ESSURE
Report
- Report Number
- 2951250-2018-03664
- Event Type
- Injury
- Date Received
- August 22, 2018
- Date of Event
- April 1, 2016
- Report Date
- October 29, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/LOWER PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO TRI CYCLEN FROM 2009 TO 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("LYSIS OF ADHESION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND VULVOVAGINAL PAIN ("VAGINAL AREA PAIN; MORE ON RIGHT SIDE"). THE PATIENT WAS TREATED WITH SURGERY (LYSIS OF ADHESION AND LAPAROSCOPIC ASSISTED.VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSI). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, PELVIC ADHESIONS AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, ABDOMINAL PAIN AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC ADHESIONS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON LATE (B)(6) -2011, ESSURE WAS INSERTED. ON (B)(6) 2016, PLAINTIFF SAW HER PHYSICIAN AND UNDERWENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSIS OF ADHESIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-AUG-2019: QUALITY SAFETY EVALUATION OF PTC. (PRODUCT TECHNICAL COMPLAINT). 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 / LOWER PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING/ ABNORMAL BLEEDING') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BLEED IN LUTEAL CYST AND DYSFUNCTIONAL UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO TRI CYCLEN FROM 2009 TO 2010. CONCURRENT CONDITIONS INCLUDED MENSES IRREGULAR WITH EXCESSIVE BLEEDING, GONORRHEA, DYSFUNCTIONAL UTERINE BLEEDING, PERINEAL PAIN, CHRONIC CERVICITIS, POLYCYSTIC OVARIAN SYNDROME, FOCAL CORTICAL DYSPLASIA, PARATUBAL CYST, UTERINE ENLARGEMENT AND ADENOMYOSIS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("LYSIS OF ADHESION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL AREA PAIN; MORE ON RIGHT SIDE") AND ABDOMINAL DISTENSION ("BELLY MAKES ME LOOK LIKE I'M ABOUT FIVE MONTHS PG (PREGNANT)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (LYSIS OF ADHESION AND LAPAROSCOPIC ASSISTED. VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSI). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE DYSMENORRHOEA, PELVIC ADHESIONS, VULVOVAGINAL PAIN, WEIGHT INCREASED AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC ADHESIONS, PELVIC PAIN, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON LATE (B)(6) 2011, ESSURE WAS INSERTED. ON (B)(6) 2016, PLAINTIFF SAW HER PHYSICIAN AND UNDERWENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSIS OF ADHESIONS. BOTH OSTIA WERE CANNULATED AND DEVICES DEPLOYED WITH GOOD COIL COUNTS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, VAGINAL BLEEDING. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-AUG-2019: PFS RECEIVED : REPORTER INFORMATION WAS ADDED. OUTCOME OF EVENT " PELVIC PAIN AND GEN. ABNORMAL BLEED" WAS UPDATED AS " RECOVERED". 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/LOWER PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO TRI CYCLEN FROM 2009 TO 2010. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6)2016, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("LYSIS OF ADHESION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND VULVOVAGINAL PAIN ("VAGINAL AREA PAIN; MORE ON RIGHT SIDE"). THE PATIENT WAS TREATED WITH SURGERY (LYSIS OF ADHESION AND LAPAROSCOPIC ASSISTED.VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSI). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, PELVIC ADHESIONS AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, ABDOMINAL PAIN AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC ADHESIONS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON LATE (B)(6)2011, ESSURE WAS INSERTED. ON (B)(6)2016, PLAINTIFF SAW HER PHYSICIAN AND UNDERWENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSIS OF ADHESIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2012: RESULTS: BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2019: PFS RECEIVED. REPORTER INFORMATION, LOT NUMBER, HISTORICAL DRUG WERE ADDED. EVENT : ABNORMAL BLEEDING (VAGINAL), LYSIS OF ADHESION, VAGINAL AREA PAIN; MORE ON RIGHT SIDE WERE ADDED. OUTCOME OF THE EVENT ABDOMINAL PAIN AND ABNORMAL BLEEDING WERE UPDATED. 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 ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT HAD ESSURE INSERTED. IN 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), MENORRHAGIA ("MENORRHAGIA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED. VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSI). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2011, ESSURE WAS INSERTED. ON (B)(6) 2016, PLAINTIFF SAW HER PHYSICIAN AND UNDERWENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSIS OF ADHESIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-NOV-2018: QUALITY SAFETY EVALUATION OF PTC. 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.
"NTANEOUS" CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT HAD ESSURE INSERTED. IN 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), MENORRHAGIA ("MENORRHAGIA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED. VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSI). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON LATE (B)(6) 2011, ESSURE WAS INSERTED. ON (B)(6) 2016, PLAINTIFF SAW HER PHYSICIAN AND UNDERWENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LEFT SALPINGECTOMY AND LYSIS OF ADHESIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBE. 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 |
|---|---|---|---|---|---|---|---|
| 646094 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882184 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other| R |