ESSURE
Report
- Report Number
- 2951250-2019-06042
- Event Type
- Injury
- Date Received
- September 11, 2019
- Date of Event
- June 1, 2009
- Report Date
- October 7, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628196) 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 "PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER DISORDER. CONCURRENT CONDITIONS INCLUDED DYSPAREUNIA, CYSTITIS INTERSTITIAL, ENDOMETRIOSIS, PELVIC PAIN, PAINFUL URINATION, DYSPAREUNIA, URINARY FREQUENCY, DYSMENORRHEA AND INCORRECT DOSE ADMINISTERED BY PRODUCT. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM 2002 TO 2009 FOR CONTRACEPTION AS WELL AS CARDIOVASCULAR SYSTEM SINCE 2016, CEFAZOLIN SODIUM AND FLUOXETINE SINCE 2017. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2010, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: ENDOMETRIOSIS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NOCTURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), DYSURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND CYSTITIS INTERSTITIAL ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSGEUSIA ("INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: METALLIC TASTE IN MOUTH"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED IRRITABILITY ("HORMONAL CHANGES DESCRIBE: SEVERE IRRITABILITY") AND DEPRESSION ("HORMONAL CHANGES DESCRIBE: DEPRESSION, PSYCH INJURY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTEROVAGINAL PROLAPSE ("BLADDER OR URINARY PROBLEMS OR CHANGES STAGE 1 UTEROVAGINAL PROLAPSE"), HYPERTENSION ("BLOOD OR HEART DISORDER/CONDITION TYPE: HIGH BLOOD PRESSURE"), ABDOMINAL PAIN LOWER ("CRAMPING"), FALLOPIAN TUBE CYST ("MANY CYSTS SURROUNDING THE DEVICE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), CYSTITIS ("BLADDER INFECTION") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY- OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE IRRITABILITY, DEPRESSION, VAGINAL HAEMORRHAGE, POLLAKIURIA, NOCTURIA, DYSURIA, CYSTITIS INTERSTITIAL, UTEROVAGINAL PROLAPSE, MIGRAINE, HYPERTENSION, DYSPAREUNIA, ENDOMETRIOSIS, FALLOPIAN TUBE CYST, ABDOMINAL PAIN, CYSTITIS AND HEADACHE OUTCOME WAS UNKNOWN AND THE DYSGEUSIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, CYSTITIS, CYSTITIS INTERSTITIAL, DEPRESSION, DYSGEUSIA, DYSPAREUNIA, DYSURIA, ENDOMETRIOSIS, FALLOPIAN TUBE CYST, HEADACHE, HYPERTENSION, IRRITABILITY, MENORRHAGIA, MIGRAINE, NOCTURIA, PELVIC PAIN, POLLAKIURIA, UTEROVAGINAL PROLAPSE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE REMOVAL DATE (B)(6) 2017. PATIENT RECEIVED TREATMENT FOR PELVIC/ ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PSYCH INJURY, URINARY PROBLEMS, BLADDER INFECTION, HORMONAL CHANGES, HEADACHES, MIGRAINE, METALLIC TASTE IN MOUTH. LOT NUMBER: 628196, MANUFACTURE DATE: 2008-10, EXPIRATION DATE: 2011-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2019: PFS RECEIVED EVENTS " ABDOMINAL PAIN, BLADDER INFECTION AND HEADACHE " WERE ADDED. OUTCOME OF EVENT " BLEEDING" WAS UPDATED AS RECOVERED. 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') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628196) 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 "PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER DISORDER. CONCURRENT CONDITIONS INCLUDED DYSPAREUNIA, CYSTITIS INTERSTITIAL, ENDOMETRIOSIS, PELVIC PAIN, PAINFUL URINATION, DYSPAREUNIA, URINARY FREQUENCY, DYSMENORRHEA AND INCORRECT DOSE ADMINISTERED BY PRODUCT. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM 2002 TO 2009 FOR CONTRACEPTION AS WELL AS CARDIOVASCULAR SYSTEM SINCE 2016, CEFAZOLIN SODIUM AND FLUOXETINE SINCE 2017. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2010, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: ENDOMETRIOSIS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NOCTURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), DYSURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND CYSTITIS INTERSTITIAL ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSGEUSIA ("INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: METALLIC TASTE IN MOUTH"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED IRRITABILITY ("HORMONAL CHANGES DESCRIBE: SEVERE IRRITABILITY") AND DEPRESSION ("HORMONAL CHANGES DESCRIBE: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTEROVAGINAL PROLAPSE ("BLADDER OR URINARY PROBLEMS OR CHANGES STAGE 1 UTEROVAGINAL PROLAPSE"), HYPERTENSION ("BLOOD OR HEART DISORDER/CONDITION TYPE: HIGH BLOOD PRESSURE"), ABDOMINAL PAIN LOWER ("CRAMPING") AND FALLOPIAN TUBE CYST ("MANY CYSTS SURROUNDING THE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY- OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE IRRITABILITY, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, POLLAKIURIA, NOCTURIA, DYSURIA, CYSTITIS INTERSTITIAL, UTEROVAGINAL PROLAPSE, MIGRAINE, HYPERTENSION, DYSPAREUNIA, ENDOMETRIOSIS AND FALLOPIAN TUBE CYST OUTCOME WAS UNKNOWN AND THE DYSGEUSIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYSTITIS INTERSTITIAL, DEPRESSION, DYSGEUSIA, DYSPAREUNIA, DYSURIA, ENDOMETRIOSIS, FALLOPIAN TUBE CYST, HYPERTENSION, IRRITABILITY, MENORRHAGIA, MIGRAINE, NOCTURIA, PELVIC PAIN, POLLAKIURIA, UTEROVAGINAL PROLAPSE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. LOT NUMBER: 628196. MANUFACTURE DATE: 2008-10. EXPIRATION DATE: 2011-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PTC 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') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628196) 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 "PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER DISORDER. CONCURRENT CONDITIONS INCLUDED DYSPAREUNIA, CYSTITIS INTERSTITIAL, ENDOMETRIOSIS, PELVIC PAIN, PAINFUL URINATION, DYSPAREUNIA, URINARY FREQUENCY, DYSMENORRHEA AND INCORRECT DOSE ADMINISTERED BY PRODUCT. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM 2002 TO 2009 FOR CONTRACEPTION AS WELL AS CARDIOVASCULAR SYSTEM SINCE 2016, CEFAZOLIN SODIUM AND FLUOXETINE SINCE 2017. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2010, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: ENDOMETRIOSIS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NOCTURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), DYSURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND CYSTITIS INTERSTITIAL ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSGEUSIA ("INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: METALLIC TASTE IN MOUTH"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED IRRITABILITY ("HORMONAL CHANGES DESCRIBE: SEVERE IRRITABILITY") AND DEPRESSION ("HORMONAL CHANGES DESCRIBE: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTEROVAGINAL PROLAPSE ("BLADDER OR URINARY PROBLEMS OR CHANGES STAGE 1 UTEROVAGINAL PROLAPSE"), HYPERTENSION ("BLOOD OR HEART DISORDER/CONDITION TYPE: HIGH BLOOD PRESSURE"), ABDOMINAL PAIN LOWER ("CRAMPING") AND FALLOPIAN TUBE CYST ("MANY CYSTS SURROUNDING THE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY- OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE IRRITABILITY, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, POLLAKIURIA, NOCTURIA, DYSURIA, CYSTITIS INTERSTITIAL, UTEROVAGINAL PROLAPSE, MIGRAINE, HYPERTENSION, DYSPAREUNIA, ENDOMETRIOSIS AND FALLOPIAN TUBE CYST OUTCOME WAS UNKNOWN AND THE DYSGEUSIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYSTITIS INTERSTITIAL, DEPRESSION, DYSGEUSIA, DYSPAREUNIA, DYSURIA, ENDOMETRIOSIS, FALLOPIAN TUBE CYST, HYPERTENSION, IRRITABILITY, MENORRHAGIA, MIGRAINE, NOCTURIA, PELVIC PAIN, POLLAKIURIA, UTEROVAGINAL PROLAPSE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2019: PFS RECEIVED. PREVIOUSLY REPORTED EVENT "INJURY NOS" REPLACE WITH "SEVERE IRRITABILITY", EVENTS- " DEPRESSION, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), BLADDER OR URINARY PROBLEMS OR CHANGES, URINARY FREQUENCY, NOCTURIA, PAINFUL URINATION, INTERSTITIAL CYSTITIS, BLADDER OR URINARY PROBLEMS OR CHANGES STAGE 1 UTEROVAGINAL PROLAPSE, MIGRAINES /HEADACHES, HIGH BLOOD PRESSURE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ENDOMETRIOSIS, METALLIC TASTE IN MOUTH, CRAMPING, PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST,MANY CYSTS SURROUNDING THE DEVICE", MEDICAL HISTORY, CONCOMITANT AND TREATMENT DRUGS, CONCOMITANT CONDITIONS, LOT NUMBER 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 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 |
|---|---|---|---|---|---|---|---|
| 789010 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 628196 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | CARDIOVASCULAR SYSTEM| CARDIOVASCULAR SYSTEM| CARDIOVASCULAR SYSTEM| CEFAZOLIN SODIUM| CEFAZOLIN SODIUM| CEFAZOLIN SODIUM| FLUOXETINE| FLUOXETINE| FLUOXETINE| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS |