ESSURE
Report
- Report Number
- 2951250-2017-11203
- Event Type
- Injury
- Date Received
- December 29, 2017
- Report Date
- July 13, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("EXPERIENCE SEVERE AND PERSISTENT PELVIC PAIN / PAIN IN SIDES / LOWER LEFT PELVIC REGION (SHARP STABBINNG)/ RIGHT PELVIC REGION (SHARP STABBING) / PAIN / PAIN IN MY LEFT SIDE"), DEVICE DISLOCATION ("ABNORMALLY PLACED ESSURE COILS") AND GENITAL HAEMORRHAGE ("BLEEDING") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227513) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 ((B)(6) 2000, (B)(6) 2006), PRETERM LABOR, DEPRESSION, ANXIETY, LOOP ELECTROSURGICAL EXCISION PROCEDURE IN 2005, NORMAL DELIVERY (LIVE CHILD) IN 2006, LIVE BIRTH IN 2000 AND LIVE BIRTH IN 2006. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL IN 2009 AND ARICEPT. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND METRORRHAGIA. FAMILY HISTORY INCLUDED HUNTINGTON'S DISEASE. CONCOMITANT PRODUCTS INCLUDED NORMENSAL (NECON) FOR CONTRACEPTION AS WELL AS ANTIDEPRESSANTS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN (SHARP STABBING) / BACKS KILLING ME") AND HEADACHE ("HEADACHES / HEADACHES (SHARP STABBING) / HORRIBLE HEADACHE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("BLOOD CLOTS WITH PERIODS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL ODOUR ("VAGINAL ODOR"), COITAL BLEEDING ("BLEEDING DURING AND AFTER SEXUAL INTERCOURSE"), DYSPAREUNIA ("PAIN DURING AND AFTER SEXUAL INTERCOURSE"), PARAESTHESIA ("TINGLING IN FINGERTIPS AND DOWN ARM / HAD TINGLING IN THE FINGERS"), NIGHT SWEATS ("NIGHT SWEATS / DOWN ON MY BACK 3 TIMES NIGHTSWEATS"), WEIGHT INCREASED ("WEIGHT GAIN / GAINED WEIGHT"), DEPRESSION ("DEPRESSION"), MENORRHAGIA ("LONG AND HEAVY PERIODS / HAVE VERY HEAVY PERIODS"), ABDOMINAL DISTENSION ("BLOATING"), FEELING ABNORMAL ("JUST DON¿T FEEL GOOD TODAY"), MUSCULOSKELETAL PAIN ("PAIN IN BOTH SHOULDERS"), MEDICAL DEVICE PAIN ("HURTING GOING TO BED"), FALLOPIAN TUBE DISORDER ("ESSURE HAS CAUSED ABNORMAL SCARING TO THE TUBES"), PROCEDURAL PAIN ("I WOKE TWICE DURING THE PROCEDURE FROM PAIN ONCE ON THE LEFT ONCE ON THE RIGHT") AND ABDOMINAL TENDERNESS ("LITTLE TENDER ON THE LEFT SIDE"). THE PATIENT WAS TREATED WITH IBUPROFEN, PANADEINE CO (TYLENOL #3), ANTIBIOTICS, SURGERY (TOTAL ROBOTIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL DISCHARGE, VAGINAL ODOUR, BACK PAIN, HEADACHE, COITAL BLEEDING, DYSPAREUNIA, PARAESTHESIA, NIGHT SWEATS, WEIGHT INCREASED, DEPRESSION, MENORRHAGIA, ABDOMINAL DISTENSION, FEELING ABNORMAL, MUSCULOSKELETAL PAIN, MEDICAL DEVICE PAIN, FALLOPIAN TUBE DISORDER, PROCEDURAL PAIN AND ABDOMINAL TENDERNESS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL TENDERNESS, BACK PAIN, COITAL BLEEDING, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE DISORDER, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, MEDICAL DEVICE PAIN, MENORRHAGIA, MENSTRUAL DISORDER, MUSCULOSKELETAL PAIN, NIGHT SWEATS, PARAESTHESIA, PELVIC PAIN, PROCEDURAL PAIN, VAGINAL DISCHARGE, VAGINAL ODOUR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED MEDICAL TREATMENT FOR VAGINAL DISCHARGE, ODOR AND BLEEDING, PAIN AND BLEEDING AFTER SEXUAL INTERCOURSE,PAIN IN LEFT SIDE/CRAMPING. PATIENT NOT SOUGHT TREATMENT FOR DEPRESSION, HEADACHES, WEIGHT GAIN. CURRENT WEIGHT: 153 LBS AFTER REMOVAL OF ESSURE, THE SEVERE AND PERSISTENT PELVIC PAIN AND OTHER SYMPTOMS SUBSIDED AND THEN STOPPED. ACCORDING TO MR: THE LEFT FALLOPIAN TUBE WAS ABNORMALLY DISTENDED AND THE COIL COULD BE VISUALIZED UNDER THE SEROSAL EDGE AND THE PROXIMAL PORTION OF THE LEFT FALLOPIAN TUBE. THE RIGHT FALLOPIAN TUBE DEMONSTRATED THE ESSURE COIL WHICH APPEARED TO COIL AT THE CORNUAL PORTION OF THE UTERUS AGAIN VISIBLE UNDER THE SEROSAL EDGE. THE REMAINDER OF THE PELVIC AND UPPER ABDOMINAL SURVEY WAS NORMAL ON (B)(6) 2012, TOTAL ROBOTIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, FULGURATION OF ENDOMETRIOSIS, ESSURE COILS REMOVAL WAS PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.2 KG/SQM. (B)(6) 2012 : SURGICAL PATHOLOGY REPORT : GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED ENDOMETRIAL CURETTINGS IS A 20 X 1.5 X 0.4 CM AGGREGATE OF TAN/PINK SOFT TISSUE FRAGMENTS AND BLOOD WRAPPED. MICROSCOPIC DESCRIPTION: SECTION OF THE ENDOMETRIUM SHOWS THE GLANDS TO BE IN PROLIFERATIVE PHASE WITH SOME BRANCHING AND DILATATION AND AN IRREGULARITY TO THEIR DISTRIBUTION IN THE BENIGN STROMA. RARE SMALL FRAGMENTS OF ENDOCERVICAL EPITHELIUM ARE ALSO SEEN. (B)(6) 2010 : HYSTEROSALPINGOGRAM : FINDINGS: CONTRAST WAS INJECTED INTO THE UTERUS SHOWING NO FILLING OF THE DISTAL FALLOPIAN TUBES.IMPRESSIONS: COMPLETE OCCLUSION OF THE FALLOPIAN TUBES BY ESSURE DEVICE. (B)(6) 2012 : PAP SMEAR : SHE HAD THE RESULTS OF HER RECENT PAP SMEAR. IT SHOWED ONLY MILDLY ATYPICAL CELLS, WHICH WERE NEGATIVE FOR THE PRESENCE OF HIGH RISK HUMAN PAPILLOMA VIRUS PARTICLES. AS SUCH, THE MILDLY ATYPICAL CELLS ARE CAUSED FROM BENIGN CONDITIONS RANGING FROM VAGINAL DRYNESS TO YEAST INFECTIONS. (B)(6) 2012 : SCANS THROUGH THE LOWER CHEST SHOW VERY MINIMAL POST INFLAMMATORY SCARRING OR ATELECTASIS IN THE ANTERIOR BASILAR SEGMENT OF THE LEFT LOWER LOBE. THERE WERE OPAQUE ESSURE FILAMENTS SEEN IN BOTH THE FALLOPIAN TUBES. FOLLOWING CONTRAST INJECTION, THERE WAS PROMINENT ENHANCEMENT OF THE UTERUS AND THERE ALSO WAS PROMINENT ENHANCEMENT OF VEINS ON BOTH SIDES OF THE UTERUS BUT MORE PROMINENT LEFT SIDE THAN RIGHT. (B)(6) 2012 : SHE HAD THE RESULTS OF HER RECENT PAP SMEAR. IT SHOWED ONLY MILDLY ATYPICAL CELLS, WHICH WERE NEGATIVE FOR THE PRESENCE OF HIGH RISK HUMAN PAPILLOMA VIRUS PARTICLES. AS SUCH, THE MILDLY ATYPICAL CELLS ARE CAUSED FROM BENIGN CONDITIONS RANGING FROM VAGINAL DRYNESS TO YEAST INFECTIONS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : ABNORMALLY PLACED ESSURE COILS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("EXPERIENCE SEVERE AND PERSISTENT PELVIC PAIN / PAIN IN SIDES / LOWER LEFT PELVIC REGION (SHARP STABBING)/ RIGHT PELVIC REGION (SHARP STABBING) / PAIN / PAIN IN MY LEFT SIDE"), DEVICE DISLOCATION ("ABNORMALLY PLACED ESSURE COILS") AND GENITAL HAEMORRHAGE ("BLEEDING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227513) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 ((B)(6)), PRETERM LABOR, DEPRESSION, ANXIETY, LOOP ELECTROSURGICAL EXCISION PROCEDURE IN 2005, NORMAL DELIVERY (LIVE CHILD) IN 2006, LIVE BIRTH IN 2000 AND LIVE BIRTH IN 2006. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL IN 2009 AND ARICEPT. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND METRORRHAGIA. FAMILY HISTORY INCLUDED HUNTINGTON'S DISEASE. CONCOMITANT PRODUCTS INCLUDED NORMENSAL (NECON) FOR CONTRACEPTION AS WELL AS ANTIDEPRESSANTS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN (SHARP STABBING) / BACKS KILLING ME") AND HEADACHE ("HEADACHES / HEADACHES (SHARP STABBING) / HORRIBLE HEADACHE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("BLOOD CLOTS WITH PERIODS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL ODOUR ("VAGINAL ODOR"), COITAL BLEEDING ("BLEEDING DURING AND AFTER SEXUAL INTERCOURSE"), DYSPAREUNIA ("PAIN DURING AND AFTER SEXUAL INTERCOURSE"), PARAESTHESIA ("TINGLING IN FINGERTIPS AND DOWN ARM / HAD TINGLING IN THE FINGERS"), NIGHT SWEATS ("NIGHT SWEATS / DOWN ON MY BACK 3 TIMES NIGHTSWEATS"), WEIGHT INCREASED ("WEIGHT GAIN / GAINED WEIGHT"), DEPRESSION ("DEPRESSION"), MENORRHAGIA ("LONG AND HEAVY PERIODS / HAVE VERY HEAVY PERIODS"), ABDOMINAL DISTENSION ("BLOATING"), FEELING ABNORMAL ("JUST DON¿T FEEL GOOD TODAY"), MUSCULOSKELETAL PAIN ("PAIN IN BOTH SHOULDERS"), MEDICAL DEVICE PAIN ("HURTING GOING TO BED"), FALLOPIAN TUBE DISORDER ("ESSURE HAS CAUSED ABNORMAL SCARING TO THE TUBES"), PROCEDURAL PAIN ("I WOKE TWICE DURING THE PROCEDURE FROM PAIN ONCE ON THE LEFT ONCE ON THE RIGHT") AND ABDOMINAL TENDERNESS ("LITTLE TENDER ON THE LEFT SIDE"). THE PATIENT WAS TREATED WITH IBUPROFEN, PANADEINE CO (TYLENOL #3), ANTIBIOTICS, SURGERY (HYSTERECTOMY) AND SURGERY (TOTAL ROBOTIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL DISCHARGE, VAGINAL ODOUR, BACK PAIN, HEADACHE, COITAL BLEEDING, DYSPAREUNIA, PARAESTHESIA, NIGHT SWEATS, WEIGHT INCREASED, DEPRESSION, MENORRHAGIA, ABDOMINAL DISTENSION, FEELING ABNORMAL, MUSCULOSKELETAL PAIN, MEDICAL DEVICE PAIN, FALLOPIAN TUBE DISORDER, PROCEDURAL PAIN AND ABDOMINAL TENDERNESS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL TENDERNESS, BACK PAIN, COITAL BLEEDING, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE DISORDER, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, MEDICAL DEVICE PAIN, MENORRHAGIA, MENSTRUAL DISORDER, MUSCULOSKELETAL PAIN, NIGHT SWEATS, PARAESTHESIA, PELVIC PAIN, PROCEDURAL PAIN, VAGINAL DISCHARGE, VAGINAL ODOUR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED MEDICAL TREATMENT FOR VAGINAL DISCHARGE, ODOR AND BLEEDING, PAIN AND BLEEDING AFTER SEXUAL INTERCOURSE,PAIN IN LEFT SIDE/CRAMPING. PATIENT NOT SOUGHT TREATMENT FOR DEPRESSION, HEADACHES, WEIGHT GAIN. CURRENT WEIGHT: (B)(6). AFTER REMOVAL OF ESSURE, THE SEVERE AND PERSISTENT PELVIC PAIN AND OTHER SYMPTOMS SUBSIDED AND THEN STOPPED. ACCORDING TO MR: THE LEFT FALLOPIAN TUBE WAS ABNORMALLY DISTENDED AND THE COIL COULD BE VISUALIZED UNDER THE SEROSAL EDGE AND THE PROXIMAL PORTION OF THE LEFT FALLOPIAN TUBE. THE RIGHT FALLOPIAN TUBE DEMONSTRATED THE ESSURE COIL WHICH APPEARED TO COIL AT THE CORNUAL PORTION OF THE UTERUS AGAIN VISIBLE UNDER THE SEROSAL EDGE. THE REMAINDER OF THE PELVIC AND UPPER ABDOMINAL SURVEY WAS NORMAL ON (B)(6) 2012, TOTAL ROBOTIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, FULGURATION OF ENDOMETRIOSIS, ESSURE COILS REMOVAL WAS PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). ON (B)(6) 2012 : SURGICAL PATHOLOGY REPORT : GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED ENDOMETRIAL CURETTINGS IS A 20 X 1.5 X 0.4 CM AGGREGATE OF TAN/PINK SOFT TISSUE FRAGMENTS AND BLOOD WRAPPED. MICROSCOPIC DESCRIPTION: SECTION OF THE ENDOMETRIUM SHOWS THE GLANDS TO BE IN PROLIFERATIVE PHASE WITH SOME BRANCHING AND DILATATION AND AN IRREGULARITY TO THEIR DISTRIBUTION IN THE BENIGN STROMA. RARE SMALL FRAGMENTS OF ENDOCERVICAL EPITHELIUM ARE ALSO SEEN. ON (B)(6) 2010 : HYSTEROSALPINGOGRAM : FINDINGS: CONTRAST WAS INJECTED INTO THE UTERUS SHOWING NO FILLING OF THE DISTAL FALLOPIAN TUBES. IMPRESSIONS: COMPLETE OCCLUSION OF THE FALLOPIAN TUBES BY ESSURE DEVICE. ON (B)(6) 2012 : PAP SMEAR : SHE HAD THE RESULTS OF HER RECENT PAP SMEAR. IT SHOWED ONLY MILDLY ATYPICAL CELLS, WHICH WERE (B)(6) FOR THE PRESENCE OF (B)(6) PARTICLES. AS SUCH, THE MILDLY ATYPICAL CELLS ARE CAUSED FROM BENIGN CONDITIONS RANGING FROM VAGINAL DRYNESS TO YEAST INFECTIONS. ON (B)(6) 2012 : SCANS THROUGH THE LOWER CHEST SHOW VERY MINIMAL POST INFLAMMATORY SCARRING OR ATELECTASIS IN THE ANTERIOR BASILAR SEGMENT OF THE LEFT LOWER LOBE. THERE WERE OPAQUE ESSURE FILAMENTS SEEN IN BOTH THE FALLOPIAN TUBES. FOLLOWING CONTRAST INJECTION, THERE WAS PROMINENT ENHANCEMENT OF THE UTERUS AND THERE ALSO WAS PROMINENT ENHANCEMENT OF VEINS ON BOTH SIDES OF THE UTERUS BUT MORE PROMINENT LEFT SIDE THAN RIGHT. ON (B)(6) 2012 : SHE HAD THE RESULTS OF HER RECENT PAP SMEAR. IT SHOWED ONLY MILDLY ATYPICAL CELLS, WHICH WERE (B)(6) FOR THE PRESENCE OF (B)(6) PARTICLES. AS SUCH, THE MILDLY ATYPICAL CELLS ARE CAUSED FROM BENIGN CONDITIONS RANGING FROM VAGINAL DRYNESS TO YEAST INFECTIONS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : ABNORMALLY PLACED ESSURE COILS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: ALL EVENTS, HISTORICAL CONDITION, CONCOMITTANT CONDITION, LOT NUMBER, REPORTER ADDED FROM PFS AND MEDICAL RECORD. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 934297 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 20227513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ANTIDEPRESSANTS.| ANTIDEPRESSANTS.| NECON.| NECON.| ANTIDEPRESSANTS| NECON |