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

Model Number ESS205

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Anemia (1706); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Itching Sensation (1943); Memory Loss/Impairment (1958); Pain (1994); Hot Flashes/Flushes (2153); Arthralgia (2355); Depression (2361); Numbness (2415); Fungal Infection (2419); Sweating (2444); Abdominal Cramps (2543); Abdominal Distention (2601); Heavier Menses (2666); Constipation (3274)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (health (b)(4) /government of (b)(4)) on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain"), genital haemorrhage ("hemorrhage / clots blood") and arthralgia ("joint pain") in a (b)(6) female patient who had essure (ess205) (batch no.12276541) inserted for sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2009, the patient experienced hypothyroidism ("hypothyroid").On (b)(6) 2017, 9 years 10 months after insertion of essure (ess205), the patient experienced uterine leiomyoma ("uterine fibroid diagnosis").On (b)(6) 2017, the patient experienced genital haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), arthralgia (seriousness criterion medically significant), procedural pain ("felt like needles in the lower abdomen immediately after essure implant"), abdominal pain ("cramps"), abdominal distension ("ballooning"), menstrual disorder ("abnormal menstruation"), menorrhagia ("menorrhagia"), ovulation pain ("mittelschmerz / painful ovulation"), dysmenorrhoea ("dysmenorrhea"), vulvovaginal pain ("vulvodynia"), pruritus ("allergy itching"), hypersensitivity ("allergy itching"), adenomyosis ("adenomyosis"), headache ("headache"), fungal infection ("infections with yeast"), skin odour abnormal ("odor"), hot flush ("hot flush"), night sweats ("night sweats"), loss of libido ("loss of libido"), sexual dysfunction ("sexual dysfunction"), incontinence ("incontinence"), anaemia ("anemia"), vitamin d deficiency ("vitamin d deficiency"), fatigue ("chronic fatigue"), alopecia ("hair loss"), adhesion ("adhesions"), dry skin ("extra dry skin"), amnesia ("forgetfulness / loss of short-term memory"), constipation ("constipation"), diarrhoea ("diarrhea"), dysgeusia ("metallic taste in the mouth"), hypoaesthesia ("numbness"), mood altered ("moodiness") and depressed mood ("sadness").The patient was treated with surgery (hysteroscopy on (b)(6) 2017, finally hysterectomy and salpingectomy to remove implants) and surgery (operated (b)(6) 2017 hip prosthesis).Essure (ess205) was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, arthralgia, procedural pain, abdominal pain, abdominal distension, menstrual disorder, menorrhagia, ovulation pain, dysmenorrhoea, vulvovaginal pain, pruritus, hypersensitivity, uterine leiomyoma, adenomyosis, headache, fungal infection, skin odour abnormal, hot flush, night sweats, loss of libido, sexual dysfunction, incontinence, anaemia, vitamin d deficiency, fatigue, alopecia, hypothyroidism, adhesion, dry skin, amnesia, constipation, diarrhoea, dysgeusia, hypoaesthesia, mood altered and depressed mood outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, adenomyosis, adhesion, alopecia, amnesia, anaemia, arthralgia, constipation, depressed mood, diarrhoea, dry skin, dysgeusia, dysmenorrhoea, fatigue, fungal infection, genital haemorrhage, headache, hot flush, hypersensitivity, hypoaesthesia, hypothyroidism, incontinence, loss of libido, menorrhagia, menstrual disorder, mood altered, night sweats, ovulation pain, pelvic pain, procedural pain, pruritus, sexual dysfunction, skin odour abnormal, uterine leiomyoma, vitamin d deficiency and vulvovaginal pain with essure (ess205).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 in a supplemental report.

Manufacturer Narrative

This case was initially received via regulatory authority (health canada / government of canada) on 19-jun-2018.The most recent information was received on 12-dec-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain"), genital haemorrhage ("hemorrhage / clots blood") and arthralgia ("joint pain") in a 46-year-old female patient who had essure (ess205) (batch no.12276541) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2009, the patient experienced hypothyroidism ("hypothyroid").On (b)(6) 2017, the patient was found to have uterine leiomyoma ("uterine fibroid diagnosis"), 9 years 10 months after insertion of essure (ess205).On (b)(6) 2017, the patient experienced genital haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), arthralgia (seriousness criterion medically significant), procedural pain ("felt like needles in the lower abdomen immediately after essure implant"), abdominal pain ("cramps"), abdominal distension ("ballooning"), menstrual disorder ("abnormal menstruation"), menorrhagia ("menorrhagia"), ovulation pain ("mittelschmerz / painful ovulation"), dysmenorrhoea ("dysmenorrhea"), vulvovaginal pain ("vulvodynia"), pruritus allergic ("allergy itching"), hypersensitivity ("allergy itching"), adenomyosis ("adenomyosis"), headache ("headache"), fungal infection ("infections with yeast"), skin odour abnormal ("odor"), hot flush ("hot flush"), night sweats ("night sweats"), loss of libido ("loss of libido"), sexual dysfunction ("sexual dysfunction"), incontinence ("incontinence"), anaemia ("anemia"), vitamin d deficiency ("vitamin d deficiency"), fatigue ("chronic fatigue"), alopecia ("hair loss"), adhesion ("adhesions"), dry skin ("extra dry skin"), amnesia ("forgetfulness / loss of short-term memory"), constipation ("constipation"), diarrhoea ("diarrhea"), dysgeusia ("metallic taste in the mouth"), hypoaesthesia ("numbness"), mood altered ("moodiness") and depressed mood ("sadness").The patient was treated with surgery (hysteroscopy on (b)(6) 2017, finally hysterectomy and salpingectomy to remove implants and operated (b)(6) 2017 hip prosthesis).Essure (ess205) was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, arthralgia, procedural pain, abdominal pain, abdominal distension, menstrual disorder, menorrhagia, ovulation pain, dysmenorrhoea, vulvovaginal pain, pruritus allergic, hypersensitivity, uterine leiomyoma, adenomyosis, headache, fungal infection, skin odour abnormal, hot flush, night sweats, loss of libido, sexual dysfunction, incontinence, anaemia, vitamin d deficiency, fatigue, alopecia, hypothyroidism, adhesion, dry skin, amnesia, constipation, diarrhoea, dysgeusia, hypoaesthesia, mood altered and depressed mood outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, adenomyosis, adhesion, alopecia, amnesia, anaemia, arthralgia, constipation, depressed mood, diarrhoea, dry skin, dysgeusia, dysmenorrhoea, fatigue, fungal infection, genital haemorrhage, headache, hot flush, hypersensitivity, hypoaesthesia, hypothyroidism, incontinence, loss of libido, menorrhagia, menstrual disorder, mood altered, night sweats, ovulation pain, pelvic pain, procedural pain, pruritus allergic, sexual dysfunction, skin odour abnormal, uterine leiomyoma, vitamin d deficiency and vulvovaginal pain with essure (ess205).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-dec-2018: quality-safety evaluation of ptc.Incident we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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
• MDR Report Key: 7624742
• MDR Text Key: 111882994
• Report Number: 2951250-2018-02733
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2007
• Device Model Number: ESS205
• Device Lot Number: 12276541
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR