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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Pain (1994); Hot Flashes/Flushes (2153); Depression (2361); Sweating (2444); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Fibrosis (3167)

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 ("pain: pelvic pain") and menorrhagia ("abnormal bleeding (menorrhagia)") in a (b)(6) female patient who had essure (batch no.952110) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included depression, fatigue, mood swings and night sweats.Previously administered products included for contraception: oral contraception on (b)(6) 2012; for anxiety: lorazepam and adderall; for hypothyroid: levoxyl; for idiopathic hypersomnia: provigil; for interstitial cystitis: elmiron; for mood disorder: prozac; for an unreported indication: elimiron, prozac, vicodin, lorazepam and levoxyl.Concurrent conditions included body mass index normal and dysfunctional uterine bleeding.Concomitant products included cilest (ortho tri-cyclen) for contraception.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, 21 days after insertion of essure, the patient experienced asthenia ("decreased energy level").On (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("painful menstrual cycle"), cervicitis ("acute and chronic cervicitis with squamous metaplasia"), adenomyosis ("adenomyosis"), uterine leiomyoma ("intramural leiomyoma") and adnexa uteri cyst ("left fallopian tube with simple paratubal cyst and tiny walthard nests").On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), alopecia ("hair loss"), hot flush ("hot flashes"), amnesia ("memory loss"), uterine cervical metaplasia ("acute and chronic cervicitis with squamous metaplasia"), libido decreased ("diminished libido"), premature menopause ("early menopause"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), fatigue ("fatigue"), weight increased ("weight gain"), irritable bowel syndrome ("irritable bowel syndrome"), depression ("depression"), night sweats ("night sweats") and mood swings ("mood swings").The patient was treated with vicodin, surgery (hysterectomy (full) and salpingectomy (bilateral removal of fallopian tubes)) and surgery (hysteroscopy and novasure ablation).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menorrhagia, dysmenorrhoea, alopecia, hot flush, amnesia, uterine cervical metaplasia, libido decreased, premature menopause, vaginal haemorrhage, cervicitis, fatigue, weight increased, irritable bowel syndrome, asthenia, depression, adenomyosis, uterine leiomyoma and adnexa uteri cyst outcome was unknown and the night sweats and mood swings was resolving.The reporter considered adenomyosis, adnexa uteri cyst, alopecia, amnesia, asthenia, cervicitis, depression, dysmenorrhoea, fatigue, hot flush, irritable bowel syndrome, libido decreased, menorrhagia, mood swings, night sweats, pelvic pain, premature menopause, uterine cervical metaplasia, uterine leiomyoma, vaginal haemorrhage and weight increased to be related to essure.(b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6).Most recent follow-up information incorporated above includes: on 23-may-2018: the case is incident.Reporter information was added.This case concerns (b)(6) patient.Her historical medication/condition and concurrent conditions were added.Essure indication was amended.Essure removal date was added.Essure lot number was added.Her concomitant medications were added.Following events: pain: pelvic pain, abnormal bleeding (menorrhagia), diminished libido, early menopause, abnormal bleeding (vaginal), acute and chronic cervicitis with squamous metaplasia, fatigue, weight gain, irritable bowel syndrome, decreased energy level, depression, adenomyosis, intramural leiomyoma and left fallopian tube with simple paratubal cyst and tiny walthard nests, night sweats, mood swings.She was recovering form events: mood swings and night sweats.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 ("pain: pelvic pain") and menorrhagia ("abnormal bleeding (menorrhagia)") in a 40-year-old female patient who had essure (batch no.952110) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included depression, fatigue, mood swings, night sweats, hyperthyroidism, hypothyroidism, idiopathic hypersomnia and intramural leiomyoma of uterus.Previously administered products included for contraception: oral contraception on (b)(6) 2012; for anxiety: lorazepam and adderall; for hypothyroid: levoxyl; for idiopathic hypersomnia: provigil; for interstitial cystitis: elmiron; for mood disorder: prozac; for an unreported indication: elimiron, prozac, vicodin, lorazepam and levoxyl.Concurrent conditions included body mass index normal and dysfunctional uterine bleeding.Concomitant products included cilest (ortho tri-cyclen) for contraception.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, 21 days after insertion of essure, the patient experienced asthenia ("decreased energy level").On (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("painful menstrual cycle"), cervicitis ("acute and chronic cervicitis with squamous metaplasia"), adenomyosis ("adenomyosis"), uterine leiomyoma ("intramural leiomyoma") and adnexa uteri cyst ("left fallopian tube with simple paratubal cyst and tiny walthard nests").On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), alopecia ("hair loss"), hot flush ("hot flashes"), amnesia ("memory loss"), uterine cervical metaplasia ("acute and chronic cervicitis with squamous metaplasia"), libido decreased ("diminished libido"), premature menopause ("early menopause"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), fatigue ("fatigue"), weight increased ("weight gain"), irritable bowel syndrome ("irritable bowel syndrome"), depression ("depression"), night sweats ("night sweats") and mood swings ("mood swings").The patient was treated with vicodin, surgery (hysterectomy (full) and salpingectomy (bilateral removal of fallopian tubes)) and surgery (hysteroscopy and novasure ablation).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menorrhagia, dysmenorrhoea, alopecia, hot flush, amnesia, uterine cervical metaplasia, libido decreased, premature menopause, vaginal haemorrhage, cervicitis, fatigue, weight increased, irritable bowel syndrome, asthenia, depression, adenomyosis, uterine leiomyoma and adnexa uteri cyst outcome was unknown and the night sweats and mood swings was resolving.The reporter considered adenomyosis, adnexa uteri cyst, alopecia, amnesia, asthenia, cervicitis, depression, dysmenorrhoea, fatigue, hot flush, irritable bowel syndrome, libido decreased, menorrhagia, mood swings, night sweats, pelvic pain, premature menopause, uterine cervical metaplasia, uterine leiomyoma, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: current weight 145 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.9 kg/sqm.On (b)(6) 2012, ultrasound pelvis revealed there is a posterior uterine fibroid measuring approximately 3 cm in greatest diameter.No other focal fibroid is identified.Otherwise unremarkable pelvic ultrasound.The endometrial stripe is not thickened.On (b)(6) 2012, findings revealed the patient had normal cavity.Both tubal ostia were noted.No coils natal were endometrium which is not surprising because intentionally placed them a little bit deeper within the tubes when she was planning ablation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-aug-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain: pelvic pain") and menorrhagia ("abnormal bleeding (menorrhagia)") in a 40-year-old female patient who had essure (batch no.952110) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included depression, fatigue, mood swings, night sweats, hyperthyroidism, hypothyroidism, idiopathic hypersomnia and intramural leiomyoma of uterus.Previously administered products included for contraception: oral contraception on (b)(6) 2012; for anxiety: lorazepam and adderall; for hypothyroid: levoxyl; for idiopathic hypersomnia: provigil; for interstitial cystitis: elmiron; for mood disorder: prozac; for an unreported indication: elimiron, prozac, vicodin, lorazepam and levoxyl.Concurrent conditions included body mass index normal and dysfunctional uterine bleeding.Concomitant products included cilest (ortho tri-cyclen) for contraception.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, 21 days after insertion of essure, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), fatigue ("fatigue"), the first episode of asthenia ("decreased energy level"), depression ("depression") and the second episode of asthenia ("energy level decreasing").In 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2012, the patient experienced weight increased ("weight gain") and irritable bowel syndrome ("irritable bowel syndrome").On (b)(6) 2016, the patient experienced dysmenorrhoea ("painful menstrual cycle"), uterine cervical metaplasia ("acute and chronic cervicitis with squamous metaplasia"), cervicitis ("acute and chronic cervicitis with squamous metaplasia"), adenomyosis ("adenomyosis"), uterine leiomyoma ("intramural leiomyoma") and adnexa uteri cyst ("left fallopian tube with simple paratubal cyst and tiny walthard nests").On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), alopecia ("hair loss"), hot flush ("hot flashes"), amnesia ("memory loss"), libido decreased ("diminished libido"), premature menopause ("early menopause / hormonal changes early menopause"), night sweats ("night sweats") and mood swings ("mood swings").The patient was treated with vicodin, surgery (hysterectomy (full) and salpingectomy (bilateral removal of fallopian tubes)) and surgery (hysteroscopy and novasure ablation).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menorrhagia, dysmenorrhoea, alopecia, hot flush, amnesia, uterine cervical metaplasia, libido decreased, premature menopause, vaginal haemorrhage, cervicitis, fatigue, weight increased, irritable bowel syndrome, depression, adenomyosis, uterine leiomyoma, adnexa uteri cyst and the last episode of asthenia outcome was unknown and the night sweats and mood swings was resolving.The reporter considered adenomyosis, adnexa uteri cyst, alopecia, amnesia, cervicitis, depression, dysmenorrhoea, fatigue, hot flush, irritable bowel syndrome, libido decreased, menorrhagia, mood swings, night sweats, pelvic pain, premature menopause, uterine cervical metaplasia, uterine leiomyoma, vaginal haemorrhage, weight increased, the first episode of asthenia and the second episode of asthenia to be related to essure.The reporter commented: current weight 145 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.9 kg/sqm.On (b)(6) 2012, ultrasound pelvis revealed there is a posterior uterine fibroid measuring approximately 3 cm in greatest diameter.No other focal fibroid is identified.Otherwise unremarkable pelvic ultrasound.The endometrial stripe is not thickened.On (b)(6) 2012, findings revealed the patient had normal cavity.Both tubal ostia were noted.No coils natal were endometrium which is not surprising because intentionally placed them a little bit deeper within the tubes when she was planning ablation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-sep-2018: plaintiff fact sheet received, event depressed energy level added.Event hormonal changes early menopause clubbed with early menopause.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: 7590928
• MDR Text Key: 110754361
• Report Number: 2951250-2018-02584
• 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: 09/10/2018

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: 02/01/2015
• Device Model Number: ESS305
• Device Lot Number: 952110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 08/09/2018; 09/04/2018
• Supplement Dates FDA Received: 08/13/2018; 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORTHO TRI-CYCLEN; ORTHO TRI-CYCLEN; ORTHO TRI-CYCLEN; ORTHO TRI-CYCLEN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 66