MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Hair Loss (1877); Menstrual Irregularities (1959); Vaginal Mucosa Damage (2124); Vertigo (2134); Hernia (2240); Depression (2361); Sleep Dysfunction (2517); Intermenstrual Bleeding (2665); Heavier Menses (2666)

Event Date 09/01/2015

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (reference number: (b)(4)) on 26-sep-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("heavy menstruations") and volvulus ("volvulus") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included bypass surgery in 2010.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), vertigo ("vertigos"), fatigue ("significant fatigue"), tinnitus ("tinnitus"), metrorrhagia ("intermenstrual bleeding"), libido decreased ("decrease of libido"), dyspareunia ("painful intercourse with vaginal dryness"), vulvovaginal dryness ("painful intercourse with vaginal dryness"), depression ("depression"), sleep disorder ("sleep disorders") and alopecia ("loss of hair").In (b)(6) 2016, the patient experienced volvulus (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal hernia ("abdominal hernia").The patient was treated with surgery (hysterography performed in 2016) and surgery (volvulus operated in emergency in (b)(6) 2016).At the time of the report, the menorrhagia, volvulus, vertigo, fatigue, tinnitus, metrorrhagia, libido decreased, dyspareunia, vulvovaginal dryness, depression, sleep disorder, alopecia and abdominal hernia outcome was unknown.The reporter provided no causality assessment for abdominal hernia, alopecia, depression, dyspareunia, fatigue, libido decreased, menorrhagia, metrorrhagia, sleep disorder, tinnitus, vertigo, volvulus and vulvovaginal dryness with essure.The reporter commented: the sleep disorders were being treated with unspecified sleeping pills, 1 tablet daily.She started steps to remove essure.Since that, abdominal hernia was diagnosed due to abdominal wall fragility consecutive to volvulus operated in emergency in (b)(6) 2016.Further company follow-up with the regulatory authority is not possible.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 28-sep-2017 for the following meddra preferred term: menorrhagia -the analysis in the global safety database revealed 492 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 pt.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: INSERT, TUBAL OCCLUSION
• 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. lamberson ; 100 bayer blvd.; p.o. box 915; whippany 07981-0915
• MDR Report Key: 6979080
• MDR Text Key: 90290200
• Report Number: 2951250-2017-05456
• 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: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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
• Date Manufacturer Received: 09/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention