ESSURE
Report
- Report Number
- 2951250-2018-03194
- Event Type
- Injury
- Date Received
- July 25, 2018
- Date of Event
- November 1, 2012
- Report Date
- September 25, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
THE PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION TO UNDER HER BOWEL"), PELVIC PAIN ("PELVIC PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY ON CONTRACEPTIVE DEVICE"), GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING") AND ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A73764- NOT VALID, 12579427 RIGHT) 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 3, JOINT PAIN AND BACK PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED FITZ-HUGH-CURTIS SYNDROME. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABNORMAL WEIGHT GAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), MENORRHAGIA ("PROLONGED MENSTRUATION"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL DISTENSION ("BLOATING"), MIGRAINE ("SEVERE MIGRAINES"), AGITATION ("TURMOIL"), HEADACHE ("HEAD PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ABDOMINAL DISCOMFORT ("FEELING LIKE HER STOMACH WAS FALLING AND THAT SOMETHING WAS WRONG"). 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 (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF THE RIGHT ESSURE), SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF THE RIGHT ESSURE), SURGERY (D AND C) AND SURGERY (TUMMY TUCK). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, ABNORMAL WEIGHT GAIN, MENSTRUATION IRREGULAR, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL DISTENSION, MIGRAINE, AGITATION, HEADACHE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISCOMFORT HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ABORTION SPONTANEOUS, AGITATION, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION & REMOVAL DATES: INSERTION DATES: (B)(6) 2014 & (B)(6) 2012. REMOVAL DATES: (B)(6) -2015 & (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - IN (B)(6) : DEVICE MIGRATED TO UNDER HER BOWEL. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: FALLOPIAN TUBES WERE OCCLUDED. PLAINTIFF LEARNED SHE WAS PREGNANT THROUGH A HOME PREGNANCY TEST SOMETIME IN (B)(6) 2012. LOT NUMBER A73764 IS NOT VALID. LOT NUMBER: 12579427, MANUFACTURE DATE:2013/06, EXPIRATION DATE: 2016/02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-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.
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION TO UNDER HER BOWEL"), PELVIC PAIN ("PELVIC PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY ON CONTRACEPTIVE DEVICE"), GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING") AND ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A73764 (LEFT), 12579427 (RIGHT)) 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 3, JOINT PAIN AND BACK PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED FITZ-HUGH-CURTIS SYNDROME. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABNORMAL WEIGHT GAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), MENORRHAGIA ("PROLONGED MENSTRUATION"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL DISTENSION ("BLOATING"), MIGRAINE ("SEVERE MIGRAINES"), AGITATION ("TURMOIL"), HEADACHE ("HEAD PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ABDOMINAL DISCOMFORT ("FEELING LIKE HER STOMACH WAS FALLING AND THAT SOMETHING WAS WRONG"). 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 (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF THE RIGHT ESSURE), SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF THE RIGHT ESSURE), SURGERY (D AND C) AND SURGERY (TUMMY TUCK). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, ABNORMAL WEIGHT GAIN, MENSTRUATION IRREGULAR, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL DISTENSION, MIGRAINE, AGITATION, HEADACHE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISCOMFORT HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ABORTION SPONTANEOUS, AGITATION, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION & REMOVAL DATES: INSERTION DATES: (B)(6) 2014 & (B)(6) 2012. REMOVAL DATES: (B)(6) 2015 & (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM: IN 2017: DEVICE MIGRATED TO UNDER HER BOWEL. HYSTEROSALPINGOGRAM: ON (B)(6) 2014: FALLOPIAN TUBES WERE OCCLUDED. PLAINTIFF LEARNED SHE WAS PREGNANT THROUGH A HOME PREGNANCY TEST SOMETIME IN (B)(6) 2012. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-SEP-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT ABDOMINAL DISCOMFORT WAS ADDED. LOT NUMBER & LAB DATA UPDATED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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.
RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION TO UNDER HER BOWEL"), PELVIC PAIN ("PELVIC PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY ON CONTRACEPTIVE DEVICE"), GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING") AND ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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 3. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED FITZ-HUGH-CURTIS SYNDROME. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABNORMAL WEIGHT GAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), MENORRHAGIA ("PROLONGED MENSTRUATION"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL DISTENSION ("BLOATING"), MIGRAINE ("SEVERE MIGRAINES"), AGITATION ("TURMOIL"), HEADACHE ("HEAD PAIN") AND ABDOMINAL PAIN ("ABDOMINAL 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 (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF THE RIGHT ESSURE), SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF THE RIGHT ESSURE), SURGERY (D AND C) AND SURGERY (TUMMY TUCK). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUATION IRREGULAR, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL DISTENSION, MIGRAINE, AGITATION, HEADACHE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ABORTION SPONTANEOUS, AGITATION, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - IN 2017: DEVICE MIGRATED TO UNDER HER BOWEL HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: FALLOPIAN TUBES WERE OCCLUDED PLAINTIFF LEARNED SHE WAS PREGNANT THROUGH A HOME PREGNANCY TEST SOMETIME IN (B)(6) 2012 . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUN-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. REPORTER, PATIENT DEMOGRAPHIC INFORMATION, OTHER RELEVANT HISTORY, PRODUCT STOP DATE ADDED. NEW EVENTS, PAIN, HEADACHE, UNUSUAL BLEEDING, ABDOMINAL PAIN AND EXCESSIVE WEIGHT GAIN WERE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 562083 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A73764 INVALID, 12579427 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R |