ESSURE
Report
- Report Number
- 2951250-2017-07130
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- June 14, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF COILS') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY ON (B)(6) 2012, ABDOMINAL ADHESIONS IN 2009, VAGINITIS CHLAMYDIAL IN 2009, LOOP ELECTROSURGICAL EXCISION PROCEDURE IN 2007, CERVICAL CANCER AND SEASONAL ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: ORAL CONTRACEPTIVE NOS FROM (B)(6) 2011 AND IMPLANON FROM 2008 TO (B)(6) 2011; FOR BIRTH CONTROL: MIRENA IN 2009. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ADVERSE EVENT WITH IMPLANON AND MIRENA; AND PREGNANCY WITH ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED CONSTIPATION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2012 FOR BIRTH CONTROL, ESTRADIOL (ESTROGEN) FOR BLEEDING BREAKTHROUGH AS WELL AS DOCUSATE SODIUM (COLACE) SINCE 2009 AND IBUPROFEN SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("BLADDER OR URINARY PROBLEMS OR CHANGES: LOWER ABDOMEN HURTS WITH SHARP PAINS WHEN MY BLADDER IS FULL/PAIN: LOWER ABDOMINAL PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ I WAS BLEEDING FOR ALMOST 8 MONTHS BEFORE MY HYSTERECTOMY WAS PERFORMED"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ I WAS BLEEDING FOR ALMOST 8 MONTHS BEFORE MY HYSTERECTOMY WAS PERFORMED") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)/PAIN ACCOMPANIED WITH NO SEX DRIVE/ NOT ABLE TO PERFORM WITHOUT A ARTIFICIAL LUBE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION SUICIDAL ("CHANGES OF MOOD, LIKE DEPRESSION AND ENCOUNTERED SUICIDAL THOUGHTS FROM TIME TO TIME") AND MOOD ALTERED ("I NOTICED CHANGE OF MOOD,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/PAIN WITH INTERCOURSE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MENOPAUSAL SYMPTOMS ("FELT AS THOUGH A PRE-MENOPAUSAL SYMPTOMS"), HOT FLUSH ("HOT FLASHES") AND FEELING COLD ("COLD FLASHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/MENSTRUAL PAIN) PAINFUL CRAMPS THAT MADE ME STAY IN BED DAYS ON END"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ANXIETY ("MENTAL ANGUISH ASSOCIATED WITH SEXUAL INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERGONE TOTAL VAGINAL HYSTERECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSPAREUNIA, ABDOMINAL PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MENOPAUSAL SYMPTOMS, MIGRAINE, HEADACHE, ANXIETY, HOT FLUSH, FEELING COLD, DEPRESSION SUICIDAL AND MOOD ALTERED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION SUICIDAL, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FEELING COLD, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HOT FLUSH, MENOPAUSAL SYMPTOMS, MENORRHAGIA, MIGRAINE, MOOD ALTERED AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THE CATHETER WAS ADVANCED INTO THE RIGHT TUBE. THE RIGHT OSTIA NOTED 5 TRAILING COILS. THE CATHETER WAS ADVANCED INTO THE LEFT TUBE. THE LEFT OSTIA NOTED 2 TRAILING COILS. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2013 PATHOLOGY REPORT REVEALED MENORRHAGIA, UTERUS (HYSTERECTOMY, - PROLIFERATIVE ENDOMETRIUM, NORMAL MYOMETRIUM. CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST: ON (B)(6) 2012: POSITIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD DYSPAREUNIA, MENORRHAGIA, HEADACHE." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUN-2019: REPORTER INFORMATION WAS ADDED. THIS CASE CONCERNS 23 YEAR OLD PATIENT. HER DEMOGRAPHIC WAS UPDATED. HER HISTORICAL MEDICATION/CONDITION AND CONCURRENT CONDITIONS WERE ADDED. ESSURE INSERTION AND REMOVAL DATE WAS UPDATED. ESSURE LOT NUMBER WAS ADDED. ESSURE INDICATION WAS ADDED. HER TREATMENT/CONCOMITANT MEDICATION WERE ADDED. PER PLAINTIFF FACT SHEET FOLLOWING EVENTS: DYSMENORRHEA (CRAMPING)/MENSTRUAL PAIN) PAINFUL CRAMPS THAT MADE ME STAY IN BED DAYS ON END; BLADDER OR URINARY PROBLEMS OR CHANGES: LOWER ABDOMEN HURTS WITH SHARP PAINS WHEN MY BLADDER IS FULL/PAIN: LOWER ABDOMINAL PAIN; ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ I WAS BLEEDING FOR ALMOST 8 MONTHS BEFORE MY HYSTERECTOMY WAS PERFORMED; APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)/PAIN ACCOMPANIED WITH NO SEX DRIVE/ NOT ABLE TO PERFORM WITHOUT A ARTIFICIAL LUBE; FELT AS THOUGH A PRE-MENOPAUSAL SYMPTOMS; MIGRAINES, HEADACHES, MENTAL ANGUISH ASSOCIATED WITH SEXUAL INTERCOURSE; HOT FLASHES, COLD FLASHES AND CHANGES OF MOOD, LIKE DEPRESSION AND ENCOUNTERED SUICIDAL THOUGHTS FROM TIME TO TIME WERE ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF COILS') AND DEPRESSION SUICIDAL ('CHANGES OF MOOD, LIKE DEPRESSION AND ENCOUNTERED SUICIDAL THOUGHTS FROM TIME TO TIME') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY ON (B)(6) 2012, ABDOMINAL ADHESIONS IN 2009, VAGINITIS CHLAMYDIAL IN 2009, LOOP ELECTROSURGICAL EXCISION PROCEDURE IN 2007, CERVICAL CANCER AND SEASONAL ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: ORAL CONTRACEPTIVE NOS FROM (B)(6) 2011 TO (B)(6) 2011 AND IMPLANON FROM 2008 TO (B)(6) 2011; FOR BIRTH CONTROL: MIRENA IN 2009. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ADVERSE EVENT WITH IMPLANON AND MIRENA; AND PREGNANCY WITH ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED CONSTIPATION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2012 TO (B)(6) 2012 FOR BIRTH CONTROL, ESTRADIOL (ESTROGEN) FOR BLEEDING BREAKTHROUGH AS WELL AS DOCUSATE SODIUM (COLACE) SINCE 2009 AND IBUPROFEN SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("BLADDER OR URINARY PROBLEMS OR CHANGES: LOWER ABDOMEN HURTS WITH SHARP PAINS WHEN MY BLADDER IS FULL/PAIN: LOWER ABDOMINAL PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ I WAS BLEEDING FOR ALMOST 8 MONTHS BEFORE MY HYSTERECTOMY WAS PERFORMED"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ I WAS BLEEDING FOR ALMOST 8 MONTHS BEFORE MY HYSTERECTOMY WAS PERFORMED") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)/PAIN ACCOMPANIED WITH NO SEX DRIVE/ NOT ABLE TO PERFORM WITHOUT A ARTIFICIAL LUBE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION SUICIDAL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MOOD ALTERED ("I NOTICED CHANGE OF MOOD,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/PAIN WITH INTERCOURSE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MENOPAUSAL SYMPTOMS ("FELT AS THOUGH A PRE-MENOPAUSAL SYMPTOMS"), HOT FLUSH ("HOT FLASHES") AND FEELING COLD ("COLD FLASHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/MENSTRUAL PAIN) PAINFUL CRAMPS THAT MADE ME STAY IN BED DAYS ON END"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ANXIETY ("MENTAL ANGUISH ASSOCIATED WITH SEXUAL INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERGONE TOTAL VAGINAL HYSTERECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEPRESSION SUICIDAL, DYSPAREUNIA, ABDOMINAL PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MENOPAUSAL SYMPTOMS, MIGRAINE, HEADACHE, ANXIETY, HOT FLUSH, FEELING COLD AND MOOD ALTERED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION SUICIDAL, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FEELING COLD, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HOT FLUSH, MENOPAUSAL SYMPTOMS, MENORRHAGIA, MIGRAINE, MOOD ALTERED AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THE CATHETER WAS ADVANCED INTO THE RIGHT TUBE. THE RIGHT OSTIA NOTED 5 TRAILING COILS. THE CATHETER WAS ADVANCED INTO THE LEFT TUBE. THE LEFT OSTIA NOTED 2 TRAILING COILS. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2013 PATHOLOGY REPORT REVEALED MENORRHAGIA, UTERUS (HYSTERECTOMY, - PROLIFERATIVE ENDOMETRIUM, NORMAL MYOMETRIUM. CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2012: POSITIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD YSPAREUNIA, MENORRHAGIA, HEADACHE." LOT NUMBER:955814, MANUFACTURING DATE:2012/02, EXPIRATION DATE:2015/02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF COILS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND DYSMENORRHOEA ("MENSTRUAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSPAREUNIA, ABDOMINAL PAIN AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA AND DYSPAREUNIA TO BE RELATED TO ESSURE. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834673 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | COLACE.| COLACE.| DEPO PROVERA.| DEPO PROVERA.| ESTROGEN.| ESTROGEN.| IBUPROFEN.| IBUPROFEN. |