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

Model Number ESS205

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

Patient Problems Abdominal Pain (1685); Anemia (1706); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Raynauds Phenomenon (2034); Skin Irritation (2076); Urinary Tract Infection (2120); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('menorrhagia (heavy menstrual bleeding)') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's concurrent conditions included depression and pelvic discomfort.Concomitant products included contraceptives, duloxetine hydrochloride (cymbalta) and sertraline hydrochloride (zoloft).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and food allergy ("allergic or hypersensitivity reaction type: food allergies").In 2008, the patient experienced tooth disorder ("dental problems").In 2009, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced menorrhagia (seriousness criterion medically significant), pelvic pain ("pelvic pain"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain ("abdominal pain"), back pain ("back pain"), iron deficiency anaemia ("anemia"), dermatitis allergic ("allergic rash"), raynaud's phenomenon ("reynauds"), psychological trauma ("psych injury"), urinary tract infection ("uti"), fatigue ("fatigue") and alopecia ("hair loss") and was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").Essure (ess205) treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, dysmenorrhoea, dyspareunia, abdominal pain, back pain, iron deficiency anaemia, dermatitis allergic, raynaud's phenomenon, fibromyalgia, psychological trauma, urinary tract infection, fatigue, alopecia, tooth disorder, hormone level abnormal, weight increased and food allergy outcome was unknown.The reporter considered abdominal pain, alopecia, back pain, dermatitis allergic, dysmenorrhoea, dyspareunia, fatigue, fibromyalgia, food allergy, hormone level abnormal, iron deficiency anaemia, menorrhagia, pelvic pain, psychological trauma, raynaud's phenomenon, tooth disorder, urinary tract infection and weight increased to be related to essure (ess205).The reporter commented: she received treatment for reynauds, fibromyalgia, psych injury and uti.Discrepancy noted: date(s) of insertion: (b)(6) 2007, (b)(6) 2007.The left tubal ostia were then occluded with the essure device; three coils were seen at the end of the procedure.Attention was then turned to the right tubal ostia which, in a similar fashion, was occluded using the essure device.One coil was seen on the right.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs +mr received.New event "allergic or hypersensitivity reaction type: food allergies" added.New reporters, plaintiffs information added.Onset dates for events were added.Concomitant conditions and drug were added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer, and describes the occurrence of pelvic pain ('pelvic pain'), dyspareunia ('dyspareunia (painful sexual intercourse)'), dysmenorrhoea ('dysmenorrhea (cramping)'), abdominal pain ('abdominal pain') and menorrhagia ('menorrhagia (heavy menstrual bleeding),abnormal bleeding (vaginal, menorrhagia)').In an adult female patient who had essure (ess205), inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed, "she did not undergo essure confirmation test".The patient's concurrent conditions included: depression, pelvic discomfort and body mass index normal.Concomitant products included: contraceptives, docusate sodium, duloxetine hydrochloride (cymbalta), minerals nos;vitamins nos (prenatal vitamins) and sertraline hydrochloride (zoloft).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced menorrhagia and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2007, the patient experienced dysmenorrhoea and food allergy ("allergic or hypersensitivity reaction type: food allergies").In (b)(6) 2008, the patient experienced cystitis ("infection (bladder/urinary tract/vaginal), type: bladder").In 2008, the patient experienced iron deficiency anaemia ("anemia"), raynaud's phenomenon ("reynauds/raynaud's disease") and tooth disorder ("dental problems").In 2009, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced pelvic pain, dyspareunia, abdominal pain, back pain ("back pain"), dermatitis allergic ("allergic rash"), psychological trauma ("psych injury"), urinary tract infection ("uti"), fatigue ("fatigue") and alopecia ("hair loss").And was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").The patient was treated with antibiotics and morphine.Essure (ess205) treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, dysmenorrhoea, dyspareunia, abdominal pain, back pain, iron deficiency anaemia, dermatitis allergic, raynaud's phenomenon, fibromyalgia, psychological trauma, urinary tract infection, fatigue, alopecia, tooth disorder, hormone level abnormal, weight increased, food allergy, vaginal haemorrhage and cystitis outcome was unknown.The reporter considered abdominal pain, alopecia, back pain, cystitis, dermatitis allergic, dysmenorrhoea, dyspareunia, fatigue, fibromyalgia, food allergy, hormone level abnormal, iron deficiency anaemia, menorrhagia, pelvic pain, psychological trauma, raynaud's phenomenon, tooth disorder, urinary tract infection, vaginal haemorrhage and weight increased to be related to essure (ess205).The reporter commented: she received treatment for reynauds, fibromyalgia, psych injury and uti.Discrepancy noted: date(s) of insertion: (b)(6) 2007.The left tubal ostia were then occluded with the essure device.Three coils were seen at the end of the procedure.Attention was then turned to the right tubal ostia which, in a similar fashion, was occluded using the essure device.One coil was seen on the right.Diagnostic results (normal ranges are provided in parenthesis if available): body mass: index was 21.4 kg/sqm.Quality safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020, pfs received: event: menorrhagia was updated to non serious.Events added: abnormal bleeding (vaginal), infection bladder, concomitant drugs, treatment drugs, medical history were added.Based on the available information.A review of our complaint records and other relevant data was conducted.Any new and reportable information that becomes available from our investigation, will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 10285668
• MDR Text Key: 204381768
• Report Number: 2951250-2020-11582
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTRACEPTIVES.; CONTRACEPTIVES.; CYMBALTA.; CYMBALTA.; DOCUSATE SODIUM.; PRENATAL VITAMINS.; ZOLOFT.; ZOLOFT.
• Patient Outcome(s): Other
• Patient Weight: 66