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

Model Number ESS305

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

Patient Problems Fatigue (1849); Headache (1880); Hearing Impairment (1881); Vertigo (2134); Visual Impairment (2138); Myalgia (2238); Arthralgia (2355); No Code Available (3191)

Event Date 06/15/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of allergy to metals ("nickel allergy") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 2 and general anesthesia.Patient had no known allergies.Previously administered products included for an unreported indication: iud and pill.Past adverse reactions to the above products included drug intolerance with pill.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), musculoskeletal pain ("joint and muscle pain"), fatigue ("fatigue"), visual impairment ("visual problems"), auditory disorder ("hearing problems"), gout ("gout"), migraine ("migraines") and vertigo ("vertigo").On an unknown date, the patient experienced complication of device removal ("essure surgical removal difficulties/complications").The patient was treated with surgery (salpingectomy and bilateral corn resection - essure removed via laparoscopy).Essure was removed.At the time of the report, the allergy to metals, musculoskeletal pain, fatigue, visual impairment, auditory disorder, gout, migraine and vertigo was resolving and the complication of device removal outcome was unknown.The reporter provided no causality assessment for allergy to metals, auditory disorder, complication of device removal, fatigue, gout, migraine, musculoskeletal pain, vertigo and visual impairment with essure.The reporter commented: nickel allergy was not known prior to insertion.Bilateral corn resection necessary due to essure surgical removal difficulties/complications.No post-operative complications were noted.Essure symptoms improved after removal, but no disappearance of all signs.Patient was very satisfied with the surgery.No x-ray after essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - in 2016: nickel allergy confirmed.X-ray - on (b)(6) 2016: essure in correct position.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 27_jul_2017 for the following meddra preferred term: allergy to metals: the analysis in the global safety database revealed 272 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: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• 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; whippany, NJ 07981-0915
• MDR Report Key: 6793791
• MDR Text Key: 82672493
• Report Number: 2951250-2017-02894
• 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
• Report Date: 08/15/2017

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/15/2017
• 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: 35 YR