ESSURE
Report
- Report Number
- 2951250-2023-02896
- Event Type
- Injury
- Date Received
- September 20, 2023
- Report Date
- October 9, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("SUGGESTIVE OF PELVIC INFLAMMATORY DISEASE") AND PELVIC PAIN ("PELVIC PAIN") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF NICKEL ALLERGY ON (B)(6) 2019, HEAVY PERIODS ON (B)(6)2018, SMOKER, VAGINAL RING, PARITY 2, GRAVIDA II, OBESITY, SEASONAL ALLERGY, ILIAC FOSSA PAIN, ALLERGIC REACTION, BACK PAIN, KIDNEY PAIN, GENERAL DISCOMFORT, HEADACHE, LOW BACK PAIN, HAIR LOSS AND HEADACHE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 66 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL DISTENSION"). ESSURE WAS REMOVED ON (B)(6) 2020. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("COLICKY"), ABDOMINAL PAIN UPPER ("SUPRAPUBIC EPIGASTRIC PAIN THAT SHE REFERS TO AS CRAMPS WITH MOVEMENT"), NAUSEA ("NAUSEA"), ADNEXA UTERI CYST ("ADNEXAL CYST"), VAGINAL DISCHARGE ("DISCHARGE WAS GRANTED"), CONSTIPATION ("CONSTIPATION") AND BLOATING ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ABDOMINAL DISTENSION, ADNEXA UTERI CYST, VAGINAL DISCHARGE AND CONSTIPATION WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BLOATING, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ADNEXA UTERI CYST, CONSTIPATION, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 83 KG. [ABDOMINAL X-RAY] ON (B)(6) 2014: ESSURE IN PELVIS APPARENTLY WELL POSITIONED.; ON (B)(6) 2014: ESSURE IN PELVIS APPARENTLY WELL POSITIONED [HYSTEROSCOPY] (DATE UNKNOWN): SIMPLE ABDOMINAL X-RAY AND TV ULTRASOUND ARE PERFORMED (BOTH IMPLANTS SYMMETRICAL UP TO THE BILATERAL INTRAMURAL PORTION.) THE CORRECT PLACEMENT OF BOTH IMPLANTS IS VERIFIED, SO THE METHOD IS NOW CONSIDERED EFFECTIVE. THE PATIENT CAN STOP USING THE ADDITIONAL CONTRACEPTIVE METHOD. NORMAL RIGHT OVARY IS VISUALIZED. BILOBED LEFT OVARY MEASURING 6CM FUNCTIONAL APPEARANCE WITHOUT INTERNAL ¿ECHOES¿. [PATHOLOGY TEST] (DATE UNKNOWN): MACROSCOPIC DESCRIPTION: 1.- "RIGHT TUBE": 5.7 CM UTERINE TUBE WITH INTRATUBAL DEVICE THAT IS EXTRACTED AND PHOTOGRAPHED. REPRESENTATIVE INCLUSION, BLOCK A1. 2.- "LEFT TUBE": 4.5 CM UTERINE TUBE WITH INTRATUBAL DEVICE THAT IS EXTRACTED AND PHOTOGRAPHED. REPRESENTATIVE INCLUSION, BLOCK B1. [ULTRASOUND SCAN] ON 16-OCT-2015: NEGATIVE ULTRASOUND IMAGE, ELONGATED 68 MM WITH A COMPLETE SEPTUM INSIDE THAT CAPTURES COLOR DOPPLER. DETECTED IN POST-ESSURE ULTRASOUND CONTROL. PRIOR TO ESSURE INSERTION, THE ULTRASOUND WAS NORMAL. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 06-OCT-2023: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("SUGGESTIVE OF PELVIC INFLAMMATORY DISEASE") AND PELVIC PAIN ("PELVIC PAIN") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF NICKEL ALLERGY ON (B)(6) 2019, HEAVY PERIODS ON (B)(6) 2018, SMOKER, VAGINAL RING, PARITY 2, GRAVIDA II, OBESITY, SEASONAL ALLERGY, ILIAC FOSSA PAIN, ALLERGIC REACTION, BACK PAIN, KIDNEY PAIN, GENERAL DISCOMFORT, HEADACHE, LOW BACK PAIN, HAIR LOSS AND HEADACHE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 66 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ABDOMINAL DISTENTION. AT AN UNKNOWN TIME, SHE EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("COLICKY"), ABDOMINAL PAIN UPPER ("SUPRAPUBIC EPIGASTRIC PAIN THAT SHE REFERS TO AS CRAMPS WITH MOVEMENT"), NAUSEA ("NAUSEA"), ADNEXA UTERI CYST ("ADNEXAL CYST"), VAGINAL DISCHARGE ("DISCHARGE WAS GRANTED"), CONSTIPATION ("CONSTIPATION") AND BLOATING ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ABDOMINAL DISTENSION, ADNEXA UTERI CYST, VAGINAL DISCHARGE AND CONSTIPATION WERE UNKNOWN. ESSURE WAS REMOVED ON (B)(6) 2020. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BLOATING, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ADNEXA UTERI CYST, CONSTIPATION, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 83 KG. [ABDOMINAL X-RAY] ON (B)(6) 2014: ESSURE IN PELVIS APPARENTLY WELL POSITIONED.; ON (B)(6) 2014: ESSURE IN PELVIS APPARENTLY WELL POSITIONED [HYSTEROSCOPY] (DATE UNKNOWN): SIMPLE ABDOMINAL X-RAY AND TV ULTRASOUND ARE PERFORMED (BOTH IMPLANTS SYMMETRICAL UP TO THE BILATERAL INTRAMURAL PORTION.) THE CORRECT PLACEMENT OF BOTH IMPLANTS IS VERIFIED, SO THE METHOD IS NOW CONSIDERED EFFECTIVE. THE PATIENT CAN STOP USING THE ADDITIONAL CONTRACEPTIVE METHOD. NORMAL RIGHT OVARY IS VISUALIZED. BILOBED LEFT OVARY MEASURING 6CM FUNCTIONAL APPEARANCE WITHOUT INTERNAL ¿ECHOES¿. [PATHOLOGY TEST] (DATE UNKNOWN): MACROSCOPIC DESCRIPTION: 1.- "RIGHT TUBE": 5.7 CM UTERINE TUBE WITH INTRATUBAL DEVICE THAT IS EXTRACTED AND PHOTOGRAPHED. REPRESENTATIVE INCLUSION, BLOCK A1. 2.- "LEFT TUBE": 4.5 CM UTERINE TUBE WITH INTRATUBAL DEVICE THAT IS EXTRACTED AND PHOTOGRAPHED. REPRESENTATIVE INCLUSION, BLOCK B1. [ULTRASOUND SCAN] ON (B)(6) 2015: NEGATIVE ULTRASOUND IMAGE, ELONGATED 68 MM WITH A COMPLETE SEPTUM INSIDE THAT CAPTURES COLOR DOPPLER. DETECTED IN POST-ESSURE ULTRASOUND CONTROL. PRIOR TO ESSURE INSERTION, THE ULTRASOUND WAS NORMAL. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1789003 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention |