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

Model Number ESS305

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Hot Flashes/Flushes (2153); Cramp(s) (2193); Anxiety (2328); Reaction (2414); Heavier Menses (2666); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Event Description

Spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("unable to definitively determine the status of the essure coils") 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 seizures, gallstones removal, hypertension in 2013, kidney infection in 2013, epilepsy, hellp syndrome, stomach ulcer and gallstones.Previously administered products included for heavy periods: mirena iud from 2005 to 2010.Concurrent conditions included flu, arnold-chiari malformation type i, cholecystitis, vomiting, low back pain, flank pain, vaginal candidiasis, contact dermatitis, chest pain, epigastric pain, blood pressure high, dizziness, acute stress disorder, tingling feet/hands, shortness of breath, panic attack, allergic rhinitis, depression, ovarian cyst, raynaud's phenomenon, gerd, irritability, restlessness, muscle tension, sleep disturbance, insomnia, energy decreased, gastroesophageal reflux, hallucinations and emotional distress.Concomitant products included desipramine since 2014, escitalopram oxalate (lexapro) since (b)(6) 2016, lorazepam (ativan) since (b)(6) 2016, naproxen sodium (aleve) and solpadeine (tylenol 1).In (b)(6) 2012, the patient experienced vaginal discharge ("vaginal discharge").On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain ("severe pelvic pain, pain"), migraine ("migraines"), dysmenorrhoea ("dysmenorrhea (cramping)"), fatigue ("fatigue"), headache ("headaches") and nausea ("nausea").In (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In 2013, the patient experienced acne cystic ("hormonal changes describe: cystic acne"), hirsutism ("hormonal changes describe: facial hair growth") and hot flush ("hormonal changes describe: mild hot flashes").In (b)(6) 2014, the patient experienced abdominal pain lower ("cramping, general pain in lower abdomen"), diarrhoea ("gastrointestinal or digestive system condition type: severe diarrhea") and abdominal distension ("other injury(ies) or complication(s) please describe: bloating").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), depression ("psychological or psychiatric problems condition: depression;") and anxiety ("psychological or psychiatric problems condition: anxiety").The patient was treated with antibiotics and surgery (hysterectomy (full), salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2018.At the time of the report, the device dislocation, pelvic pain, migraine and abdominal pain lower had not resolved and the abdominal pain, acne cystic, hirsutism, hot flush, dysmenorrhoea, dyspareunia, fatigue, diarrhoea, headache, nausea, depression, anxiety, vaginal discharge and abdominal distension outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne cystic, anxiety, depression, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, hirsutism, hot flush, migraine, nausea, pelvic pain and vaginal discharge to be related to essure.The reporter commented: on or about (b)(6) 2017 plaintiff underwent an ultrasound, and healthcare provider was unable to definitively determine the status of the essure coils, and offered full hysterectomy to remove the essure coils.Plaintiff is currently investigating her options for removal of the essure devices.Insertion details: the right tubal ostia was cannulated and after deployment, 12 coils were visible.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: full occlusion of fallopian tubes.Ultrasound scan - in (b)(6) 2017: unable to definitively determine status of essure.Concerning the injuries in the case, the following ones were described in patient's medical records: headache, fatigue, nausea, abdominal pain, diarrhea, headache, vaginal discharge, pelvic pain, dyspareunia, abdominal distension, dysmenorrhea, anxiety, migraine.Most recent follow-up information incorporated above includes: on 17-aug-2018: plaintiff fact sheet and medical records received- case category changed from other event to incident.Historical condition were 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.

• 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: 7808665
• MDR Text Key: 117983578
• Report Number: 2951250-2018-03676
• 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: 08/23/2018

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: 08/17/2018
• Initial Date FDA Received: 08/23/2018
• 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: ALEVE; ATIVAN; DESIPRAMINE; LEXAPRO; TYLENOL 1
• Patient Outcome(s): Other; Required Intervention