ESSURE
Report
- Report Number
- 2951250-2018-01892
- Event Type
- Injury
- Date Received
- April 19, 2018
- Date of Event
- October 18, 2012
- Report Date
- July 13, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 620743) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MENOMETRORRHAGIA. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM. CONCOMITANT PRODUCTS INCLUDED CILEST (SPRINTEC), FLUOXETINE HYDROCHLORIDE (PROZAC), GALENIC /FEXOFENADINE HCL/PSEUDOEPHEDRINE/ (ALLEGRA-D 12 HOUR), LEVOTHYROXINE AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR XR). ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2012, 5 YEARS 11 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY; CYSTOSCOPY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 7-MAR-2007: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD:ABNORMAL UTERINE BLEEDING . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAR-2018: THE MEDICAL RECORD RECEIVED:EVENTS ABNORMAL UTERINE BLEEDING ADDED,REPORTERS ADDED . INCIDENT: AT THE TIME OF REPORTING, 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 PELVIC PAIN ("PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 620743) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MENOMETRORRHAGIA. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM. CONCOMITANT PRODUCTS INCLUDED CILEST (SPRINTEC), FLUOXETINE HYDROCHLORIDE (PROZAC), GALENIC /FEXOFENADINE HCL/PSEUDOEPHEDRINE/ (ALLEGRA-D 12 HOUR), LEVOTHYROXINE AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR XR). ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2012, 5 YEARS 11 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY; CYSTOSCOPY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: TOTAL BILATERAL OCCLUSION . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD:ABNORMAL UTERINE BLEEDING, PELVIC PAIN, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, 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 PELVIC PAIN ("PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 620743) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MENOMETRORRHAGIA. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM. CONCOMITANT PRODUCTS INCLUDED CILEST (SPRINTEC), FLUOXETINE HYDROCHLORIDE (PROZAC), GALENIC /FEXOFENADINE HCL/PSEUDOEPHEDRINE/ (ALLEGRA-D 12 HOUR), LEVOTHYROXINE AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR XR). ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2012, 5 YEARS 11 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY; CYSTOSCOPY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD:ABNORMAL UTERINE BLEEDING, PELVIC PAIN, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS DYSMENORRHEA AND LOWER ABDOMINAL PAIN ADDED. OUTCOME OF EVENTS UPDATED. INCIDENT: AT THE TIME OF REPORTING, 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 PELVIC PAIN ("PAIN") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 620743) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM. CONCOMITANT PRODUCTS INCLUDED CILEST (SPRINTEC), FLUOXETINE HYDROCHLORIDE (PROZAC), GALENIC /FEXOFENADINE HCL/PSEUDOEPHEDRINE/ (ALLEGRA-D 12 HOUR), LEVOTHYROXINE AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR XR). ON (B)(6) 2016, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED: LOT NUMBER, REPORTER INFORMATION, PATIENT DETAILS, OTHER RELEVANT HISTORY, LAB DATA, PRODUCT INFORMATION, CONCOMITANT DRUG EVENT SEVERE PHYSICAL INJURIES UPDATED WITH EVENTS PAIN, ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) WERE ADDED. ESSURE LEGAL MANUFACTURE 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: AT THE TIME OF REPORTING, 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 |
|---|---|---|---|---|---|---|---|
| 288323 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 620743 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R | ALLEGRA-D 12 HOUR| ALLEGRA-D 12 HOUR| ALLEGRA-D 12 HOUR| ALLEGRA-D 12 HOUR| EFFEXOR XR| EFFEXOR XR| EFFEXOR XR| EFFEXOR XR| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| PROZAC| PROZAC| PROZAC| PROZAC| SPRINTEC| SPRINTEC| SPRINTEC| SPRINTEC| ALLEGRA-D 12 HOUR| EFFEXOR XR| LEVOTHYROXINE| PROZAC| SPRINTEC |