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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Diarrhea (1811); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Pain (1994); Respiratory Distress (2045); Visual Impairment (2138); Myalgia (2238); Arthralgia (2355); Depression (2361); Palpitations (2467); Cognitive Changes (2551); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("atrocious pain in the abdomen"), osteochondritis ("degenerative osteochondritis"), genital haemorrhage ("bleeding") and back pain (" lower back") in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida.Previously administered products included for an unreported indication: iud.Past adverse reactions to the above products included device expulsion with iud.Concurrent conditions included intervertebral disc protrusion.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced procedural pain ("the procedure was painful/ gynaecologist could not manage to place the insert in the left uterine tube").In 2013, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and diarrhoea ("diarrhoea").In (b)(6) 2014, the patient experienced back pain (seriousness criterion medically significant), breast pain ("my left breast was very painful") and fatigue ("fatigue settled in more and more").In (b)(6) 2016, the patient experienced osteochondritis (seriousness criterion medically significant) with arthralgia.In (b)(6) 2016, the patient experienced tendonitis ("attacks of acute tendonitis"), headache ("violent headaches"), the first episode of balance disorder ("loss of balance") and dyspnoea ("i had to stop every 100 metres to catch my breath / shortness of breath").On an unknown date, the patient experienced amnesia ("memory loss"), depression ("depression"), myalgia ("muscle pain almost everywhere"), renal pain ("pain in kidneys (forcing me to stop playing tennis)/ major pain in kidneys"), visual impairment ("visual disturbances"), the second episode of balance disorder ("disturbance of balance"), ear infection ("frequent otitis"), abdominal pain lower ("pain in lower abdomen"), menorrhagia ("very heavy menstrual bleeding"), uterine pain ("my uterus was much too painful"), adenomyosis ("suspected adenomyosis"), ovarian cyst ("small functional cyst on the right ovary"), palpitations ("palpitations") and musculoskeletal pain ("shoulder pain").The patient was treated with palliative care (underwent general anaesthetic).At the time of the report, the abdominal pain was resolving, the osteochondritis, genital haemorrhage, back pain, diarrhoea, breast pain, fatigue, amnesia, depression, myalgia, renal pain, visual impairment, the last episode of balance disorder, ear infection, abdominal pain lower, menorrhagia, tendonitis, headache, dyspnoea, uterine pain, adenomyosis, ovarian cyst and palpitations outcome was unknown and the procedural pain had resolved.The reporter considered abdominal pain, abdominal pain lower, adenomyosis, amnesia, back pain, breast pain, depression, diarrhoea, dyspnoea, ear infection, fatigue, genital haemorrhage, headache, menorrhagia, musculoskeletal pain, myalgia, osteochondritis, ovarian cyst, palpitations, procedural pain, renal pain, tendonitis, uterine pain, visual impairment, the first episode of balance disorder and the second episode of balance disorder to be related to essure.The reporter commented: no preliminary screening for allergy to nickel was performed before essure insertion.The gynaecologist could not manage to place the insert in the left uterine tube and she had to have general anaesthetic.Bilateral salpingectomy and subtotal hysterectomy are planned.Diagnostic results: at 3 months, the confirmatory test on ultrasound showed the inserts in the correct place.In 2014, examination and mammography were normal.(b)(6) 2014, mri for monitoring of protrusions, detected after the birth of my fourth child, found no progression that could explain the major back pain.Sick leave for 2 weeks.(b)(6) 2015, full check-up found no abnormalities.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on (b)(6) 2017 for the following meddra preferred terms: - abdominal pain: the analysis in the global safety database revealed 1.151 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pts.Further company follow-up with the regulatory authority is not possible.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.; whippany, NJ 07981
• MDR Report Key: 6847948
• MDR Text Key: 85113217
• Report Number: 2951250-2017-03385
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/07/2017
• 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