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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Cyst(s) (1800); Erythema (1840); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Skin Irritation (2076); Swelling (2091); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Cramp(s) (2193); Myalgia (2238); Toxicity (2333); Fungal Infection (2419); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormally heavy menstrual bleeding / prolonged menstruation/ abnormal bleeding (menorrhagia)"), pelvic pain ("severe pelvic pain, even when not menstruating/ pelvic pain"), adenomyosis ("uterine endometriosis") and endometriosis ("ovarian endometriosis") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she was not underwent essure confirmation test".The patient's past medical history included eczema and explorative laparotomy in 2009.Previously administered products included for prevent pregnancy: paragard iud from (b)(6) 2008 to 2009; for an unreported indication: depo-provera and paragard.Past adverse reactions to the above products included weight increased with depo-provera.Concurrent conditions included migraine with aura since 2005, anxiety, depressive disorder, asthma, gastroesophageal reflux disease, scoliosis, endometriosis and headache.Concomitant products included alprazolam (xanax) since 2013, citalopram hydrobromide (celexa) since 2013 and gabapentin since 2017.In (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criterion medically significant), weight increased ("weight gain"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), fibromyalgia ("fibromyalgia"), chest pain ("chest pain"), dry skin ("dryness/ dry patches that look like a burn"), fungal infection ("chronic yeast infections/ yeast infections"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), visual impairment ("i have trouble reading/ vision changes"), fatigue ("chronic fatigue/ fatigue"), migraine ("worsening of her migraines/ migraines"), headache ("headaches"), abdominal pain ("severe abdominal cramping, even when not menstruating/ abdominal pain"), abdominal pain upper ("stomach pain"), dysmenorrhoea ("abnormally severe menstrual pain,even when not menstruating/ dysmenorrhea (cramping)"), dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), bacterial vaginosis ("bacterial vaginosis"), allergy to metals ("nickel allergy") and rash papular ("red bumpy").In 2015, the patient experienced alopecia ("hair loss").In 2016, the patient experienced dental caries ("dental problems teeth rotting").On an unknown date, the patient experienced weight decreased ("weight loss"), dysgeusia ("metallic taste in mouth"), ovarian cyst ("ovarian cyst"), adenomyosis (seriousness criterion medically significant), endometriosis (seriousness criterion medically significant), erythema ("redness/patches resembling burn marks/ looks like burn lot of bump"), mass ("bumps nos/ looks like burn lot of bump"), skin irritation ("skin irritation"), blister ("blisters"), feeling abnormal ("brain fog"), memory impairment ("forgetfulness"), strabismus ("have to squint"), abdominal pain lower ("lower abdominal pain, even when not menstruating"), menstrual disorder ("abnormal menstruation"), vaginal infection ("chronic vaginal infections"), rash ("rashes") and pruritus ("itching").The patient was treated with morphine sulfate, tramadol, ibuprofen (ibuprof), surgery (ablation), surgery (ablation), surgery (ablation in 2009) and surgery (ablation in 2009).Essure treatment was not changed.At the time of the report, the vaginal haemorrhage, weight decreased, female sexual dysfunction, dental caries, chest pain, bladder disorder, urinary tract disorder, visual impairment, strabismus, headache, abdominal pain upper, vaginal discharge, bacterial vaginosis, allergy to metals and rash papular outcome was unknown and the menorrhagia, pelvic pain, weight increased, alopecia, dysgeusia, ovarian cyst, adenomyosis, endometriosis, fibromyalgia, erythema, mass, skin irritation, blister, dry skin, feeling abnormal, memory impairment, fungal infection, fatigue, migraine, abdominal pain, abdominal pain lower, dysmenorrhoea, menstrual disorder, dyspareunia, vaginal infection, rash and pruritus had not resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, adenomyosis, allergy to metals, alopecia, bacterial vaginosis, bladder disorder, blister, chest pain, dental caries, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, erythema, fatigue, feeling abnormal, female sexual dysfunction, fibromyalgia, fungal infection, headache, mass, memory impairment, menorrhagia, menstrual disorder, migraine, ovarian cyst, pelvic pain, pruritus, rash, rash papular, skin irritation, strabismus, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vaginal infection, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: as per pfs, onset date of event allergy to metals was in 2006.Diagnostic results: current weight as of (b)(6) 2018: (b)(6).Approximate weight at the time of essure placement: (b)(6).Most recent follow-up information incorporated above includes: on 22-may-2018: plaintiff fact sheet received.Patient¿s demographic information, relevant history updated.Essure start date updated from 2009 to (b)(6) 2009.Events yeast infections, vision changes, dry patches that look like a burn, teeth rotting were clubbed with previously reported events.Events rash papular were newly added and tooth disorder was replaced with dental caries.Incident category was updated to incident for vaginal bleeding and menorrhagia.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981
• MDR Report Key: 7590935
• MDR Text Key: 110754927
• Report Number: 2951250-2018-02585
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CELEXA; GABAPENTIN; XANAX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 23 YR