ESSURE
Report
- Report Number
- 2951250-2016-02125
- Event Type
- Injury
- Date Received
- October 3, 2016
- Date of Event
- April 1, 2006
- Report Date
- January 22, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) / HEAVY BLEEDING") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12281414) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NAUSEA, EMESIS (CLEAR FLUID IN SMALL AMOUNT.), HEADACHE, HYPEREMESIS, MULTIGRAVIDA, ABORTION INDUCED (TERMINATION OF PREGNANCY), PARITY 2, GASTROESOPHAGEAL REFLUX DISEASE, ECTOPIC PREGNANCY (TREATED BY LAPAROTOMY,), SPONTANEOUS ABORTION (AND THREE THERAPEUTIC ABORTIONS), MULTIGRAVIDA (TWO AT 36 WEEKS.), BREAST LUMP REMOVAL, ARM OPERATION, GESTATIONAL DIABETES, MENSTRUATION ABNORMAL, ASTHMA, DELAYED PERIOD ON (B)(6) 2010, PAP SMEAR ABNORMAL, MISCARRIAGE, TERMINATION OF PREGNANCY - ELECTIVE, BREAST LUMP AND FALLOPIAN TUBE OPERATION. TYLENOL WITH NAUSEA BUT NO VOMITING AT THIS TIME. THERE WAS NO BILIARY DILATATION WITH COMMON DUCT MEASURING 2 MM. PATIENT WHO DESIRES NO FUTURE FERTILITY AND NO ACUTE ABNORMALITY THERE IS NO ASCITES. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ALLERGIES: LATEX; FOR AN UNREPORTED INDICATION: TYLENOL. CONCURRENT CONDITIONS INCLUDED GENERAL ANESTHESIA, HYPEREMESIS GRAVIDARUM (HYPEREMESIS GRAVIDA RUM EMBX-6119/09), IRREGULAR PERIODS, DYSFUNCTIONAL UTERINE BLEEDING, CRAMP IN LOWER ABDOMEN, INGUINAL HERNIA, RIGHT LOWER QUADRANT PAIN AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE, IBUPROFEN, METOCLOPRAMIDE (REGLAN), OMEPRAZOLE, ONDANSETRON (ZOFRAN), PAROXETINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (ZANTAC) AND SERTRALINE (ZOLOFT). IN 2005, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN / CRAMPING"). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, 7 MONTHS 20 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2009, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("ABNORMAL CLOTTING DURING MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("RIGHT SIDED ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THREE VISIBLE COILS ON LEFT AND FOUR ON RIGHT. DIAGNOSTIC RESULTS: ULTRASOUND PELVIC TRANSVAGINAL AND TRANSABDOMINAL: INDICATION: ABDOMINAL PAIN, RULE OUT INGUINAL HERNIA, RIGHT LOWER QUADRANT PAIN AND HISTORY OF FALLOPIAN TUBE SURGERY. IMPRESSION: 1. FIBROID UTERUS. 2. ECHOGENIC STRUCTURES WITHIN THE FALLOPIAN TUBES COMPATIBLE WITH THE PATIENTS HISTORY OF PRIOR SURGERY. THE VISUALIZED RIGHT FALLOPIAN TUBE IS DISTENDED WITH FLUID. IT IS UNCERTAIN WHETHER THIS IS SIMPLE OR COMPLEX FLUID. IF CLINICALLY INDICATED, AN MRI OF THE PELVIS COULD BE PERFORMED FOR FURTHER EVALUATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUL-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) / HEAVY BLEEDING") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO: 12281414) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE, IBUPROFEN, OMEPRAZOLE, PAROXETINE HYDROCHLORIDE AND SERTRALINE. IN 2005, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN / CRAMPING"). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2009, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("ABNORMAL CLOTTING DURING MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("RIGHT SIDED ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED - NEW EVENT " ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), LOWER ABDOMINAL PAIN, RIGHT SIDED ABDOMINAL PAIN, SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST" WERE ADDED. LOT NUMBER WAS ADDED. NEW REPORTER WERE ADDED. CONCOMITANT DRUGS ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) / HEAVY BLEEDING") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12281414) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA, EMESIS (CLEAR FLUID IN SMALL AMOUNT.), HEADACHE, HYPEREMESIS, MULTIGRAVIDA, ABORTION INDUCED (TERMINATION OF PREGNANCY), PARITY 2, GASTROESOPHAGEAL REFLUX DISEASE, ECTOPIC PREGNANCY (TREATED BY LAPAROTOMY,), SPONTANEOUS ABORTION (AND THREE THERAPEUTIC ABORTIONS), MULTIGRAVIDA (TWO AT 36 WEEKS.), BREAST LUMP REMOVAL, ARM OPERATION, GESTATIONAL DIABETES, MENSTRUATION ABNORMAL, ASTHMA, DELAYED PERIOD ON (B)(6) 2010, PAP SMEAR ABNORMAL, MISCARRIAGE, TERMINATION OF PREGNANCY - ELECTIVE, BREAST LUMP AND FALLOPIAN TUBE OPERATION. TYLENOL WITH NAUSEA BUT NO VOMITING AT THIS TIME. THERE WAS NO BILIARY DILATATION WITH COMMON DUCT MEASURING 2 MM. PATIENT WHO DESIRES NO FUTURE FERTILITY AND NO ACUTE ABNORMALITY THERE IS NO ASCITES. *ULTRASOUND PELVIC TRANSVAGINAL AND TRANSABDOMINAL: INDICATION: ABDOMINAL PAIN, RULE OUT INGUINAL HERNIA, RIGHT LOWER QUADRANT PAIN AND HISTORY OF FALLOPIAN TUBE SURGERY. IMPRESSION: 1. FIBROID UTERUS. 2. ECHOGENIC STRUCTURES WITHIN THE FALLOPIAN TUBES COMPATIBLE WITH THE PATIENTS HISTORY OF PRIOR SURGERY. THE VISUALIZED RIGHT FALLOPIAN TUBE IS DISTENDED WITH FLUID. IT IS UNCERTAIN WHETHER THIS IS SIMPLE OR COMPLEX FLUID. IF CLINICALLY INDICATED, AN MRI OF THE PELVIS COULD BE PERFORMED FOR FURTHER EVALUATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ALLERGIES: LATEX; FOR AN UNREPORTED INDICATION: TYLENOL. CONCURRENT CONDITIONS INCLUDED GENERAL ANESTHESIA, HYPEREMESIS GRAVIDARUM (HYPEREMESIS GRAVIDA RUM (B)(6)), IRREGULAR PERIODS, DYSFUNCTIONAL UTERINE BLEEDING, CRAMP IN LOWER ABDOMEN, INGUINAL HERNIA, RIGHT LOWER QUADRANT PAIN AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE, IBUPROFEN, METOCLOPRAMIDE (REGLAN), OMEPRAZOLE, ONDANSETRON (ZOFRAN), PAROXETINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (ZANTAC) AND SERTRALINE HYDROCHLORIDE (ZOLOFT). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 7 MONTHS 21 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2006, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN / CRAMPING"). IN AUGUST 2006, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("ABNORMAL CLOTTING DURING MENSES") AND ABDOMINAL PAIN ("RIGHT SIDED ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THREE VISIBLE COILS ON LEFT AND FOUR ON RIGHT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED- OUTCOME OF MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE UPDATED TO RECOVERED / RESOLVED. 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.
FOLLOW UP INFORMATION RECEIVED ON 20-OCT-2016: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT (PTC) THIS ADVERSE EVENT REPORT IS RELATED TO A PTC AND THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). SAMPLE WAS NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE KNOWN, POSSIBLE UNDESIRABLE EVENTS AND ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORT IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD SEVERE PELVIC PAIN AND ABNORMAL BLEEDING (INTERPRETED AS GENITAL BLEEDING). SHE UNDERWENT A VAGINAL HYSTERECTOMY APPROXIMATELY 6 YEARS AFTER INSERTION. THESE EVENTS ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, PELVIC PAIN AND GENITAL BLEEDING MAY OCCUR. GIVEN THE NATURE OF THE REPORTED EVENTS AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. ACCORDING TO TECHNICAL ANALYSIS, A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A PLAINTIFF IN UNITED STATES ON 06-SEP-2016 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) PLACED IN 2005, FOR PERMANENT CONTRACEPTION. SOMETIME AFTER THE PROCEDURE, PLAINTIFF BEGAN EXPERIENCE ONE OR MORE OF THE FOLLOWING SYMPTOMS, INCLUDING, BUT NOT LIMITED TO: SEVERE ABNORMAL MENSTRUAL PAIN, ABNORMAL MENSTRUAL CYCLE, EXCESSIVE BLEEDING, SEVERE PELVIC PAIN, BACK PAIN, PAIN DURING INTERCOURSE, HEADACHES, ALLERGIC REACTION, MOOD SWINGS, ABDOMINAL PAIN, MIGRATION OF THE DEVICE, UNWANTED PREGNANCY, AND FATIGUE. SHE REPORTED TO HER HEALTHCARE PROVIDER THAT SHE WAS EXPERIENCING SEVERE PELVIC PAIN, ABNORMAL CLOTTING DURING MENSES, AND ABNORMAL BLEEDING. ON OR ABOUT (B)(6) 2011, PLAINTIFF SAW HER PHYSICIAN AND UNDERWENT A VAGINAL HYSTERECTOMY. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD SEVERE PELVIC PAIN AND ABNORMAL BLEEDING (INTERPRETED AS GENITAL BLEEDING). SHE UNDERWENT A VAGINAL HYSTERECTOMY APPROXIMATELY 6 YEARS AFTER INSERTION. THESE EVENTS ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, PELVIC PAIN AND GENITAL BLEEDING MAY OCCUR. GIVEN THE NATURE OF THE REPORTED EVENTS AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646428 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12281414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | CITALOPRAM HYDROBROMIDE| CITALOPRAM HYDROBROMIDE| CITALOPRAM HYDROBROMIDE| IBUPROFEN| IBUPROFEN| IBUPROFEN| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| PAROXETINE HYDROCHLORIDE| PAROXETINE HYDROCHLORIDE| PAROXETINE HYDROCHLORIDE| REGLAN| REGLAN| SERTRALINE| ZANTAC| ZANTAC| ZOFRAN| ZOFRAN| ZOLOFT| ZOLOFT |