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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Breast Cancer (1759); Diarrhea (1811); Pain (1994); Weakness (2145); Myalgia (2238); Arthralgia (2355); Depression (2361); Weight Changes (2607); Heavier Menses (2666)

Event Date 01/01/2007

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (b)(4) on (b)(6) 2017.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("abdominal pains") and breast cancer ("hormonal-requiring breast cancer") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.In 2007, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), bone pain ("bone pains"), musculoskeletal pain ("joint and muscular pains") and neuralgia ("neuropathic pains").In (b)(6) 2016, the patient experienced breast cancer (seriousness criterion medically significant).On an unknown date, the patient experienced metrorrhagia ("metrorrhagias"), diarrhoea ("diarrheas"), asthenia ("asthenia"), weight increased ("weight gain (more than 10kg in 1 year)"), libido decreased ("libido decreased") and depression ("depression").The patient was treated with hormones nos and surgery (essure removal).Essure was removed.In 2017, the abdominal pain, bone pain, musculoskeletal pain and neuralgia had resolved.At the time of the report, the breast cancer, metrorrhagia, diarrhoea, asthenia, weight increased, libido decreased and depression outcome was unknown.The reporter provided no causality assessment for abdominal pain, asthenia, bone pain, breast cancer, depression, diarrhoea, libido decreased, metrorrhagia, musculoskeletal pain, neuralgia and weight increased with essure.The reporter commented: the events happened at the home of the consumer.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 (b)(6) 2017 for the following meddra preferred term: abdominal pain.The analysis in the global safety database revealed 1.509 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.Further company follow-up with the regulatory authority is not possible.Company causality comment 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; mullerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; mullerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd. p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 7038086
• MDR Text Key: 92304001
• Report Number: 2951250-2017-06687
• 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: 11/16/2017

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: 10/23/2017
• Initial Date FDA Received: 11/16/2017
• 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