ESSURE
Report
- Report Number
- 2951250-2019-04789
- Event Type
- Injury
- Date Received
- August 14, 2019
- Date of Event
- September 1, 2011
- Report Date
- September 24, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('MILD ACUTE ENDOMETRITIS') AND ABDOMINAL PAIN LOWER ('PAIN LOWER ABDOMEN') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, NAUSEA, VOMITING, PREGNANCY (NAUSEA AND VOMITING IN PREGNANCY.), GERD, CESAREAN SECTION, APPENDECTOMY, BREAST PROSTHESIS IMPLANTATION AND BACTERIAL VAGINOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ANTIEMETICS, PRENATAL VITAMIN, ACETAMINOPHEN, HYDROCODONE AND CLINDAMYCIN. CONCURRENT CONDITIONS INCLUDED BREAST LUMP, PELVIC PAIN FEMALE, PERINEAL PAIN, ENDOMETRIOSIS, INFLAMMATION, ENDOCERVICAL SQUAMOUS METAPLASIA, LEIOMYOMA AND HERNIATED DISC. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LO LOESTRIN FE). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES / HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). THE PATIENT WAS TREATED WITH IBUPROFEN, PARACETAMOL (TYLENOL) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, MENORRHAGIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, MIGRAINE, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 185 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: (AS PER PFS): RESULTS: EVERYTHING LOOKED GOOD. (AS PER MR): IMPRESSION: CLASS I OCCLUSION OF BOTH FALLOPIAN TUBES BY THE ESSURE DEVICES WHICH ARE IN EXCELLENT POSITION.. PATHOLOGY TEST - ON (B)(6) 2016: FINAL PATHOLOGY DIAGNOSIS: UTERUS. FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: CERVIX: MILD ACUTE AND CHRONIC INFLAMMATION WITH SQUAMOUS METAPLASIA. ENDOMETRIUM: SECRETORY PHASE. MYOMETRIUM: MINUTE LEIOMYOMA. UTERINE SEROSA; FIBROUS ADHESIONS. FALLOPIAN RUBES: NO SIGNIFICANT HISTOPATHOLOGIC DIAGNOSIS. GROSS DESCRIPTION: BOTH THE FALLOPIAN TUBE SEGMENTS HAVE A WIRE COIL WITHIN THE LUMEN.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS:DYSPAREUNIA, DYSMENORRHEA, MENORRHAGIA & THE FOLLOWING ONE WAS DESCRIBED IN PATIENT MEDICAL RECORDS: ENDOMETRITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-AUG-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 ENDOMETRITIS ('MILD ACUTE ENDOMETRITIS') AND ABDOMINAL PAIN LOWER ('PAIN LOWER ABDOMEN') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, NAUSEA, VOMITING, PREGNANCY (NAUSEA AND VOMITING IN PREGNANCY.), GERD, CESAREAN SECTION, APPENDECTOMY, BREAST PROSTHESIS IMPLANTATION AND BACTERIAL VAGINOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ANTIEMETICS, PRENATAL VITAMIN, ACETAMINOPHEN, HYDROCODONE AND CLINDAMYCIN. CONCURRENT CONDITIONS INCLUDED BREAST LUMP, PELVIC PAIN FEMALE, PERINEAL PAIN, ENDOMETRIOSIS, INFLAMMATION, ENDOCERVICAL SQUAMOUS METAPLASIA, LEIOMYOMA NOS AND HERNIATED DISC. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LO LOESTRIN FE). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN: PELVIC"), ABDOMINAL PAIN ("PAIN: ABDOMINAL"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND HEADACHE ("OTHER INJURIES/SYMPTOMS: HEADACHES"). THE PATIENT WAS TREATED WITH IBUPROFEN, PARACETAMOL (TYLENOL) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, WEIGHT INCREASED AND HEADACHE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER AND MIGRAINE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN: APAREUNIA, DYSMENNORHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN AND MENORRHAGIA (HEAVY MENSTRUAL BLEEDING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: (AS PER PFS): RESULTS: EVERYTHING LOOKED GOOD. (AS PER MR): IMPRESSION: CLASS I OCCLUSION OF BOTH FALLOPIAN TUBES BY THE ESSURE DEVICES WHICH ARE IN EXCELLENT POSITION. BILATERAL OCCLUSION.. PATHOLOGY TEST - ON (B)(6) 2016: FINAL PATHOLOGY DIAGNOSIS: UTERUS. FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: CERVIX: MILD ACUTE AND CHRONIC INFLAMMATION WITH SQUAMOUS METAPLASIA. ENDOMETRIUM: SECRETORY PHASE. MYOMETRIUM: MINUTE LEIOMYOMA. UTERINE SEROSA; FIBROUS ADHESIONS. FALLOPIAN RUBES: NO SIGNIFICANT HISTOPATHOLOGIC DIAGNOSIS. GROSS DESCRIPTION: BOTH THE FALLOPIAN TUBE SEGMENTS HAVE A WIRE COIL WITHIN THE LUMEN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS:DYSPAREUNIA, DYSMENORRHEA, MENORRHAGIA & THE FOLLOWING ONE WAS DESCRIBED IN PATIENT MEDICAL RECORDS: ENDOMETRITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED- NEW EVENTS-" PAIN: PELVIC/ ABDOMINAL , HEADACHES" WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('MILD ACUTE ENDOMETRITIS') AND ABDOMINAL PAIN LOWER ('PAIN LOWER ABDOMEN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, NAUSEA, VOMITING, PREGNANCY (NAUSEA AND VOMITING IN PREGNANCY.), GERD, CESAREAN SECTION, APPENDECTOMY, BREAST PROSTHESIS IMPLANTATION AND BACTERIAL VAGINOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ANTIEMETICS, PRENATAL VITAMIN, ACETAMINOPHEN, HYDROCODONE AND CLINDAMYCIN. CONCURRENT CONDITIONS INCLUDED BREAST LUMP, PELVIC PAIN FEMALE, PERINEAL PAIN, ENDOMETRIOSIS, INFLAMMATION, ENDOCERVICAL SQUAMOUS METAPLASIA, LEIOMYOMA AND HERNIATED DISC. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;FERROUS FUMARATE; NORETHISTERONE ACETATE (LO LOESTRIN FE). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES / HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). THE PATIENT WAS TREATED WITH IBUPROFEN, PARACETAMOL (TYLENOL) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, MENORRHAGIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, MIGRAINE, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). HYSTEROSALPINGOGRAM - ON (B)(6) 2012: (AS PER PFS): RESULTS: EVERYTHING LOOKED GOOD. (AS PER MR): IMPRESSION: CLASS I OCCLUSION OF BOTH FALLOPIAN TUBES BY THE ESSURE DEVICES WHICH ARE IN EXCELLENT POSITION.. PATHOLOGY TEST - ON (B)(6) 2016: FINAL PATHOLOGY DIAGNOSIS: UTERUS. FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: CERVIX: MILD ACUTE AND CHRONIC INFLAMMATION WITH SQUAMOUS METAPLASIA. ENDOMETRIUM: SECRETORY PHASE. MYOMETRIUM: MINUTE LEIOMYOMA. UTERINE SEROSA; FIBROUS ADHESIONS. FALLOPIAN RUBES: NO SIGNIFICANT. HISTOPATHOLOGIC DIAGNOSIS. GROSS DESCRIPTION: BOTH THE FALLOPIAN TUBE SEGMENTS HAVE A WIRE COIL WITHIN THE LUMEN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS:DYSPAREUNIA, DYSMENORRHEA, MENORRHAGIA & THE FOLLOWING ONE WAS DESCRIBED IN PATIENT MEDICAL RECORDS: ENDOMETRITIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-AUG-2019: PFS & MR WAS RECEIVED. LOT NUMBER WAS ADDED. PREVIOUSLY ADDED INJURY NOS WAS REPLACED WITH ABNORMAL BLEEDING (VAGINAL) AND NEW EVENTS ABNORMAL BLEEDING (MENORRHAGIA), APAREUNIA, BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES / HEADACHES, DYSMENORRHEA, DYSPAREUNIA,WEIGHT GAIN, LOWER ABDOMINAL PAIN WERE ADDED. ENDOMETRITIS AS A EVENT WAS CAPTURED FROM MR. NEW REPORTERS WERE ADDED. PATIENT DEMOGRAPHIC WAS ADDED. TREATMENT DRUGS WERE ADDED. CONCOMITANT AND HISTORICAL CONDITIONS WERE ADDED. EVENT ONSET DATES WERE ADDED. LAB DATA WAS 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 |
|---|---|---|---|---|---|---|---|
| 688999 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863581 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | LO LOESTRIN FE| LO LOESTRIN FE| LO LOESTRIN FE |