ESSURE
Report
- Report Number
- 2951250-2020-06051
- Event Type
- Injury
- Date Received
- April 29, 2020
- Date of Event
- June 1, 2012
- Report Date
- September 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND OVARIAN CYSTECTOMY ('CYSTECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NEXPLANON. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UNDERWENT OVARIAN CYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY/ HYSTERECTOMY PARTIAL VAGINAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE OVARIAN CYSTECTOMY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED OVARIAN CYSTECTOMY AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DETAIL: TUBAL OSTIA ALL THE WAY TO THE BLACK MARK THEN DEPLOYED. A TOTAL OF THREE COILS WERE VISUALIZED OUTSIDE THE RIGHT SIDE TUBAL OSTIA. A TOTAL NUMBER OF TWO COILS WERE VISUALIZED OUTSIDE OF THE LEFT TUBAL OSTIA. DISCREPANCY NOTED DATE(S) OF INSERTION: (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2020: PLAINTIFF FACT SHEET REPORT RECEIVED. REPORTER, HISTORICAL DRUG, PATIENT DEMOGRAPHICS WERE ADDED. UPDATED OUTCOME OF EVENT PELVIC PAIN FEMALE AS RECOVERED AND SEVERITY. 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 OVARIAN CYSTECTOMY ('CYSTECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UNDERWENT OVARIAN CYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND OVARIAN CYSTECTOMY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED OVARIAN CYSTECTOMY AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DETAIL: TUBAL OSTIA ALL THE WAY TO THE BLACK MARK THEN DEPLOYED. A TOTAL OF THREE COILS WERE VISUALIZED OUTSIDE THE RIGHT SIDE TUBAL OSTIA. A TOTAL NUMBER OF TWO COILS WERE VISUALIZED OUTSIDE OF THE LEFT TUBAL OSTIA. DISCREPANCY NOTED DATE(S) OF INSERTION: (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-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 OVARIAN CYSTECTOMY ('CYSTECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UNDERWENT OVARIAN CYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND OVARIAN CYSTECTOMY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED OVARIAN CYSTECTOMY AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DETAIL: TUBAL OSTIA ALL THE WAY TO THE BLACK MARK THEN DEPLOYED. A TOTAL OF THREE COILS WERE VISUALIZED OUTSIDE THE RIGHT SIDE TUBAL OSTIA. A TOTAL NUMBER OF TWO COILS WERE VISUALIZED OUTSIDE OF THE LEFT TUBAL OSTIA. DISCREPANCY NOTED DATE(S) OF INSERTION: (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-MAY-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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'), VAGINAL HAEMORRHAGE ('ABNORMAL VAGINAL BLEEDING/HEAVY VAGINAL BLEEDING') AND OVARIAN CYSTECTOMY ('OVARIAN CYSTECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SLIPPED DISC, PAP SMEAR ABNORMAL, PELVIC PAIN FEMALE, HAEMORRHAGIC OVARIAN CYST AND CERVICAL DYSPLASIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NEXPLANON. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN) AND OXYCODONE. 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), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA ("MENORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT OVARIAN CYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH ETONOGESTREL (NEXPLANON) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY/ HYSTERECTOMY PARTIAL VAGINAL AND NOVASURE ENDOMETRIAL ABLATION 2014). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE OVARIAN CYSTECTOMY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA, OVARIAN CYSTECTOMY, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DETAIL: TUBAL OSTIA ALL THE WAY TO THE BLACK MARK THEN DEPLOYED. A TOTAL OF THREE COILS WERE VISUALIZED OUTSIDE THE RIGHT SIDE TUBAL OSTIA. A TOTAL NUMBER OF TWO COILS WERE VISUALIZED OUTSIDE OF THE LEFT TUBAL OSTIA. DISCREPANCY NOTED DATE(S) OF INSERTION: (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-SEP-2020: PFS AND MR RECEIVED: NEW EVENTS: ABNORMAL VAGINAL BLEEDING, MENORRHAGIA WERE ADDED. ABNORMAL VAGINAL BLEEDING MADE MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED DUE TO ADDED SURGERY ABLATION. OUTCOME OF EVENTS: ABNORMAL VAGINAL BLEEDING, MENORRHAGIA ADDED. ONSET DATE OF EVENTS: ABNORMAL VAGINAL BLEEDING, MENORRHAGIA, PELVIC PAIN ADDED. CONCOMITANT DRUGS, MEDICAL HISTORY, PATIENT MIDDLE NAME 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') AND OVARIAN CYSTECTOMY ('CYSTECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UNDERWENT OVARIAN CYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND OVARIAN CYSTECTOMY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED OVARIAN CYSTECTOMY AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DETAIL: TUBAL OSTIA ALL THE WAY TO THE BLACK MARK THEN DEPLOYED. A TOTAL OF THREE COILS WERE VISUALIZED OUTSIDE THE RIGHT SIDE TUBAL OSTIA. A TOTAL NUMBER OF TWO COILS WERE VISUALIZED OUTSIDE OF THE LEFT TUBAL OSTIA. DISCREPANCY NOTED DATE(S) OF INSERTION: (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAR-2020: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. THE CASE WAS UPGRADED FROM NON-SERIOUS INCIDENT TO SERIOUS INCIDENT. PREVIOUSLY REPORTED UNSPECIFIED EVENT ¿INJURY¿ WAS UPDATED TO MORE SPECIFIED EVENTS¿ PELVIC PAIN AND OVARIAN CYSTECTOMY. PATIENT DEMOGRAPHICS, LAB DATA, ESSURE LOT NUMBER, ESSURE REMOVAL DATE AND REPORTER WERE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474920 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880435 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | OXYCODONE.| VICODIN. |