[185129003]
This spontaneous case was reported by a lawyer and describes the occurrence of fatal breast cancer metastatic ('metastatic breast adenocarcinoma') and device dislocation ('migration of essure device location of device: do not recall') in an adult female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. Concomitant products included paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets). On (b)(6) 2013, the patient had essure inserted. On an unknown date, the patient was found to have breast cancer metastatic (seriousness criterion death) and experienced device dislocation (seriousness criterion medically significant), genital haemorrhage ("general abnormal bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), vaginal infection ("bladder/urinary problems: vaginal infection") with vaginal discharge and vaginal odour, vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and pain in extremity ("legs pain"). By the time of death, the device dislocation, genital haemorrhage, dysmenorrhoea, pelvic pain, abdominal pain, vaginal infection, vaginal haemorrhage, menorrhagia and pain in extremity outcome was unknown. The patient died on (b)(6) 2019 and the reported cause of death was breast cancer metastatic. An autopsy was not performed. The reporter considered abdominal pain, breast cancer metastatic, device dislocation, dysmenorrhoea, genital haemorrhage, menorrhagia, pain in extremity, pelvic pain, vaginal haemorrhage and vaginal infection to be related to essure. The reporter commented: discrepancy noted in insertion date-?? -??? -2014 certificate of death: cause of death: metastatic breast adenocarcinoma approximate interval between onset and death : > 2 years. Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2014: essure confirmation test (unspecified) was conducted, however, result was unknown. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on 3-mar-2020: the case become fatal. Pfs received. Reporters information added. Dob was updated. Event: essure device abnormal bleeding (vaginal), menorrhagia, migration of essure device location of device: do not recall, metastatic breast adenocarcinoma, legs pain were added. Concomitant drug and lab data were added. Event: genital hemorrhage was updated as non-serious. On (b)(6) 2020: certificate of death received. Reporters information were added. An adult female patient had fallopian tube occlusion insert (essure) inserted and 5 years and 4 months after insertion, this patient died due to breast cancer metastatic at the age of 30. This event is unanticipated in the reference safety information for essure. Breast cancer is the most common cancer occurring in women. The natural incidence of breast cancer starts to increase approximately at the age of 40 years. Risk factors include, among others, positive family history for breast cancer or ovarian cancer, nulliparity, early menarche and late menopause, sedentary lifestyle and adult weight gain. Early onset breast cancer, as describe in this case, is often hereditary and associated to genetic mutations in brca1 or brca2 gene. In this case, information regarding patient`s medical history and family history were not provided. Essure promotes female sterilization by tubal occlusion, which is attributed to the space filling design of the device and the local benign occlusive tissue response. Therefore, considering the likely hereditary genetic basis of the reported breast cancer and essure mode of action, with no interference in hormonal physiology, company assesses breast cancer metastatic as unrelated to essure. Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5