ESSURE
Report
- Report Number
- 2951250-2019-07476
- Event Type
- Injury
- Date Received
- September 20, 2019
- Report Date
- July 7, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND FIBROMA ('TUMORS / FIBROID') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12278094-NOT VALID,12275287) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2008, THE PATIENT WAS FOUND TO HAVE FIBROMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("RIGHT SIDED TUBAL SPASM DURING INSERTION."). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, FIBROMA, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE SPASM, FIBROMA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: (B)(6) 2005(LEFT), (B)(6) 2005(RIGHT). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 58.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 12275287, MANUFACTURING DATE: 2005-01, EXPIRATION DATE: 2006-12 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-MAR-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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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 FIBROMA ('TUMORS / FIBROID') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12278094,12275287) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2008, THE PATIENT WAS FOUND TO HAVE FIBROMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("RIGHT SIDED TUBAL SPASM DURING INSERTION."). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, FIBROMA, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE SPASM, FIBROMA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: (B)(6) 2005(LEFT), (B)(6) 2005(RIGHT) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 58.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED : LOT NUMBER ADDED. RIGHT SIDED TUBAL SPASM EVENT WAS ADDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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'), EMBEDDED DEVICE ('PRESENT EMBEDDED WITHIN THE RIGHT AND LEFT CORNU ARE SILVER METALLIC COILED WIRES') AND FIBROMA ('TUMORS / FIBROID') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12278094-NOT VALID,12275287) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2008, THE PATIENT WAS FOUND TO HAVE FIBROMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("RIGHT SIDED TUBAL SPASM DURING INSERTION."). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) AND TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, FIBROMA, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE AND HEAVY MENSTRUAL BLEEDING HAD RESOLVED AND THE EMBEDDED DEVICE AND FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FALLOPIAN TUBE SPASM, FIBROMA, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: (B)(6) 2005(LEFT), (B)(6) 2005(RIGHT) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 58.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION.. LOT NUMBER: 12275287 MANUFACTURING DATE: 2005-01 EXPIRATION DATE: 2006-12 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: MR RECEIVED : EVENT "PRESENT EMBEDDED WITHIN THE RIGHT AND LEFT CORNU ARE SILVER METALLIC COILED WIRES", REPORTER ADDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') AND FIBROMA ('TUMORS / FIBROID') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2008, THE PATIENT WAS FOUND TO HAVE FIBROMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE (ESS205) WAS REMOVED ON 13-APR-2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, FIBROMA, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FIBROMA, GENITAL HAEMORRHAGE, 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) 2005: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2019: PFS RECEIVED: EVENT(TUMOR WAS UPDATED TO TUMOR FIBROIDS), EVENTS VAGINAL BLEEDING & MENORRHAGIA WERE ADDED. OUTCOME OF EVENTS (RECOVERED / RESOLVED), NEW REPORTER, LAB TEST AND PATIENT HEIGHT UPDATED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND FIBROMA ('TUMORS / FIBROID') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12278094-NOT VALID,12275287) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2008, THE PATIENT WAS FOUND TO HAVE FIBROMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("RIGHT SIDED TUBAL SPASM DURING INSERTION."). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, FIBROMA, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE SPASM, FIBROMA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: (B)(6) 2005(LEFT), (B)(6) 2005(RIGHT) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 58.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-MAR-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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 ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE DYSMENORRHOEA, DYSPAREUNIA AND NEOPLASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, NEOPLASM AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2005: RESULT: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED. LAB DATA ADDED. EVENTS : DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC/ABDOMINAL, GENERAL ABNORMAL BLEEDING, TUMORS WERE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 894055 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12278094-NOT VALID,12275287 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |