ESSURE
Report
- Report Number
- 2951250-2017-07936
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- December 7, 2009
- Report Date
- November 20, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2020587) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL ISSUES, DENTAL PROBLEMS"), ALOPECIA ("HAIR LOSS"), DERMATITIS ATOPIC ("ATOPIC ECZEMA"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("LOWER BACK PAIN, MIDDLE BACK PAIN"). 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, TOOTH DISORDER, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED, THE MENSTRUATION IRREGULAR, VAGINAL HAEMORRHAGE, MENORRHAGIA, DERMATITIS ATOPIC, NAUSEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ABDOMINAL PAIN AND BACK PAIN OUTCOME WAS UNKNOWN AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DERMATITIS ATOPIC, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 157 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION AND PATIENT RELEVANT HISTORY ADDED. INDICATION (PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES) ADDED. LOT NUMBER (2020587) ADDED. EVENTS ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), ATOPIC ECZEMA, NAUSEA, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, ABDOMINAL PAIN AND LOWER BACK PAIN, MIDDLE BACK PAIN 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 ('PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2020587-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND MIGRAINE. ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/HEAVY COLTTY PERIOD") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6)2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6)2010, THE PATIENT EXPERIENCED TOOTH FRACTURE ("CRACKED TEETH"), ALOPECIA ("HAIR LOSS"), DERMATITIS ATOPIC ("ATOPIC ECZEMA"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN, MIDDLE BACK PAIN"), CONSTIPATION ("CONSTIPATION") AND ANXIETY ("ANXIETY"). 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, TOOTH FRACTURE, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED, THE MENSTRUATION IRREGULAR, VAGINAL HAEMORRHAGE, MENORRHAGIA, DERMATITIS ATOPIC, NAUSEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ABDOMINAL PAIN, BACK PAIN, CONSTIPATION AND ANXIETY OUTCOME WAS UNKNOWN AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, CONSTIPATION, DERMATITIS ATOPIC, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, TOOTH FRACTURE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 157 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2010: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: CONSTIPATION AND ANXIETY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2019: SOCIAL MEDIA RECEIVED. EVENT DENTAL ISSUE WAS UPDATED TO CRACKED TEETH. NEW EVENTS WERE ADDED: CONSTIPATION AND ANXIETY. REPORTER INFORMATION WAS ADDED. ON (B)(6)2019: FU 4 & 5 WERE PROCESSED TOGETHER. PFS RECEIVED. NO NEW SIGNIFICANT INFORMATION WAS ADDED. NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2020587-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL ISSUES, DENTAL PROBLEMS"), ALOPECIA ("HAIR LOSS"), DERMATITIS ATOPIC ("ATOPIC ECZEMA"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("LOWER BACK PAIN, MIDDLE BACK PAIN"). 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, TOOTH DISORDER, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED, THE MENSTRUATION IRREGULAR, VAGINAL HAEMORRHAGE, MENORRHAGIA, DERMATITIS ATOPIC, NAUSEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ABDOMINAL PAIN AND BACK PAIN OUTCOME WAS UNKNOWN AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DERMATITIS ATOPIC, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 157 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-AUG-2018: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT: NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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 ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), TOOTH DISORDER ("DENTAL ISSUES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT ). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUATION IRREGULAR, TOOTH DISORDER AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, MENSTRUATION IRREGULAR, PELVIC PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834316 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 2020587-NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R |