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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Anemia (1706); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Weight Changes (2607); Heavier Menses (2666); Fibrosis (3167)

Event Date 11/17/2015

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain / pain") and haemorrhagic anaemia ("severe anemia") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2015, 2 years 11 months after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal )") and menorrhagia ("menorrhagia").In (b)(6) 2017, the patient experienced hormone level abnormal ("hormone unbalance"), weight increased ("weight gain"), migraine ("migraines") and headache ("headaches").In (b)(6) 2017, the patient experienced haemorrhagic anaemia (seriousness criterion medically significant).On (b)(6) 2017, the patient experienced uterine leiomyoma ("fibroid").On an unknown date, the patient experienced menstrual disorder ("menstruation issues").The patient was treated with surgery (supracervical hysterectomy (full)).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menstrual disorder, hormone level abnormal, weight increased, menorrhagia, migraine, headache and uterine leiomyoma outcome was unknown, the haemorrhagic anaemia was resolving and the vaginal haemorrhage had resolved.The reporter considered haemorrhagic anaemia, headache, hormone level abnormal, menorrhagia, menstrual disorder, migraine, pelvic pain, uterine leiomyoma, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: it was reported that she underwent treatment due to complications from the essure device.Current weight (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: essure device was successfully occluded.Most recent follow-up information incorporated above includes: on 18-may-2018: pfs received.Events: hormone unbalance, weight gain, abnormal bleeding (vaginal ) , menorrhagia , migraines, headaches,severe anemia, fibroid 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 pelvic pain ("severe pelvic pain / pain") and haemorrhagic anaemia ("severe anemia") in a 27-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included obesity.Concomitant products included medroxyprogesterone (depo provera).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced depression ("psychological or psychiatric problems: depression") and anxiety ("mental anguish").On (b)(6) 2015, 2 years 11 months after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal )") and menorrhagia ("menorrhagia").In (b)(6) 2017, the patient experienced hormone level abnormal ("hormone unbalance"), weight increased ("weight gain"), migraine ("migraines") and headache ("headaches").In (b)(6) 2017, the patient experienced haemorrhagic anaemia (seriousness criterion medically significant).On (b)(6) 2017, the patient experienced uterine leiomyoma ("fibroid").On an unknown date, the patient experienced menstrual disorder ("menstruation issues").The patient was treated with surgery (supracervical hysterectomy (full) / bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain and vaginal haemorrhage had resolved, the haemorrhagic anaemia was resolving and the menstrual disorder, hormone level abnormal, weight increased, menorrhagia, migraine, headache, uterine leiomyoma, depression and anxiety outcome was unknown.The reporter considered anxiety, depression, haemorrhagic anaemia, headache, hormone level abnormal, menorrhagia, menstrual disorder, migraine, pelvic pain, uterine leiomyoma, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: it was reported that she underwent treatment due to complications from the essure device.Current weight 165 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: essure device was successfully occluded.Most recent follow-up information incorporated above includes: on 23-jul-2018: plaintiff fact sheet received: events depression and mental anguish are added.Historical & concomitant drugs & conditions were added.Product, patient & reporter information updated.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
• MDR Report Key: 7581412
• MDR Text Key: 110518919
• Report Number: 2951250-2018-02545
• 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: 08/01/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO PROVERA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 77