ESSURE
Report
- Report Number
- 2951250-2020-10269
- Event Type
- Injury
- Date Received
- July 2, 2020
- Date of Event
- March 1, 2011
- Report Date
- July 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: MW5056496) ON 19-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 06-JUL-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / PAIN'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND OVARIAN CYST ('CYST ON OVARIES') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED CALCIUM CARBONATE;SALICYLIC ACID (NOETRAS) AND IBUPROFEN FOR PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("HORRIBLE BACK PAIN / BACK PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING") AND THE FIRST EPISODE OF DYSPAREUNIA ("PAIN DURING INTERCOURSE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED OVARIAN CYST (SERIOUSNESS CRITERION HOSPITALIZATION), THE SECOND EPISODE OF DYSPAREUNIA ("PAINFUL SEX"), MENSTRUAL DISORDER ("BAD PERIODS"), ABDOMINAL DISTENSION ("ALWAYS FEELING BLOATED"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), PAIN ("BODY HURTS ALL THE TIME"), MIGRAINE ("MIGRAINES / HEAD HURTS EVERYDAY"), WEIGHT LOSS POOR ("CAN'T LOSE WEIGHT"), DEPRESSION ("DEPRESSED") WITH FATIGUE AND HAIR TEXTURE ABNORMAL ("HAIR FEELS DIFFERENT") AND WAS FOUND TO HAVE THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN") AND THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT IS JUST IN MY LOWER STOMACH FEELS PREGNANT"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL AND ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, BACK PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD NOT RESOLVED AND THE OVARIAN CYST, THE LAST EPISODE OF DYSPAREUNIA, MENSTRUAL DISORDER, ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, PAIN, MIGRAINE, WEIGHT LOSS POOR, THE LAST EPISODE OF WEIGHT INCREASED, DEPRESSION AND HAIR TEXTURE ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, BACK PAIN, DEPRESSION, GENITAL HAEMORRHAGE, HAIR TEXTURE ABNORMAL, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, OVARIAN CYST, PAIN, PELVIC PAIN, VAGINAL HAEMORRHAGE, WEIGHT LOSS POOR, THE FIRST EPISODE OF DYSPAREUNIA, THE FIRST EPISODE OF WEIGHT INCREASED, THE SECOND EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2018 (DISCREPANCY NOTED) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2011: RESULTS: COILS WERE IN PROPER PLACE.; IN (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 802745 MANUFACTURING DATE: 2010-11 EXPIRATION DATE:2013-11 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUL-2020: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL SUPPORT). A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: MW5056496) ON 19-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-JUN-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / PAIN'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND OVARIAN CYST ('CYST ON OVARIES') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED CALCIUM CARBONATE; SALICYLIC ACID (NOETRAS) AND IBUPROFEN FOR PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("HORRIBLE BACK PAIN / BACK PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING") AND THE FIRST EPISODE OF DYSPAREUNIA ("PAIN DURING INTERCOURSE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED OVARIAN CYST (SERIOUSNESS CRITERION HOSPITALIZATION), THE SECOND EPISODE OF DYSPAREUNIA ("PAINFUL SEX"), MENSTRUAL DISORDER ("BAD PERIODS"), ABDOMINAL DISTENSION ("ALWAYS FEELING BLOATED"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), PAIN ("BODY HURTS ALL THE TIME"), MIGRAINE ("MIGRAINES / HEAD HURTS EVERYDAY"), WEIGHT LOSS POOR ("CAN'T LOSE WEIGHT"), DEPRESSION ("DEPRESSED") WITH FATIGUE AND HAIR TEXTURE ABNORMAL ("HAIR FEELS DIFFERENT") AND WAS FOUND TO HAVE THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN") AND THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT IS JUST IN MY LOWER STOMACH FEELS PREGNANT"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL AND ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, BACK PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD NOT RESOLVED AND THE OVARIAN CYST, THE LAST EPISODE OF DYSPAREUNIA, MENSTRUAL DISORDER, ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, PAIN, MIGRAINE, WEIGHT LOSS POOR, THE LAST EPISODE OF WEIGHT INCREASED, DEPRESSION AND HAIR TEXTURE ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, BACK PAIN, DEPRESSION, GENITAL HAEMORRHAGE, HAIR TEXTURE ABNORMAL, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, OVARIAN CYST, PAIN, PELVIC PAIN, VAGINAL HAEMORRHAGE, WEIGHT LOSS POOR, THE FIRST EPISODE OF DYSPAREUNIA, THE FIRST EPISODE OF WEIGHT INCREASED, THE SECOND EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2018 (DISCREPANCY NOTED) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2011: RESULTS: COILS WERE IN PROPER PLACE.; IN (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-JUN-2020: PIF RECEIVED. ESSURE REMOVAL DONE. CASE UPGRADED AS SERIOUS INCIDENT. ESSURE REMOVAL DATE ADDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 687031 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802745 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | IBUPROFEN| IBUPROFEN| NOETRAS| NOETRAS |