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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Gastritis (1874); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tinnitus (2103); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") and ovarian cyst ("suspect ovarian cyst that developed very quickly") in a 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 allergy to metals.I had always been in good health.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), ovarian cyst (seriousness criterion medically significant), migraine ("migraines"), neuralgia ("nerve pain"), headache ("headaches"), hyperacusis ("painful and highly incapacitating hyperacusis"), tinnitus ("tinnitus"), allergy to metals ("allergy to nickel, cobalt and chrome"), gastric disorder ("stomach problems with new food intolerances") and food intolerance ("stomach problems with new food intolerance").The patient was treated with surgery (essure removal, total hysterectomy) and surgery (total hysterectomy).Essure was removed.At the time of the report, the pelvic pain, ovarian cyst, migraine, neuralgia, headache, hyperacusis, tinnitus and allergy to metals outcome was unknown and the gastric disorder and food intolerance had resolved.The reporter considered allergy to metals, food intolerance, gastric disorder, headache, hyperacusis, migraine, neuralgia, ovarian cyst, pelvic pain and tinnitus to be related to essure.The reporter commented: an article on a blog.The suspect ovarian cyst developed very quickly and required total hysterectomy.It was my gp who sounded the alarm as concerns the inserts and my allergic background and who had tested me against nickel, chrome, cobalt, which came back positive.The gynaecologist, who knew about my allergic diathesis, did not see any problem with placing the inserts.Just a few days after removal, my stomach problems were over.I was able to start eating milk products again, gluten and all the vegetables excluded from my diet, much to my surprise.That's when i had the proof i needed.I had always been in good health, i had no choice with that cyst.I am recovering little by little, and hope the other symptoms will resolve.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on an unknown date: positive against nickel, chrome, cobalt (abnormal nos).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 (b)(6) 2017 for the following meddra preferred term: pelvic pain: the analysis in the global safety database revealed 3083 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 consumer is not possible.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 shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6727515
• MDR Text Key: 80538013
• Report Number: 2951250-2017-02578
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 07/20/2017

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: Physician
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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