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

Model Number ESS305

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Fatigue (1849); Hair Loss (1877); Headache (1880); Low Blood Pressure/ Hypotension (1914); Visual Impairment (2138); Arthralgia (2355); Irritability (2421); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 02-may-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("haemorrhagic menstrual periods") in a female patient who had essure (batch no.20227412) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In (b)(6) 2010, the patient had essure inserted.In 2012, 1734 days before insertion of essure, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), osteoarthritis ("development of advanced coxarthrosis") with arthralgia, musculoskeletal pain ("muscle and joint pain / muscle pain for 5 years (every day)"), hypotension ("low blood pressure regularly at 100"), fatigue ("chronic fatigue"), headache ("headaches"), visual impairment ("problems with vision"), balance disorder ("frequent loss of balance"), alopecia ("hair loss"), food intolerance ("development of food intolerance, including gluten, milk and eggs"), gluten sensitivity ("development of food intolerance, including gluten, milk and eggs") and cow's milk intolerance ("development of food intolerance, including gluten, milk and eggs").In (b)(6) 2017, the patient experienced device difficult to use ("salpingectomy for removal of essure failed, implants remained").On an unknown date, the patient experienced tendonitis ("multiple tendonitis leading to discontinuation of sports activities"), back pain ("back and lower back pain"), disturbance in attention ("difficulty concentrating"), irritability ("irritability") and weight decreased ("weight loss of more than 10 kg").The patient was treated with surgery (thermocoagulation of endometrium with novasure (b)(6) 2015, salpingectomy (b)(6) 2017, hysterectomy (b)(6) 2017) and immobilization (regular wearing of a brace on elbow and wrist).Essure was removed in (b)(6) 2017.At the time of the report, the menorrhagia, device difficult to use, osteoarthritis, musculoskeletal pain, tendonitis, back pain, hypotension, fatigue, headache, disturbance in attention, visual impairment, balance disorder, irritability, alopecia, food intolerance, gluten sensitivity, cow's milk intolerance and weight decreased outcome was unknown.The reporter provided no causality assessment for alopecia, back pain, balance disorder, cow's milk intolerance, device difficult to use, disturbance in attention, fatigue, food intolerance, gluten sensitivity, headache, hypotension, irritability, menorrhagia, musculoskeletal pain, osteoarthritis, tendonitis, visual impairment and weight decreased with essure.The reporter commented: over the 6 years, physical deterioration, the doctors were no able to find the cause.Changes in eating habits after developing food intolerance.All of this led to difficulties with everyday activities, work, family and social life.Diagnostic results (normal ranges are provided in parenthesis if available): blood pressure measurement - on an unknown date: regularly at 100 mmhg.On (b)(6) 2015 : x-ray.On (b)(6) 2015: mri.On (b)(6) 2015: pelvic ultrasound.On (b)(6) 2016: test for food intolerance: intolerance to gluten, milk and eggs.On (b)(6) 2017: plain film of abdomen.On (b)(6) 2017: plain film of abdomen.Further company follow-up with the regulatory authority is not possible.Company causality comment: this non-medically confirmed case report received via regulatory authority refers to a female consumer who had essure (fallopian tube occlusion insert) and experienced haemorrhagic menstrual periods starting 2 years after insertion amongst other non serious events.The consumer underwent a thermocoagulation of endometrium with novasure, a salpingectomy that failed to remove essure inserts, and later a hysterectomy that completely removed essure 7 years after insertion.The event is anticipated in the reference safety information for essure.Changes in bleeding pattern may occur during essure therapy.In this case although there is no information about the consumer's historical and concomitant medical conditions, considering the nature of the event and the positive temporal relationship a causal relationship with essure cannot be excluded.This case was regarded as incident since a device removal was required.Further company follow-up with regulatory authority is not possible.A product technical analysis is awaited.

Manufacturer Narrative

This case was initially received via regulatory authority (b)(6) (reference number: (b)(4)) on (b)(6) 2017.The most recent information was received on 13-jun-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("haemorrhagic menstrual periods") in a female patient who had essure (batch no.20227412) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In (b)(6) 2010, the patient had essure inserted.In 2012, 1734 days before insertion of essure, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), osteoarthritis ("development of advanced coxarthrosis") with arthralgia, musculoskeletal pain ("muscle and joint pain / muscle pain for 5 years (every day)"), hypotension ("low blood pressure regularly at 100"), fatigue ("chronic fatigue"), headache ("headaches"), visual impairment ("problems with vision"), balance disorder ("frequent loss of balance"), alopecia ("hair loss"), food intolerance ("development of food intolerance, including gluten, milk and eggs"), gluten sensitivity ("development of food intolerance, including gluten, milk and eggs") and cow's milk intolerance ("development of food intolerance, including gluten, milk and eggs").In (b)(6) 2017, the patient experienced device difficult to use ("salpingectomy for removal of essure failed, implants remained").On an unknown date, the patient experienced tendonitis ("multiple tendonitis leading to discontinuation of sports activities"), back pain ("back and lower back pain"), disturbance in attention ("difficulty concentrating"), irritability ("irritability") and weight decreased ("weight loss of more than 10 kg").The patient was treated with surgery (thermocoagulation of endometrium with novasure (b)(6), salpingectomy (b)(6), hysterectomy (b)(6)) and immobilization (regular wearing of a brace on elbow and wrist).Essure was removed in (b)(6) 2017.At the time of the report, the menorrhagia, device difficult to use, osteoarthritis, musculoskeletal pain, tendonitis, back pain, hypotension, fatigue, headache, disturbance in attention, visual impairment, balance disorder, irritability, alopecia, food intolerance, gluten sensitivity, cow's milk intolerance and weight decreased outcome was unknown.The reporter provided no causality assessment for alopecia, back pain, balance disorder, cow's milk intolerance, device difficult to use, disturbance in attention, fatigue, food intolerance, gluten sensitivity, headache, hypotension, irritability, menorrhagia, musculoskeletal pain, osteoarthritis, tendonitis, visual impairment and weight decreased with essure.The reporter commented: over the 6 years, physical deterioration, the doctors were no able to find the cause.Changes in eating habits after developing food intolerance.All of this led to difficulties with everyday activities, work, family and social life.Diagnostic results (normal ranges are provided in parenthesis if available): blood pressure measurement - on an unknown date: regularly at 100 mmhg (b)(6) 2015 : x-ray; (b)(6) 2015: mri; (b)(6) 2015: pelvic ultrasound; (b)(6) 2016: test for food intolerance: intolerance to gluten, milk and eggs; (b)(6) 2017: plain film of abdomen.(b)(6) 2017: plain film of abdomen; the list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on (b)(6) 2017 for the following meddra preferred term: menorrhagia.The analysis in the global safety database revealed (b)(4) 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.Most recent follow-up information incorporated above includes: on (b)(6) 2017: quality safety evaluation of ptc.Company causality comment.Incident: at the time of reporting, 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. shaw lamberson ; 100 bayer blvd. p.o box 915; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6572802
• MDR Text Key: 75379514
• Report Number: 2951250-2017-01946
• 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,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2012
• Device Model Number: ESS305
• Device Lot Number: 20227412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• 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