ESSURE
Report
- Report Number
- 2951250-2017-00360
- Event Type
- Injury
- Date Received
- February 3, 2017
- Date of Event
- January 12, 2013
- Report Date
- October 11, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING / HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 771092) INSERTED FOR FEMALE STERILIZATION. 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 CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2 (B)(6) 1997, (B)(6) 2005). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA SHOT. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL DISCHARGE AND IRREGULAR PERIODS. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (TYLENOL) FROM 2010 TO 2014 AND ZOLPIDEM TARTRATE (AMBIEN) FROM 2014 TO 2015. IN (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER. ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS- CONDITION:MENTAL ANGUISH"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING) / EXTRIME CRAMPING"). IN 2016, THE PATIENT EXPERIENCED CYSTITIS NONINFECTIVE ("INFLAMMATORY BLADDER DISEASE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMOTIONAL DISORDER ("EMOTIONAL"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("BLADDER INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL INFECTION ("VAGINAL INFECTION"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES - DESCRIBE") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY WITH REMOVAL OF BOTH ESSURE COILS ON 18-NOV-2014), SURGERY (18NOV2014 VIA SUPRACERVICAL HYSTERECTOMY PARTIAL (UTERUS ONLY)), SURGERY (ABLATION), SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN HAD RESOLVED AND THE DEVICE DISLOCATION, EMOTIONAL DISORDER, URINARY TRACT INFECTION, CYSTITIS, DEPRESSION, ANXIETY, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, FATIGUE, GASTROINTESTINAL DISORDER, CYSTITIS NONINFECTIVE, WEIGHT INCREASED, VAGINAL INFECTION, HORMONE LEVEL ABNORMAL AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, CYSTITIS, CYSTITIS NONINFECTIVE, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. SHE HAD UNDERGONE ESSURE CONFIRMATION TEST. SHE HAD MRI IN JULY WHICH SHOWS SMALL GROWTH IN UTERUS AND SMALL OVARIAN CYST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-OCT-2018: PLAINTIFF FACT SHEET WAS RECEIVED. REPORTER INFORMATION WAS UPDATED AND CONCOMITANT DRUG WERE ADDED.NEW EVENTS VAGINAL DISCHARGE, ABDOMINAL PAIN, SHE DID NOT UNDERGO CONFIRMATION TEST WERE ADDED. EVENTS ONSET DATE UPDATED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), GENITAL HEMORRHAGE ("EXCESSIVE BLEEDING") AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 771092) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2 (B)(6) 1997, (B)(6) 2005). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA SHOT. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL DISCHARGE AND IRREGULAR PERIODS. CONCOMITANT PRODUCTS INCLUDED ZOLPIDEM TARTRATE (AMBIEN). IN (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2016, THE PATIENT EXPERIENCED CYSTITIS NONINFECTIVE ("INFLAMMATORY BLADDER DISEASE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA"), EMOTIONAL DISORDER ("EMOTIONAL"), VAGINAL HEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("BLADDER INFECTION"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), THE FIRST EPISODE OF ABDOMINAL PAIN LOWER ("ABDOMINAL PAIN NEAR OVARIES"), WEIGHT INCREASED ("WEIGHT GAIN") AND THE SECOND EPISODE OF ABDOMINAL PAIN LOWER ("EXTREME CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY WITH REMOVAL OF BOTH ESSURE COILS ON (B)(6) 2014), SURGERY (ABLATION) AND SURGERY (B)(6) 2014 VIA SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL HEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE DEVICE DISLOCATION, EMOTIONAL DISORDER, URINARY TRACT INFECTION, CYSTITIS, DEPRESSION, ANXIETY, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, FATIGUE, GASTROINTESTINAL DISORDER, CYSTITIS NONINFECTIVE, WEIGHT INCREASED AND THE LAST EPISODE OF ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, CYSTITIS, CYSTITIS NONINFECTIVE, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL PAIN LOWER AND THE SECOND EPISODE OF ABDOMINAL PAIN LOWER TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. SHE HAD UNDERGONE ESSURE CONFIRMATION TEST. SHE HAD MRI IN JULY WHICH SHOWS SMALL GROWTH IN UTERUS AND SMALL OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING / HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 771092) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2 ((B)(6) 1997, (B)(6) 2005). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA SHOT. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL DISCHARGE AND IRREGULAR PERIODS. CONCOMITANT PRODUCTS INCLUDED ZOLPIDEM TARTRATE (AMBIEN). IN JANUARY 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING) / EXTRIME CRAMPING"). IN 2016, THE PATIENT EXPERIENCED CYSTITIS NONINFECTIVE ("INFLAMMATORY BLADDER DISEASE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), EMOTIONAL DISORDER ("EMOTIONAL"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("BLADDER INFECTION"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL INFECTION ("VAGINAL INFECTION"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES - DESCRIBE"), MENTAL DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS- CONDITION:") AND THE SECOND EPISODE OF GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2014 VIA SUPRACERVICAL HYSTERECTOMY PARTIAL (UTERUS ONLY)), SURGERY (ABLATION), SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMOTIONAL DISORDER, URINARY TRACT INFECTION, CYSTITIS, DEPRESSION, ANXIETY, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, FATIGUE, CYSTITIS NONINFECTIVE, WEIGHT INCREASED, VAGINAL INFECTION, MENTAL DISORDER AND THE LAST EPISODE OF GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, CYSTITIS, CYSTITIS NONINFECTIVE, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT INCREASED, THE FIRST EPISODE OF GASTROINTESTINAL DISORDER AND THE SECOND EPISODE OF GASTROINTESTINAL DISORDER TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. SHE HAD UNDERGONE ESSURE CONFIRMATION TEST. SHE HAD MRI IN JULY WHICH SHOWS SMALL GROWTH IN UTERUS AND SMALL OVARIAN CYST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- VAGINAL INFECTION, HORMONAL CHANGES ¿ DESCRIBE, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS- CONDITION, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES CANNOT BE EVALUATED NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-FEB-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND BEGAN TO EXPERIENCE SEVERE PELVIC PAIN AND EXCESSIVE BLEEDING (INTERPRETED AS GENITAL BLEEDING). SHE UNDERWENT PARTIAL HYSTERECTOMY AND REMOVAL OF BOTH COILS APPROXIMATELY 7.5 YEARS AFTER INSERTION. PELVIC PAIN AND GENITAL BLEEDING, CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE, ARE ANTICIPATED EVENTS ACCORDING TO THE REFERENCE SAFETY INFORMATION OF ESSURE. THIS REPORT PROVIDED LIMITED INFORMATION, HOWEVER, AS PELVIC PAIN AND GENITAL BLEEDING CAN OCCUR DURING THE USE OF ESSURE AND NO ALTERNATIVE EXPLANATIONS WERE REPORTED, A CAUSALITY OF THE ESSURE MICRO-INSERTS CANNOT BE EXCLUDED (RELATED). ADDITIONAL NON-SERIOUS EVENTS WERE ALSO REPORTED. THE CASE WAS CLASSIFIED AS INCIDENT BECAUSE OF SURGICAL INTERVENTION AND DEVICE REMOVAL. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION IS EXPECTED ONLY THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 771092) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2 ((B)(6) 1997, (B)(6) 2005). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA SHOT. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT AND VAGINAL DISCHARGE. CONCOMITANT PRODUCTS INCLUDED ZOLPIDEM TARTRATE (AMBIEN). IN (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2016, THE PATIENT EXPERIENCED CYSTITIS NONINFECTIVE ("INFLAMMATORY BLADDER DISEASE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA"), EMOTIONAL DISORDER ("EMOTIONAL"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("BLADDER INFECTION"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), ADNEXA UTERI PAIN ("ABDOMINAL PAIN NEAR OVARIES") AND ABDOMINAL PAIN ("ABDOMINAL PAIN NEAR OVARIES"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY WITH REMOVAL OF BOTH ESSURE COILS ON (B)(6) 2014). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL HAEMORRHAGE AND MENORRHAGIA WAS RESOLVING AND THE GENITAL HAEMORRHAGE, DEVICE DISLOCATION, EMOTIONAL DISORDER, URINARY TRACT INFECTION, CYSTITIS, DEPRESSION, ANXIETY, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, FATIGUE, GASTROINTESTINAL DISORDER, CYSTITIS NONINFECTIVE, ADNEXA UTERI PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ANXIETY, BLADDER DISORDER, CYSTITIS, CYSTITIS NONINFECTIVE, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. SHE HAD UNDERGONE ESSURE CONFIRMATION TEST. SHE HAD MRI IN JULY WHICH SHOWS SMALL GROWTH IN UTERUS AND SMALL OVARIAN CYST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-FEB-2018: THE PFS AND MEDICAL RECORD RECEIVED:THE EVENT EMOTIONAL, ABNORMAL VAGINAL BLEEDING, MENORRHAGIA, URINARY TRACT INFECTION, BLADDER INFECTION, DEPRESSION, ANXIETY, BLADDER PROBLEMS, URINARY PROBLEMS, MIGRAINE, HEADACHES, MIGRATION OF ESSURE DEVICE, FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION, INFLAMMATORY BLADDER DISEASE, OVARIES PAIN, ABDOMINAL PAIN ADDED. THE PRODUCT LOT NUMBER ADDED AND REPORTER ADDED. THE EVENT ABNORMAL BLEEDING,DYSMENORRHOEA,DYSPAREUNIA,PAIN OUTCOME ADDED AS RECOVERING AND CONCURRENT CONDITION,CONCOMITANT MEDICATION,MEDICAL HISTORY ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") IN A FEMALE PATIENT WHO RECEIVED ESSURE (ESS205) FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN ( B)(6) 2007, THE PATIENT STARTED ESSURE (ESS205). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY WITH REMOVAL OF BOTH ESSURE COILS ON (B)(6) 2014). ESSURE (ESS205) WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND DYSPAREUNIA TO BE RELATED TO ESSURE (ESS205). COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND BEGAN TO EXPERIENCE SEVERE PELVIC PAIN AND EXCESSIVE BLEEDING (INTERPRETED AS GENITAL BLEEDING). SHE UNDERWENT PARTIAL HYSTERECTOMY AND REMOVAL OF BOTH COILS APPROXIMATELY 7.5 YEARS AFTER INSERTION. PELVIC PAIN AND GENITAL BLEEDING, CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE, ARE ANTICIPATED EVENTS ACCORDING TO THE REFERENCE SAFETY INFORMATION OF ESSURE. THIS REPORT PROVIDED LIMITED INFORMATION, HOWEVER, AS PELVIC PAIN AND GENITAL BLEEDING CAN OCCUR DURING THE USE OF ESSURE AND NO ALTERNATIVE EXPLANATIONS WERE REPORTED, A CAUSALITY OF THE ESSURE MICRO-INSERTS CANNOT BE EXCLUDED (RELATED). ADDITIONAL NON-SERIOUS EVENTS WERE ALSO REPORTED. THE CASE WAS CLASSIFIED AS INCIDENT BECAUSE OF SURGICAL INTERVENTION AND DEVICE REMOVAL. A PRODUCT TECHNICAL ANALYSIS IS AWAITED. FURTHER INFORMATION IS EXPECTED ONLY THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 82442 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 771092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | AMBIEN| AMBIEN| AMBIEN| AMBIEN| TYLENOL [PARACETAMOL] |