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

Catalog Number ESS305

Device Problem Difficult to Remove (1528)

Patient Problems Fatigue (1849); Menstrual Irregularities (1959); Pain (1994); Tingling (2171); Arthralgia (2355); Abdominal Distention (2601)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of back pain ("lancinating back pain") in a (b)(6) female patient who received essure.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii and parity 2.Patient relevant gynaecological history included laser treatment of cervix in (b)(6) 2011.She had no allergy to nickel known before placement.Previously administered products included iud nos with an associated reaction of metrorrhagia, cerazette and combined contraceptive with an associated reaction of drug intolerance.On (b)(6) 2011, the patient started essure.On (b)(6) 2013, 701 days after starting essure, the patient experienced back pain (seriousness criteria medically significant and clinically significant/intervention required), menstruation irregular ("irregular menstrual cycles 2 to 3 months"), musculoskeletal pain ("muscle and joint pain"), paraesthesia ("tingling all over body like electrical discharges, neck and back"), pain in extremity ("morning pain in legs"), fatigue ("general fatigue") and abdominal distension ("bloating").The patient was treated with surgery (essure removal (salpingectomy, resection of uterine horns with ultrasonic dissection)).The patient experienced complication of device removal ("operative problems on removal of essure / complications").Essure was withdrawn.At the time of the report, the back pain, paraesthesia and pain in extremity had resolved and the complication of device removal, menstruation irregular and musculoskeletal pain outcome was unknown and the fatigue and abdominal distension was resolving.The reporter considered back pain, complication of device removal, menstruation irregular, musculoskeletal pain, paraesthesia, pain in extremity, fatigue and abdominal distension to be related to essure.The reporter commented: causal relation between essure and symptoms was probable.Diagnostic results: on (b)(6) 2011: confirmation test (abdominal plain film) - correct position confirmed.Unknown date: pathological anatomy examination of uterus and tubes: (bilateral salpingectomy) fragments of tubal walls histologically similar to normal.No suspect signs of malignancy.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and had lancinating back pain.Essure was removed via salpingectomy and uterine horn resection.Pathological anatomy examination revealed fragments of tubal walls histologically similar to normal.The event resolved.This event is anticipated in the reference safety information for essure.Back pain may have multiple causes including radiculopathy, spinal stenosis, metastatic cancer, spinal infection, pancreatitis, nephrolithiasis, pyelonephritis, abdominal aortic aneurysm, among others.In the present case, the event started two years after essure insertion.She also reported muscle pain which could have contributed to the occurrence of back pain.Furthermore, pathology results showed histologically normal tubal walls.However, given the nature of the event lancinating back pain, and since she recovered from the event following essure removal, causality cannot be totally excluded.This case was regarded as incident since device removal was required.Non-serious events were also reported.A product technical analysis and further information are expected.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of back pain ("lancinating back pain") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii from 1995 to 2001 and parity 2 from 1995 to 2001.Patient relevant gynaecological history included laser treatment of cervix in (b)(6) 2011.She had no allergy to nickel known before placement.Previously administered products included for an unreported indication: combined contraceptive, cerazette and iud nos.Past adverse reactions to the above products included drug intolerance with combined contraceptive; and metrorrhagia with iud nos.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2013, 1 year 11 months after insertion of essure, the patient experienced back pain (seriousness criteria medically significant and intervention required), menstruation irregular ("irregular menstrual cycles 2 to 3 months"), musculoskeletal pain ("muscle and joint pain"), paraesthesia ("tingling all over body like electrical discharges, neck and back"), pain in extremity ("morning pain in legs"), fatigue ("general fatigue") and abdominal distension ("bloating").On an unknown date, the patient experienced complication of device removal ("operative problems on removal of essure / complications").The patient was treated with surgery (essure removal (salpingectomy, resection of uterine horns with ultrasonic dissection)).Essure was removed.At the time of the report, the back pain, paraesthesia and pain in extremity had resolved, the complication of device removal, menstruation irregular and musculoskeletal pain outcome was unknown and the fatigue and abdominal distension was resolving.The reporter considered abdominal distension, back pain, complication of device removal, fatigue, menstruation irregular, musculoskeletal pain, pain in extremity and paraesthesia to be related to essure.The reporter commented: causal relation between essure and symptoms was probable.Diagnostic results: on (b)(6) 2011: confirmation test (abdominal plain film) - correct position confirmed.Unknown date: pathological anatomy examination of uterus and tubes: (bilateral salpingectomy) fragments of tubal walls histologically similar to normal.No suspect signs of malignancy.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 24_apr_2017 for the following meddra preferred term: back pain.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.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 19-apr-2017: ptc investigation result was provided.On 21-apr-2017: no response of reporter to final follow-up.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and had lancinating back pain.Essure was removed via salpingectomy and uterine horn resection.Pathological anatomy examination revealed fragments of tubal walls histologically similar to normal.The event resolved.This event is anticipated in the reference safety information for essure.Back pain may have multiple causes including radiculopathy, spinal stenosis, metastatic cancer, spinal infection, pancreatitis, nephrolithiasis, pyelonephritis, abdominal aortic aneurysm, among others.In the present case, the event started two years after essure insertion.She also reported muscle pain which could have contributed to the occurrence of back pain.Furthermore, pathology results showed histologically normal tubal walls.However, given the nature of the event lancinating back pain, and since she recovered from the event following essure removal, causality cannot be totally excluded.This case was regarded as incident since device removal was required.Non-serious events were also reported.A product technical analysis resulted in an unconfirmed but plausible product quality defect.Further information could not be obtained from the reporter despite attempts.

• 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, NJ 07981-0915
• MDR Report Key: 6436117
• MDR Text Key: 70979892
• Report Number: 2951250-2017-01071
• 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,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

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 Catalogue Number: ESS305
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 45 YR