ESSURE
Report
- Report Number
- 2951250-2017-03548
- Event Type
- Injury
- Date Received
- September 11, 2017
- Date of Event
- June 1, 2012
- Report Date
- May 23, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / LOWER ABDOMEN PAIN-CONSTANT PAIN INTERMITTENT FROM MODERATE O SEVERE / PAINFUL CRAMPS"), PELVIC PAIN ("PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND PERIHEPATITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL INFECTION - FITZ HUGH CURTIS SYNDROME") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 787230) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 2000, (B)(6) 2002) AND RECURRENT ABORTION (5). CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, DEPRESSION, DIZZINESS, BLOOD PRESSURE HIGH, SINUS DISORDER, HOT FLASHES, ANESTHESIA, HIGH CHOLESTEROL, PELVIC ADHESIONS AND ENDOMETRIAL POLYP. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FROM (B)(6) 2012 TO (B)(6) 2012 FOR CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 21 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ALOPECIA ("HAIR LOSS / HAIR LOSS"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE / VAGINAL DISCHARGE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN / BACK PAIN - INTERMITTENT FROM MODERATE TO SEVERE") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY), SURGERY (BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT D & C HYSTEROSCOPY WITH ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. IN 2017, THE ABDOMINAL PAIN LOWER, DYSMENORRHOEA, MENSTRUAL DISORDER, BACK PAIN, DYSPAREUNIA, ALOPECIA AND VAGINAL DISCHARGE HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, PERIHEPATITIS, MIGRAINE, HEADACHE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, PERIHEPATITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING SOMETIME LATE 2012 OR EARLY 2013, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAD RESOLVED AND THAT SHE FEELS MUCH BETTER. PFS- CURRENT WEIGHT: 238LBS. SHE DID NOT ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. MR- RIGHT- TWO TRAILING COILS, LEFT- THREE TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 53.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. (B)(6) 2012 : HYSTEROSALPINGOGRAM : RIGHT TUBAL OCCLUSION DEVICE APPROPRIATELY POSITIONED WITHOUT EVIDENCE OF RIGHT TUBAL PATENCY. INCIDENTAL MILD VENOUS OR LYMPHATIC CONTRAST INTRAVASATION ALONG THE RIGHT SIDE OF THE UTERUS AND FALLOPIAN TUBE. LEFT TUBAL OCCLUSION DEVICE APPEARS APPROPRIATELY POSITIONED WITHOUT EVIDENCE OF LEFT TUBAL PATENCY, ALTHOUGH THE PROXIMAL RADIOPAQUE MARKER OF THE OUTER COIL IS ABSENT. (B)(6) 2017 : SURGICAL PATHOLOGY REPORT : CLINICAL INFORMATION: PELVIC PAIN, MENORRHAGIA, DYSPAREUNIA. DIAGNOSIS: ENDOMETRIAL SCRAPINGS: DISORDERED PROLIFERATIVE ENDOMETRIUM. FINDINGS CONSISTENT WITH ENDOMETRIAL POLYP. BILATERAL FALLOPIAN TUBES, SALPINGECTOMIES: ESSURE CONTRACEPTIVE DEVICE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S PFS: CONFIRMING : PELVIC PAIN. MENORRHAGIA." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAY-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 ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / LOWER ABDOMEN PAIN-CONSTANT PAIN INTERMITTENT FROM MODERATE O SEVERE / PAINFUL CRAMPS"), PELVIC PAIN ("PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND PERIHEPATITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL INFECTION - FITZ HUGH CURTIS SYNDROME") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 787230) 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) 2002) AND RECURRENT ABORTION (5). CONCURRENT CONDITIONS INCLUDED OBESITY, DEPRESSION, DIZZINESS, BLOOD PRESSURE HIGH, SINUS DISORDER, HOT FLASHES, ANESTHESIA, HIGH CHOLESTEROL, PELVIC ADHESIONS AND ENDOMETRIAL POLYP. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FROM (B)(6) 2012 TO (B)(6) 2012 FOR CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 21 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ALOPECIA ("HAIR LOSS / HAIR LOSS"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE / VAGINAL DISCHARGE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN / BACK PAIN - INTERMITTENT FROM MODERATE TO SEVERE") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT D & C HYSTEROSCOPY WITH ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. IN 2017, THE ABDOMINAL PAIN LOWER, DYSMENORRHOEA, MENSTRUAL DISORDER, BACK PAIN, DYSPAREUNIA, ALOPECIA AND VAGINAL DISCHARGE HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, PERIHEPATITIS, MIGRAINE, HEADACHE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, PERIHEPATITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING SOMETIME LATE 2012 OR EARLY 2013, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAD RESOLVED AND THAT SHE FEELS MUCH BETTER. PFS- CURRENT WEIGHT: (B)(6) LBS. SHE DID NOT ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. MR- RIGHT- TWO TRAILING COILS, LEFT- THREE TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 53.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED . (B)(6) 2012 : HYSTEROSALPINGOGRAM : RIGHT TUBAL OCCLUSION DEVICE APPROPRIATELY POSITIONED WITHOUT EVIDENCE OF RIGHT TUBAL PATENCY. INCIDENTAL MILD VENOUS OR LYMPHATIC CONTRAST INTRAVASATION ALONG THE RIGHT SIDE OF THE UTERUS AND FALLOPIAN TUBE. LEFT TUBAL OCCLUSION DEVICE APPEARS APPROPRIATELY POSITIONED WITHOUT EVIDENCE OF LEFT TUBAL PATENCY, ALTHOUGH THE PROXIMAL RADIOPAQUE MARKER OF THE OUTER COIL IS ABSENT. (B)(6) 2017 : SURGICAL PATHOLOGY REPORT : CLINICAL INFORMATION: PELVIC PAIN, MENORRHAGIA, DYSPAREUNIA. DIAGNOSIS: ENDOMETRIAL SCRAPINGS: DISORDERED PROLIFERATIVE ENDOMETRIUM. FINDINGS CONSISTENT WITH ENDOMETRIAL POLYP. BILATERAL FALLOPIAN TUBES, SALPINGECTOMIES: ESSURE CONTRACEPTIVE DEVICE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S PFS: CONFIRMING : PELVIC PAIN. MENORRHAGIA" . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-FEB-2018: EVENTS- "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL INFECTION - FITZ HUGH CURTIS SYNDROME, MIGRAINES, HEADACHES, PAIN, WEIGHT GAIN", REPORTER, LOT NUMBER, HISTORICAL CONDITION ADDED FROM PFS. HISTORICAL AND CONCOMITTANT CONDITION, LAB DATA ADDED FROM 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ALOPECIA ("HAIR LOSS") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. IN 2017, THE ABDOMINAL PAIN LOWER, DYSMENORRHOEA, MENSTRUAL DISORDER, BACK PAIN, DYSPAREUNIA, ALOPECIA AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENSTRUAL DISORDER AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING SOMETIME LATE 2012 OR EARLY 2013, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAD RESOLVED AND THAT SHE FEELS MUCH BETTER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 636729 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 787230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | DEPO PROVERA| DEPO PROVERA |