ESSURE
Report
- Report Number
- 2951250-2025-00211
- Event Type
- Injury
- Date Received
- March 17, 2025
- Date of Event
- May 1, 2022
- Report Date
- March 27, 2025
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BAYER CASE NUMBER: (B)(4). ABDOMINAL PAIN [ABDOMINAL PAIN] NAUSEA [NAUSEA] ALONG WITH HEAVY PERIODS AND PAIN AT TIMES SOME PERIODS CAN LAST UP TO 2-3 WEEKS STEADY. [PROLONGED HEAVY PERIODS] ALONG WITH HEAVY PERIODS AND PAIN AT TIME [PAIN MENSTRUAL] POSSIBLE CYST [CYST] CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY US FDA (REFERENCE NUMBER: MW5167065) ON 10-MAR-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 26-MAR-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND NAUSEA ("NAUSEA") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 893038) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF BIRTH TWIN IN 2012 AND PARITY 2 (I HAD A SET OF TWINS. (B)(6) 2012). IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2022 SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND NAUSEA (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). ON UNKNOWN DATE SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING ("ALONG WITH HEAVY PERIODS AND PAIN AT TIMES SOME PERIODS CAN LAST UP TO 2-3 WEEKS STEADY."), DYSMENORRHOEA ("ALONG WITH HEAVY PERIODS AND PAIN AT TIME") AND CYST ("POSSIBLE CYST"). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ABDOMINAL PAIN, NAUSEA, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA OR CYST. THE REPORTER COMMENTED: ABDOMINAL PAIN, NAUSEA. SEEN DR AND DID X-RAY, THEY RECOMMENDED ME TO SEE THE DR WHO PUT THE ESSURE IN MY BODY. THAT DR BLEW ME OFF SAID IT WAS ONLY BOWL BACK UP. WOULD EVEN LOOK AT X-RAY OR MRI SCAN DISK OF SOMETHING WAS WRONG TYPE OF EVENT: SERIOUS INJURY I HAVE HAD X-RAY AND CT SCAN AND SHOWED POSSIBLE CYST LIKE. I HAVE REVISIT THE DR WHO DONE IT. HE DON'T EVEN REMEMBER DOING IT AND HAS NO CHART ON ME ANYMORE. HE PASSED IT OFF AS I WAS ONLY CONSTIPATED AND WOULD NOT EVEN TAKE A LOOK AT THE TEST DISC OR EVEN TRY TO BE CONCERNED ABOUT MY HEALTH. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73 KG. [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): POSSIBLE CYST LIKE [MAGNETIC RESONANCE IMAGING] (DATE UNKNOWN): NOT AVAILABLE [X-RAY] (DATE UNKNOWN): POSSIBLE CYST LIKE BATCH NUMBER: 893038, MANUFACTURE DATE: 2011-08-31, EXPIRATION DATE: 2014-08-31. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 26-MAR-2025: QUALITY SAFETY EVALUATION OF PTC. CASE COMMENTS: 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.
BAYER CASE NUMBER: (B)(4). ABDOMINAL PAIN [ABDOMINAL PAIN], NAUSEA [NAUSEA], ALONG WITH HEAVY PERIODS AND PAIN AT TIMES SOME PERIODS CAN LAST UP TO 2-3 WEEKS STEADY. [PROLONGED HEAVY PERIODS] , ALONG WITH HEAVY PERIODS AND PAIN AT TIME [PAIN MENSTRUAL] , POSSIBLE CYST [CYST] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY US FDA (REFERENCE NUMBER: MW5167065) ON 10-MAR-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 21-MAR-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND NAUSEA ("NAUSEA") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 893038) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF BIRTH TWIN IN 2012 AND PARITY 2 (I HAD A SET OF TWINS. (B)(6) 2012). IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2022 SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND NAUSEA (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). ON UNKNOWN DATE SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING ("ALONG WITH HEAVY PERIODS AND PAIN AT TIMES SOME PERIODS CAN LAST UP TO 2-3 WEEKS STEADY."), DYSMENORRHOEA ("ALONG WITH HEAVY PERIODS AND PAIN AT TIME") AND CYST ("POSSIBLE CYST"). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ABDOMINAL PAIN, NAUSEA, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA OR CYST. THE REPORTER COMMENTED: ABDOMINAL PAIN, NAUSEA. SEEN DR AND DID X-RAY, THEY RECOMMENDED ME TO SEE THE DR WHO PUT THE ESSURE IN MY BODY. THAT DR BLEW ME OFF SAID IT WAS ONLY BOWL BACK UP. WOULD EVEN LOOK AT X-RAY OR MRI SCAN DISK OF SOMETHING WAS WRONG TYPE OF EVENT: SERIOUS INJURY I HAVE HAD X-RAY AND CT SCAN AND SHOWED POSSIBLE CYST LIKE. I HAVE REVISIT THE DR WHO DONE IT. HE DON'T EVEN REMEMBER DOING IT AND HAS NO CHART ON ME ANYMORE. HE PASSED IT OFF AS I WAS ONLY CONSTIPATED AND WOULD NOT EVEN TAKE A LOOK AT THE TEST DISC OR EVEN TRY TO BE CONCERNED ABOUT MY HEALTH. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73 KG. [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): POSSIBLE CYST LIKE. [MAGNETIC RESONANCE IMAGING] (DATE UNKNOWN): NOT AVAILABLE. [X-RAY] (DATE UNKNOWN): POSSIBLE CYST LIKE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 21-MAR-2025: NEW EVENTS HEAVY & PROLONGED MENSES, MENSTRUAL PAIN & CYST WERE ADDED. EVENT OUTCOME UPDATED TO NOT RECOVERED NOT RESOLVED TO ALL EVENTS. PATIENTS DATE OF BIRTH ADDED. ESSURE INSERTION DATE ADDED. LAB DATA ADDED. REPORTER CAUSALITY COMMENT ADDED. 21-MAR-2025: MEDICAL HISTORY ADDED. CASE COMMENTS: 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.
BAYER CASE NUMBER: (B)(4). ABDOMINAL PAIN [ABDOMINAL PAIN]. NAUSEA [NAUSEA]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY US FDA (REFERENCE NUMBER: MW5167065) ON 10-MAR-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND NAUSEA ("NAUSEA") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO: 893038) FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2022, SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND NAUSEA (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ABDOMINAL PAIN OR NAUSEA. THE REPORTER COMMENTED: ABDOMINAL PAIN, NAUSEA. SEEN DR AND DID X-RAY, THEY RECOMMENDED ME TO SEE THE DR WHO PUT THE ESSURE IN MY BODY. THAT DR BLEW ME OFF SAID IT WAS ONLY BOWL BACK UP. WOULD EVEN LOOK AT X-RAY OR MRI SCAN DISK OF SOMETHING WAS WRONG TYPE OF EVENT: SERIOUS INJURY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73 KG. [MAGNETIC RESONANCE IMAGING] (DATE UNKNOWN): NOT AVAILABLE. [X-RAY] (DATE UNKNOWN): NOT AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 11-MAR-2025: PROCESS WITH INITIAL. 11-MAR-2025: PROCESS WITH INITIAL. CASE COMMENTS: 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 |
|---|---|---|---|---|---|---|---|
| 1284358 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893038 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female | Other |