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 Adhesion(s) (1695); Autoimmune Disorder (1732); Cyst(s) (1800); Hair Loss (1877); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Abnormal Vaginal Discharge (2123); Discomfort (2330); Sensitivity of Teeth (2427); Pregnancy (3193); Dyspareunia (4505); Menorrhagia (4508)

Event Date 12/24/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain / pelvic pain aggravated by stretching') in a (b)(6) year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's concurrent conditions included nickel sensitivity (she cannot wear ¿fake¿ jewelry, which often has nickel in it, because it causes her skin to break out).On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced pelvic pain (seriousness criterion medically significant), 3 months 31 days after insertion of essure.In (b)(6) 2015, the patient experienced pelvic discomfort ("discomfort / still experiencing discomfort").On (b)(6) 2015, the patient experienced dyspareunia ("painful intercourse / sharp pains in her groin area after intercourse").On (b)(6) 2016, the patient experienced polymenorrhagia ("excessive and frequent menstruation"), coital bleeding ("post-coital bleeding") and back pain ("low back pain").On an unknown date, the patient experienced uterine haemorrhage ("abnormal uterine bleeding"), alopecia ("hair loss / continued to suffer from hair loss"), menometrorrhagia ("menometrorrhagia"), vaginal odour ("vaginal odor"), infection ("infections"), teeth brittle ("brittle teeth"), pelvic adhesions ("adhesive disease"), groin pain ("sharp pains in her groin area after intercourse"), menstruation irregular ("irregular menses"), ovarian cyst ("simple complex right ovarian cyst"), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergy") and autoimmune disorder ("auto immune disorder") and was found to have a pregnancy with contraceptive device ("post essure pregnancy").The patient was treated with physical therapy (exercises).Essure treatment was not changed.At the time of the report, the pelvic pain, uterine haemorrhage, alopecia, polymenorrhagia, dyspareunia, coital bleeding, back pain, pelvic discomfort, menometrorrhagia, vaginal odour, infection, teeth brittle, pelvic adhesions, groin pain, menstruation irregular and ovarian cyst had not resolved and the genital haemorrhage, hypersensitivity, autoimmune disorder and pregnancy with contraceptive device outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.The pregnancy outcome was unknown to the reporter.The reporter considered alopecia, autoimmune disorder, back pain, coital bleeding, dyspareunia, genital haemorrhage, groin pain, hypersensitivity, infection, menometrorrhagia, menstruation irregular, ovarian cyst, pelvic adhesions, pelvic discomfort, pelvic pain, polymenorrhagia, pregnancy with contraceptive device, teeth brittle, uterine haemorrhage and vaginal odour to be related to essure.The reporter commented: patient has not been tested for a nickel allergy, but cannot wear "fake" jewelry, which often has nickel in it because it causes her skin to break out.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: results: bilateral fallopian tubes were occluded by coils; on (b)(6) 2014: results: bilateral fallopian tubes were occluded.Ultrasound scan vagina - on (b)(6) 2015: results: normal results.Diagnostic results: on (b)(6) 2014, physician noted that her exam was consistent with adhesive disease.On (b)(6) 2015, diagnostic laparoscopy showed no evidence of endometrial implants or pathology.Transvaginal ultrasound : simple complex right ovarian cyst but was otherwise unremarkable.Most recent follow-up information incorporated above includes: on 28-aug-2020: pfs received.Event: abnormal bleeding, auto immune disorder , hypersensitivity, post essure pregnancy, device ineffective 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 ('severe pelvic pain / pelvic pain aggravated by stretching') in a 36-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included pelvic pain.Concurrent conditions included nickel sensitivity (she cannot wear ¿fake¿ jewelry, which often has nickel in it, because it causes her skin to break out.).On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced pelvic pain (seriousness criterion medically significant), 3 months 31 days after insertion of essure.In (b)(6) 2015, the patient experienced pelvic discomfort ("discomfort / still experiencing discomfort").On (b)(6) 2015, the patient experienced dyspareunia ("painful intercourse / sharp pains in her groin area after intercourse").On (b)(6) 2016, the patient experienced polymenorrhagia ("excessive and frequent menstruation"), coital bleeding ("post-coital bleeding") and back pain ("low back pain").On an unknown date, the patient experienced abnormal uterine bleeding ("abnormal uterine bleeding"), alopecia ("hair loss / continued to suffer from hair loss"), menometrorrhagia ("menometrorrhagia"), vaginal odour ("vaginal odor"), infection ("infections"), teeth brittle ("brittle teeth"), pelvic adhesions ("adhesive disease"), groin pain ("sharp pains in her groin area after intercourse"), menstruation irregular ("irregular menses"), ovarian cyst ("simple complex right ovarian cyst"), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergy") and autoimmune disorder ("auto immune disorder") and was found to have a pregnancy with contraceptive device ("post essure pregnancy").The patient was treated with physical therapy (exercises).Essure treatment was not changed.At the time of the report, the pelvic pain, abnormal uterine bleeding, alopecia, polymenorrhagia, dyspareunia, coital bleeding, back pain, pelvic discomfort, menometrorrhagia, vaginal odour, infection, teeth brittle, pelvic adhesions, groin pain, menstruation irregular and ovarian cyst had not resolved and the genital haemorrhage, hypersensitivity, autoimmune disorder and pregnancy with contraceptive device outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.The pregnancy outcome was unknown to the reporter.The reporter considered abnormal uterine bleeding, alopecia, autoimmune disorder, back pain, coital bleeding, dyspareunia, genital haemorrhage, groin pain, hypersensitivity, infection, menometrorrhagia, menstruation irregular, ovarian cyst, pelvic adhesions, pelvic discomfort, pelvic pain, polymenorrhagia, pregnancy with contraceptive device, teeth brittle and vaginal odour to be related to essure.The reporter commented: patient has not been tested for a nickel allergy, but cannot wear "fake" jewelry, which often has nickel in it because it causes her skin to break out.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: results: bilateral fallopian tubes were occluded by coils; on (b)(6) 2014: results: bilateral fallopian tubes were occluded.Ultrasound scan vagina - on (b)(6) 2015: results: normal results.Diagnostic results: on (b)(6) 2014, physician noted that her exam was consistent with adhesive disease.On (b)(6) 2015, diagnostic laparoscopy showed no evidence of endometrial implants or pathology.Transvaginal ultrasound : simple complex right ovarian cyst but was otherwise unremarkable.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, back pain most recent follow-up information incorporated above includes: on 11-jun-2021: mr received.Reporter information, patient's date of birth and medical history 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.

• 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: 10515636
• MDR Text Key: 206472407
• Report Number: 2951250-2020-14115
• 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: 06/17/2021

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
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR