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

Model Number ESS305

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

Patient Problems Anemia (1706); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Scar Tissue (2060); Visual Disturbances (2140); Vomiting (2144); Anxiety (2328); Arthralgia (2355); Malaise (2359); Depression (2361); Irritability (2421); Weight Changes (2607)

Event Date 01/01/2013

Event Type  Injury  

Event Description

"ntaneous" case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included blood pressure high and anxiety.Concomitant products included salbutamol (albuterol) for allergic respiratory disease, alprazolam since 2011 for anxiety as well as amlodipine since 2006.On (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced hypertension ("high blood pressure").In (b)(6) 2011, the patient experienced anxiety ("anxiety"), premature menopause ("early onset menopause"), malaise ("general malaise"), menstruation irregular ("irregular menstrual cycle"), alopecia ("hair loss"), irritability ("irritability"), arthralgia ("joint pain"), loss of libido ("loss of libido"), anaemia ("anemia"), disturbance in attention ("inability to concentrate") and feeling abnormal ("brain fog").In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), visual impairment ("vision changes") and dust allergy ("dust allergy").In (b)(6) 2015, the patient experienced allergy to metals ("allergy to metals") and blood heavy metal increased ("elevated nickel level").On an unknown date, the patient experienced nausea ("nausea with vomiting"), scar ("4-6" abdominal scar"), weight decreased ("weight loss"), depression ("depression"), dysgeusia ("metallic taste in mouth") and vomiting ("vomiting").The patient was treated with ondansetron (zofran).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, nausea, menstruation irregular, irritability, arthralgia, loss of libido, weight decreased, depression, anaemia, disturbance in attention, feeling abnormal and vomiting had resolved and the anxiety, scar, premature menopause, hypertension, allergy to metals, blood heavy metal increased, malaise, alopecia, visual impairment, dust allergy and dysgeusia outcome was unknown.The reporter considered allergy to metals, alopecia, anaemia, anxiety, arthralgia, blood heavy metal increased, depression, disturbance in attention, dust allergy, dysgeusia, feeling abnormal, hypertension, irritability, loss of libido, malaise, menstruation irregular, nausea, pelvic pain, premature menopause, scar, visual impairment, vomiting and weight decreased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: tubes were blocked.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received event " severe and persistent pelvic pain, anxiety, a 4-6" abdominal scar, early onset menopause, high blood pressure, general malaise, elevated nickel level, an irregular menstrual cycle, hair loss, irritability loss of libido, vision changes, weight loss, depression, allergies to heavy metals/dust, anemia and inability to concentrate/brain fog, nausea, vomiting, metallic taste in mouth" were added.Concomitant and treatment drug added.Lab data, patient and product information added.Outcome of events nausea, vomiting, severe and persistent pelvic pain, irregular menstrual cycle, joint pain, loss of libido, irritability, weight loss, depression, inability to concentrate/brain fog, and anemia were improved.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: 7849865
• MDR Text Key: 119327204
• Report Number: 2951250-2018-03877
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/06/2018
• 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
• Treatment: ALBUTEROL; ALPRAZOLAM; AMLODIPINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR