ESSURE
Report
- Report Number
- 2951250-2019-03517
- Event Type
- Injury
- Date Received
- July 9, 2019
- Date of Event
- April 1, 2012
- Report Date
- February 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
- NM, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/PELVIC PAIN') IN AN ADOLESCENT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY AND DISSOCIATIVE IDENTITY DISORDER. CONCOMITANT PRODUCTS INCLUDED ARIPIPRAZOLE SINCE 2012, BUPROPION HYDROCHLORIDE (FORFIVO XL), BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2013, BUPROPION HYDROCHLORIDE (ZYBAN), LEVONORGESTREL (MIRENA), PAROXETINE, SERTRALINE SINCE 2013 AND TRAZODONE HYDROCHLORIDE (OLEPTRO). 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), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE AND SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, ALOPECIA AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE DEVICE WAS THEN RELEASED AND THE WHEEL AGAIN WAS TURNED WITH NOTING APPROXIMATELY 3 RINGS ON THE RIGHT SIDE VISUALIZED IN THE ENDOMETRIAL CAVITY, ATTENTION WAS THEN TURNED TO THE LEFT SIDE WHERE THE SAME PROCEDURE WAS DONE AND 4 RINGS WERE NOTED IN THE ENDOMETRIAL CAVITY 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 11-JUL-2019: 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 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 ('PAIN/PELVIC PAIN') IN AN ADOLESCENT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POST-TRAUMATIC STRESS DISORDER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBUTRIN, SERTRALINE, ARIPIPRAZOLE, AMITRIPTYLINE, PAROXETINE, ZYBAN, FORFIVO, OLEPTRO, MIRENA AND MIRENA. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY, DISSOCIATIVE IDENTITY DISORDER, DEPRESSION AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED ARIPIPRAZOLE SINCE 2012, BUPROPION HYDROCHLORIDE (FORFIVO XL), BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2013, BUPROPION HYDROCHLORIDE (ZYBAN), LEVONORGESTREL (MIRENA), PAROXETINE, SERTRALINE SINCE 2013 AND TRAZODONE HYDROCHLORIDE (OLEPTRO). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE AND SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED, THE MIGRAINE, HEADACHE AND ALOPECIA WAS RESOLVING AND THE DYSPAREUNIA AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE DEVICE WAS THEN RELEASED AND THE WHEEL AGAIN WAS TURNED WITH NOTING APPROXIMATELY 3 RINGS ON THE RIGHT SIDE VISUALIZED IN THE ENDOMETRIAL CAVITY, ATTENTION WAS THEN TURNED TO THE LEFT SIDE WHERE THE SAME PROCEDURE WAS DONE AND 4 RINGS WERE NOTED IN THE ENDOMETRIAL CAVITY 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 13-FEB-2020: PLAINTIFF FACT SHEET RECEIVED. OUTCOME UPDATED FOR EVENTS PAIN MIGRAINE, HEADACHES, DYSMENORRHEA & HAIR LOSS. PATIENT & REPORTER UPDATED. 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 ('PAIN/PELVIC PAIN') IN AN ADOLESCENT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY AND PERSONALITY DISORDER. CONCOMITANT PRODUCTS INCLUDED ARIPIPRAZOLE SINCE 2012, BUPROPION HYDROCHLORIDE (FORFIVO XL), BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2013, BUPROPION HYDROCHLORIDE (ZYBAN), LEVONORGESTREL (MIRENA), PAROXETINE, SERTRALINE SINCE 2013 AND TRAZODONE HYDROCHLORIDE (OLEPTRO). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE AND SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, ALOPECIA AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE DEVICE WAS THEN RELEASED AND THE WHEEL AGAIN WAS TURNED WITH NOTING APPROXIMATELY 3 RINGS ON THE RIGHT SIDE VISUALIZED IN THE ENDOMETRIAL CAVITY, ATTENTION WAS THEN TURNED TO THE LEFT SIDE WHERE THE SAME PROCEDURE WAS DONE AND 4 RINGS WERE NOTED IN THE ENDOMETRIAL CAVITY. 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 1-JUL-2019: PFS RECEIVED. LOT NUMBER AND LAB DATA ADDED. CONCOMITANT MEDICATION AND CONDITION ADDED. EVENTS : MIGRAINES / HEADACHES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, HAIR LOSS, LOWER BACK PAIN WERE ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565276 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 940970 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | ARIPIPRAZOLE| ARIPIPRAZOLE| ARIPIPRAZOLE| FORFIVO XL| FORFIVO XL| FORFIVO XL| MIRENA| MIRENA| MIRENA| OLEPTRO| OLEPTRO| OLEPTRO| PAROXETINE| PAROXETINE| PAROXETINE| SERTRALINE| SERTRALINE| SERTRALINE| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| ZYBAN| ZYBAN| ZYBAN| ARIPIPRAZOLE| FORFIVO XL| MIRENA| OLEPTRO| PAROXETINE| SERTRALINE| WELLBUTRIN| ZYBAN |