MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Difficult to Remove (1528); Expulsion (2933)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Cyst(s) (1800); Flatus (1865); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Thyroid Problems (2102); Anxiety (2328); Injury (2348); Depression (2361); Inadequate Pain Relief (2388); Sweating (2444); Sleep Dysfunction (2517); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("sharp and persistent pelvic pains") in an adult female patient who had essure (batch no.772500) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "difficult to remove the essure" in (b)(6) 2012.The patient's past medical history included knee arthroscopy in 2007, tonsillectomy in (b)(6) 2013 and hysterectomy on (b)(6) 2014.Patient was not allergic to nickel or any other component of essure.Previously administered products included for an unreported indication: diazepam.Concurrent conditions included nulliparous, nausea and vomiting.Concomitant products included anaesthetics (anesthesia) and eugynon (levora) in 2009.In (b)(6) 2011, after insertion of essure, the patient experienced adrenal insufficiency ("adrenal fatigue").On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced embedment difficult to remove the essure depending on location of the essure in the uterine muscle)(seriousness criteria medically significant and intervention required), with pelvic pain, weight increased ("weight gain"), restless legs syndrome ("restless legs at night") and abdominal pain ("abdominal pain"),abdominal pain lower ("cramping"), thyroid disorder ("thyroid") and formication ("skin is crawling").In 2012, the patient experienced vaginal haemorrhage ("spotting").In 2013, the patient experienced allergy to chemicals ("chemical sensitivities"), food allergy ("food sensitivities") and gluten sensitivity ("gluten sensitivities").On an unknown date, the patient experienced injury ("severe and permanent injuries"), menorrhagia ("heavy periods"), night sweats ("night sweats"), dyspareunia ("painful intercourse"), abdominal distension ("severe bloating"), insomnia ("insomnia"), depression ("depression"), the first episode of anxiety ("anxiety"), feeling abnormal ("brain fog"), ovarian cyst ("ovarian cysts"), fallopian tube cyst ("fallopian tube cysts"), the second episode of anxiety ("mental anguish") and pain ("severe and persistent pain"), device expulsion difficult to remove the essure depending on location of the essure in the uterine muscle).The patient was treated with ibuprofen, liothyronine sodium (triiodothyroni) and surgery (remove essure with supracervical hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the injury, night sweats, dyspareunia, abdominal distension, insomnia, restless legs syndrome, feeling abnormal, allergy to chemicals, food allergy, gluten sensitivity, ovarian cyst, fallopian tube cyst, the last episode of anxiety, vaginal haemorrhage, abdominal pain, thyroid disorder and formication outcome was unknown, the abdominal pain lower, menorrhagia, adrenal insufficiency, depression and pain had resolved and the weight increased had not resolved.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, adrenal insufficiency, allergy to chemicals, depression, dyspareunia, fallopian tube cyst, feeling abnormal, food allergy, formication, gluten sensitivity, insomnia, menorrhagia, night sweats, ovarian cyst, pain, restless legs syndrome, thyroid disorder, vaginal haemorrhage, weight increased, the first episode of anxiety and the second episode of anxiety with essure.The reporter considered injury to be related to essure.The reporter commented: patient's weight is (b)(6).Patient had received medical treatment for adrenal fatigue, depression, anxiety, cramping, pelvic pain, spotting, heavy periods, chemical sensitivity, food sensitivity, food allergies and gluten sensitivities.She has not sought medical treatment for night sweats, painful intercourse, severe bloating, insomnia, weight issues (gain) restless legs at night mental health, brain fog (cloudiness, forgetfulness), ovarian cysts and fallopian tube cysts.Patient tried acupuncture and herbal supplements for adrenal fatigue.Right essure showed 3 coils visible in the endometrial cavity whereas right essure showed 4 coils.The patient tolerated the procedure well and was taken in stable condition to the recovery room.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine - on an unknown date: negative.On ??- (b)(6) 2012 hysterosalpingogram test was performed.Most recent follow-up information incorporated above includes: on (b)(6) 2017: essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (b)(4, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Reporters, essure lot number, events embedment, device expulsion, cramping,heavy periods, night sweats, painful intercourse, severe bloating, insomnia, weight issues (gain) restless legs at night, adrenal fatigue(tired restless, lethargic), slow thyroid (weight gain), depression, anxiety, mental health brain fog (cloudiness, forgetfulness), chemical and food sensitivities, food allergies, gluten sensitivities, ovarian cysts, fallopian tube cysts, mental anguish, pain, spotting, abdominal pain, skin is crawling, device difficult to remove, treatment medications, patient notes, lab data, concomitant drugs, historical conditions, concomitant disease 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("difficult to remove the essure depending on location of the essure in the uterine muscle") in an adult female patient who had essure (batch no.772500) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "difficult to remove the essure depending on location of the essure in the uterine muscle" in (b)(6) 2012.The patient's past medical history included knee arthroscopy in 2007, tonsillectomy in (b)(6) 2013 and hysterectomy on (b)(6) 2014.Patient was not allergic to nickel or any other component of essure.Previously administered products included for an unreported indication: diazepam.Concurrent conditions included nulliparous, nausea and vomiting.Concomitant products included anaesthetics (anesthesia) and eugynon (levora) in 2009.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced weight increased ("weight gain"), restless legs syndrome ("restless legs at night"), adrenal insufficiency ("adrenal fatigue") and abdominal pain ("abdominal pain").In (b)(6) 2012, the patient experienced abdominal pain lower ("cramping"), thyroid disorder ("thyroid") and formication ("skin is crawling").In 2012, the patient experienced vaginal haemorrhage ("spotting").In 2013, the patient experienced allergy to chemicals ("chemical sensitivities"), food allergy ("food sensitivities") and gluten sensitivity ("gluten sensitivities").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, injury ("severe and permanent injuries"), menorrhagia ("heavy periods"), night sweats ("night sweats"), dyspareunia ("painful intercourse"), abdominal distension ("severe bloating"), insomnia ("insomnia"), depression ("depression"), the first episode of anxiety ("anxiety"), feeling abnormal ("brain fog"), ovarian cyst ("ovarian cysts"), fallopian tube cyst ("fallopian tube cysts"), the second episode of anxiety ("mental anguish"), pain ("severe and persistent pain") and device expulsion ("difficult to remove the essure depending on location of the essure in the uterine muscle").The patient was treated with ibuprofen, liothyronine sodium (triiodothyroni) and surgery (remove essure with supracervical hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the embedded device, injury, night sweats, dyspareunia, abdominal distension, insomnia, restless legs syndrome, feeling abnormal, allergy to chemicals, food allergy, gluten sensitivity, ovarian cyst, fallopian tube cyst, the last episode of anxiety, vaginal haemorrhage, abdominal pain, thyroid disorder, device expulsion and formication outcome was unknown, the abdominal pain lower, menorrhagia, adrenal insufficiency, depression and pain had resolved and the weight increased had not resolved.The reporter considered device expulsion, embedded device and injury to be related to essure.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, adrenal insufficiency, allergy to chemicals, depression, dyspareunia, fallopian tube cyst, feeling abnormal, food allergy, formication, gluten sensitivity, insomnia, menorrhagia, night sweats, ovarian cyst, pain, restless legs syndrome, thyroid disorder, vaginal haemorrhage, weight increased, the first episode of anxiety and the second episode of anxiety with essure.The reporter commented: patient's weight is (b)(6).Patient had received medical treatment for adrenal fatigue, depression, anxiety, cramping, pelvic pain, spotting, heavy periods, chemical sensitivity, food sensitivity, food allergies and gluten sensitivities.She has not sought medical treatment for night sweats, painful intercourse, severe bloating, insomnia, weight issues (gain) restless legs at night mental health, brain fog (cloudiness, forgetfulness), ovarian cysts and fallopian tube cysts.Patient tried acupuncture and herbal supplements for adrenal fatigue.Right essure showed 3 coils visible in the endometrial cavity whereas right essure showed 4 coils.The patient tolerated the procedure well and was taken in stable condition to the recovery room.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine - on an unknown date: negative.On (b)(6) 2012 hysterosalpingogram test was performed.Most recent follow-up information incorporated above includes: on 11-dec-2017: correction to valid following company internal routine quality monitoring.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("difficult to remove the essure depending on location of the essure in the uterine muscle") in an adult female patient who had essure (batch no.772500) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "difficult to remove the essure depending on location of the essure in the uterine muscle" in (b)(6) 2012.The patient's past medical history included knee arthroscopy in 2007, tonsillectomy in (b)(6) 2013 and hysterectomy on (b)(6) 2014.Patient was not allergic to nickel or any other component of essure.Previously administered products included for an unreported indication: diazepam.Concurrent conditions included nulliparous, nausea and vomiting.Concomitant products included anaesthetics (anesthesia) and eugynon (levora) from 2009 to 2011.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced weight increased ("weight gain"), restless legs syndrome ("restless legs at night"), adrenal insufficiency ("adrenal fatigue") and abdominal pain ("abdominal pain").In (b)(6) 2012, the patient experienced abdominal pain lower ("cramping"), thyroid disorder ("thyroid") and formication ("skin is crawling").In 2012, the patient experienced vaginal haemorrhage ("spotting").In 2013, the patient experienced allergy to chemicals ("chemical sensitivities"), food allergy ("food sensitivities") and gluten sensitivity ("gluten sensitivities").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, injury ("severe and permanent injuries"), menorrhagia ("heavy periods"), night sweats ("night sweats"), dyspareunia ("painful intercourse"), abdominal distension ("severe bloating"), insomnia ("insomnia"), depression ("depression"), the first episode of anxiety ("anxiety"), feeling abnormal ("brain fog"), ovarian cyst ("ovarian cysts"), fallopian tube cyst ("fallopian tube cysts"), the second episode of anxiety ("mental anguish"), pain ("severe and persistent pain") and device expulsion ("difficult to remove the essure depending on location of the essure in the uterine muscle").The patient was treated with ibuprofen, liothyronine sodium (triiodothyroni) and surgery (remove essure with supracervical hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the embedded device, injury, night sweats, dyspareunia, abdominal distension, insomnia, restless legs syndrome, feeling abnormal, allergy to chemicals, food allergy, gluten sensitivity, ovarian cyst, fallopian tube cyst, the last episode of anxiety, vaginal haemorrhage, abdominal pain, thyroid disorder, device expulsion and formication outcome was unknown, the abdominal pain lower, menorrhagia, adrenal insufficiency, depression and pain had resolved and the weight increased had not resolved.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, adrenal insufficiency, allergy to chemicals, depression, dyspareunia, fallopian tube cyst, feeling abnormal, food allergy, formication, gluten sensitivity, insomnia, menorrhagia, night sweats, ovarian cyst, pain, restless legs syndrome, thyroid disorder, vaginal haemorrhage, weight increased, the first episode of anxiety and the second episode of anxiety with essure.The reporter considered device expulsion, embedded device and injury to be related to essure.The reporter commented: patient's weight is 144.Patient had received medical treatment for adrenal fatigue, depression, anxiety, cramping, pelvic pain, spotting, heavy periods, chemical sensitivity, food sensitivity, food allergies and gluten sensitivities.She has not sought medical treatment for night sweats, painful intercourse, severe bloating, insomnia, weight issues (gain) restless legs at night mental health, brain fog (cloudiness, forgetfulness), ovarian cysts and fallopian tube cysts.Patient tried acupuncture and herbal supplements for adrenal fatigue.Right essure showed 3 coils visible in the endometrial cavity whereas right essure showed 4 coils.The patient tolerated the procedure well and was taken in stable condition to the recovery room.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine - on an unknown date: negative.On (b)(6) 2012 hysterosalpingogram test was performed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-may-2018: quality-safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7066112
• MDR Text Key: 93179900
• Report Number: 2951250-2017-09228
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2013
• Device Model Number: ESS305
• Device Lot Number: 772500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANESTHESIA; ANESTHESIA; ANESTHESIA; LEVORA; LEVORA; LEVORA; ANESTHESIA; LEVORA
• Patient Outcome(s): Other; Required Intervention