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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Mechanical Problem (1384); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Pelvic Inflammatory Disease (2000); Urinary Tract Infection (2120); Uterine Perforation (2121); Anxiety (2328); Depression (2361); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Fallopian Tube Perforation (4506); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/14/2017

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: pelvis"), device breakage ("fractured implant") and fallopian tube perforation ("perforation (fallopian tube(s))") in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included bacterial vaginosis and cervical cancer.In 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), depression ("depression") and anxiety ("mental anguish").In september 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced vulvovaginitis ("vulvo vaginitis"), candida infection ("candida") and incontinence ("incontinence").In (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), infection ("infections"), menstrual disorder ("menstruation issues") and urinary tract infection ("uti").The patient was treated with surgery ((bilateral salpingooophorectomy)), surgery ((bilateral salpingooophorectomy)) and surgery ((bilateral salpingooophorectomy)).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, fallopian tube perforation, infection, menstrual disorder, vaginal haemorrhage, menorrhagia, urinary tract infection, vulvovaginitis, candida infection, depression, anxiety and incontinence outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, candida infection, depression, device breakage, device dislocation, fallopian tube perforation, incontinence, infection, menorrhagia, menstrual disorder, pelvic pain, urinary tract infection, vaginal haemorrhage and vulvovaginitis to be related to essure.The reporter commented: plaintiff and underwent treatment due to complications from the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: essure device was successfully occluded.Most recent follow-up information incorporated above includes: on 4-jun-2018: plaintiff fact sheet and medical records received.New reporters added.Patient demographic information and patient relevant history added.Essure insertion date updated to (b)(6) 2009 and removal date (b)(6) 2017 added.Events migration of essure device location of device: pelvis, perforation (fallopian tube(s)), abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), uti, vulvo vaginitis, candida, depression, mental anguish and incontinence added incident no lot number or sample available for investigation.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 device dislocation ("migration of essure device location of device: pelvis"), device breakage ("fractured implant") and fallopian tube perforation ("perforation (fallopian tube(s))") in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included bacterial vaginosis and cervical cancer.Concomitant products included nsaid's and paracetamol (acetaminophen).In (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), depression ("depression") and anxiety ("mental anguish").In (b)(6) 2009, the patient experienced vulvovaginitis ("vulvo vaginitis"), candida infection ("candida") and urinary incontinence ("incontinence / urinary incontinence").In (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain").On (b)(6) 2014, the patient experienced urinary tract infection ("uti").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and fallopian tube perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infections") and menstrual disorder ("menstruation issues").The patient was treated with surgery ((bilateral salpingooophorectomy)).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, fallopian tube perforation, infection, menstrual disorder, vaginal haemorrhage, menorrhagia, urinary tract infection, vulvovaginitis, candida infection, depression, anxiety and urinary incontinence outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, candida infection, depression, device breakage, device dislocation, fallopian tube perforation, infection, menorrhagia, menstrual disorder, pelvic pain, urinary incontinence, urinary tract infection, vaginal haemorrhage and vulvovaginitis to be related to essure.The reporter commented: plaintiff and underwent treatment due to complications from the essure device.She did not claim that essure worsened a previously existing injury/condition.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: essure device was successfully occluded.Most recent follow-up information incorporated above includes: on (b)(6) 2018: previously reported event ¿incontinence¿ updated to ¿urinary incontinence¿ from pfs.Incident: no lot number or sample available for investigation.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 device dislocation ('migration of essure device location of device: pelvis'), device breakage ('fractured implant') and fallopian tube perforation ('perforation (fallopian tube(s))') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included recurrent abortion, induced abortion, premature delivery, lung cancer, pulmonary disorder, menopause, insomnia and chronic pain.Concurrent conditions included asthma since (b)(6) 2009, bacterial vaginosis, cervical cancer, chronic cystitis, urge incontinence, defecation urgency, pelvic discomfort, continuous urinary leakage, bladder pain, escherichia coli infection (on (b)(6) 2014 and (b)(6) 2014 both were pan sensitive) and urine odour foul.Concomitant products included cetirizine hydrochloride (aller tec), ethinylestradiol;ferrous fumarate;norethisterone acetate (loestrin fe), fluticasone propionate;salmeterol xinafoate (advair) since (b)(6) 2009, nsaids, oxycodone, paracetamol (acetaminophen), salbutamol sulfate (proair) since (b)(6) 2009 and temazepam.On (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2009, the patient experienced vulvovaginitis ("vulvo vaginitis"), candida infection ("candida") and urinary incontinence ("incontinence / urinary incontinence").In (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain").On (b)(6) 2014, the patient experienced urinary tract infection ("uti"), 5 years 11 months after insertion of essure.On (b)(6) 2015, the patient experienced depression ("depression") and anxiety ("mental anguish").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and fallopian tube perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infections") and menstrual disorder ("menstruation issues").The patient was treated with surgery ((bilateral salpingooopherectomy)).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, fallopian tube perforation, infection, menstrual disorder, vulvovaginitis, candida infection, depression, anxiety and urinary incontinence outcome was unknown and the pelvic pain, vaginal haemorrhage, menorrhagia and urinary tract infection had resolved.The reporter considered anxiety, candida infection, depression, device breakage, device dislocation, fallopian tube perforation, infection, menorrhagia, menstrual disorder, pelvic pain, urinary incontinence, urinary tract infection, vaginal haemorrhage and vulvovaginitis to be related to essure.The reporter commented: plaintiff and underwent treatment due to complications from the essure device.She did not claim that essure worsened a previously existing injury/condition.Patient received treatment for pain, bleeding, breakage, bladder/urinary tract problems.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: results: essure device was successfully occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received: outcome of events: vaginal hemorrhage.Menorrhagia, pelvic pain, uti were updated.Rcc note 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device: pelvis'), device breakage ('fractured implant') and fallopian tube perforation ('perforation (fallopian tube(s))') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included recurrent abortion, induced abortion, premature delivery, lung cancer, pulmonary disorder, menopause, insomnia and chronic pain.Concurrent conditions included asthma since (b)(6) 2009, bacterial vaginosis, cervical cancer, chronic cystitis, urge incontinence, defecation urgency, pelvic discomfort, continuous urinary leakage, bladder pain, escherichia coli infection (on (b)(6) 2014 and (b)(6) 2014 both were pan sensitive) and urine odour foul.Concomitant products included cetirizine hydrochloride (aller tec), ethinylestradiol;ferrous fumarate;norethisterone acetate (loestrin fe), fluticasone propionate;salmeterol xinafoate (advair) since (b)(6)2009, nsaids, oxycodone, paracetamol (acetaminophen), salbutamol sulfate (proair) since (b)(6) 2009 and temazepam.On (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2009, the patient experienced vulvovaginitis ("vulvo vaginitis"), candida infection ("candida") and urinary incontinence ("incontinence / urinary incontinence").In (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain").On (b)(6) 2014, the patient experienced urinary tract infection ("uti"), 5 years 11 months after insertion of essure.On (b)(6) 2015, the patient experienced depression ("depression") and anxiety ("mental anguish").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and fallopian tube perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infections") and menstrual disorder ("menstruation issues").The patient was treated with surgery ((bilateral salpingooopherectomy)).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, fallopian tube perforation, infection, menstrual disorder, vulvovaginitis, candida infection, depression, anxiety and urinary incontinence outcome was unknown and the pelvic pain, vaginal haemorrhage, menorrhagia and urinary tract infection had resolved.The reporter considered anxiety, candida infection, depression, device breakage, device dislocation, fallopian tube perforation, infection, menorrhagia, menstrual disorder, pelvic pain, urinary incontinence, urinary tract infection, vaginal haemorrhage and vulvovaginitis to be related to essure.The reporter commented: plaintiff and underwent treatment due to complications from the essure device.She did not claim that essure worsened a previously existing injury/condition.Patient received treatment for pain, bleeding, breakage, bladder/urinary tract problems.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: results: essure device was successfully occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 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 device dislocation ('migration of essure device location of device: pelvis'), device breakage ('fractured implant'), fallopian tube perforation ('perforation (fallopian tube(s))') and fallopian tube diverticulosis ('salpingitis isthmica nodosum') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included recurrent abortion, induced abortion, premature delivery, lung cancer, pulmonary disorder, menopause, insomnia, chronic pain, dysmenorrhea, back pain, pelvic mass, cystoscopy and grand multiparity.Previously administered products included for an unreported indication: antibiotics.Concurrent conditions included asthma since 2009, bacterial vaginosis, cervical cancer, chronic cystitis, urge incontinence, defecation urgency, pelvic discomfort, continuous urinary leakage, bladder pain, escherichia coli infection (on (b)(6) 2014 and (b)(6) 2014 both were pan sensitive) and urine odour foul.Concomitant products included cetirizine hydrochloride (aller tec), ethinylestradiol;ferrous fumarate;norethisterone acetate (loestrin fe), fluticasone propionate;salmeterol xinafoate (advair) since (b)(6) 2009, nsaids, oxycodone, paracetamol (acetaminophen), salbutamol sulfate (proair) since (b)(6) 2009 and temazepam.On (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and heavy menstrual bleeding ("abnormal bleeding (menorrhagia)").In (b)(6) 2009, the patient experienced vulvovaginitis ("vulvo vaginitis"), candida infection ("candida") and urinary incontinence ("incontinence / urinary incontinence").In (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain").On (b)(6) 2014, the patient experienced urinary tract infection ("uti"), 5 years 11 months after insertion of essure.On (b)(6) 2015, the patient experienced depression ("depression") and anxiety ("mental anguish").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and fallopian tube perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), fallopian tube diverticulosis (seriousness criteria medically significant and intervention required), infection ("infections") and menstrual disorder ("menstruation issues").The patient was treated with surgery ((bilateral salpingooopherectomy)).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, fallopian tube perforation, fallopian tube diverticulosis, infection, menstrual disorder, vulvovaginitis, candida infection, depression, anxiety and urinary incontinence outcome was unknown and the pelvic pain, vaginal haemorrhage, heavy menstrual bleeding and urinary tract infection had resolved.The reporter considered anxiety, candida infection, depression, device breakage, device dislocation, fallopian tube diverticulosis, fallopian tube perforation, heavy menstrual bleeding, infection, menstrual disorder, pelvic pain, urinary incontinence, urinary tract infection, vaginal haemorrhage and vulvovaginitis to be related to essure.The reporter commented: five coils were noted in the right tubal ostia left ostia and 3 coils were visible.Plaintiff and underwent treatment due to complications from the essure device.She did not claim that essure worsened a previously existing injury/condition.Patient received treatment for pain, bleeding, breakage, bladder/urinary tract problems.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2017: mild wall thickening the urinary bladder suggesting cystitis.Correlation with urinalysis may be helpful.Hysterosalpingogram - on (b)(6) 2009: results: essure device was successfully occluded.Concerning the injuries reported in this case, the following one is confirmed in patients¿ medical records:fallopian tube diverticulosis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-may-2021: mr received: event salpingitis isthmica nodosum added and made medically significant and intervention required due to surgery".Reporter, medical history, historical drug , lab test and rcc 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.

• 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: 7612736
• MDR Text Key: 111433663
• Report Number: 2951250-2018-02683
• 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: 05/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 09/14/2018; 01/09/2020; 06/18/2020; 05/11/2021
• Supplement Dates FDA Received: 09/21/2018; 06/05/2020; 07/04/2020; 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ACETAMINOPHEN; ACETAMINOPHEN; ACETAMINOPHEN; ADVAIR; ADVAIR; ADVAIR; ALLER TEC; ALLER TEC; ALLER TEC; LOESTRIN FE; LOESTRIN FE; LOESTRIN FE; NSAID'S; NSAIDS; NSAIDS; NSAIDS; OXYCODONE; OXYCODONE; OXYCODONE; PROAIR [SALBUTAMOL SULFATE]; PROAIR [SALBUTAMOL SULFATE]; PROAIR [SALBUTAMOL SULFATE]; TEMAZEPAM; TEMAZEPAM; TEMAZEPAM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR