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 Bacterial Infection (1735); Cyst(s) (1800); Diarrhea (1811); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Failure of Implant (1924); Inflammation (1932); Menstrual Irregularities (1959); Miscarriage (1962); Nausea (1970); Rash (2033); Urinary Tract Infection (2120); Discharge (2225); Urticaria (2278); Anxiety (2328); Malaise (2359); Depression (2361); Fungal Infection (2419); Sensitivity of Teeth (2427); Abdominal Cramps (2543); Hematuria (2558); Weight Changes (2607); Heavier Menses (2666); Patient Problem/Medical Problem (2688); No Code Available (3191); Pregnancy (3193); Constipation (3274)

Event Date 01/01/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pains / increasingly intense pain / pain,'), pregnancy with contraceptive device ('pregnancy (stillbirth or miscarriage)'), abortion spontaneous ('pregnancy (stillbirth or miscarriage)') and genital haemorrhage ('abnormal bleeding (general),') in a (b)(6) year old female patient who had essure (batch no.708870) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included multigravida and parity 3 ((b)(6) 2001, (b)(6) 2006, (b)(6) 2011).Previously administered products included for an unreported indication: lidocaine and rocephin.Concurrent conditions included obesity, shortness of breath, sulfonamide allergy, inflammation, blood in urine, flank pain, frequency urinary, right upper quadrant pain, hepatic steatosis, malaise and lsil.Concomitant products included doxycycline from (b)(6) 2011 to (b)(6) 2011 for female sterilisation as well as amitriptyline since 2013, buspirone since 2013, loratadine, naproxen sodium (midol extended relief caplet) from 2013 to 2014, naproxen from 2013 to 2014 and sertraline hydrochloride (zoloft) since 2013.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criterion medically significant).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced menorrhagia ("increased bleeding during menstruation / bleeding/menorrhagia") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In 2011, the patient experienced anger ("angry"), irritability ("irritable"), mood altered ("mood changes"), genital haemorrhage (seriousness criterion medically significant), vaginal infection ("vaginitis") with vaginal discharge, fungal infection ("yeast infections"), anxiety ("anxiety"), obsessive-compulsive disorder ("ocd"), rash ("rash"), urticaria ("hives"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), urinary tract infection ("urinary tract infection") and amenorrhoea ("amenorrhea") and was found to have weight increased ("weight gain").In 2012, the patient experienced constipation ("constipation") and diarrhoea ("diarrhea").In 2013, the patient experienced toothache ("dental problems/pain in my teeth; two teeth extractions; need a third but can't afford it right now").In 2014, the patient experienced fatigue ("fatigue").In (b)(6) 2014, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and experienced abortion spontaneous (seriousness criterion medically significant).In 2017, the patient experienced gallbladder disorder ("gastrointestinal or digestive system condition type: gallbladder disorder").In (b)(6) 2017, the patient experienced breast discharge ("nipple discharge").In (b)(6) 2018, the patient experienced ovarian cyst ("ovarian cyst").On an unknown date, the patient experienced depression ("depression"), abdominal pain lower ("lower abdominal pain / cramping"), back pain ("back pain"), vulvovaginal pain ("vaginal area pain"), breast pain ("breasts pain") and alopecia ("hair loss").Essure treatment was not changed.At the time of the report, the pelvic pain, menorrhagia, anxiety and obsessive-compulsive disorder had not resolved and the pregnancy with contraceptive device, abortion spontaneous, anger, irritability, mood altered, genital haemorrhage, vaginal haemorrhage, vaginal infection, fungal infection, depression, rash, urticaria, bladder disorder, urinary tract disorder, migraine, headache, breast discharge, nausea, toothache, dysmenorrhoea, dyspareunia, fatigue, weight increased, gallbladder disorder, constipation, urinary tract infection, diarrhoea, amenorrhoea, abdominal pain lower, back pain, vulvovaginal pain, breast pain, ovarian cyst and alopecia outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first and second trimesters.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain lower, abortion spontaneous, alopecia, amenorrhoea, anger, anxiety, back pain, bladder disorder, breast discharge, breast pain, constipation, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, fungal infection, gallbladder disorder, genital haemorrhage, headache, irritability, menorrhagia, migraine, mood altered, nausea, obsessive-compulsive disorder, ovarian cyst, pelvic pain, pregnancy with contraceptive device, rash, toothache, urinary tract disorder, urinary tract infection, urticaria, vaginal haemorrhage, vaginal infection, vulvovaginal pain and weight increased to be related to essure.The reporter commented: the patient experienced a second episode of pregnancy under case# (b)(4).Plaintiff currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 35.8 kg/sqm.Hysterosalpingogram on (b)(6) 2011: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-apr-2020: pfs received: event hair loss added.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
• 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: 10014917
• MDR Text Key: 189583879
• Report Number: 2951250-2020-06346
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2013
• Device Model Number: ESS305
• Device Lot Number: 708870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• 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
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 104