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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Unspecified Infection (1930); Itching Sensation (1943); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Rash (2033); Swelling (2091); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Vertigo (2134); Visual Impairment (2138); Burning Sensation (2146); Chills (2191); Dizziness (2194); Anxiety (2328); Discomfort (2330); Arthralgia (2355); Depression (2361); Numbness (2415); Respiratory Tract Infection (2420); Irritability (2421); Neck Pain (2433); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Dysuria (2684); Constipation (3274)

Event Date 11/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain / cramps in the pelvic area"), intra-abdominal haemorrhage ("bleeding internally / postoperative intraabdominal bleed"), genital haemorrhage ("heavy bleeding"), rectal haemorrhage ("bleeding from the rectum"), haematochezia ("bleeding in fecal matter") and hemianaesthesia ("right side of her face went numbas well as her right side of her body - mainly her arm and leg") in a (b)(6) female patient who had essure (batch no.B42242) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included: micronor.Concurrent conditions included allergic rhinitis and allergic reaction (ears itch and turn red and burn).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and migraine ("migraine").On unknown date the patient experienced abdominal distension, abdominal pain, acne, adnexa uteri pain, allergy to metals, alopecia, anxiety, arthralgia, arthropathy, asthenia, attention deficit/hyperactivity disorder, back pain, bacterial vaginosis, balance disorder, bladder pain, chest discomfort, chest pain, chills, coital bleeding, confusional state, constipation, dental caries, depression, disturbance in attention, dizziness, dysgeusia, dyspareunia, dyspepsia, dyspnoea, dysuria, fallopian tube spasm, fatigue, feeling abnormal, fibromyalgia, food intolerance, gastrointestinal pain, gastrooesophageal reflux disease, genital haemorrhage, haematochezia, headache, hemianaesthesia, hypertonic bladder, hypoaesthesia, insomnia, intra-abdominal haemorrhage, irritability, irritable bowel syndrome, memory impairment, menorrhagia, menstruation irregular, mood swings, muscle spasms, musculoskeletal pain, myalgia, nausea, neck pain, neuralgia, neuromyopathy, night sweats, palpitations, photosensitivity reaction, plantar fasciitis, radiculopathy, rash, rectal haemorrhage, restless legs syndrome, skin burning sensation, swelling, thinking abnormal, upper respiratory tract infection, urinary incontinence, urinary retention, uterine cervical pain, vaginal discharge, vertigo, visual impairment, vomiting, vulvovaginal dryness, vulvovaginal mycotic infection, vulvovaginal pain, vulvovaginal pruritus, weight decreased, decreased appetite, influenza like illness, and paraesthesia.Patient underwent a total hysterectomy and bilateral salpingectomy for essure removal on (b)(6) 2014, on the same day she experienced intra-abdominal haemorrhage (seriousness criterion medically significant) due to it she underwent a fulguration of the bleeding vessel and an evacuation of hemoperitoneum.In 2015, the patient experienced dental caries ("tooth decay") which was treated with tool extraction.The patient was treated with gabapentin for fibromyalgia.At the time of the report, the pelvic pain, genital haemorrhage, vaginal discharge, uterine cervical pain, dyspareunia, rectal haemorrhage, haematochezia, abdominal distension, swelling, rash, menorrhagia, fallopian tube spasm, adnexa uteri pain, dysgeusia, vulvovaginal pain, vulvovaginal pruritus and coital bleeding had resolved, the intra-abdominal haemorrhage, musculoskeletal pain, nausea, fatigue, fibromyalgia, arthralgia, migraine, gastrointestinal pain, food intolerance, abdominal pain, hypoaesthesia, irritable bowel syndrome, vertigo and hemianaesthesia had not resolved and the headache, menstruation irregular, vomiting, dental caries, bladder pain, asthenia, weight decreased, chills, night sweats, gastrooesophageal reflux disease, dyspepsia, constipation, dizziness, visual impairment, disturbance in attention, memory impairment, insomnia, restless legs syndrome, upper respiratory tract infection, skin burning sensation, photosensitivity reaction, dyspnoea, palpitations, chest pain, dysuria, irritability, anxiety, urinary incontinence, attention deficit/hyperactivity disorder, depression, feeling abnormal, urinary retention, neuromyopathy, arthropathy, bacterial vaginosis, vulvovaginal mycotic infection, plantar fasciitis, hypertonic bladder, muscle spasms, neuralgia, back pain, neck pain, balance disorder, confusional state, thinking abnormal, radiculopathy and chest discomfort outcome was unknown.The reporter considered abdominal distension, abdominal pain, acne, adnexa uteri pain, allergy to metals, alopecia, anxiety, arthralgia, arthropathy, asthenia, attention deficit/hyperactivity disorder, back pain, bacterial vaginosis, balance disorder, bladder pain, chest discomfort, chest pain, chills, coital bleeding, confusional state, constipation, dental caries, depression, disturbance in attention, dizziness, dysgeusia, dyspareunia, dyspepsia, dyspnoea, dysuria, fallopian tube spasm, fatigue, feeling abnormal, fibromyalgia, food intolerance, gastrointestinal pain, gastrooesophageal reflux disease, genital haemorrhage, haematochezia, headache, hemianaesthesia, hypertonic bladder, hypoaesthesia, insomnia, intra-abdominal haemorrhage, irritability, irritable bowel syndrome, memory impairment, menorrhagia, menstruation irregular, migraine, mood swings, muscle spasms, musculoskeletal pain, myalgia, nausea, neck pain, neuralgia, neuromyopathy, night sweats, palpitations, pelvic pain, photosensitivity reaction, plantar fasciitis, radiculopathy, rash, rectal haemorrhage, restless legs syndrome, skin burning sensation, swelling, thinking abnormal, upper respiratory tract infection, urinary incontinence, urinary retention, uterine cervical pain, vaginal discharge, vertigo, visual impairment, vomiting, vulvovaginal dryness, vulvovaginal mycotic infection, vulvovaginal pain, vulvovaginal pruritus, weight decreased, decreased appetite, influenza like illness, and of paraesthesia to be related to essure.The reporter commented: before essure she was health.According to the reporter all injuries and health problems started from the day she had essure implanted in on (b)(6) 2013, and got rapidly worse with each day that passed.She experienced a postoperative intra-abdominal bleed from the left ovarian vessel.She also stated that hysterectomy to remove essure, and ever since then, her sex drive and ability to climax and orgasm have gone down dramatically.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on an unknown date: negative for nickel sulfate.Hysterosalpingogram - on (b)(6) 2014: bilateral obstructed fallopian tube.Most recent follow-up information incorporated above includes: on 21-may-2018: plaintiff fact sheet and social media received: essure lot number , insertion and removal dates where added.Plaintiff underwent a total hysterectomy and bilateral salpingectomy for essure removal.Several adverse events were added including: pelvic pain / cramps in the pelvic area; postoperative intraabdominal bleed and nickel allergy.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 / cramps in the pelvic area"), intra-abdominal haemorrhage ("bleeding internally / postoperative intraabdominal bleed"), genital haemorrhage ("heavy bleeding"), rectal haemorrhage ("bleeding from the rectum"), haematochezia ("bleeding in fecal matter") and hemianaesthesia ("right side of her face went numbs well as her right side of her body - mainly her arm and leg") in a 29-year-old female patient who had essure (batch no.B42242) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: micronor.Concurrent conditions included allergic rhinitis and allergy to metals (ears itch and turn red and burn).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and migraine ("migraine").On (b)(6) 2014, the patient experienced intra-abdominal haemorrhage (seriousness criterion medically significant).In 2015, the patient experienced dental caries ("tooth decay").On an unknown date, error in f_event_with_onset_srsns_nt:-6502-ora-06502: pl/sql: numeric or value error: character string buffer too small.Detail: line 1 ora-06512: at "bbs_owner.Pkg_custom_auto_narrative", line 10282 the patient was treated with gabapentin, surgery (total hysterectomy and bilateral salpingectomy), surgery (fulguration of the bleeding vessel and an evacuation of hemoperitoneum), surgery (tooth extraction), alternative therapy (acumpucture) and alternative therapy (acumpucture).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, genital haemorrhage, vaginal discharge, uterine cervical pain, dyspareunia, rectal haemorrhage, haematochezia, abdominal distension, swelling, rash, menorrhagia, fallopian tube spasm, adnexa uteri pain, dysgeusia, vulvovaginal pain, vulvovaginal pruritus and coital bleeding had resolved, the intra-abdominal haemorrhage, musculoskeletal pain, nausea, influenza like illness, fatigue, fibromyalgia, arthralgia, migraine, gastrointestinal pain, adverse food reaction, abdominal pain, hypoaesthesia, irritable bowel syndrome, vertigo and hemianaesthesia had not resolved and the headache, menstruation irregular, vomiting, dental caries, bladder pain, asthenia, weight decreased, chills, night sweats, decreased appetite, gastrooesophageal reflux disease, dyspepsia, constipation, dizziness, visual impairment, disturbance in attention, memory impairment, insomnia, restless legs syndrome, upper respiratory tract infection, skin burning sensation, photosensitivity reaction, dyspnoea, palpitations, chest pain, dysuria, irritability, anxiety, urinary incontinence, attention deficit/hyperactivity disorder, depression, feeling abnormal, urinary retention, neuromyopathy, arthropathy, bacterial vaginosis, vulvovaginal mycotic infection, plantar fasciitis, hypertonic bladder, muscle spasms, neuralgia, back pain, neck pain, balance disorder, confusional state, thinking abnormal, radiculopathy, chest discomfort, alopecia, allergy to metals and acne outcome was unknown.The reporter considered abdominal distension, abdominal pain, acne, adnexa uteri pain, adverse food reaction, allergy to metals, alopecia, anxiety, arthralgia, arthropathy, asthenia, attention deficit/hyperactivity disorder, back pain, bacterial vaginosis, balance disorder, bladder pain, chest discomfort, chest pain, chills, coital bleeding, confusional state, constipation, decreased appetite, dental caries, depression, disturbance in attention, dizziness, dysgeusia, dyspareunia, dyspepsia, dyspnoea, dysuria, fallopian tube spasm, fatigue, feeling abnormal, fibromyalgia, gastrointestinal pain, gastrooesophageal reflux disease, genital haemorrhage, haematochezia, headache, hemianaesthesia, hypertonic bladder, hypoaesthesia, influenza like illness, insomnia, intra-abdominal haemorrhage, irritability, irritable bowel syndrome, memory impairment, menorrhagia, menstruation irregular, migraine, mood swings, muscle spasms, musculoskeletal pain, myalgia, nausea, neck pain, neuralgia, neuromyopathy, night sweats, palpitations, paraesthesia, pelvic pain, photosensitivity reaction, plantar fasciitis, radiculopathy, rash, rectal haemorrhage, restless legs syndrome, skin burning sensation, swelling, thinking abnormal, upper respiratory tract infection, urinary incontinence, urinary retention, uterine cervical pain, vaginal discharge, vertigo, visual impairment, vomiting, vulvovaginal dryness, vulvovaginal mycotic infection, vulvovaginal pain, vulvovaginal pruritus and weight decreased to be related to essure.The reporter commented: before essure she was health according to the reporter all injuries and health problems started from the day she had essure implanted in on (b)(6) 2013, and got rapidly worse with each day that passed.She experienced a postoperative intra-abdominal bleed from the left ovarian vessel.She also stated that hysterectomy to remove essure, and ever since then, her sex drive and ability to climax and orgasm have gone down dramatically diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on an unknown date: negative for nickel sulfate hysterosalpingogram - on (b)(6) 2014: bilateral obstructed fallopian tube quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 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: 7600110
• MDR Text Key: 111048331
• Report Number: 2951250-2018-02624
• 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
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: ESS305
• Device Lot Number: B42242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR