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 Cyst(s) (1800); Diarrhea (1811); Hair Loss (1877); Headache (1880); Pain (1994); Urinary Tract Infection (2120); Vomiting (2144); Cramp(s) (2193); Anxiety (2328); Depression (2361); Weight Changes (2607)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") and menorrhagia ("severe menstrual flow") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included guillain barre syndrome, shingles, constipation, bacterial vaginosis, yeast vaginitis, appendicitis and vomiting.Previously administered products included for an unreported indication: amoxicillin, diazepam, flagyl, bactrim and diflucan.In (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("severe menstrual cramps/ (cramping)"), dyspareunia ("extreme discomfort during intercourse"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), urinary tract infection ("uti"), depression ("depression"), anxiety ("anxiety"), migraine ("migraines"), headache ("headaches"), nausea ("nausea") and fatigue ("fatigue").In 2010, the patient experienced alopecia ("hair loss").In 2011, the patient experienced syncope ("fainting spells").In 2013, the patient experienced irritable bowel syndrome ("irritable bowel syndrome"), abdominal distension ("gaseous bloating/ severe bloating") and diarrhoea ("diarrhea").In (b)(6) 2014, the patient experienced ovarian cyst ("ovarian cysts").In (b)(6) 2017, the patient experienced nephrolithiasis ("nephrolithiasis").On an unknown date, the patient experienced abdominal pain ("abdominal pain"), abdominal pain lower ("lower abdominal pain/ cramping"), weight decreased ("weight loss"), adenomyosis ("adenomyosis"), endometriosis ("endometriosis") and back pain ("lower back pain").The patient was treated with surgery (hysterectomy with bilateral salpingectomy) and surgery (ablation).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, menorrhagia, abdominal pain, urinary tract infection, depression, anxiety, migraine, headache, nausea, syncope, fatigue, weight decreased, irritable bowel syndrome, diarrhoea, ovarian cyst, adenomyosis, endometriosis, nephrolithiasis, alopecia and back pain outcome was unknown and the dysmenorrhoea, abdominal pain lower, dyspareunia, vaginal haemorrhage and abdominal distension had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, alopecia, anxiety, back pain, depression, diarrhoea, dysmenorrhoea, dyspareunia, endometriosis, fatigue, headache, irritable bowel syndrome, menorrhagia, migraine, nausea, nephrolithiasis, ovarian cyst, pelvic pain, syncope, urinary tract infection, vaginal haemorrhage and weight decreased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2008: total bilateral occlusion concerning the injuries reported in this case, the following one/ones were reported via medical record confirming events abdominal pain, back pain, ovarian cyst, adenomyosis and endometriosis, diarrhea.Most recent follow-up information incorporated above includes: on 12-mar-2018: plaintiff fact sheet- all relevant medical history, concurrent condition, concomitant medication were added.Events abnormal bleeding (vaginal), menorrhagia),uti, depression, anxiety, migraines / headaches, nausea, fainting spells, dysmenorrhea(cramping), dyspareunia (painful sexual intercourse), pain, fatigue, weight loss, irritable bowel syndrome: gaseous bloating; diarrhea, severe bloating; ovarian cysts; adenomyosis and endometriosis; nephrolithiasis, hair loss were added.Follow-up 1 and 2 processed together.On 6-apr-2018: follow-up 1 and 2 processed together.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: 7529003
• MDR Text Key: 108749588
• Report Number: 2951250-2018-02279
• 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: 05/21/2018

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: 03/12/2018
• Initial Date FDA Received: 05/21/2018
• 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
• Patient Outcome(s): Other; Required Intervention