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

Model Number ESS305

Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Itching Sensation (1943); Menstrual Irregularities (1959); Pain (1994); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Anxiety (2328); Arthralgia (2355); Depression (2361); Fasciitis (2375); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 01/01/2012

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain/pain") and endometriosis ("essure worsened a previously existing injury/condition: endometriosis") in a female patient who had essure (batch no.855630) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included endometriosis, right lower quadrant pain, breast tenderness, bloating, hair loss, pain of lower extremities, low back pain, disorientated, plantar fasciitis, vaginal itching and amenorrhea.Concomitant products included leuprorelin acetate (lupron) for pain as well as vicodin.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), depression ("depression"), anxiety ("mental anguish") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2012, the patient experienced weight increased ("weight gain").In (b)(6) 2015, the patient experienced vaginal haemorrhage ("abnormal bleeding(vaginal)") and menorrhagia ("abnormal bleeding( menorrhagia)").In (b)(6) 2016, the patient experienced vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced endometriosis (seriousness criterion medically significant), menstrual disorder ("menstruation issues") and abdominal pain lower ("lower abdominal pain").Essure treatment was not changed.At the time of the report, the pelvic pain, endometriosis, menstrual disorder, vaginal haemorrhage, menorrhagia, dysmenorrhoea, depression, anxiety, vaginal discharge, weight increased, dyspareunia and abdominal pain lower outcome was unknown.The reporter considered abdominal pain lower, anxiety, depression, dysmenorrhoea, dyspareunia, endometriosis, menorrhagia, menstrual disorder, pelvic pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: current weight (b)(6).Insertion of essure: there were 3 coils noted in the tube.The same was done on the left tube.Again, 3 coils were noted at the end.Procedure was performed well.The plaintiff had multiple hospital visits for management of chronic pelvic pain (lupron therapy, motrin).The plaintiff is currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).Hysterosalpingogram - on (b)(6) 2011: confirmed essure device was successfully.Occluded; on (b)(6) 2011: bilateral tubal occlusion.On (b)(6) 2015 ultrasound pelvis revealed, probable endometrioma 1 x 2 x 3cm within the left adnexa, with mild compression of the adjacent fallopian tube resulting in mild hydrosalpinx.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records:lower abdominal pain, dysmenorrhea, weight gain,chronic pelvic pain,vaginal discharge,vaginal pain with intercourse.Most recent follow-up information incorporated above includes: on (b)(6) 2018: events:abnormal bleeding (vaginal, menorrhagia), dysmenorrhea (cramping), psychological or psychiatric problems condition: depression and mental anguish, vaginal discharge, weight gain, dyspareunia (painful sexual intercourse) and endometriosis were added.Concomitant drug, concomitant disease , lab data were 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

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain/pain") and endometriosis ("essure worsened a previously existing injury/condition: endometriosis") in an adult female patient who had essure (batch no.855630) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included endometriosis, right lower quadrant pain, breast tenderness, bloating, hair loss, pain of lower extremities, low back pain, disorientated, plantar fasciitis, vaginal itching and amenorrhea.Concomitant products included leuprorelin acetate (lupron) for pain as well as vicodin.On (b)(6) 2011, the patient had essure inserted.In january 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), depression ("depression"), anxiety ("mental anguish") and dyspareunia ("dyspareunia (painful sexual intercourse)").In july 2012, the patient experienced weight increased ("weight gain").In august 2015, the patient experienced vaginal haemorrhage ("abnormal bleeding(vaginal)") and menorrhagia ("abnormal bleeding( menorrhagia)").In november 2016, the patient experienced vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced endometriosis (seriousness criterion medically significant), menstrual disorder ("menstruation issues") and abdominal pain lower ("lower abdominal pain").Essure treatment was not changed.At the time of the report, the pelvic pain, endometriosis, menstrual disorder, vaginal haemorrhage, menorrhagia, dysmenorrhoea, depression, anxiety, vaginal discharge, weight increased, dyspareunia and abdominal pain lower outcome was unknown.The reporter considered abdominal pain lower, anxiety, depression, dysmenorrhoea, dyspareunia, endometriosis, menorrhagia, menstrual disorder, pelvic pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: current weight 208 lbs.Insertion of essure:there were 3 coils noted in the tube.The same was done on the left tube.Again, 3 coils were noted at the end.Procedure was performed well.The plaintiff had multiple hospital visits for management of chronic pelvic pain (lupron therapy, motrin).The plaintiff is currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 72.5 kgs.Hysterosalpingogram - on 1-oct-2011: confirmed essure device was successfully occluded; on 8-oct-2011: bilateral tubal occlusion.On 13-aug-2015 ultrasound pelvis revealed, probable endometrioma 1 x 2 x 3cm within the left adnexa, with mild compression of the adjacent fallopian tube resulting in mild hydrosalpinx.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records:lower abdominal pain, dysmenorrhea, weight gain,chronic pelvic pain,vaginal discharge,vaginal pain with intercourse quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-aug-2018: quality safety evaluation of product technical complaints.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

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain/pain") and endometriosis ("essure worsened a previously existing injury/condition: endometriosis") in an adult female patient who had essure (batch no.855630) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included endometriosis, right lower quadrant pain, breast tenderness, bloating, hair loss, pain of lower extremities, low back pain, disorientated, plantar fasciitis, vaginal itching and amenorrhea.Concomitant products included leuprorelin acetate (lupron) for pain as well as gabapentin since 2014, naproxen, paracetamol (acetaminophen) since 2011 and vicodin.On (b)(6)2011, the patient had essure inserted.In (b)(6)2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), depression ("depression"), anxiety ("mental anguish") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6)2012, the patient experienced weight increased ("weight gain").In (b)(6)2015, the patient experienced vaginal haemorrhage ("abnormal bleeding(vaginal)") and menorrhagia ("abnormal bleeding( menorrhagia)").In (b)(6)2016, the patient experienced vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced endometriosis (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), abdominal pain lower ("lower abdominal pain") and vulvovaginitis ("infection; vulgo vaginitis").Essure treatment was not changed.At the time of the report, the pelvic pain, endometriosis, menstrual disorder, vaginal haemorrhage, menorrhagia, dysmenorrhoea, depression, anxiety, vaginal discharge, weight increased, dyspareunia, abdominal pain lower and vulvovaginitis outcome was unknown.The reporter considered abdominal pain lower, anxiety, depression, dysmenorrhoea, dyspareunia, endometriosis, menorrhagia, menstrual disorder, pelvic pain, vaginal discharge, vaginal haemorrhage, vulvovaginitis and weight increased to be related to essure.The reporter commented: current weight 208 lbs.Insertion of essure:there were 3 coils noted in the tube.The same was done on the left tube.Again, 3 coils were noted at the end.Procedure was performed well.The plaintiff had multiple hospital visits for management of chronic pelvic pain (lupron therapy, motrin).The plaintiff is currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 72.5 kgs.Hysterosalpingogram - on (b)(6)2011: confirmed essure device was successfully occluded; on (b)(6)2011: bilateral tubal occlusion.On (b)(6)2015 ultrasound pelvis revealed, probable endometrioma 1 x 2 x 3cm within the left adnexa, with mild compression of the adjacent fallopian tube resulting in mild hydrosalpinx.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records:lower abdominal pain, dysmenorrhea, weight gain,chronic pelvic pain,vaginal discharge,vaginal pain with intercourse quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6)2018: pfs received: new event infection; vulgo vaginitis and concomitant drugs were 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 pelvic pain ('pelvic pain/pain') and endometriosis ('essure worsened a previously existing injury/condition: endometriosis') in an adult female patient who had essure (batch no.855630) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cervicitis, uterine leiomyoma and endosalpingiosis.On (b)(6) 2015 ultrasound pelvis revealed, probable endometrioma 1 x 2 x 3cm within the left adnexa, with mild compression of the adjacent fallopian tube resulting in mild hydrosalpinx.Concurrent conditions included endometriosis, right lower quadrant pain, breast tenderness, bloating, hair loss, pain of lower extremities, low back pain, disorientated, plantar fasciitis, vaginal itching, amenorrhea and asthma.Concomitant products included leuprorelin acetate (lupron) for pain as well as gabapentin since 2014, hydrocodone bitartrate;paracetamol (vicodin), medroxyprogesterone acetate (depo-provera), naproxen, paracetamol (acetaminophen) since 2011 and salbutamol sulfate (albuterol sulfate).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient was found to have weight increased ("weight gain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), depression ("depression"), anxiety ("mental anguish") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2015, the patient experienced endometriosis (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding(vaginal)") and menorrhagia ("abnormal bleeding( menorrhagia)").In (b)(6) 2016, the patient experienced vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced device expulsion ("silver metal coil is identified in the right aspect of the endometrial cavity located near the right fallopian tube."), menstrual disorder ("menstruation issues"), abdominal pain lower ("lower abdominal pain") and vulvovaginitis ("infection; vulgo vaginitis").The patient was treated with surgery (hysterectomy with left salpingectomy and partial right salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, endometriosis, device expulsion, menstrual disorder, vaginal haemorrhage, menorrhagia, dysmenorrhoea, depression, anxiety, vaginal discharge, weight increased, dyspareunia, abdominal pain lower and vulvovaginitis outcome was unknown.The reporter considered abdominal pain lower, anxiety, depression, device expulsion, dysmenorrhoea, dyspareunia, endometriosis, menorrhagia, menstrual disorder, pelvic pain, vaginal discharge, vaginal haemorrhage, vulvovaginitis and weight increased to be related to essure.The reporter commented: current weight 208 lbs.Insertion of essure:there were 3 coils noted in the tube.The same was done on the left tube.Again, 3 coils were noted at the end.Procedure was performed well.The plaintiff had multiple hospital visits for management of chronic pelvic pain (lupron therapy, motrin).The plaintiff is currently planning for essure removal.She received treatment for pain, abnormal bleeding, psychotic injury, bladder/urinary problems.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 72.5 kgs.Hysterosalpingogram - on (b)(6) 2011: results: confirmed essure device was successfully occluded; on (b)(6) 2011: results: bilateral tubal occlusion.Lot number: 855630 manufacture date: 2011-04 expiration date: 2014-04.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records:lower abdominal pain, dysmenorrhea, weight gain,chronic pelvic pain,vaginal discharge,vaginal pain with intercourse.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 23-mar-2021: quality safety evaluation of product technical complaint.We received a lot number in this case.A technical investigation was 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain/pain') and endometriosis ('essure worsened a previously existing injury/condition: endometriosis') in an adult female patient who had essure (batch no.855630) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cervicitis, uterine leiomyoma and endosalpingiosis.Concurrent conditions included endometriosis, right lower quadrant pain, breast tenderness, bloating, hair loss, pain of lower extremities, low back pain, disorientated, plantar fasciitis, vaginal itching, amenorrhea and asthma.Concomitant products included leuprorelin acetate (lupron) for pain as well as gabapentin since 2014, hydrocodone bitartrate;paracetamol (vicodin), medroxyprogesterone acetate (depo-provera), naproxen, paracetamol (acetaminophen) since 2011 and salbutamol sulfate (albuterol sulfate).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient was found to have weight increased ("weight gain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), depression ("depression"), anxiety ("mental anguish") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2015, the patient experienced endometriosis (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding(vaginal)") and menorrhagia ("abnormal bleeding( menorrhagia)").In (b)(6) 2016, the patient experienced vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced device expulsion ("silver metal coil is identified in the right aspect of the endometrial cavity located near the right fallopian tube."), menstrual disorder ("menstruation issues"), abdominal pain lower ("lower abdominal pain") and vulvovaginitis ("infection; vulgo vaginitis").The patient was treated with surgery (hysterectomy with left salpingectomy and partial right salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, endometriosis, device expulsion, menstrual disorder, vaginal haemorrhage, menorrhagia, dysmenorrhoea, depression, anxiety, vaginal discharge, weight increased, dyspareunia, abdominal pain lower and vulvovaginitis outcome was unknown.The reporter considered abdominal pain lower, anxiety, depression, device expulsion, dysmenorrhoea, dyspareunia, endometriosis, menorrhagia, menstrual disorder, pelvic pain, vaginal discharge, vaginal haemorrhage, vulvovaginitis and weight increased to be related to essure.The reporter commented: current weight 208 lbs.Insertion of essure:there were 3 coils noted in the tube.The same was done on the left tube.Again, 3 coils were noted at the end.Procedure was performed well.The plaintiff had multiple hospital visits for management of chronic pelvic pain (lupron therapy, motrin).The plaintiff is currently planning for essure removal.She received treatment for pain, abnormal bleeding, psychotic injury, bladder/urinary problems.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 72.5 kgs.Hysterosalpingogram - on (b)(6) 2011: results: confirmed essure device was successfully occluded; on (b)(6) 2011: results: bilateral tubal occlusion.On (b)(6) 2015 ultrasound pelvis revealed, probable endometrioma 1 x 2 x 3cm within the left adnexa, with mild compression of the adjacent fallopian tube resulting in mild hydrosalpinx.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records:lower abdominal pain, dysmenorrhea, weight gain,chronic pelvic pain,vaginal discharge,vaginal pain with intercourse.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021: medical record received.Event added: a silver metal coil is identified in the right aspect of the endometrial cavity located near the right fallopian tube.Reporters information, essure removal date and medical history added.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.

• 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: 7628986
• MDR Text Key: 112026178
• Report Number: 2951250-2018-02756
• 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,Followup,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2014
• Device Model Number: ESS305
• Device Lot Number: 855630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 08/14/2018; 09/18/2018; 03/11/2021; 03/23/2021
• Supplement Dates FDA Received: 08/16/2018; 09/25/2018; 03/22/2021; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ACETAMINOPHEN; ACETAMINOPHEN; ALBUTEROL SULFATE; ALBUTEROL SULFATE; DEPO-PROVERA; DEPO-PROVERA; GABAPENTIN; GABAPENTIN; GABAPENTIN; LUPRON; LUPRON; LUPRON; LUPRON; LUPRON; NAPROXEN; NAPROXEN; NAPROXEN; VICODIN; VICODIN; VICODIN; VICODIN; VICODIN; LUPRON; VICODIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 73