ESSURE
Report
- Report Number
- 2951250-2019-09960
- Event Type
- Injury
- Date Received
- October 17, 2019
- Date of Event
- November 1, 2013
- Report Date
- December 10, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SKIN RASH, PID PELVIC INFLAMMATORY DISEASE, SCAR, ECTOPIC PREGNANCY, FEVER, IRREGULAR MENSTRUAL CYCLE, NAUSEA, DYSURIA, LOWER ABDOMINAL PAIN, ANEMIA, BLADDER PAIN, MULTIGRAVIDA, PARITY 2 AND BLADDER INCONTINENCE. CONCURRENT CONDITIONS INCLUDED COLITIS, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, VOMITING, APPETITE ABSENT, TACHYCARDIA, UTERINE BLEEDING, STRESS URINARY INCONTINENCE, STRESS INCONTINENCE, URINARY INCONTINENCE, SNEEZING, COUGHING, URINARY URGENCY AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL) FOR ABDOMINAL PAIN, PARACETAMOL (TYLENOL) FOR PAIN AND INTERMITTENT FEVER AS WELL AS CIPROFLOXACIN, FERROUS SULFATE, IBUPROFEN SINCE 2017 TO (B)(6) 2019, IRON FROM (B)(6) 2017 TO (B)(6) 2019, METRONIDAZOLE, NAPROXEN, RANITIDINE AND VITAMINS NOS (MULTIVITAMINS) FROM (B)(6) 2017 TO (B)(6) 2019. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND DYSGEUSIA ("METALLIC TASTE IN MOUTH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, FATIGUE, MIGRAINE AND DYSGEUSIA HAD RESOLVED AND THE ABDOMINAL PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHEA, APAREUNIA. BOTH COILS WERE PLACED. IN A SATISFACTORY FASHION WITH THREE AND FOUR COILS ON THE LEFT AND RIGHT RESPECTIVELY. DISCREPANCY NOTED: ESSURE REMOVAL DATE (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2018: RIGHT-SIDED COLITIS WITH MILD DISTAL ILEITIS.; ON (B)(6) 2018: RIGHT-SIDED COLITIS WHICH APPEARS ACUTE. MOST LIKELY ETIOLOGY IS INFECTIOUS COLITIS ALTHOUGH INFLAMMATORY COLITIS RELATED TO CROHN'S DISEASE OR ULCERATIVE COLITIS SHOULD ALSO BE CONSIDERED. TUBAL LIGATION COILS WITHIN THE PROXIMAL ASPECTS OF THE FALLOPIAN TUBES BILATERALLY.. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. SATISFACTORY TUBAL OCCLUSION. CONCERNING THE INJURIES WERE REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-NOV-2019: FU 3 & 4 TOGETHER PROCESSED. PFS & MR RECEIVED- LOT NUMBER WAS ADDED. NEW EVENTS ABNORMAL BLEEDING (GENERAL), MIGRAINES / HEADACHES AND METALLIC TASTE IN MOUTH WERE ADDED. THE OUTCOME OF EVENTS PELVIC PAIN, FATIGUE, DYSPAREUNIA WERE UPDATED FROM UNKNOWN TO RECOVERED. EVENT ONSET DATE WAS ADDED. CONCOMITANT DRUGS, LAB DATA AND MEDICAL HISTORY WERE ADDED. PATIENT'S HEIGHT WAS ADDED. REPORTER'S INFORMATION WAS ADDED. ON 21-NOV-2019: FU 3 & 4 TOGETHER PROCESSED. PFS & MR RECEIVED- NO NEW SIGNIFICANT INFORMATION. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SKIN RASH, PID PELVIC INFLAMMATORY DISEASE, SCAR, ECTOPIC PREGNANCY, FEVER, IRREGULAR MENSTRUAL CYCLE, NAUSEA, DYSURIA, LOWER ABDOMINAL PAIN, ANEMIA, BLADDER PAIN, MULTIGRAVIDA, PARITY 2 AND BLADDER INCONTINENCE. CONCURRENT CONDITIONS INCLUDED COLITIS, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, VOMITING, APPETITE ABSENT, TACHYCARDIA, UTERINE BLEEDING, STRESS URINARY INCONTINENCE, STRESS INCONTINENCE, URINARY INCONTINENCE, SNEEZING, COUGHING, URINARY URGENCY AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL) FOR ABDOMINAL PAIN, PARACETAMOL (TYLENOL) FOR PAIN AND INTERMITTENT FEVER AS WELL AS CIPROFLOXACIN (CIPRO), FERROUS SULFATE, IBUPROFEN SINCE 2017 TO (B)(6) 2019, IRON FROM (B)(6) 2017 TO (B)(6) 2019, METRONIDAZOLE (FLAGYL), NAPROXEN (NAPROSYN), RANITIDINE HYDROCHLORIDE (ZANTAC) AND VITAMINS NOS (MULTIVITAMINS) FROM (B)(6) 2017 TO (B)(6) 2019. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND DYSGEUSIA ("METALLIC TASTE IN MOUTH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, FATIGUE, MIGRAINE AND DYSGEUSIA HAD RESOLVED AND THE ABDOMINAL PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHEA, APAREUNIA. BOTH COILS WERE PLACED. IN A SATISFACTORY FASHION WITH THREE AND FOUR COILS ON THE LEFT AND RIGHT RESPECTIVELY. DISCREPANCY NOTED: ESSURE REMOVAL DATE (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2018: RIGHT-SIDED COLITIS WITH MILD DISTAL ILEITIS.; ON (B)(6) 2018: RIGHT-SIDED COLITIS WHICH APPEARS ACUTE. MOST LIKELY ETIOLOGY IS INFECTIOUS COLITIS ALTHOUGH INFLAMMATORY COLITIS RELATED TO CROHN'S DISEASE OR ULCERATIVE COLITIS SHOULD ALSO BE CONSIDERED. TUBAL LIGATION COILS WITHIN THE PROXIMAL ASPECTS OF THE FALLOPIAN TUBES BILATERALLY.. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. SATISFACTORY TUBAL OCCLUSION.. CONCERNING THE INJURIES WERE REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHEA. LOT NUMBER:952114, MANUFACTURE DATE: 2012-02, EXPIRATION DATE: 2015-02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-DEC-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHEA, APAREUNIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST UNKNOWN, RESULT: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-SEP-2019: PFS RECEIVED, EVENT INJURY WAS DELETED. NEW EVENTS PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHEA, APAREUNIA, FATIGUE, MENORRHAGIA, AND LAB DATA WERE ADDED. PATIENT'S DATE OF BIRTH AND REPORTER ADDRESS WERE ADDED. DEVICE REMOVAL DATE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 995524 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 952114 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | CIPRO [CIPROFLOXACIN]| CIPROFLOXACIN| FERROUS SULFATE| FERROUS SULFATE| FLAGYL [METRONIDAZOLE]| IBUPROFEN| IBUPROFEN| IRON| IRON| METRONIDAZOLE| MULTIVITAMINS [VITAMINS NOS]| MULTIVITAMINS [VITAMINS NOS]| NAPROSYN [NAPROXEN]| NAPROXEN| RANITIDINE| TORADOL| TORADOL| TYLENOL| TYLENOL| ZANTAC |