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

Model Number ESS305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Diarrhea (1811); Fatigue (1849); Flatus (1865); Headache (1880); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Menstrual Irregularities (1959); Pain (1994); Thyroid Problems (2102); Tinnitus (2103); Myalgia (2238); Inadequate Pain Relief (2388); Intermenstrual Bleeding (2665); Heavier Menses (2666); Constipation (3274)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("disabling severe pain") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine mass ("abnormal lump of 10cm in uterus"), polyp ("polyps"), metrorrhagia ("repetitive metrorrhagia"), myalgia ("painful muscles"), muscle rigidity ("muscular rigidity"), dyspareunia ("painful sexual intercourse"), headache ("heavy headache"), menorrhagia ("hemorrhagic periods every 15 days"), polymenorrhoea ("hemorrhagic periods every 15 days"), fatigue ("chronic fatigue"), tinnitus ("tinnitus"), hyposmia ("decreased sense of smell"), thyroid disorder ("unstable thyroid"), premature menopause ("precocious menopause"), ovarian cyst ("left ovary cyst"), urinary incontinence ("urinary incontinence"), gastrointestinal motility disorder ("repetitive severe diarrhea, constipation and gas in colon"), flatulence ("repetitive severe diarrhea, constipation and gas in colon"), dry mouth ("dry mouth"), hypersensitivity ("more intense allergy"), back pain ("intense lumbar pain") and intervertebral disc protrusion ("lumbar disk hernia painful between l4 and l5").The patient was treated with nefopam hydrochloride (acupan).Essure treatment was not changed.At the time of the report, the pelvic pain, uterine mass, polyp, metrorrhagia, myalgia, muscle rigidity, dyspareunia, headache, menorrhagia, polymenorrhoea, fatigue, tinnitus, hyposmia, thyroid disorder, premature menopause, ovarian cyst, urinary incontinence, gastrointestinal motility disorder, flatulence, dry mouth, hypersensitivity, back pain and intervertebral disc protrusion outcome was unknown.The reporter provided no causality assessment for back pain, dry mouth, dyspareunia, fatigue, flatulence, gastrointestinal motility disorder, headache, hypersensitivity, hyposmia, intervertebral disc protrusion, menorrhagia, metrorrhagia, muscle rigidity, myalgia, ovarian cyst, pelvic pain, polymenorrhoea, polyp, premature menopause, thyroid disorder, tinnitus, urinary incontinence and uterine mass with essure.The reporter commented: the headache was 8/10 on painful scale and came near to loss conscious because of pain at several times.She was looking for an allergist to do heavy metal allergy tests.A hysterectomy was planned.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) 2018 for the following meddra preferred term: pelvic pain the analysis in the global safety database revealed 9.995 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.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
• MDR Report Key: 7298976
• MDR Text Key: 101021889
• Report Number: 2951250-2018-00941
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• 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
• Date Manufacturer Received: 02/22/2018
• 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