ESSURE
Report
- Report Number
- 2951250-2017-08959
- Event Type
- Injury
- Date Received
- November 27, 2017
- Date of Event
- June 1, 2013
- Report Date
- May 15, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS) / PUNCTURED THROUGH UTERUS WALL / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), PELVIC PAIN ("PAIN / PELVIC PAIN"), SJOGREN'S SYNDROME ("AUTOIMMUNE DISORDER - TYPE OF DISORDER: SJOGRENS DISEASE") AND COELIAC DISEASE ("AUTOIMMUNE DISORDER TYPE OF DISORDER:CELIAC DISEASE") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW BACK PAIN, NAUSEA, VOMITING, MENORRHAGIA AND CESAREAN SECTION IN 2013. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TORADOL, VALIUM, SPIRONOLACTONE, RANITIDINE HCL AND PILOCARPINE. CONCURRENT CONDITIONS INCLUDED PREGNANCY, NORMAL DELIVERY (LIVE CHILD), MISSED ABORTION, ELBOW OPERATION, LIMB OPERATION AND PELVIC PAIN. CONCOMITANT PRODUCTS INCLUDED AMITRIPTYLINE FROM 2017 TO 2018, PILOCARPINE FROM 2016 TO 2017, SPIRONOLACTONE FROM 2015 TO 2017 AND VITAMINS NOS (ACCOMIN MULTIVITAMIN) SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITION TYPE: ON HER LEGS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/HEAVY BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), NAUSEA ("NAUSEA") AND ABDOMINAL DISCOMFORT ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION - TYPE : UPSET STOMACH"). ON (B)(6) 2014, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("DENTAL PROBLEMS GUM DISEASE"). ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COELIAC DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREMENSTRUAL DYSPHORIC DISORDER ("HORMONAL CHANGES DESCRIBE: PREMENSTRUAL DYSPHORIC DISORDER") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY(FULL) AND TO REMOVE THE ESSURE, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY(FULL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PELVIC PAIN, SJOGREN'S SYNDROME, COELIAC DISEASE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, NAUSEA, GINGIVAL DISORDER, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISCOMFORT, PREMENSTRUAL DYSPHORIC DISORDER AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, COELIAC DISEASE, DYSMENORRHOEA, FATIGUE, GINGIVAL DISORDER, MENORRHAGIA, NAUSEA, PELVIC PAIN, PREMENSTRUAL DYSPHORIC DISORDER, RASH, SJOGREN'S SYNDROME, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT AS OF NOW 240 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 234 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. HYSTEROSCOPY: ON (B)(6) 2012: BOTH OSTIA SEEN. PATHOLOGY TEST: ON (B)(6) 2017: FINAL DIAGNOSIS: A. UTERUS, CERVIX, AND FALLOPIAN TUBES: TOTAL HYSTERECTOMY: 1. UTERINE FUNDUS: A) ADENOMYOSIS, MILD. B) ENDOMETRIOSIS, FOCAL, UTERINE SEROSA (A4). C) ESSURE IMPLANT DISPLACED. 2. ENDOMETRIUM: A) PROLIFERATIVE TYPE. B) NO ENDOMETRIOSIS. C) NEGATIVE FOR ENDOMETRIAL INTRAEPITHELIAL NEOPLASIA. 3. CERVIX: NO DIAGNOSTIC ABNORMALITY. 4. FALLOPIAN LUBES: A) ESSURE DEVICE IN PROPER POSITION, ONE (1) TUBE. B) NO ESSURE DEVICE IN SECOND TUBE. C) TUBES OTHERWISE WITH NO DIAGNOSTIC ABNORMALITY. 5. SPECIMEN WEIGHT 184 GRAMS. CLINICAL HISTORY: PELVIC PAIN. GROSS DESCRIPTION: THE ENDOCERVICAL CANAL MEASURES UP TO 6.5 CM IN LENGTH, ENDOMETRIUM UP TO 0.2 CM IN THICKNESS; THE MYOMETRIUM UP TO 2.3 CM IN THICKNESS. PRESENT AND DISPLACED INTO UTERINE WALL/CAVITY IS A SILVER COILED WIRE (ESSURE IMPLANT), IDENTIFIED WITHIN THE RIGHT FALLOPIAN TUBE IS A SILVER COILED WIRE (ESSURE IMPLANT). REPRESENTATIVE SECTIONS ARE SUBMITTED AS FALLOWS: CASSETTES A1·A1D ANTERIOR CERVIX TO "ENDOMETRIUM": AL1·A17 POSTERIOR CERVIX TO "ENDOMETRIUM"; A18 LEFT FALLOPIAN TUBE; A19 RIGHT FALLOPIAN TUBE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2019: PFS AND MR RECEIVED. LOT NUMBER WAS ADDED. EVENTS : ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), RASHES OR SKIN CONDITION, DYSMENORRHEA (CRAMPING), NAUSEA, HORMONAL CHANGES DESCRIBE, AUTOIMMUNE DISORDER - TYPE OF DISORDER, DENTAL PROBLEMS GUM DISEASE, VAGINAL PROBLEM, FATIGUE, WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION - TYPE : UPSET STOMACH, MIGRATION OF ESSURE DEVICE- UTERUS CLUBBED WITH PERFORATION (UTERUS) WAS ADDED. SEVERITY PELVIC PAIN WAS UPDATED. OUTCOME DYSMENORRHEA (CRAMPING), . CONCOMITANT CONDITION AND HISTORICAL DRUG WAS ADDED. LAB DATA WAS UPDATED. REPORTER AND REPORTER INFORMATION WAS 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 UTERINE PERFORATION ("PERFORATION (UTERUS) / PUNCTURED THROUGH UTERUS WALL / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), PELVIC PAIN ("PAIN / PELVIC PAIN"), SJOGREN'S SYNDROME ("AUTOIMMUNE DISORDER - TYPE OF DISORDER: SJOGRENS DISEASE") AND COELIAC DISEASE ("AUTOIMMUNE DISORDER TYPE OF DISORDER:CELIAC DISEASE") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW BACK PAIN, NAUSEA, VOMITING, MENORRHAGIA AND CESAREAN SECTION IN 2013. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TORADOL, VALIUM, SPIRONOLACTONE, RANITIDINE HCL AND PILOCARPINE. CONCURRENT CONDITIONS INCLUDED PREGNANCY, NORMAL DELIVERY (LIVE CHILD), MISSED ABORTION, ELBOW OPERATION, LIMB OPERATION AND PELVIC PAIN. CONCOMITANT PRODUCTS INCLUDED AMITRIPTYLINE FROM 2017 TO 2018, PILOCARPINE FROM 2016 TO 2017, SPIRONOLACTONE FROM 2015 TO 2017 AND VITAMINS NOS (ACCOMIN MULTIVITAMIN) SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITION TYPE: ON HER LEGS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/HEAVY BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), NAUSEA ("NAUSEA") AND ABDOMINAL DISCOMFORT ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION - TYPE : UPSET STOMACH"). IN (B)(6) 2014, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("DENTAL PROBLEMS GUM DISEASE"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COELIAC DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREMENSTRUAL DYSPHORIC DISORDER ("HORMONAL CHANGES DESCRIBE: PREMENSTRUAL DYSPHORIC DISORDER") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY(FULL) AND TO REMOVE THE ESSURE, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY(FULL).). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PELVIC PAIN, SJOGREN'S SYNDROME, COELIAC DISEASE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, NAUSEA, GINGIVAL DISORDER, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISCOMFORT, PREMENSTRUAL DYSPHORIC DISORDER AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, COELIAC DISEASE, DYSMENORRHOEA, FATIGUE, GINGIVAL DISORDER, MENORRHAGIA, NAUSEA, PELVIC PAIN, PREMENSTRUAL DYSPHORIC DISORDER, RASH, SJOGREN'S SYNDROME, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT AS OF NOW 240 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 234 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION.. HYSTEROSCOPY - ON(B)(6) 2012: BOTH OSTIA SEEN. PATHOLOGY TEST - ON (B)(6) 2017: FINAL DIAGNOSIS: A. UTERUS, CERVIX, AND FALLOPIAN TUBES: TOTAL HYSTERECTOMY: 1. UTERINE FUNDUS: A) ADENOMYOSIS, MILD B) ENDOMETRIOSIS, FOCAL, UTERINE SEROSA (A4). C) ESSURE IMPLANT DISPLACED. 2. ENDOMETRIUM: A) PROLIFERATIVE TYPE. B) NO ENDOMETRIOSIS C) NEGATIVE FOR ENDOMETRIAL INTRAEPITHELIAL NEOPLASIA. 3. CERVIX: NO DIAGNOSTIC ABNORMALITY. 4. FALLOPIAN LUBES: A) ESSURE DEVICE IN PROPER POSITION, ONE (1) TUBE. B) NO ESSURE DEVICE IN SECOND TUBE, C) TUBES OTHERWISE WITH NO DIAGNOSTIC ABNORMALITY. 5. SPECIMEN WEIGHT 184 GRAMS. CLINICAL HISTORY: PELVIC PAIN GROSS DESCRIPTION: THE ENDOCERVICAL CANAL MEASURES UP TO 6.5 CM IN LENGTH, ENDOMETRIUM UP TO 0.2 CM IN THICKNESS; THE MYOMETRIUM UP TO 2.3 CM IN THICKNESS. PRESENT AND DISPLACED INTO UTERINE WALL/CAVITY IS A SILVER COILED WIRE (ESSURE IMPLANT), IDENTIFIED WITHIN THE RIGHT FALLOPIAN TUBE IS A SILVER COILED WIRE (ESSURE IMPLANT). REPRESENTATIVE SECTIONS ARE SUBMITTED AS FALLOWS: CASSETTES A1·A1D ANTERIOR CERVIX TO ENDORNYOMETRIUM: AL1·A17 POSTERIOR CERVIX TO ENDOMYOMETRIUM; A18 LEFT FALLOPIAN TUBE; A19 RIGHT FALLOPIAN TUBE.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 839713 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 844600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | ACCOMIN MULTIVITAMIN| ACCOMIN MULTIVITAMIN| AMITRIPTYLINE| AMITRIPTYLINE| PILOCARPINE| PILOCARPINE| SPIRONOLACTONE| SPIRONOLACTONE |