ESSURE
Report
- Report Number
- 2951250-2017-08436
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- November 1, 2016
- Report Date
- November 5, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS / PERFORATION (UTERUS)"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 836496, 871978) INSERTED FOR FEMALE STERILISATION. 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 MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, DYSFUNCTIONAL UTERINE BLEEDING AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) SINCE 2015, ESOMEPRAZOLE MAGNESIUM (NEXIUM) SINCE 2015, PRENATAL VITAMINS SINCE (B)(6) 2010 AND VERAPAMIL SINCE (B)(6) 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / GLOBAL PELVIC PAIN") AND PAIN ("BODY ACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFECTION ("INFECTIONS"), ANXIETY ("ANXIETY"), FEELING ABNORMAL ("HORMONAL CHANGES DESCRIBE: EASILY UPSET, OR ANGRY"), ALOPECIA ("HAIR FALLING OUT"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), ADNEXA UTERI PAIN ("OVARIAN PAIN") AND ABDOMINAL DISTENSION ("BLOATING"). 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 (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, INFECTION, ANXIETY, PELVIC PAIN, FEELING ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, PAIN, ABDOMINAL PAIN LOWER AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN, THE FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ALOPECIA AND ABDOMINAL DISTENSION HAD RESOLVED AND THE FATIGUE WAS RESOLVING. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ADNEXA UTERI PAIN, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, PAIN, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. HCG PREGNANCY TEST WAS NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN, DYSMENORRHEA, MENORRHAGIA & DYSPAREUNIA,¿ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS AND MEDICAL RECORD RECEIVED. MEDICALLY CONFIRMED CASE. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. CONCOMITANT DISEASE, LABORATORY DATA, CONCOMITANT DRUGS WERE ADDED. UPDATED SUSPECT DRUG INDICATION. EVENTS HORMONAL CHANGES DESCRIBE: EASILY UPSET, OR ANGRY, VAGINAL BLEEDING, MENORRHAGIA, APAREUNIA, DEPRESSION, MIGRAINES, HEADACHES, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, WEIGHT GAIN, BODY ACHES, HAIR FALLING OUT, LOWER ABDOMINAL PAIN, OVARIAN PAIN AND BLOATING ADDED. 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.
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS / PERFORATION (UTERUS)"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 836496, 871978) INSERTED FOR FEMALE STERILISATION. 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 MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, DYSFUNCTIONAL UTERINE BLEEDING AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) SINCE 2015, ESOMEPRAZOLE MAGNESIUM (NEXIUM) SINCE 2015, PRENATAL VITAMINS SINCE (B)(6) 2010 AND VERAPAMIL SINCE (B)(6) 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / GLOBAL PELVIC PAIN") AND PAIN ("BODY ACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFECTION ("INFECTIONS"), ANXIETY ("ANXIETY"), ANGER ("HORMONAL CHANGES DESCRIBE: EASILY UPSET, OR ANGRY"), ALOPECIA ("HAIR FALLING OUT"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), ADNEXA UTERI PAIN ("OVARIAN PAIN") AND ABDOMINAL DISTENSION ("BLOATING"). 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 (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, INFECTION, ANXIETY, PELVIC PAIN, ANGER, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, PAIN, ABDOMINAL PAIN LOWER AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN, THE FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ALOPECIA AND ABDOMINAL DISTENSION HAD RESOLVED AND THE FATIGUE WAS RESOLVING. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ADNEXA UTERI PAIN, ALOPECIA, ANGER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, PAIN, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION . HCG PREGNANCY TEST WAS NEGATIVE . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN, DYSMENORRHEA, MENORRHAGIA & DYSPAREUNIA,¿ BATCH NUMBER: 836496 EXP DATE:2014/03, MAN DATE:2011/03. BATCH NUMBER: 871978 EXP DATE:2014/06, MAN DATE:2011/06 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("PIECE OF THE COIL BROKE OFF WHEN INSERTED INTO RIGHT TUBE"), UTERINE PERFORATION ("MIGARTION OF DEVICE/ONE ESSURE COIL WAS IMBEDDED IN MY UTERUS/ MIGARTION OF ESSURE DEVICE-LOCATION: MD FOUND IN US, ONE COIL WAS MISSING AND UNABLE TO LOCATE UNTIL HYSTERECTOMY AND FOUND EMBEDDED IN UTERUS"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 836496, 871978) INSERTED FOR FEMALE STERILISATION. 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 MULTIGRAVIDA, PARITY 4 AND GASTRITIS (TREATMENT: ENDOSCOPY AND COLONOSCOPY). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: YASMIN. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, DYSFUNCTIONAL UTERINE BLEEDING AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) SINCE 2015, ESOMEPRAZOLE MAGNESIUM (NEXIUM) SINCE 2015, PRENATAL VITAMINS SINCE SEPTEMBER 2010, SERTRALINE (ZOLOFT) AND VERAPAMIL SINCE SEPTEMBER 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND COITAL BLEEDING ("BLEEDING DURING SEX"). IN JANUARY 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING/ ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("MENORRHAGIA"). IN MARCH 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/ (INABILITY TO HAVE SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / GLOBAL PELVIC PAIN"), PAIN ("BODY ACHES/ HORMONAL CHANGES- DESCERIBE: BODY ACHE") AND ALOPECIA ("HAIR FALLING OUT? HORMONAL CHANGES- DESCRIBE: HAIR FALLING OUT"). IN OCTOBER 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIACTRC PROBLEMS-CONDITION: DEPRESSION"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN NOVEMBER 2016, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE INSERTION ("PIECE OF THE COIL BROKE OFF WHEN INSERTED INTO RIGHT TUBE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFECTION ("INFECTIONS"), ANXIETY ("ANXIETY"), ANGER ("HORMONAL CHANGES DESCRIBE: EASILY UPSET, OR ANGRY"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), ADNEXA UTERI PAIN ("OVARIAN PAIN") AND ABDOMINAL DISTENSION ("BLOATING"). 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 (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, UTERINE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, INFECTION, ANXIETY, PELVIC PAIN, ANGER, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, DYSMENORRHOEA, WEIGHT INCREASED, PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI PAIN AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN AND THE FEMALE SEXUAL DYSFUNCTION, DEPRESSION, MIGRAINE, DYSPAREUNIA, FATIGUE, ALOPECIA, ABDOMINAL DISTENSION AND COITAL BLEEDING HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ADNEXA UTERI PAIN, ALOPECIA, ANGER, ANXIETY, COITAL BLEEDING, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, PAIN, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. HYSTEROSALPINGOGRAM - ON 2-FEB-2012: TOTAL BILATERAL OCCLUSION ULTRASOUND PELVIS - IN NOVEMBER 2016: ONE OF THE COIL WAS MISSING HCG PREGNANCY TEST WAS NEGATIVE CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN, DYSMENORRHEA, MENORRHAGIA & DYSPAREUNIA,¿ BATCH NUMBER: 836496 EXP DATE:2014/03 MAN DATE:2011/03 . BATCH NUMBER: 871978 EXP DATE:2014/06 MAN DATE:2011/06 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. OTHER RELEVANT HISTORY AND LAB DATA UPDATED. EVENT: BLEEDING DURING SEX, PIECE OF THE COIL BROKE OFF WHEN INSERTED INTO RIGHT TUBE: COMPLICATION OF DEVICE INSERTION NEWLY ADDED. OUTCOME OF MIGRAINE AND PAIN DURING SEX/BLEEDING WERE CHANGED FROM "UNKNOWN" TO "RECOVERED / RESOLVED" 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFECTION ("INFECTIONS"), ANXIETY ("ANXIETY") AND PELVIC PAIN ("PAIN"). 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 (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, INFECTION, ANXIETY AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANXIETY, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, INFECTION, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE 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 |
|---|---|---|---|---|---|---|---|
| 836178 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 836496, 871978 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | FLEXERIL| FLEXERIL| FLEXERIL| NEXIUM| NEXIUM| NEXIUM| PRENATAL VITAMINS| PRENATAL VITAMINS| PRENATAL VITAMINS| VERAPAMIL| VERAPAMIL| VERAPAMIL| ZOLOFT |