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

Model Number ESS305

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abortion (1688); Diarrhea (1811); Erythema (1840); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Uterine Perforation (2121); Myalgia (2238); Arthralgia (2355); Abdominal Cramps (2543); Abdominal Distention (2601); Weight Changes (2607); No Code Available (3191); Pregnancy (3193)

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation (uterine comua myometrial)"), pregnancy with contraceptive device ("unwanted pregnancy"), high risk pregnancy ("high risk pregnancy") and abortion ("abortion") in a (b)(6) -year-old female patient who had essure (batch no.B04948) 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 past medical history included morbid obesity, multigravida (pregnancies: 3), parity 2 (total number of live births: 2; date of births: (b)(6) 2010, (b)(6) 2013), cholestasis in 2010, pre-eclampsia (delivered at 35: weeks, son had mild cerebral palsy), premature delivery (delivered at 37 weeks due to beginning pre-eclampsia, no issues.) on (b)(6) 2013, migraine, tonsillectomy, adenoidectomy and premenopause (menses duration:6).Previously administered products included for an unreported indication: seasonique from 2008 to 2012, sulfa, lortab, boostrix and ursodiol.Past adverse reactions to the above products included bronchitis with ursodiol; nausea with lortab; and vomiting with sulfa.Concurrent conditions included dysfunctional uterine bleeding.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced back pain ("back pain (sharp-lower back)/lower back pain/severe and persistent back") and abdominal pain lower ("stomach cramps (sharp pain & bad diarrhea)/cramping").In (b)(6) 2014, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), high risk pregnancy (seriousness criterion medically significant), abortion (seriousness criterion medically significant), abdominal pain upper ("stomach back pain"), allergy to metals ("nickel allergy/metal allergy") with swelling, hypersensitivity ("hypersensitivity reaction"), erythema ("redness"), pelvic pain ("pain"), vaginal haemorrhage ("random spotting"), gastric disorder ("gastric issues"), headache ("headaches"), abdominal distension ("bloating"), dyspareunia ("pelvic pain during intercourse"), weight decreased ("weight loss"), pruritus ("itch/itching from metal touching skin"), arthralgia ("joint pain"), myalgia ("muscle pain") and alopecia ("hair loss").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with surgery (on (b)(6) 2014, she underwent total laparoscopic hysterectomy and bilateral salpingectomy) and surgery (abortion).Essure was removed on (b)(6) 2014.At the time of the report, the uterine perforation, pregnancy with contraceptive device, high risk pregnancy, abortion, abdominal pain upper, abdominal pain lower, allergy to metals, erythema, pelvic pain, dyspareunia and weight decreased outcome was unknown and the back pain, hypersensitivity, vaginal haemorrhage, gastric disorder, headache, abdominal distension, pruritus, arthralgia, myalgia and alopecia had resolved.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal distension, abdominal pain lower, abdominal pain upper, abortion, allergy to metals, alopecia, arthralgia, back pain, dyspareunia, erythema, gastric disorder, headache, high risk pregnancy, hypersensitivity, myalgia, pelvic pain, pregnancy with contraceptive device, pruritus, uterine perforation, vaginal haemorrhage and weight decreased to be related to essure.The reporter commented: plaintiff did not claim that essure caused birth defects.The date she learned of the perforation: (b)(6) 2014.Severe and persistent back pain - gone a few weeks after removal, gastric issues- subsided a week after surgery, headaches- gone a few weeks after removal, bloating- gone a few months after removal, weight loss- lost approximately 10 pounds 2 months after surgery, random spotting- stopped immediately, itching from metal touching skin- gone a few days after removal- , joint and muscle pain- gone a few weeks after removal, and hair loss- gone a few months after removal.Essure was removed due to unsatisfactory device location hysterectomy for concomitant condition.Unnecessary hysterectomy was reported.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6) kg/sqm.Computerised tomogram - on (b)(6) 2014: perforation: pregnancy test - in (b)(6) 2014: the pregnancy was terminated.Last pap: (b)(6) 2012: results: normal.On (b)(6) 2014, hysterosalpingogram showed possible right fallopian tube patency with potential malposition of the essure device on the right side.On (b)(6) 2014, ultrasound scan showed the patient had the sonogram for abnormal uterine bleeding.The sonogram reveals normal uterus, normal ovaries, arid bright spots in endometrium, possible endometritis; right essure coil possibly imbedded in myometrial; otherwise normal myometrium and endometrium.On (b)(6) 2014, hysterosalpingogram showed on the second film, both essure devices are present in the pelvis in the normal position.Most recent follow-up information incorporated above includes: on (b)(6) 2017: the case is medically confirmed.This case refers to (b)(6) year old patient.Patient demographics were updated.Lab data was added.Her historical condition/medication was added.Essure implantation and explantation date was added.Essure indication was added.Event: severe and permanent injuries was updated to event's: unwanted pregnancy, back pain (sharp-lower back)/lower back pain/severe and persistent back pain, stomach cramps(sharp pain & bad diarrhea); high risk pregnancy; abortion, stomach back pain; cramping; nickel allergy; perforation (uterine comua, myometrial); swelling; metal allergy; redness; itch; body swelling; gastric issues; headaches; bloating; pelvic pain during intercourse; weight loss; random spotting; itching from metal touching skin; joint pain; muscle pain; hair loss and hypersensitivity reaction were added.Reporter assessed events were related with essure.Continued in the narrative.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only¿.Incident: at the time of reporting, 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.

Manufacturer Narrative

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation (uterine comua myometrial)"), pregnancy with contraceptive device ("unwanted pregnancy"), high risk pregnancy ("high risk pregnancy") and abortion ("abortion") in a 31-year-old female patient who had essure (batch no.B04948) 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 past medical history included morbid obesity, multigravida (pregnancies: 3), parity 2 (total number of live births: 2; date of births: (b)(6) 2010, (b)(6) 2013), cholestasis in 2010, pre-eclampsia (delivered at 35: weeks, son had mild cerebral palsy), premature delivery (delivered at 37 weeks due to beginning pre-eclampsia, no issues.) on (b)(6) 2013, migraine, tonsillectomy, adenoidectomy and premenopause (menses duration:6).Previously administered products included for an unreported indication: season from 2008 to 2012, sulfa, lortab, boostrix and ursodiol.Past adverse reactions to the above products included bronchitis with ursodiol; nausea with lortab; and vomiting with sulfa.Concurrent conditions included dysfunctional uterine bleeding.On (b)(6) 2013, the patient had essure inserted.In october 2013, the patient experienced back pain ("back pain (sharp-lower back)/lower back pain/severe and persistent back") and abdominal pain lower ("stomach cramps (sharp pain & bad diarrhea)/cramping").In november 2014, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), high risk pregnancy (seriousness criterion medically significant), abortion (seriousness criterion medically significant), abdominal pain upper ("stomach back pain"), allergy to metals ("nickel allergy/metal allergy") with swelling, hypersensitivity ("hypersensitivity reaction"), erythema ("redness"), pelvic pain ("pain"), vaginal haemorrhage ("random spotting"), gastric disorder ("gastric issues"), headache ("headaches"), abdominal distension ("bloating"), dyspareunia ("pelvic pain during intercourse"), weight decreased ("weight loss"), pruritus ("itch/itching from metal touching skin"), arthralgia ("joint pain"), myalgia ("muscle pain") and alopecia ("hair loss").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (on (b)(6) 2014, she underwent total laparoscopic hysterectomy and bilateral salpingectomy) and surgery (abortion).Essure was removed on (b)(6) 2014.At the time of the report, the uterine perforation, pregnancy with contraceptive device, high risk pregnancy, abortion, abdominal pain upper, abdominal pain lower, allergy to metals, erythema, pelvic pain, dyspareunia and weight decreased outcome was unknown and the back pain, hypersensitivity, vaginal haemorrhage, gastric disorder, headache, abdominal distension, pruritus, arthralgia, myalgia and alopecia had resolved.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal distension, abdominal pain lower, abdominal pain upper, abortion, allergy to metals, alopecia, arthralgia, back pain, dyspareunia, erythema, gastric disorder, headache, high risk pregnancy, hypersensitivity, myalgia, pelvic pain, pregnancy with contraceptive device, pruritus, uterine perforation, vaginal haemorrhage and weight decreased to be related to essure.The reporter commented: plaintiff did not claim that essure caused birth defects.The date she learned of the perforation: (b)(6) 2014 -(b)(6) 2014.Severe and persistent back pain - gone a few weeks after removal, gastric issues- subsided a week after surgery, headaches- gone a few weeks after removal, bloating- gone a few months after removal, weight loss- lost approximately 10 pounds 2 months after surgery, random spotting- stopped immediately, itching from metal touching skin- gone a few days after removal- , joint and muscle pain- gone a few weeks after removal, and hair loss- gone a few months after removal.Essure was removed due to unsatisfactory device location hysterectomy for concomitant condition.Unnecessary hysterectomy was reported.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 43 kg/sqm.Computerised tomogram - on (b)(6)2014: perforation: pregnancy test - in november 2014: the pregnancy was terminated.Last pap: (b)(6) 2012: results: normal.On (b)(6) 2014, hysterosalpingogram showed possible right fallopian tube patency with potential malposition of the essure device on the right side.On (b)(6) 2014, ultrasound scan showed the patient had the sonogram for abnormal uterine bleeding.The sonogram reveals normal uterus, normal ovaries, arid bright spots in endometrium, possible endometritis; right essure coil possibly imbedded in myometrial; otherwise normal myornetrium and endometrium.On (b)(6) 2014, hysterosalpingogram showed on the second film, both essure devices are present in the pelvis in the normal position.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of ptc incident at the time of reporting, 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
• MDR Report Key: 7078840
• MDR Text Key: 93597835
• Report Number: 2951250-2017-09749
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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 Expiration Date: 02/29/2016
• Device Model Number: ESS305
• Device Lot Number: B04948
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 78