were found via the hsg test.Company causality comment: this litigation case report refers to a female plaintiff who had essure(fallopian tube occlusion insert) inserted on (b)(6) 2007, and reported adverse events including left essure coil was seen medially abutting the endometrium/ left essure coil protruding into the endometrial cavity/uterine foreign body, pelvic pain and menorrhagia with regular cycles.The plaintiff had surgery to remove the essure implant approximately eight years and six months after insertion ((b)(6) 2016).During essure micro-insert therapy, there is a risk that the device could move out of the fallopian tubes.This movement could be a device expulsion into the uterus/out of the body, device dislocation into the fallopian tube or can occur as a result of a perforation during insertion.In this particular case, after eight years four months after insertion, plaintiff underwent an ultrasound of the pelvis which showed the left essure coil was seen medially abutting the endometrium.Later, she underwent total laparoscopic hysterectomy and bilateral salpingectomy due to her menorrhagia, pelvic pain, and the uterine foreign body.This case was classified as incident since device removal was required.A product technical analysis is being sought.Follow-up information will be obtained through the litigation process.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("left essure coil was seen medially abutting the endometrium/ left essure coil protruding into the endometrial cavity/ uterine foreign body"), pelvic pain ("pelvic pain") and menorrhagia ("menorrhagia with regular cycles") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure placement, plaintiff menstrual cycle was normal and regular, and she did not rely on oral contraceptives or other forms of birth control to manage her menstrual cycle.Concurrent conditions included general anesthesia (underwent the essure procedure under general anesthesia) since 2007.On (b)(6) 2007, the patient had essure inserted.In 2013, 8 years 4 months after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), back pain ("back pain"), insomnia ("insomnia"), dysmenorrhoea ("dysmenorrhea"), oedema peripheral ("lower extremity edema") and headache ("headaches").In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), back pain ("back pain"), insomnia ("insomnia"), dysmenorrhoea ("dysmenorrhea"), oedema peripheral ("lower extremity edema") and headache ("headaches").On (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced abdominal distension ("bloating"), abdominal pain lower ("cramps"), diarrhoea ("diarrhea"), nausea ("nausea") and memory impairment ("forgetfulness").In (b)(6) 2016, the patient experienced device expulsion ("the right essure coil was not visualized/ the right essure coil could not be located within the right fallopian tube/ radiology could not identify any retained coils").On an unknown date, the patient experienced fatigue ("fatigue"), menometrorrhagia ("menometrorrhagia"), arthralgia ("joint pain"), alopecia ("hair loss") and weight increased ("weight gain").On an unknown date, the patient experienced fatigue ("fatigue"), menometrorrhagia ("menometrorrhagia"), arthralgia ("joint pain"), alopecia ("hair loss") and weight increased ("weight gain").The patient was treated with surgery (robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, pelvic pain, menorrhagia, device expulsion, back pain, fatigue, insomnia, dysmenorrhoea, menometrorrhagia, oedema peripheral, headache, arthralgia, alopecia, weight increased, abdominal distension, abdominal pain lower, nausea and memory impairment outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, arthralgia, back pain, device dislocation, device expulsion, diarrhoea, dysmenorrhoea, fatigue, headache, insomnia, memory impairment, menometrorrhagia, menorrhagia, nausea, oedema peripheral, pelvic pain and weight increased to be related to essure.Diagnostic results: on (b)(6) 2016, patient underwent an ultrasound of the pelvis in which the left essure coil was seen medially abutting the endometrium and the right essure coil was not visualized.On (b)(6) 2016, patient underwent an hsg test which showed that bilateral fallopian tube occlusion and noted bilateral fallopian tube occlusion devices.The operative report noted the left essure coil protruding into the endometrial cavity, but stated that the right essure coil could not be located within the right fallopian tube.On (b)(6) 2016, patient was evaluated for a possible retained right essure coil.Radiology could not identify any retained coils, despite the fact that on (b)(6) 2016 both coils were found via the hsg test.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.Based on the available information, a product quality defect could not be confirmed but is considered plausible.A relationship between the reported medical events and a quality defect cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases cannot be evaluated.Most recent follow-up information incorporated above includes: on 27-apr-2017: quality-safety evaluation of product technical complaint.Company causality comment: this litigation case report refers to a female plaintiff who had essure(fallopian tube occlusion insert) inserted on (b)(6) 2007, and reported adverse events including left essure coil was seen medially abutting the endometrium/ left essure coil protruding into the endometrial cavity/uterine foreign body, pelvic pain and menorrhagia with regular cycles.The plaintiff had surgery to remove the essure implant approximately eight years and six months after insertion ((b)(6) 2016).During essure micro-insert therapy, there is a risk that the device could move out of the fallopian tubes.This movement could be a device expulsion into the uterus/out of the body, device dislocation into the fallopian tube or can occur as a result of a perforation during insertion.In this particular case, eight years four months after insertion, plaintiff underwent an ultrasound of the pelvis which showed the left essure coil was seen medially abutting the endometrium.Later, she underwent total laparoscopic hysterectomy and bilateral salpingectomy due to her menorrhagia, pelvic pain, and the uterine foreign body.This case was classified as incident since device removal was required.Based on the available information, a product quality defect could not be confirmed but is considered plausible.A relationship between the reported medical events and a quality defect cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases cannot be evaluated.Follow-up information will be obtained through the litigation process.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('left essure coil was seen medially abutting the endometrium/ left essure coil protruding into the endometrial cavity/ uterine foreign body/perforation- yes'), device dislocation ('the right essure coil was not visualized/ the right essure coil could not be located within the right fallopian tube/ radiology could not identify any retained coils/the right device could not be found/migration-yes'), pelvic pain ('pelvic pain') and menorrhagia ('menorrhagia with regular cycles/abnormal bleeding') in a 23-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure placement, plaintiff menstrual cycle was normal and regular, and she did not rely on oral contraceptives or other forms of birth control to manage her menstrual cycle.Concurrent conditions included general anesthesia (underwent the essure procedure under general anesthesia.) since 2007.On (b)(6) 2007, the patient had essure inserted.In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain") and headache ("headaches"), 8 years 4 months after insertion of essure.In 2013, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), insomnia ("insomnia"), dysmenorrhoea ("dysmenorrhea") and oedema peripheral ("lower extremity edema").On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced abdominal distension ("bloating"), abdominal pain lower ("cramps"), diarrhea ("diarrhea"), nausea ("nausea") and memory impairment ("forgetfulness").In (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced fatigue ("fatigue").On an unknown date, the patient experienced menometrorrhagia ("menometrorrhagia"), arthralgia ("joint pain"), alopecia ("hair loss") and hypersensitivity ("hypersensitivity") and was found to have weight increased ("weight gain").The patient was treated with surgery (a robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016, robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy and robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device dislocation, pelvic pain, menorrhagia, back pain, fatigue, insomnia, dysmenorrhoea, menometrorrhagia, oedema peripheral, headache, arthralgia, alopecia, weight increased, abdominal distension, abdominal pain lower, nausea, memory impairment and hypersensitivity outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, arthralgia, back pain, device dislocation, diarrhoea, dysmenorrhoea, fatigue, headache, hypersensitivity, insomnia, memory impairment, menometrorrhagia, menorrhagia, nausea, oedema peripheral, pelvic pain, uterine perforation and weight increased to be related to essure.The reporter commented: on (b)(6) 2016, patient was evaluated for a possible retained right essure coil.Radiology could not identify any retained coils.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2016: patient underwent an hsg test which showed that bilateral fallopian tube occlusion and noted bilateral fallopian tube occlusion devices.The operative report noted the left essure coil protruding into the endometrial cavity, but stated that the right essure coil could not be located within the right fallopian tube.Pathology test - on an unknown date: the pathology report from her removal surgery noted that the left device was protruding into the endometrial cavity and the right device could not be found.Ultrasound pelvis - on (b)(6) 2016: the left essure coil was seen medially abutting the endometrium and the right essure coil was not visualized.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 25-sep-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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('left essure coil was seen medially abutting the endometrium/ left essure coil protruding into the endometrial cavity/ uterine foreign body/perforation- yes'), device dislocation ('the right essure coil was not visualized/ the right essure coil could not be located within the right fallopian tube/ radiology could not identify any retained coils/the right device could not be found/migration-yes'), pelvic pain ('pelvic pain') and menorrhagia ('menorrhagia with regular cycles/abnormal bleeding') in a 23-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure placement, plaintiff menstrual cycle was normal and regular, and she did not rely on oral contraceptives or other forms of birth control to manage her menstrual cycle.Concurrent conditions included general anesthesia (underwent the essure procedure under general anesthesia.) since 2007.On (b)(6) 2007, the patient had essure inserted.In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain") and headache ("headaches"), 8 years 4 months after insertion of essure.In 2013, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), insomnia ("insomnia"), dysmenorrhoea ("dysmenorrhea") and oedema peripheral ("lower extremity edema").On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced abdominal distension ("bloating"), abdominal pain lower ("cramps"), diarrhoea ("diarrhea"), nausea ("nausea") and memory impairment ("forgetfulness").In (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced fatigue ("fatigue").On an unknown date, the patient experienced menometrorrhagia ("menometrorrhagia"), arthralgia ("joint pain"), alopecia ("hair loss") and hypersensitivity ("hypersensitivity") and was found to have weight increased ("weight gain").The patient was treated with surgery (a robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy ).Essure was removed on (b)(6)2016.At the time of the report, the uterine perforation, device dislocation, pelvic pain, menorrhagia, back pain, fatigue, insomnia, dysmenorrhoea, menometrorrhagia, oedema peripheral, headache, arthralgia, alopecia, weight increased, abdominal distension, abdominal pain lower, nausea, memory impairment and hypersensitivity outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, arthralgia, back pain, device dislocation, diarrhoea, dysmenorrhoea, fatigue, headache, hypersensitivity, insomnia, memory impairment, menometrorrhagia, menorrhagia, nausea, oedema peripheral, pelvic pain, uterine perforation and weight increased to be related to essure.The reporter commented: on (b)(6) 2016, patient was evaluated for a possible retained right essure coil.Radiology could not identify any retained coils.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2016: patient underwent an hsg test which showed that bilateral fallopian tube occlusion and noted bilateral fallopian tube occlusion devices.The operative report noted the left essure coil protruding into the endometrial cavity, but stated that the right essure coil could not be located within the right fallopian tube.Pathology test - on an unknown date: the pathology report from her removal surgery noted that the left device was protruding into the endometrial cavity and the right device could not be found.Ultrasound pelvis - on (b)(6) 2016: the left essure coil was seen medially abutting the endometrium and the right essure coil was not visualized.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.Based on the available information, a product quality defect could not be confirmed but is considered plausible.A relationship between the reported medical events and a quality defect cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases cannot be evaluated.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2020: pif received.Event added:genital bleeding, hypersensitivity, lawyer added.Event device dislocation updated to uterine perforation.Event device expulsion updated to device dislocation.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 uterine perforation ('left essure coil was seen medially abutting the endometrium/ left essure coil protruding into the endometrial cavity/ uterine foreign body/perforation- yes'), device dislocation ('the right essure coil was not visualized/ the right essure coil could not be located within the right fallopian tube/ radiology could not identify any retained coils/the right device could not be found/migration-yes'), pelvic pain ('pelvic pain') and heavy menstrual bleeding ('menorrhagia with regular cycles/abnormal bleeding') in a 31-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure placement, plaintiff menstrual cycle was normal and regular, and she did not rely on oral contraceptives or other forms of birth control to manage her menstrual cycle.Concurrent conditions included general anesthesia (underwent the essure procedure under general anesthesia.) since 2007.On 5-oct-2007, the patient had essure inserted.In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain") and headache ("headaches"), 8 years 4 months after insertion of essure.In 2013, the patient experienced heavy menstrual bleeding (seriousness criteria medically significant and intervention required), insomnia ("insomnia"), dysmenorrhoea ("dysmenorrhea") and oedema peripheral ("lower extremity edema").On 29-feb-2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required).On (b)(6) -2016, the patient experienced abdominal distension ("bloating"), abdominal pain lower ("cramps"), diarrhoea ("diarrhea"), nausea ("nausea") and memory impairment ("forgetfulness").In (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced fatigue ("fatigue").On an unknown date, the patient experienced menometrorrhagia ("menometrorrhagia"), arthralgia ("joint pain"), alopecia ("hair loss") and hypersensitivity ("hypersensitivity") and was found to have weight increased ("weight gain").The patient was treated with surgery (a robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016, robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy and robotic-assisted total laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device dislocation, pelvic pain, heavy menstrual bleeding, back pain, fatigue, insomnia, dysmenorrhoea, menometrorrhagia, oedema peripheral, headache, arthralgia, alopecia, weight increased, abdominal distension, abdominal pain lower, nausea, memory impairment and hypersensitivity outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, arthralgia, back pain, device dislocation, diarrhoea, dysmenorrhoea, fatigue, headache, heavy menstrual bleeding, hypersensitivity, insomnia, memory impairment, menometrorrhagia, nausea, oedema peripheral, pelvic pain, uterine perforation and weight increased to be related to essure.The reporter commented: on (b)(6) 2016, patient was evaluated for a possible retained right essure coil.Radiology could not identify any retained coils.Five intracavitary coils are noted on the right and 11 intracavitary coils are noted on the left following deployment diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2016: patient underwent an hsg test which showed that bilateral fallopian tube occlusion and noted bilateral fallopian tube occlusion devices.The operative report noted the left essure coil protruding into the endometrial cavity, but stated that the right essure coil could not be located within the right fallopian tube.Pathology test - on an unknown date: the pathology report from her removal surgery noted that the left device was protruding into the endometrial cavity and the right device could not be found.Ultrasound pelvis - on 29-feb-2016: the left essure coil was seen medially abutting the endometrium and the right essure coil was not visualized.Quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 3-jun-2021: mr received.Reporter information, reporter causality comment added 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.
|
| |
|
Search Alerts/Recalls
|
|
