ESSURE
Report
- Report Number
- 2951250-2017-08264
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- October 1, 2013
- Report Date
- August 27, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 3030259) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPLE CESAREAN SECTIONS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA FROM 2008 TO (B)(6) 2013, IRON FROM 2008 TO (B)(6) 2013, IBUPROFEN FROM 2008 TO (B)(6) 2013 AND MOTRIN FROM 2008 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED BETA-LACTAMASE SENSITIVE PENICILLINS (PENICILLIN), CLINDAMYCIN, KETOROLAC TROMETHAMINE (TORADOL), ONDANSETRON (ZOFRAN), PARACETAMOL (TYLENOL) AND VICODIN (NORCO). IN JULY 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 2 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). ON(B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6)2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHE"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6)2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). ON (B)(6)2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6)2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN") AND THE SECOND EPISODE OF MIGRAINE ("MIGRAINE HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL LAPAROSCOPIC HYSTERECTOMY) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, THE LAST EPISODE OF MIGRAINE, ALOPECIA, FATIGUE AND VAGINAL DISCHARGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, TOOTH DISORDER, HEADACHE, NAUSEA, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF MIGRAINE AND THE SECOND EPISODE OF MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING SOMETIME IN OCTOBER 2013, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED (B)(6)2014: HYSTEROSALPINGOGRAM WITH RESULTS BILATERAL TUBAL OCCLUSION. WAS INFORMED SAME DAY BY HEALTHCARE PROVIDER OF SUCCESSFUL OCCLUSION OF THE FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORDS CONFIRMING EVENTS VAGINAL BLEEDING, WEIGHT GAIN, MIGRAINE HEADACHES, NAUSEA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLAINTIFF FACT SHEET RECEIVED: HISTORICAL DRUGS WAS ADDED AND EVENTS OUTCOME 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 ("PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 3030259) INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CESAREAN SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED BETA-LACTAMASE SENSITIVE PENICILLINS (PENICILLIN), CLINDAMYCIN, KETOROLAC TROMETHAMINE (TORADOL), ONDANSETRON (ZOFRAN), PARACETAMOL (TYLENOL) AND VICODIN (NORCO). IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 2 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHE"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN") AND THE SECOND EPISODE OF MIGRAINE ("MIGRAINE HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL LAPAROSCOPIC HYSTERECTOMY) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, TOOTH DISORDER, FATIGUE, HEADACHE, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, THE LAST EPISODE OF MIGRAINE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF MIGRAINE AND THE SECOND EPISODE OF MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING SOMETIME IN (B)(6) 2013, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED . (B)(6) 2014: HYSTEROSALPINGOGRAM WITH RESULTS BILATERAL TUBAL OCCLUSION. WAS INFORMED SAME DAY BY HEALTHCARE PROVIDER OF SUCCESSFUL OCCLUSION OF THE FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORDS CONFIRMING EVENTS VAGINAL BLEEDING, WEIGHT GAIN, MIGRAINE HEADACHES, NAUSEA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAR-2018: PLAINTIFF FACT SHEET- ALL RELEVANT MEDICAL HISTORY, CONCURRENT CONDITION, CONCOMITANT MEDICATION WERE ADDED.EVENTS WEIGHT LOSS, WEIGHT GAIN, VAGINAL DISCHARGE, PELVIC PAIN, NAUSEA, HEADACHE, MIGRAINE, FATIGUE, TOOTH DISORDER, VAGINAL HEMORRHAGE WERE 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 3030259-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPLE CESAREAN SECTIONS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MOTRIN FROM 2008 TO (B)(6)2013, DEPO PROVERA FROM 2008 TO (B)(6) 2013, IRON FROM 2008 TO (B)(6) 2013 AND IBUPROFEN FROM 2008 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED BETA-LACTAMASE SENSITIVE PENICILLINS (PENICILLIN), CLINDAMYCIN, KETOROLAC TROMETHAMINE (TORADOL), ONDANSETRON (ZOFRAN), PARACETAMOL (TYLENOL) AND VICODIN (NORCO). IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 2 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHE"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN") AND THE SECOND EPISODE OF MIGRAINE ("MIGRAINE HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL LAPAROSCOPIC HYSTERECTOMY) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, THE LAST EPISODE OF MIGRAINE, ALOPECIA, FATIGUE AND VAGINAL DISCHARGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, TOOTH DISORDER, HEADACHE, NAUSEA, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF MIGRAINE AND THE SECOND EPISODE OF MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING SOMETIME IN (B)(6) 2013, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED (B)(6) 2014: HYSTEROSALPINGOGRAM WITH RESULTS BILATERAL TUBAL OCCLUSION. WAS INFORMED SAME DAY BY HEALTHCARE PROVIDER OF SUCCESSFUL OCCLUSION OF THE FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORDS CONFIRMING EVENTS VAGINAL BLEEDING, WEIGHT GAIN, MIGRAINE HEADACHES, NAUSEA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: UPDATE OF INFORMATION (BATCH IS INVALID) 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 ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), MENORRHAGIA ("PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING SOMETIME IN (B)(6) 2013, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2013: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. INCIDENT. 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 |
|---|---|---|---|---|---|---|---|
| 836454 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 3030259-INVALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | CLINDAMYCIN| CLINDAMYCIN| CLINDAMYCIN| NORCO| NORCO| NORCO| PENICILLIN| PENICILLIN| PENICILLIN| TORADOL| TORADOL| TORADOL| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| ZOFRAN| ZOFRAN| ZOFRAN |