ESSURE
Report
- Report Number
- 2951250-2019-01430
- Event Type
- Injury
- Date Received
- April 22, 2019
- Date of Event
- September 1, 2012
- Report Date
- December 24, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('RIGHT ESSURE COIL DID NOT EXTE THE CORNEAL REGION OF THE UTERUS AT ALL AND WAS COMPLETELY WITHIN THE TUBE'), PELVIC PAIN ('PAIN') AND GENITAL HAEMORRHAGE ('UNUSUAL AND EXCESSIVE BLEEDING/ HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA ON (B)(6) 2012, APICOECTOMY IN (B)(6) 2011, PELVIC PAIN FEMALE, ABDOMINAL CRAMPS, ACHE, HEAVY PERIODS AND PERINEAL PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO NOVUM, DEPO PROVERA, IBUPROFEN AND DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MELOXICAM AND MESTRANOL;NORETHISTERONE (ORTHO-NOVUM SQ) FROM 2009 TO 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING / LOWER ABDOMEN PAIN"), MENSTRUATION IRREGULAR ("UNUSUAL PERIODS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR THINNING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY PERIODS") AND DEVICE EXPULSION ("LEFT COIL WAS ABOUT HALFWAY INTO THE UTERUS"). THE PATIENT WAS TREATED WITH IBUPROFEN, PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL COMPLETE FORMULA CAPLETS) AND SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, MENSTRUATION IRREGULAR, ABDOMINAL PAIN, MENORRHAGIA, ALOPECIA AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, DEVICE DISLOCATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUATION IRREGULAR AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF REMOVAL: (B)(6) 2017 (PER PFS). TRAILING COILS- 3 AND 7. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULTS: COILS WERE PROPERLY IN PLACE, FULL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: NEGATIVE. LOT NUMBER: 922610 MANUFACTURING DATE: 2011/11 EXPIRATION DATE: 2014/11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-DEC-2020: QUALITY-SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 DEVICE DISLOCATION ('RIGHT ESSURE COIL DID NOT EXIT THE CORNEAL REGION OF THE UTERUS AT ALL AND WAS COMPLETELY WITHIN THE TUBE'), PELVIC PAIN ('PAIN') AND GENITAL HAEMORRHAGE ('UNUSUAL AND EXCESSIVE BLEEDING/ HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA ON (B)(6) 2012, APICOECTOMY IN (B)(6) 2011, PELVIC PAIN FEMALE, ABDOMINAL CRAMPS, ACHE, HEAVY PERIODS AND PERINEAL PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO NOVUM, DEPO PROVERA, IBUPROFEN AND DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MELOXICAM AND MESTRANOL;NORETHISTERONE (ORTHO-NOVUM SQ) FROM 2009 TO 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING / LOWER ABDOMEN PAIN"), MENSTRUATION IRREGULAR ("UNUSUAL PERIODS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR THINNING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY PERIODS") AND DEVICE EXPULSION ("LEFT COIL WAS ABOUT HALFWAY INTO THE UTERUS"). THE PATIENT WAS TREATED WITH IBUPROFEN, PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL COMPLETE FORMULA CAPLETS) AND SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS AND LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, MENSTRUATION IRREGULAR, ABDOMINAL PAIN, MENORRHAGIA, ALOPECIA AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, DEVICE DISLOCATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUATION IRREGULAR AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF REMOVAL: (B)(6) 2017 (PER PFS). TRAILING COILS- 3 AND 7. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULTS: COILS WERE PROPERLY IN PLACE, FULL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-DEC-2020: MR RECEIVED : EVENTS- "RIGHT ESSURE COIL DID NOT EXTEND INTO THE CORNEAL REGION OF THE UTERUS AT ALL AND WAS COMPLETELY WITHIN TUBE, LEFT COIL WAS ABOUT HALFWAY INTO THE UTERUS", REPORTER ADDED. 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 ("PAIN") AND GENITAL HAEMORRHAGE ("UNUSUAL AND EXCESSIVE BLEEDING/ HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA ON (B)(6) 2012 AND APICOECTOMY IN (B)(6) 2011. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO NOVUM, DEPO PROVERA, IBUPROFEN AND DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MELOXICAM AND MESTRANOL; NORETHISTERONE (ORTHO-NOVUM SQ) FROM 2009 TO 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING / LOWER ABDOMEN PAIN"), MENSTRUATION IRREGULAR ("UNUSUAL PERIODS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR THINNING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY PERIODS"). THE PATIENT WAS TREATED WITH IBUPROFEN, PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL COMPLETE FORMULA CAPLETS) AND SURGERY (ESSURE REMOVAL SURGERY). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, MENSTRUATION IRREGULAR, ABDOMINAL PAIN, MENORRHAGIA AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUATION IRREGULAR AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULTS: COILS WERE PROPERLY IN PLACE, FULL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-APR-2019: PFS AND SOCIAL MEDIA WERE RECEIVED: ESSURE REMOVAL SURGERY WAS ADDED. REPORTER WAS ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330213 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922610 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| MELOXICAM| MELOXICAM| MELOXICAM| ORTHO-NOVUM SQ| ORTHO-NOVUM SQ| ORTHO-NOVUM SQ |