ESSURE
Report
- Report Number
- 2951250-2017-02773
- Event Type
- Injury
- Date Received
- August 8, 2017
- Date of Event
- January 1, 2008
- Report Date
- August 14, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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 UTERINE PERFORATION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)/PERFORATION (UTERUS)"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)/PERFORATION (UTERUS)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 820499) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, MULTIGRAVIDA, VAGINAL DELIVERY AND OVERACTIVE BLADDER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PLACEBO PILLS. CONCURRENT CONDITIONS INCLUDED AUTOIMMUNE DISORDER NOS ((B)(6)2016 TO(B)(6)2016), GENITAL BLEEDING, MENSTRUAL DISORDER, IRREGULAR PERIODS, PER VAGINAL BLEEDING, VULVOVAGINAL RASH, DYSMENORRHOEA, MENORRHAGIA, HORMONAL IMBALANCE, PELVIC FLOOR DYSSYNERGIA, NABOTHIAN CYST, PELVIC CONGESTION, CONSTIPATION AND EMBEDDED DEVICE. CONCOMITANT PRODUCTS INCLUDED CILEST (ORTHO TRI-CYCLEN) AND NORMENSAL (NECON) FOR BLEEDING GENITAL, INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) FOR CONTRACEPTION AS WELL AS MACROGOL (MIRALAX). ON (B)(6)2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2008, THE PATIENT EXPERIENCED MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ("APAREUNIA(INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND COITAL BLEEDING ("POSTCOITAL BLEEDING/BLEEDING WITH INTERCOURSE"). THE PATIENT WAS TREATED WITH ORAL CONTRACEPTIVE NOS, SURGERY (UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY,CYSTOSCOPY), SURGERY (UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY,CYSTOSCOPY), SURGERY (ABLATION,HYSTERECTOMY), SURGERY (ABLATION,HYSTERECTOMY) AND PHYSICAL THERAPY (PELVIC PHYSICAL THERAPY). ESSURE (ESS205) WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, COITAL BLEEDING AND DYSPAREUNIA HAD RESOLVED AND THE DEVICE EXPULSION, MENORRHAGIA, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND FEMALE SEXUAL DYSFUNCTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COITAL BLEEDING, DEVICE EXPULSION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2007: TOTAL BILATERAL OCCLUSION DIAGNOSTIC LAPAROSCOPY AND HYSTEROSCOPY,DILATION AND CURETTAGE WERE DONE. PELVIC ULTRASOUND WAS PERFORMED. ENDOMETRIAL BIOPSY WAS DONE ON (B)(6)2009. ULTRASOUND SHOWED THIN LINEAR ECHOGENIC REGIONS EXTENDING FROM THE VERY SUPERIOR FUNDAL ENDOMETRIUM INTO BOTH UTERINE CORNUA, PRESUMABLY RELATED TO ESSURE PLACEMENT IN THE INTRAMYOMETRIAL PORTIONS OF THE FALLOPIAN TUBES. THESE CANNOT CLEARLY BE SEEN OUTSIDE THE UTERUS ALTHOUGH THE EXTRAUTERINE FALLOPIAN TUBE MAY NOT BE WELL VISUALIZED. GIVEN THE PRESENCE OF A SMALL ECHOGENIC REGION IN THE UPPER FUNDAL ENDOMETRIUM, ONE OR BOTH OF THESE DEVICES PRESUMABLY EXTENDS TO THIS REGION. ON (B)(6)2014,TRANSVAGINAL ULTRASOUND WAS PERFORMED. HISTOLOGY SHOWED UTERUS, CERVIX, LEFT FALLOPIAN TUBE (PART 2) AND RIGHT FALLOPIAN TUBE (PART 1), HYSTERECTOMY AND BILATERAL SALPINGECTOMY:-ENDOMETRIUM: PROLIFERATIVE ENDOMETRIUM WITH STROMAL BREAKDOWN,MYOMETRIUM: WITHOUT HISTOPATHOLOGIC CHANGE,CERVIX: CHRONIC CYSTIC CERVICITIS WITH TUNNEL CLUSTERS,FALLOPIAN TUBES: RIGHT: WITHOUT HISTOPATHOLOGIC CHANGE,LEFT: WITHOUT HISTOPATHOLOGIC CHANGE.COMMENT:GROSS DESCRIPTION FOR ANATOMIC LOCATIONS OF COILS: THE LEFT SIDE ESSURE COIL IS PROTRUDING INTO THE POSTERIOR ENDOMETRIUM AND THE RIGHT SIDE COIL IS IN THE MYOMETRIUM. THE RIGHT FALLOPIAN TUBE IS CONTINUOUS AND FIMBRIATED AND UPON SECTIONING REVEALS A METALLIC COIL NEAR THE UTERINE FUNDUS. THE RIGHT SIDE FALLOPIAN TUBE STUMP ALSO DISPLAYS A PROTRUDING 2.5 CM SEGMENT OF METALLIC COIL. COLPOSCOPY WAS DONE ON (B)(6)2006. CONCERNING THE INJURIES REPORTED IN THIS CASE,THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS:VAGINAL HAEMORRHAGE,DYSPAREUNIA,PELVIC PAIN,VULVOVAGINAL PAIN,COITAL BLEEDING,MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLANTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED.EVENTS EXTRACTED PER PFS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS),PAIN, PERFORATION (UTERUS).LOT NUMBER,CONCOMITANT DRUGS,CONCOMITANT DISEASE,HISTORICAL CONDITION ,LAB TEST 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)/PERFORATION (UTERUS)"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)/PERFORATION (UTERUS)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 820499(NOT VALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, MULTIGRAVIDA, GRAVIDA, OVERACTIVE BLADDER, RHINOPLASTY AND NASAL SEPTAL OPERATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PLACEBO PILLS. CONCURRENT CONDITIONS INCLUDED AUTOIMMUNE DISORDER ((B)(6) 2016), GENITAL BLEEDING, MENSTRUAL DISORDER, IRREGULAR PERIODS, PER VAGINAL BLEEDING, VULVOVAGINAL RASH, DYSMENORRHOEA, MENORRHAGIA, HORMONAL IMBALANCE, PELVIC FLOOR DYSSYNERGIA, NABOTHIAN CYST, PELVIC CONGESTION, CONSTIPATION, EMBEDDED DEVICE, HYPOTHYROIDISM, ASTHMA AND MULTIPLE SCLEROSIS. CONCOMITANT PRODUCTS INCLUDED CILEST (ORTHO TRI-CYCLEN) AND NORMENSAL (NECON) FOR BLEEDING GENITAL, INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) FOR CONTRACEPTION AS WELL AS AMANTADINE, BACLOFEN, FLUOXETINE, GLATIRAMER, LEVOTHYROXINE, MACROGOL (MIRALAX), PREDNISONE, SALBUTAMOL (ALBUTEROL) AND SPIRONOLACTONE. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2008, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA(INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND COITAL BLEEDING ("POSTCOITAL BLEEDING/BLEEDING WITH INTERCOURSE"). THE PATIENT WAS TREATED WITH ORAL CONTRACEPTIVE NOS, SURGERY (UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY,CYSTOSCOPY), SURGERY (UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY,CYSTOSCOPY), SURGERY (ABLATION,HYSTERECTOMY), SURGERY (ABLATION,HYSTERECTOMY) AND PHYSICAL THERAPY (PELVIC PHYSICAL THERAPY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, COITAL BLEEDING AND DYSPAREUNIA HAD RESOLVED AND THE DEVICE EXPULSION, MENORRHAGIA, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND FEMALE SEXUAL DYSFUNCTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COITAL BLEEDING, DEVICE EXPULSION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: TOTAL BILATERAL OCCLUSION DIAGNOSTIC LAPAROSCOPY AND HYSTEROSCOPY,DILATION AND CURETTAGE WERE DONE. PELVIC ULTRASOUND WAS PERFORMED. ENDOMETRIAL BIOPSY WAS DONE ON (B)(6) 2009. ULTRASOUND SHOWED THIN LINEAR ECHOGENIC REGIONS EXTENDING FROM THE VERY SUPERIOR FUNDAL ENDOMETRIUM INTO BOTH UTERINE CORNUA, PRESUMABLY RELATED TO ESSURE PLACEMENT IN THE INTRAMYOMETRIAL PORTIONS OF THE FALLOPIAN TUBES. THESE CANNOT CLEARLY BE SEEN OUTSIDE THE UTERUS ALTHOUGH THE EXTRAUTERINE FALLOPIAN TUBE MAY NOT BE WELL VISUALIZED. GIVEN THE PRESENCE OF A SMALL ECHOGENIC REGION IN THE UPPER FUNDAL ENDOMETRIUM, ONE OR BOTH OF THESE DEVICES PRESUMABLY EXTENDS TO THIS REGION. ON (B)(6) 2014,TRANSVAGINAL ULTRASOUND WAS PERFORMED. HISTOLOGY SHOWED UTERUS, CERVIX, LEFT FALLOPIAN TUBE (PART 2) AND RIGHT FALLOPIAN TUBE (PART 1), HYSTERECTOMY AND BILATERAL SALPINGECTOMY:-ENDOMETRIUM: PROLIFERATIVE ENDOMETRIUM WITH STROMAL BREAKDOWN,MYOMETRIUM: WITHOUT HISTOPATHOLOGIC CHANGE,CERVIX: CHRONIC CYSTIC CERVICITIS WITH TUNNEL CLUSTERS,FALLOPIAN TUBES: RIGHT: WITHOUT HISTOPATHOLOGIC CHANGE,LEFT: WITHOUT HISTOPATHOLOGIC CHANGE.COMMENT:GROSS DESCRIPTION FOR ANATOMIC LOCATIONS OF COILS: THE LEFT SIDE ESSURE COIL IS PROTRUDING INTO THE POSTERIOR ENDOMETRIUM AND THE RIGHT SIDE COIL IS IN THE MYOMETRIUM. THE RIGHT FALLOPIAN TUBE IS CONTINUOUS AND FIMBRIATED AND UPON SECTIONING REVEALS A METALLIC COIL NEAR THE UTERINE FUNDUS. THE RIGHT SIDE FALLOPIAN TUBE STUMP ALSO DISPLAYS A PROTRUDING 2.5 CM SEGMENT OF METALLIC COIL. COLPOSCOPY WAS DONE ON (B)(6) 2006. CONCERNING THE INJURIES REPORTED IN THIS CASE,THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: VAGINAL HAEMORRHAGE, DYSPAREUNIA, PELVIC PAIN, VULVOVAGINAL PAIN, COITAL BLEEDING, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-AUG-2018: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT: NO VALID 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 PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VULVOVAGINAL PAIN ("VAGINAL PAIN"), COITAL BLEEDING ("POSTCOITAL BLEEDING") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY,BILATERAL SALPINGECTOMY, CYSTOSCOPY AND REMOVAL OF ESSURE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VULVOVAGINAL PAIN, COITAL BLEEDING AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COITAL BLEEDING, DYSPAREUNIA, PELVIC PAIN AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE (ESS205). 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 |
|---|---|---|---|---|---|---|---|
| 555698 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 820499(INVALID) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ALBUTEROL| AMANTADINE| BACLOFEN| FLUOXETINE| GLATIRAMER| IUD NOS| IUD NOS| LEVOTHYROXINE| MIRALAX| MIRALAX| NECON| NECON| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| PREDNISONE| SPIRONOLACTONE |