ESSURE
Report
- Report Number
- 2951250-2020-12158
- Event Type
- Injury
- Date Received
- July 24, 2020
- Date of Event
- January 1, 2013
- Report Date
- November 4, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC/ EVERYDAY WORSENS WITH PERIOD') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST." CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (TYLENOL) SINCE JANUARY 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GEN. ABNORMAL. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND METRORRHAGIA ("MENORRHAGIA (BLEEDING B/W PERIODS),"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY SCHEDULED (B)(6) 2020). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN, MENORRHAGIA, METRORRHAGIA, DYSPAREUNIA, VAGINAL HAEMORRHAGE AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2011, SHE IMPLANTED ESSURE. (AS PER PFS PLEASE NOTE DISCREPANCY). DISCREPANCY NOTED IN DATE OF BIRTH WAS CONFIRMED. LOT NUMBER:852005 MANUFACTURING DATE:2011/04 EXPIRATION DATE:2014/04. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-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 / CHRONIC/ EVERYDAY WORSENS WITH PERIOD') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MENORRHAGIA, DYSMENORRHEA, PELVIC PAIN FEMALE, DYSPAREUNIA AND CYSTOSCOPY. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (TYLENOL) SINCE (B)(6) 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL. BLEED") AND METRORRHAGIA ("MENORRHAGIA (BLEEDING B/W PERIODS),"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, MCCALLS CUL-DE-PLASTY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE ABDOMINAL PAIN, METRORRHAGIA AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2011, SHE IMPLANTED ESSURE. (AS PER PFS PLEASE NOTE DISCREPANCY) DISCREPANCY NOTED IN DATE OF BIRTH WAS CONFIRMED CURRENT WEIGHT 260 LBS. DISCREPANCY NOTED IN DATE OF REMOVAL (B)(6) 2020 (PREVIOUSLY REPORTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.2 KG/SQM. LOT NUMBER:852005 MANUFACTURING DATE:2011/04 EXPIRATION DATE:2014/04. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-OCT-2020: PFS AND MR RECEIVED: OUTCOME OF EVENTS: PELVIC PAIN, DYSPAREUNIA, GENITAL HEMORRHAGE, VAGINAL HEMORRHAGE, MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA WERE UPDATED. MEDICAL HISTORY, PATIENT DEMOGRAPHIC DETAILS, REPORTER INFORMATION 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC/ EVERYDAY WORSENS WITH PERIOD') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (TYLENOL) SINCE (B)(6) 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GEN. ABNORMAL. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND METRORRHAGIA ("MENORRHAGIA (BLEEDING B/W PERIODS),"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY SCHEDULED (B)(6) 2020). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN, MENORRHAGIA, METRORRHAGIA, DYSPAREUNIA, VAGINAL HAEMORRHAGE AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2011, SHE IMPLANTED ESSURE. (AS PER PFS PLEASE NOTE DISCREPANCY). DISCREPANCY NOTED IN DATE OF BIRTH WAS CONFIRMED . LOT NUMBER: 852005, MANUFACTURING DATE: 2011/04, EXPIRATION DATE:2014/04. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUL-2020: PFS RECEIVED. NEW EVENT ADDED: VAGINAL HEMORRHAGE, ENDOMETRIOSIS. CONCOMITANT MEDICATIONS 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 |
|---|---|---|---|---|---|---|---|
| 782463 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 852005 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | TYLENOL| TYLENOL| TYLENOL| TYLENOL |