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

Model Number ESS305

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Increased Sensitivity (2065); Skin Irritation (2076); Swelling (2091); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Visual Disturbances (2140); Cramp(s) (2193); Weight Changes (2607); Heavier Menses (2666)

Event Date 04/01/2015

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in an adult female patient who had essure (batch no.32016) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included diabetes from 2009 to 2018, hypertension from 2009 to 2018, anemia from 2008 to 2009, nickel sensitivity, morbid obesity and nickel sensitivity.Previously administered products included for an unreported indication: implanon from 2009 to 2010 and loestrin in 2010.Concomitant products included medroxyprogesterone acetate (depo-provera) from (b)(6) 2015 to (b)(6) 2015 for birth control.On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2015, the patient experienced genital haemorrhage ("abnormal bleeding (general)"), hirsutism ("hair growth on face"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), rash ("allergic or hypersensitivity reaction type: rashes"), urticaria ("hives"), dry skin ("dry patches"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines / headaches"), amnesia ("neurological conditions or problems type: memory loss"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth") and fluid retention ("fluid retention") and was found to have skin papilloma ("warts") and weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain") and vulvovaginal pain ("vaginal pain").In 2015, the patient experienced endometriosis ("reproductive system disorder or condition type of disorder or condition: endometriosis"), tooth fracture ("dental problems: teeth started cracking"), vaginal discharge ("vaginal discharge"), photophobia ("vision/eye problems type: light sensitivity"), night blindness ("night blindness") and fatigue ("fatigue").On an unknown date, the patient experienced mood swings ("hormonal changes describe: mood swings"), allergy to metals ("nickel allergy"), alopecia ("hair loss"), tooth disorder ("dental problems: roots were deteriorating") and swelling ("swelling").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, mood swings, vaginal haemorrhage, menorrhagia, rash, urticaria, skin papilloma, dry skin, bladder disorder, urinary tract disorder, migraine, endometriosis, tooth fracture, amnesia, allergy to metals, photophobia, night blindness, alopecia, dysgeusia, abdominal pain, vulvovaginal pain, fluid retention and tooth disorder outcome was unknown, the dysmenorrhoea, weight increased and swelling was resolving and the dyspareunia, vaginal discharge and fatigue had resolved.The reporter considered abdominal pain, allergy to metals, alopecia, amnesia, bladder disorder, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, fluid retention, genital haemorrhage, hirsutism, menorrhagia, migraine, mood swings, night blindness, pelvic pain, photophobia, rash, skin papilloma, swelling, tooth disorder, tooth fracture, urinary tract disorder, urticaria, vaginal discharge, vaginal haemorrhage, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 58.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2015: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-mar-2020: plaintiff fact sheet received.Reporters, patient demographics, medical history, historical drug, laboratory data, concomitant medication were added.On (b)(6) 2015, she implanted essure (previously reported as (b)(6) 2015).On (b)(6) 2018, she explanted essure.Essure lot number added.Injury event was updated to hormonal changes describe: mood swings, hair growth on face, abnormal bleeding (general), abnormal bleeding (vaginal, menorrhagia), allergic or hypersensitivity reaction type: rashes and hives, warts, dry patches, bladder or urinary problems or changes, migraines / headaches, reproductive system disorder or condition type of disorder or condition: endometriosis, dental problems: teeth started cracking and roots were deteriorating, neurological conditions or problems type: memory loss, nickel allergy, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pain ,vaginal discharge, vision/eye problems type: light sensitivity and night blindness, fatigue, weight gain / loss specify which one: weight gain, hair loss, metallic taste in mouth, abdominal pain, vaginal pain, fluid retention, hair loss, swelling.Updated events onset date, outcome.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in an adult female patient who had essure (batch no.32016-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included diabetes from 2009 to 2018, hypertension from 2009 to 2018, anemia from 2008 to 2009, nickel sensitivity, morbid obesity and nickel sensitivity.Previously administered products included for an unreported indication: implanon from 2009 to 2010 and loestrin in 2010.Concomitant products included medroxyprogesterone acetate (depo-provera) from (b)(6) 2015 to (b)(6) 2015 for birth control.On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2015, the patient experienced genital haemorrhage ("abnormal bleeding (general)"), hirsutism ("hair growth on face"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: rashes"), urticaria ("hives"), dry skin ("dry patches"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines / headaches"), amnesia ("neurological conditions or problems type: memory loss"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth") and fluid retention ("fluid retention") and was found to have skin papilloma ("warts") and weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain") and vulvovaginal pain ("vaginal pain").In 2015, the patient experienced endometriosis ("reproductive system disorder or condition type of disorder or condition: endometriosis"), tooth fracture ("dental problems: teeth started cracking"), vaginal discharge ("vaginal discharge"), photophobia ("vision/eye problems type: light sensitivity"), night blindness ("night blindness") and fatigue ("fatigue").On an unknown date, the patient experienced mood swings ("hormonal changes describe: mood swings"), allergy to metals ("nickel allergy"), alopecia ("hair loss"), tooth disorder ("dental problems: roots were deteriorating") and swelling ("swelling").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6)2018.At the time of the report, the pelvic pain, mood swings, vaginal haemorrhage, menorrhagia, dermatitis allergic, urticaria, skin papilloma, dry skin, bladder disorder, urinary tract disorder, migraine, endometriosis, tooth fracture, amnesia, allergy to metals, photophobia, night blindness, alopecia, dysgeusia, abdominal pain, vulvovaginal pain, fluid retention and tooth disorder outcome was unknown, the dysmenorrhoea, weight increased and swelling was resolving and the dyspareunia, vaginal discharge and fatigue had resolved.The reporter considered abdominal pain, allergy to metals, alopecia, amnesia, bladder disorder, dermatitis allergic, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, fluid retention, genital haemorrhage, hirsutism, menorrhagia, migraine, mood swings, night blindness, pelvic pain, photophobia, skin papilloma, swelling, tooth disorder, tooth fracture, urinary tract disorder, urticaria, vaginal discharge, vaginal haemorrhage, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 58.2 kg/sqm.Hysterosalpingogram - on (b)(6)2015: total bilateral occlusion.Lot number 32016 is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6)2020: quality safety evaluation of ptc.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in an adult female patient who had essure (batch no.32016-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included diabetes from 2009 to 2018, hypertension from 2009 to 2018, anemia from 2008 to 2009, nickel sensitivity, morbid obesity and nickel sensitivity.Previously administered products included for an unreported indication: implanon from 2009 to 2010 and loestrin in 2010.Concomitant products included medroxyprogesterone acetate (depo-provera) from (b)(6) 2015 to (b)(6) 2015 for birth control.On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2015, the patient experienced genital haemorrhage ("abnormal bleeding (general)"), hirsutism ("hair growth on face"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dermatitis allergic ("allergic or hypersensitivity reaction type: rashes"), urticaria ("hives"), dry skin ("dry patches"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines / headaches"), amnesia ("neurological conditions or problems type: memory loss"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth") and fluid retention ("fluid retention") and was found to have skin papilloma ("warts") and weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain") and vulvovaginal pain ("vaginal pain").In 2015, the patient experienced endometriosis ("reproductive system disorder or condition type of disorder or condition: endometriosis"), tooth fracture ("dental problems: teeth started cracking"), vaginal discharge ("vaginal discharge"), photophobia ("vision/eye problems type: light sensitivity"), night blindness ("night blindness") and fatigue ("fatigue").On an unknown date, the patient experienced mood swings ("hormonal changes describe: mood swings"), allergy to metals ("nickel allergy"), alopecia ("hair loss"), tooth disorder ("dental problems: roots were deteriorating") and swelling ("swelling").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, mood swings, vaginal haemorrhage, menorrhagia, dermatitis allergic, urticaria, skin papilloma, dry skin, bladder disorder, urinary tract disorder, migraine, endometriosis, tooth fracture, amnesia, allergy to metals, photophobia, night blindness, alopecia, dysgeusia, abdominal pain, vulvovaginal pain, fluid retention and tooth disorder outcome was unknown, the dysmenorrhoea, weight increased and swelling was resolving and the dyspareunia, vaginal discharge and fatigue had resolved.The reporter considered abdominal pain, allergy to metals, alopecia, amnesia, bladder disorder, dermatitis allergic, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, fatigue, fluid retention, genital haemorrhage, hirsutism, menorrhagia, migraine, mood swings, night blindness, pelvic pain, photophobia, skin papilloma, swelling, tooth disorder, tooth fracture, urinary tract disorder, urticaria, vaginal discharge, vaginal haemorrhage, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 58.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2015: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-apr-2020: update of information (batch is not valid).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: 9916562
• MDR Text Key: 196610493
• Report Number: 2951250-2020-02885
• 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,Followup
• Report Date: 04/15/2020

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
• Device Lot Number: 32016-NOT VALID
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 03/18/2020; 04/03/2020
• Supplement Dates FDA Received: 04/06/2020; 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO-PROVERA; DEPO-PROVERA; DEPO-PROVERA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 159