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

Model Number ESS305

Device Problem Difficult to Remove (1528)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Pain (1994); Pelvic Inflammatory Disease (2000); Rash (2033); Anxiety (2328); Depression (2361); Abdominal Cramps (2543)

Event Date 07/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("pelvic inflammation (severe)"), autoimmune disorder ("auto immune disorder") and abdominal adhesions ("bladder was adhered to her uterus") in a (b)(6) female patient who had essure (batch no.A90483) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii, parity 1 (date of birth: (b)(6) 2013) on (b)(6) 2013 and spontaneous abortion (reason unknown).Patient was not allergic to nickel or any other component of essure.Concurrent conditions included anxiety since 2007, panic attacks since 2007 and depression.Concomitant products included fluoxetine in 2007 for depression and anxiety.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), abdominal pain lower ("cramping/abdominal cramping (severe)"), pelvic pain ("severe and persistent pelvic pain (severe)/ pelvic cramping"), headache ("headaches") and back pain ("back pain/ severe and persistent low back pain (severe)").On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), abdominal adhesions (seriousness criterion medically significant), weight increased ("weight gain"), fatigue ("fatigue"), urinary incontinence ("leaking bladder/ leakage of urine"), rash ("rash on knee/ rash"), alopecia ("hair loss"), dyspareunia ("painful intercourse"), anxiety ("anxiety attacks/ anxiety got worse"), depression ("depression/ depression got worse"), abdominal pain ("severe and persistent abdominal pain"), hypersensitivity ("hypersensitivity reaction/ her body cannot tolerate"), nail growth abnormal ("nails not growing"), nail disorder ("nails not breaking"), panic attack ("panic attacks") and complication of device removal ("complications from essure removal procedure").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy) and surgery (had to be reconstructed).Essure was removed in (b)(6) 2014.At the time of the report, the pelvic inflammatory disease, abdominal pain lower, weight increased and alopecia was resolving, the autoimmune disorder, abdominal adhesions, fatigue, urinary incontinence, rash, headache, dyspareunia, hypersensitivity, nail growth abnormal, nail disorder, panic attack and complication of device removal outcome was unknown, the pelvic pain, back pain and abdominal pain had resolved and the anxiety and depression had not resolved.The reporter considered abdominal adhesions, abdominal pain, abdominal pain lower, alopecia, anxiety, autoimmune disorder, back pain, complication of device removal, depression, dyspareunia, fatigue, headache, hypersensitivity, nail disorder, nail growth abnormal, panic attack, pelvic inflammatory disease, pelvic pain, rash, urinary incontinence and weight increased to be related to essure.The reporter commented: she had essure removed in approximately (b)(6) 2014.The procedure was laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy (incidental cystectomy occurred), lysis of adhesions, conversion to laparotomy, cystectomy repair, cystoscopy, bilateral retrograde pyelograms.She did retain the essure or any portion of it in her possession, after essure removed.Approximate weight at the time of essure placement: 176 (unit unspecified).Current weight as of (b)(6) 2018: (b)(6) (unit unspecified).Diagnostic results: she underwent essure confirmation test in (b)(6) 2013.Type of test was transabdominal and endovaginal pelvic ultrasound and hysterosalpingogram.Most recent follow-up information incorporated above includes: on 5-jan-2018: plaintiff fact sheet received.Reporter, patient¿s demographic, relevant history and lab data updated.Essure lot number, indication and stop date were added.Essure start date updated.Event severe and permanent injuries was replaced with events pelvic inflammation, abdominal cramping, pelvic pain, weight gain, fatigue, leaking bladder/leakage of urine, rash on knee, headaches, hair loss, painful intercourse, anxiety attacks, depression, low back pain, auto immune disorder, abdominal pain, hypersensitivity reaction, nails not growing, nails not breaking, panic attacks, bladder was adhered to her uterus and complications from essure removal procedure.Essure legal manufacturer has changed from bayer healthcare, llc, (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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('pelvic inflammation (severe)'), autoimmune disorder ('auto immune disorder') and pelvic adhesions ('bladder was adhered to her uterus') in a 38-year-old female patient who had essure (batch no.A90483) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 1 (date of birth: (b)(6) 2013) on (b)(6) 2013, gravida ii, early miscarriage (reason unknown), cesarean section, irritable bowel syndrome, post-traumatic stress disorder and anxiety.Patient was not allergic to nickel or any other component of essure.Concurrent conditions included anxiety since 2007, panic attacks since 2007, depression, bloating, vaginal candidiasis, persistent cough.Concomitant products included fluoxetine (prozac) since 2007 for depression and anxiety as well as bupropion hydrochloride (wellbutrin), cetirizine hydrochloride, fexofenadine hydrochloride (allegra), macrogol 3350 (miralax), topiramate (topamax) and trazodone.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), abdominal pain lower ("cramping/abdominal cramping (severe)"), pelvic pain ("severe and persistent pelvic pain (severe)/ pelvic cramping"), headache ("headaches") and back pain ("back pain/ severe and persistent low back pain (severe)").On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), pelvic adhesions (seriousness criterion medically significant), fatigue ("fatigue"), urinary incontinence ("leaking bladder/ leakage of urine"), rash ("rash on knee/ rash"), alopecia ("hair loss"), dyspareunia ("painful intercourse"), anxiety ("anxiety attacks/ anxiety got worse"), depression ("depression/ depression got worse"), abdominal pain ("severe and persistent abdominal pain"), hypersensitivity ("hypersensitivity reaction/ her body cannot tolerate"), nail growth abnormal ("nails not growing"), nail disorder ("nails not breaking"), panic attack ("panic attacks") and complication of device removal ("complications from essure removal procedure") and was found to have weight increased ("weight gain").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy and had to be reconstructed).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic inflammatory disease, abdominal pain lower, weight increased and alopecia was resolving, the autoimmune disorder, pelvic adhesions, fatigue, urinary incontinence, rash, headache, dyspareunia, hypersensitivity, nail growth abnormal, nail disorder, panic attack and complication of device removal outcome was unknown, the pelvic pain, back pain and abdominal pain had resolved and the anxiety and depression had not resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, anxiety, autoimmune disorder, back pain, complication of device removal, depression, dyspareunia, fatigue, headache, hypersensitivity, nail disorder, nail growth abnormal, panic attack, pelvic adhesions, pelvic inflammatory disease, pelvic pain, rash, urinary incontinence and weight increased to be related to essure.The reporter commented: she had essure removed on (b)(6) 2015.The procedure was laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy, lysis of adhesions, incidental cystectomy occurred, conversion to laparotomy, cystectomy repair, cystoscopy, bilateral retrograde pyelograms.She did retain the essure or any portion of it in her possession, after essure removed.Diagnostic results: she underwent essure confirmation test in (b)(6) 2013.Type of test was transabdominal and endovaginal pelvic ultrasound and hysterosalpingogram.*on (b)(6) 2015 test for nickel allergy most recent follow-up information incorporated above includes: on (b)(6) 2019: this record was detected to be a duplicate to record us-bayer-2014-085542 (reported via fda made) to which all information was transferred.Then this duplicate record # us-bayer-2016-214952 will be deleted 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: 7182837
• MDR Text Key: 97002385
• Report Number: 2951250-2018-00314
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

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: A90483
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALLEGRA; CETIRIZINE HYDROCHLORIDE; FLUOXETINE; MIRALAX; PROZAC; TOPAMAX; TRAZODONE; WELLBUTRIN; FLUOXETINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR