ESSURE
Report
- Report Number
- 2951250-2017-07225
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- June 1, 2016
- Report Date
- October 30, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION OF IMPLANT/ MIGRATION OF ESSURE DEVICE: UTERUS/ ONE OF MY COILS HAD MIGRATED TO UTERUS WHERE IT HAD PUSHED UP AGAINTS AND COLLAPSED THE GESTATIONAL SAC/PERFORATION (UTERUS)/DEVICE INEFFECTIVE/ FAILURE TO OCCLUDE (CLOSE) FALLOPAIN TUBE (S)"), ABORTION SPONTANEOUS ("MISCARRIAGE/ PREGNANCY (STILLBIRTH OR MISCARRIAGE)/COLLPASED GESTATIONAL SAC"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE/ PREGNANCY (STILLBIRTH OR MISCARRIAGE)"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PERINATAL DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: POSTPARTUM DEPRESSION") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 4 (((B)(6) 1995, (B)(6) 1998, (B)(6) 2007, (B)(6) 2013)), MISCARRIAGE, D & C, DEPRESSION AND POSTPARTUM DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID;BETA VULGARIS ROOT;IRON AMINO ACID CHELATE;ROSA CANINA FRUIT;RUBUS IDAEUS LEAF (IRON SUPPLEMENT WITH VIT C & HERBS), ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;COLECALCIFEROL;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;VITAMIN B12 NOS;ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA), CYANOCOBALAMIN, ESCITALOPRAM OXALATE (LEXAPRO), FAMOTIDINE, FLUOXETINE HYDROCHLORIDE (PROZAC), FOLIC ACID, HYDROXYZINE, IBUPROFEN, PARACETAMOL (TYLENOL REGULAR), PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("MENORRHAGIA/ PERIODS GOT EXTREME HEAVY"). IN 2014, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND RASH ("RASHES FROM MY WEDDING BANDS AND JEWELRY THAT CONTAINED NICKEL"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED PERINATAL DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON (B)(6) 2016, THE PATIENT EXPERIENCED CYSTOCELE ("SYMPYTOMATIC CYSTOCELE WITH INCOMPLETE UTERINE PROLAPSE") AND UTERINE PROLAPSE ("SYMPYTOMATIC CYSTOCELE WITH INCOMPLETE UTERINE PROLAPSE"), 3 YEARS 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, DYSPAREUNIA, PERINATAL DEPRESSION, ALLERGY TO METALS, RASH AND UTERINE PROLAPSE OUTCOME WAS UNKNOWN AND THE DEPRESSION, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ALLERGY TO METALS, CYSTOCELE, DEPRESSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PERINATAL DEPRESSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, RASH, UTERINE PERFORATION, UTERINE PROLAPSE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLANTIFF EXPERIENCES ANOTHER EPISODE OF PREGNANCY , LINKED CASE IS :(B)(4) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RESULT: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-DEC-2018: PLAINTIFF FACT SHEET RECEIVED. NEW EVENTS ADDED- ABNORMAL BLEEDING VAGINAL, MENORRHAGIA/ PERIODS GOT EXTREME HEAVY, POSTPARTUM DEPRESSION, NICKEL ALLERGY, RASHES FROM MY WEDDING BANDS AND JEWELRY THAT CONTAINED NICKEL, SYMPYTOMATIC CYSTOCELE WITH INCOMPLETE UTERINE PROLAPSE WERE NEWLY ADDED. EVENT VERBATIM WAS UPDATED AS MIGRATION OF IMPLANT/ MIGRATION OF ESSURE DEVICE: UTERUS/ ONE OF MY COILS HAD MIGRATED TO UTERUS WHERE IT HAD PUSHED UP AGAINTS AND COLLAPSED THE GESTATIONAL SAC/PERFORATION (UTERUS)/DEVICE INEFFECTIVE/ FAILURE TO OCCLUDE (CLOSE) FALLOPAIN TUBE (S). EVENT VERBATIM WAS UPDATED AS MISCARRIAGE/ PREGNANCY (STILLBIRTH OR MISCARRIAGE)/COLLPASED GESTATIONAL SAC. REPORTER INFORMATION UPDATED. PATIENT DEMOGRAPHIC INFORMATION UPDATED. PRODUCT INFORMATION UPDATED. LAB DATA UPDATED INCIDENT WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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 UTERINE PERFORATION ("MIGRATION OF IMPLANT/ MIGRATION OF ESSURE DEVICE: UTERUS/ ONE OF MY COILS HAD MIGRATED TO UTERUS WHERE IT HAD PUSHED UP AGAINST AND COLLAPSED THE GESTATIONAL SAC/PERFORATION (UTERUS)/DEVICE INEFFECTIVE/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE (S)"), ABORTION SPONTANEOUS ("MISCARRIAGE/ PREGNANCY (STILLBIRTH OR MISCARRIAGE)/COLLAPSED GESTATIONAL SAC"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE/ PREGNANCY (STILLBIRTH OR MISCARRIAGE)"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PERINATAL DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: POSTPARTUM DEPRESSION") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 (B)(6) 1995, (B)(6) 1998, (B)(6) 2007, (B)(6) 2013)), MISCARRIAGE, D & C, DEPRESSION, POSTPARTUM DEPRESSION, COMPLICATION OF DELIVERY, BURNING SENSATION, SUPRAPUBIC PAIN AND CRAMP IN LOWER ABDOMEN. CONCURRENT CONDITIONS INCLUDED RECTOCELE, COLPORRHAPHY, CULDOPLASTY, CYSTOSCOPY, POSTPARTUM HEMORRHAGE, POSTPARTUM DEPRESSION, URINARY TRACT INFECTION, BLIGHTED OVUM AND MISSED ABORTION. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID;BETA VULGARIS ROOT;IRON AMINO ACID CHELATE;ROSA CANINA FRUIT;RUBUS IDAEUS LEAF (IRON SUPPLEMENT WITH VIT C & HERBS), ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;CHOLECALCIFEROL;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;VITAMIN B12 NOS;ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA), CYANOCOBALAMIN, ESCITALOPRAM OXALATE (LEXAPRO), FAMOTIDINE, FLUOXETINE HYDROCHLORIDE (PROZAC), FOLIC ACID, HYDROXYZINE, IBUPROFEN, PARACETAMOL (TYLENOL REGULAR), PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN FEBRUARY 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("MENORRHAGIA/ PERIODS GOT EXTREME HEAVY"). IN 2014, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND DERMATITIS CONTACT ("RASHES FROM MY WEDDING BANDS AND JEWELRY THAT CONTAINED NICKEL"). IN OCTOBER 2015, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN DECEMBER 2015, THE PATIENT EXPERIENCED PERINATAL DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN JUNE 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON (B)(6) 2016, THE PATIENT EXPERIENCED CYSTOCELE ("SYMPTOMATIC CYSTOCELE WITH INCOMPLETE UTERINE PROLAPSE") AND UTERINE PROLAPSE ("SYMPTOMATIC CYSTOCELE WITH INCOMPLETE UTERINE PROLAPSE"), 3 YEARS 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, DYSPAREUNIA, PERINATAL DEPRESSION, ALLERGY TO METALS, DERMATITIS CONTACT AND UTERINE PROLAPSE OUTCOME WAS UNKNOWN AND THE DEPRESSION, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ALLERGY TO METALS, CYSTOCELE, DEPRESSION, DERMATITIS CONTACT, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PERINATAL DEPRESSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, UTERINE PROLAPSE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF EXPERIENCES ANOTHER EPISODE OF PREGNANCY , LINKED CASE IS :2018-240101 THERE WERE TWO TRAILING COILS ON THE RIGHT AND THREE TRAILING COILS ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RESULT: TOTAL BILATERAL OCCLUSION. BILATERAL TUBAL OCCLUSION WITH NORMAL APPEARANCE OF THE UTERUS. PREGNANCY TEST - ON (B)(6) 2015: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2016: ESSURE IS IMAGED NEXT TO GS POSSIBLY PUSHING ON TO GS; ON (B)(6) 2016: ESSURE COILS SEEN EACH SIDE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: IRREGULAR INTRAUTERINE GESTATIONAL SAC WITH ONE OF THE ESSURE COILS ABUTTING THE SAC. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DEPRESSION, MENORRHAGIA, CYSTOCELE 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 NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('MIGRATION OF IMPLANT/ MIGRATION OF ESSURE DEVICE: UTERUS/ ONE OF MY COILS HAD MIGRATED TO UTERUS WHERE IT HAD PUSHED UP AGAINTS AND COLLAPSED THE GESTATIONAL SAC/PERFORATION (UTERUS)/DEVICE INEFFECTIVE/ FAILURE TO OCCLUDE (CLOSE) FALLOPAIN TUBE (S)'), ABORTION SPONTANEOUS ('MISCARRIAGE/ PREGNANCY (STILLBIRTH OR MISCARRIAGE)/COLLPASED GESTATIONAL SAC'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('MISCARRIAGE/ PREGNANCY (STILLBIRTH OR MISCARRIAGE)'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') AND PERINATAL DEPRESSION ('PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: POSTPARTUM DEPRESSION') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 (((B)(6) 1995, (B)(6) 1998, (B)(6) 2007, (B)(6) 2013)), MISCARRIAGE, D & C, DEPRESSION, POSTPARTUM DEPRESSION, COMPLICATION OF DELIVERY, BURNING SENSATION, SUPRAPUBIC PAIN AND CRAMP IN LOWER ABDOMEN. CONCURRENT CONDITIONS INCLUDED RECTOCELE, COLPORRHAPHY, CULDOPLASTY, CYSTOSCOPY, POSTPARTUM HEMORRHAGE, POSTPARTUM DEPRESSION, URINARY TRACT INFECTION, BLIGHTED OVUM AND MISSED ABORTION. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID;BETA VULGARIS ROOT;IRON AMINO ACID CHELATE;ROSA CANINA FRUIT;RUBUS IDAEUS LEAF (IRON SUPPLEMENT WITH VIT C & HERBS), ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;COLECALCIFEROL;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;VITAMIN B12 NOS;ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA), CYANOCOBALAMIN, ESCITALOPRAM OXALATE (LEXAPRO), FAMOTIDINE, FLUOXETINE HYDROCHLORIDE (PROZAC), FOLIC ACID, HYDROXYZINE, IBUPROFEN, PARACETAMOL (TYLENOL REGULAR), PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("MENORRHAGIA/ PERIODS GOT EXTREME HEAVY"). IN 2014, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY RASHES FROM MY WEDDING BONDS AND JEWELRY THAT CONTAINED NICKEL") AND DERMATITIS CONTACT ("RASHES FROM MY WEDDING BANDS AND JEWELRY THAT CONTAINED NICKEL"). IN OCTOBER 2015, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED PERINATAL DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEPRESSION ("PSYCH INJURY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION"). IN (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE PATIENT EXPERIENCED CYSTOCELE ("SYMPYTOMATIC CYSTOCELE WITH INCOMPLETE UTERINE PROLAPSE") AND UTERINE PROLAPSE ("SYMPYTOMATIC CYSTOCELE WITH INCOMPLETE UTERINE PROLAPSE"), 3 YEARS 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA") AND NERVOUSNESS ("I FEEL KINDA NERVOUS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, PERINATAL DEPRESSION, DYSPAREUNIA, ALLERGY TO METALS, DERMATITIS CONTACT, CYSTOCELE, UTERINE PROLAPSE, WEIGHT INCREASED AND NERVOUSNESS OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA AND DEPRESSION HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ALLERGY TO METALS, CYSTOCELE, DEPRESSION, DERMATITIS CONTACT, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, NERVOUSNESS, PELVIC PAIN, PERINATAL DEPRESSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, UTERINE PROLAPSE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLANTIFF HAD ANOTHER EPISODE OF PREGNANCY , LINKED CASE IS :(B)(4). THERE WERE TWO TRAILING COILS ON THE RIGHT AND THREE TRAILING COILS ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RESULT: TOTAL BILATERAL OCCLUSION. BILATERAL TUBAL OCCLUSION WITH NORMAL APPEARANCE OF THE UTERUS. PREGNANCY TEST - ON (B)(6) 2015: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2016: ESSURE IS IMAGED NEXT TO GS POSSIBLY PUSHING ON TO GS; ON (B)(6) 2016: ESSURE COILS SEEN EACH SIDE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: IRREGULAR INTRAUTERINE GESTATIONAL SAC WITH ONE OF THE ESSURE COILS ABUTTING THE SAC. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DEPRESSION, MENORRHAGIA, CYSTOCELE ,I AM DIFFICULTY TO GET ALONG WITH SOMETIME, I FEEL KINDA NERVOUS WERE REPORTED VIA SOCIAL MEDIA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-OCT-2019: PLAINTIFF FACT SHEET AND SOCIAL MEDIA RECEIVED : PATIENT DEMOGRAPHIC AND NEW EVENT - I FEEL KINDA NERVOUS WERE ADDED NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("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) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA") AND DEPRESSION ("DEPRESSION"). 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 (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, DYSPAREUNIA AND DEPRESSION OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE 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 |
|---|---|---|---|---|---|---|---|
| 834803 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | AMBIEN.| AMBIEN.| AMBIEN.| CYANOCOBALAMIN.| CYANOCOBALAMIN.| CYANOCOBALAMIN.| FAMOTIDINE.| FAMOTIDINE.| FAMOTIDINE.| FOLIC ACID.| FOLIC ACID.| FOLIC ACID.| HYDROXYZINE.| HYDROXYZINE.| HYDROXYZINE.| IBUPROFEN.| IBUPROFEN.| IBUPROFEN.| IRON SUPPLEMENT WITH VIT C & HERBS.| IRON SUPPLEMENT WITH VIT C & HERBS.| IRON SUPPLEMENT WITH VIT C & HERBS.| LEXAPRO.| LEXAPRO.| LEXAPRO.| PRENATAL MULTIVITAMIN + DHA| PRENATAL MULTIVITAMIN + DHA.| PRENATAL MULTIVITAMIN + DHA.| PROZAC.| PROZAC.| PROZAC.| TYLENOL REGULAR.| TYLENOL REGULAR.| TYLENOL REGULAR.| VITAMIN B6.| VITAMIN B6.| VITAMIN B6. |