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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Hair Loss (1877); Hemorrhage/Bleeding (1888); Pain (1994); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Cramp(s) (2193); Arthralgia (2355); Fungal Infection (2419); Cognitive Changes (2551); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 12/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') and genital haemorrhage ('heavy and persistent bleeding / blood clots') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("severe cramping"), vision blurred ("blurred vision"), feeling abnormal ("brain fog"), abdominal pain ("abdomen pain"), arthralgia ("joint pain"), abdominal distension ("bloating"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), back pain ("back pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), psychological trauma ("psych injury"), bladder disorder ("bladder problems"), vaginal infection ("vaginal infection"), vaginal discharge ("vaginal discharge"), gastrointestinal disorder ("gi conditions") and alopecia ("hair loss") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy(full)).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, abdominal pain, dysmenorrhoea, dyspareunia, back pain, gastrointestinal disorder, alopecia and weight increased had resolved and the genital haemorrhage, abdominal pain lower, vision blurred, feeling abnormal, arthralgia, abdominal distension, menorrhagia, psychological trauma, bladder disorder, vaginal infection and vaginal discharge outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, bladder disorder, dysmenorrhoea, dyspareunia, feeling abnormal, gastrointestinal disorder, genital haemorrhage, menorrhagia, pelvic pain, psychological trauma, vaginal discharge, vaginal infection, vision blurred and weight increased to be related to essure.The reporter commented: plaintiff never experienced any of these conditions prior to undergoing the essure procedure.Patient received treatment for pelvic pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), psych injury, bladder problems, vaginal infection and vaginal discharge.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2014: essure confirmation test(s) (unspecified) bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-sep-2019: pfs received.Date of explant added.This case become incident.Following events were added: pelvic pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), back pain, menorrhagia (heavy menstrual bleeding), psych injury, bladder problems, vaginal infection ,vaginal discharge, gi conditions, hair loss and weight gain.Outcome of the event abdominal pain was changed from unknown to recovered.Reporter information and lab data were added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records information become available from our investigation, this will be and other non-conformances data; should any new and reportable provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in a 44-year-old female patient who had essure (batch no.50717071) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included abortion (in 2000 and 2009.).Previously administered products included for an unreported indication: iud nos in 2009 and mirena.Concurrent conditions included uterine leiomyoma, lightheadedness, smoker, nausea, vaginal itching, vaginal burning sensation, dysuria, gas, acid reflux (oesophageal), neck pain, photophobia, sleepy, angular cheilitis, ear pain, myalgia, scleroderma, chest pain, allergic reaction and anaphylaxis.Concomitant products included celecoxib (celexa) since 2000, hydroxyzine since (b)(6) 2017 and sertraline hydrochloride (zoloft) since 2000 for depression as well as cefixime (flexeril) from (b)(6) 2019 to (b)(6) 2019, clonazepam from (b)(6) 2017 to (b)(6) 2018, cholecalciferol (cholecalciferol), cyanocobalamin (cobalamin), cyclobenzaprine, ibuprofen, lamotrigine from (b)(6) 2017 to (b)(6) 2018, nystatin, piroxicam (paxil) from (b)(6) 2018 to (b)(6) 2018, probiotics nos since (b)(6) 2019, sertraline, triamcinolone acetonide, vitamin b complex since 2017 and vitamin d nos (vitamin d) since 2017.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced menorrhagia ("menorrhagia (heavy menstrual bleeding)") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), arthralgia ("joint pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), back pain ("back pain/ lower back pain"), migraine ("migraines / headaches") and musculoskeletal pain ("shoulder pain").In (b)(6) 2014, the patient experienced vulvovaginal mycotic infection ("infection (bladder/urinary tract/vaginal) type: yeast infections").In (b)(6) 2016, the patient was found to have weight increased ("weight gain").In (b)(6) 2017, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and urinary incontinence ("bladder or urinary problems or changes incontinence").On (b)(6) 2017, the patient experienced anxiety ("psych injury/ psychological or psychiatric problems condition: anxiety") and panic attack ("psychological or psychiatric problems condition: panic attacks"), 4 years 2 months after insertion of essure.On (b)(6) 2017, the patient experienced rash ("rashes or skin conditions type: face rashes").In (b)(6) 2018, the patient experienced vaginal discharge ("vaginal discharge"), gastrointestinal bacterial overgrowth ("gi conditions/ gastrointestinal or digestive system condition type: small intestinal bacterial overgrowth (sibo)") and alopecia ("hair loss").On an unknown date, the patient experienced genital haemorrhage ("heavy and persistent bleeding / blood clots"), abdominal pain lower ("severe cramping"), vision blurred ("blurred vision"), feeling abnormal ("brain fog"), abdominal pain ("abdomen pain"), abdominal distension ("bloating"), bladder disorder ("bladder problems"), vaginal infection ("vaginal infection") and headache ("headaches").The patient was treated with surgery (hysterectomy(full) bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, arthralgia, dysmenorrhoea, dyspareunia, back pain, vaginal discharge, gastrointestinal bacterial overgrowth, alopecia, weight increased, vulvovaginal mycotic infection and headache had resolved and the abdominal pain lower, vision blurred, feeling abnormal, abdominal distension, menorrhagia, anxiety, bladder disorder, vaginal infection, vaginal haemorrhage, urinary incontinence, migraine, panic attack, rash and musculoskeletal pain outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, arthralgia, back pain, bladder disorder, dysmenorrhoea, dyspareunia, feeling abnormal, gastrointestinal bacterial overgrowth, genital haemorrhage, headache, menorrhagia, migraine, musculoskeletal pain, panic attack, pelvic pain, rash, urinary incontinence, vaginal discharge, vaginal haemorrhage, vaginal infection, vision blurred, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: plaintiff never experienced any of these conditions prior to undergoing the essure procedure.Patient received treatment for pelvic pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), psych injury, bladder problems, vaginal infection and vaginal discharge.On (b)(6) 2019- she performed cystoscopy surgery.There was noted to be 3 trailing coils noted.2 trailing coils noted.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: essure confirmation test(s) (unspecified) bilateral occlusion.Lot number:50717071, manufacturing date:2013/02, expiration date:2016/02.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-feb-2020: quality safety evaluation of product technical complaint.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 pelvic pain ('pelvic pain') in a 44-year-old female patient who had essure (batch no.50717071) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included abortion (in 2000 and 2009.).Previously administered products included for an unreported indication: iud nos in 2009 and mirena.Concurrent conditions included uterine leiomyoma, lightheadedness, smoker, nausea, vaginal itching, vaginal burning sensation, dysuria, gas, acid reflux (oesophageal), neck pain, photophobia, sleepy, angular cheilitis, ear pain, myalgia, scleroderma, chest pain, allergic reaction and anaphylaxis.Concomitant products included celecoxib (celexa) since 2000, hydroxyzine since (b)(6) 2017 and sertraline hydrochloride (zoloft) since 2000 for depression as well as cefixime (flexeril) from march 2019 to april 2019, clonazepam from november 2017 to february 2018, cholecalciferol (cholecalciferol), cyanocobalamin (cobalamin), cyclobenzaprine, ibuprofen, lamotrigine from november 2017 to february 2018, nystatin, piroxicam (paxil) from march 2018 to may 2018, probiotics nos since november 2019, sertraline, triamcinolone acetonide, vitamin b complex since 2017 and vitamin d nos (vitamin d) since 2017.On (b)(6) 2013, the patient had essure inserted.In august 2013, the patient experienced menorrhagia ("menorrhagia (heavy menstrual bleeding)") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In december 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), arthralgia ("joint pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), back pain ("back pain/ lower back pain"), migraine ("migraines / headaches") and musculoskeletal pain ("shoulder pain").In march 2014, the patient experienced vulvovaginal mycotic infection ("infection (bladder/urinary tract/vaginal) type: yeast infections").In january 2016, the patient was found to have weight increased ("weight gain").In january 2017, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and incontinence ("bladder or urinary problems or changes incontinence").On (b)(6) 2017, the patient experienced anxiety ("psych injury/ psychological or psychiatric problems condition: anxiety") and panic attack ("psychological or psychiatric problems condition: panic attacks"), 4 years 2 months after insertion of essure.On (b)(6) 2017, the patient experienced rash ("rashes or skin conditions type: face rashes").In july 2018, the patient experienced vaginal discharge ("vaginal discharge"), gastrointestinal bacterial overgrowth ("gi conditions/ gastrointestinal or digestive system condition type: small intestinal bacterial overgrowth (sibo)") and alopecia ("hair loss").On an unknown date, the patient experienced genital haemorrhage ("heavy and persistent bleeding / blood clots"), abdominal pain lower ("severe cramping"), vision blurred ("blurred vision"), feeling abnormal ("brain fog"), abdominal pain ("abdomen pain"), abdominal distension ("bloating"), bladder disorder ("bladder problems"), vaginal infection ("vaginal infection") and headache ("headaches").The patient was treated with surgery (hysterectomy(full) bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, arthralgia, dysmenorrhoea, dyspareunia, back pain, vaginal discharge, gastrointestinal bacterial overgrowth, alopecia, weight increased, vulvovaginal mycotic infection and headache had resolved and the abdominal pain lower, vision blurred, feeling abnormal, abdominal distension, menorrhagia, anxiety, bladder disorder, vaginal infection, vaginal haemorrhage, incontinence, migraine, panic attack, rash and musculoskeletal pain outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, arthralgia, back pain, bladder disorder, dysmenorrhoea, dyspareunia, feeling abnormal, gastrointestinal bacterial overgrowth, genital haemorrhage, headache, incontinence, menorrhagia, migraine, musculoskeletal pain, panic attack, pelvic pain, rash, vaginal discharge, vaginal haemorrhage, vaginal infection, vision blurred, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: plaintiff never experienced any of these conditions prior to undergoing the essure procedure.Patient received treatment for pelvic pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), psych injury, bladder problems, vaginal infection and vaginal discharge.On (b)(6) 2019- she performed cystoscopy surgery.There was noted to be 3 trailing coils noted.2 trailing coils noted diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: essure confirmation test(s) (unspecified) bilateral occlusion.Most recent follow-up information incorporated above includes: on (b)(6) 2019: plaintiff fact sheet and medical record was received.Lot number were added.Event added from pfs- abnormal bleeding (vaginal), incontinence, migraine headache, panic attacks, face rashes, shoulder pain, yeast infection, headaches.And previously reported event- psych injury updated to event- anxiety and event- gastrointestinal disorder updated to event- small intestinal bacterial overgrowth.Reporter information, medical history, concomitant drug, events onset date were added.Events outcomes, lab data were updated.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: 9121828
• MDR Text Key: 165577115
• Report Number: 2951250-2019-08509
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 02/18/2020

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: 02/01/2016
• Device Model Number: ESS305
• Device Lot Number: 50717071
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 12/31/2019; 12/31/2019
• Supplement Dates FDA Received: 01/15/2020; 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CELEXA [CELECOXIB]; CELEXA [CELECOXIB]; CHOLECALCIFEROL; CHOLECALCIFEROL; CLONAZEPAM; CLONAZEPAM; COBALAMIN; COBALAMIN; CYCLOBENZAPRINE; CYCLOBENZAPRINE; FLEXERIL [CEFIXIME]; FLEXERIL [CEFIXIME]; HYDROXYZINE; HYDROXYZINE; IBUPROFEN; IBUPROFEN; LAMOTRIGINE; LAMOTRIGINE; NYSTATIN; NYSTATIN; PAXIL [PIROXICAM]; PAXIL [PIROXICAM]; PROBIOTICS NOS; PROBIOTICS NOS; SERTRALINE; SERTRALINE; TRIAMCINOLONE ACETONIDE; TRIAMCINOLONE ACETONIDE; VITAMIN B COMPLEX; VITAMIN B COMPLEX; VITAMIN D [VITAMIN D NOS]; VITAMIN D [VITAMIN D NOS]; ZOLOFT; ZOLOFT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR