ESSURE
Report
- Report Number
- 2951250-2018-00311
- Event Type
- Injury
- Date Received
- January 11, 2018
- Date of Event
- November 1, 2013
- Report Date
- April 20, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL DISTENSION ("ABDOMINAL SWELLING") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THYROID DISORDER ("THYROID DISORDER"), BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE") AND PALPITATIONS ("HEART PALPITATIONS"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE ABDOMINAL DISTENSION, THYROID DISORDER, BLOOD PRESSURE INCREASED AND PALPITATIONS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BLOOD PRESSURE INCREASED, PALPITATIONS AND THYROID DISORDER TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PTC. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL SWELLING / BLOATING") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE 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 UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MASTECTOMY IN 2012. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD NOS IN 2010. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) AND NADOLOL SINCE 2010. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM ("THYROID DISORDER") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE") AND PALPITATIONS ("HEART PALPITATIONS"). THE PATIENT WAS TREATED WITH SURGERY ((BILATERAL ESSURE MICROSURGICAL REMOVAL)) AND SURGERY ((BILATERAL ESSURE MICROSURGICAL REMOVAL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL DISTENSION AND HYPOTHYROIDISM WAS RESOLVING, THE GENITAL HAEMORRHAGE AND BLOOD PRESSURE INCREASED OUTCOME WAS UNKNOWN AND THE PALPITATIONS AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BLOOD PRESSURE INCREASED, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, PALPITATIONS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 52.154 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL SWELLING / BLOATING") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE 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 UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MASTECTOMY IN 2012. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD NOS IN 2010. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) AND NADOLOL SINCE 2010. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM ("THYROID DISORDER") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE") AND PALPITATIONS ("HEART PALPITATIONS"). THE PATIENT WAS TREATED WITH SURGERY ((BILATERAL ESSURE MICROSURGICAL REMOVAL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL DISTENSION AND HYPOTHYROIDISM WAS RESOLVING, THE GENITAL HAEMORRHAGE AND BLOOD PRESSURE INCREASED OUTCOME WAS UNKNOWN AND THE PALPITATIONS AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BLOOD PRESSURE INCREASED, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, PALPITATIONS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 52.154 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS GENITAL BLEEDING, ABDOMINAL PAIN, WEIGHT GAIN, HYPOTHYRODISM ARE ADDED. HISTORICAL & CONCOMITANT DRUGS CONDITONS ARE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN') AND ABDOMINAL DISTENSION ('ABDOMINAL SWELLING / BLOATING') IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE 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 UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MASTECTOMY IN 2012. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD NOS. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) AND NADOLOL SINCE 2010. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HYPOTHYROIDISM ("THYROID DISORDER") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), PALPITATIONS ("HEART PALPITATIONS") AND SCAR ("SCAR") AND WAS FOUND TO HAVE BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE"). THE PATIENT WAS TREATED WITH SURGERY ((BILATERAL ESSURE MICROSURGICAL REMOVAL)). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL DISTENSION AND HYPOTHYROIDISM WAS RESOLVING, THE GENITAL HAEMORRHAGE, BLOOD PRESSURE INCREASED AND SCAR OUTCOME WAS UNKNOWN AND THE PALPITATIONS AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BLOOD PRESSURE INCREASED, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, PALPITATIONS, SCAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 52.154 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED. NEW EVENT ADDED:SCAR. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN') AND ABDOMINAL DISTENSION ('ABDOMINAL SWELLING / BLOATING') IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE 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 UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MASTECTOMY IN 2012. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD NOS. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) AND NADOLOL SINCE 2010. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HYPOTHYROIDISM ("THYROID DISORDER") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), PALPITATIONS ("HEART PALPITATIONS"), SCAR ("SCAR"), FEELING COLD ("I WAS FREEZING COLD"), HYPERSOMNIA ("SLEEPING 10 TO 13 HRS A DAY"), DRY SKIN ("DRY SKIN"), ALOPECIA ("HAIR LOSS") AND IRRITABILITY ("IRRITABLE") AND WAS FOUND TO HAVE BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE"). THE PATIENT WAS TREATED WITH SURGERY ((BILATERAL ESSURE MICROSURGICAL REMOVAL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL DISTENSION AND HYPOTHYROIDISM WAS RESOLVING, THE GENITAL HAEMORRHAGE, BLOOD PRESSURE INCREASED, SCAR, FEELING COLD, HYPERSOMNIA, DRY SKIN, ALOPECIA AND IRRITABILITY OUTCOME WAS UNKNOWN AND THE PALPITATIONS AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, BLOOD PRESSURE INCREASED, DRY SKIN, FEELING COLD, GENITAL HAEMORRHAGE, HYPERSOMNIA, HYPOTHYROIDISM, IRRITABILITY, PALPITATIONS, SCAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 52.154 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED-NEW EVENT I WAS FREEZING COLD ,SLEEPING ,DRY SKIN ,HAIR LOSS WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL DISTENSION ("ABDOMINAL SWELLING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THYROID DISORDER ("THYROID DISORDER"), BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE") AND PALPITATIONS ("HEART PALPITATIONS"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE ABDOMINAL DISTENSION, THYROID DISORDER, BLOOD PRESSURE INCREASED AND PALPITATIONS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BLOOD PRESSURE INCREASED, PALPITATIONS AND THYROID DISORDER TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JAN-2018: REPORTERS, PATIENT DETAILS AND PRODUCT STOP DATE WERE ADDED. EVENT ¿SEVERE AND PERMANENT INJURIES¿ UPDATED WITH NEW EVENTS ¿ABDOMINAL SWELLING, THYROID DISORDER, INCREASED BLOOD PRESSURE AND HEART PALPITATIONS¿. ESSURE REMOVAL DATE PROVIDED: CASE IS NOW CONSIDERED INCIDENT. ESSURE LEGAL MANUFACTURER 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 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 |
|---|---|---|---|---|---|---|---|
| 26409 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other| R | NADOLOL| NADOLOL| NADOLOL| NADOLOL| XANAX| XANAX| XANAX| XANAX |