ESSURE
Report
- Report Number
- 2951250-2019-10178
- Event Type
- Injury
- Date Received
- October 11, 2019
- Date of Event
- February 1, 2018
- Report Date
- October 30, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT SIDE TOWARDS UTERUS'), PELVIC INFECTION ('PELVIC INFECTION/INFECTION (OTHER) DESCRIBE: PELVIC') AND PELVIC INFLAMMATORY DISEASE ('INFLAMMATORY DISEASE IN THE PELVIS CAUSING LEFT HYDRONEPHROSIS.') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901330) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "ATTEMPTED TO IMPLANT DEVICE MULTIPLE TIMES". THE PATIENT'S MEDICAL HISTORY INCLUDED LUTEAL CYST OF OVARY AND PELVIC INFECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, HYDRONEPHROSIS AND ENDOMETRIOSIS OF UTERUS. IN NOVEMBER 2011, THE PATIENT EXPERIENCED DYSGEUSIA ("METALLIC TASTE") AND OVULATION PAIN ("OTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: TWINGES DURING OVULATION"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN DECEMBER 2011, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("GI CONDITIONS/ GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING") AND LYMPHADENOPATHY ("SOTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: SWOLLEN GLANDS"). IN AUGUST 2017, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN/ CHRONIC"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN JANUARY 2018, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN FEBRUARY 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL INFECTION ("BLADDER OR URINARY PROBLEMS OR CHANGES URINARY STENT IMPLANTED DUE TO ABDOMINAL INFECTION"), 6 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBS"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND HEADACHE ("HEADACHES") AND UNDERWENT URETHRAL STENT INSERTION ("URINARY STENT IMPLANTED/BLADDER OR URINARY PROBLEMS OR CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY. (FULL),SALPINGECTOMY (BILATERAL), (B)(6) 2018 ADDITIONAL SURGERIES). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, MENORRHAGIA, URETHRAL STENT INSERTION, VAGINAL HAEMORRHAGE AND ABDOMINAL INFECTION OUTCOME WAS UNKNOWN AND THE PELVIC INFECTION, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, MIGRAINE, HEADACHE, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, DYSGEUSIA, OVULATION PAIN AND LYMPHADENOPATHY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL INFECTION, ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DEVICE DISLOCATION, DYSGEUSIA, FATIGUE, HEADACHE, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, OVULATION PAIN, PELVIC INFECTION, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, URETHRAL STENT INSERTION, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR CHRONIC PAIN ,PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MIGRATION,BLADDER PROBS., URINARY PROBLEMS., OTHER, VAGINAL DISCHARGE,MIGRAINE, HEADACHES, FATIGUE, WEIGHT GAIN, GI CONDITIONS, METALLIC TASTE, TWINGES DURING OVULATION, PELVIC INFECTION, SWOLLEN GLANDS, URINARY STENT IMPLANTED. PLAINTIFF PERFORMED ADDITIONAL SURGERIES ON (B)(6) 2018 THE INTRODUCER WAS RETRACTED AND APPROXIMATELY 2 COILS WERE VISUALIZED. ATTENTION WAS THEN TURNED TO THE LEFT OSTIA WHERE A SIMILAR PROCEDURE WAS PERFORMED, UPON RETRACTION OF THE INTRODUCER, 3 COILS WERE VISUALIZED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.8 KG/SQM. COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2018: FINDINGS: THERE IS EVIDENCE OF TUBAL LIGATION CLIPS BILATERALLY. THERE MAY BE WALL THICKENING IN THE RECTUM. AN APPEARANCE OF A CORPUS LUTEAL CYST WITHIN THE RIGHT OVARY IS SUSPECTED MEASURING 2.1CM. IMPRESSION: EXTENSIVE STRANDING OF THE FAT IN THE PELVIS SURROUNDING THE BLADDER WALL UTERUS AND RECTUM WITH SMALL AMOUNTS OF COMPLEX FLUID IN THE INTRAPERITONEAL AND EXTRA PERITONEAL SPACES OF THE PELVIS WITHOUT A WLL DEFINED DRAINABLE FLUID COLLECTION AT THIS TIME.. CYSTOSCOPY - ON (B)(6) 2018: LEFT RETROGRADE PYELOGRAM, POSSIBLE LEFT URETEROSCOPY, POSSIBLE LEFT STENT INSERTION (LEFT). HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S): (UNSPECIFIED): BILATERAL OCCLUSION MICRO INSERTS ARE IDENTIFIED WITHIN PROXIMAL RIGHT AND LEFT FALLOPIAN TUBES IN GOOD POSITION AND ALIGNMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC INFECTION, MIGRAINE, MENORRHAGIA, ABDOMINAL INFECTION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2019: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ('MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT SIDE TOWARDS UTERUS'), PELVIC INFECTION ('PELVIC INFECTION/ INFECTION (OTHER) DESCRIBE: PELVIC') AND PELVIC INFLAMMATORY DISEASE ('INFLAMMATORY DISEASE IN THE PELVIS CAUSING LEFT HYDRONEPHROSIS.') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901330) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "ATTEMPTED TO IMPLANT DEVICE MULTIPLE TIMES". THE PATIENT'S MEDICAL HISTORY INCLUDED LUTEAL CYST OF OVARY AND PELVIC INFECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, HYDRONEPHROSIS AND ENDOMETRIOSIS OF UTERUS. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSGEUSIA ("METALLIC TASTE") AND OVULATION PAIN ("OTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: TWINGES DURING OVULATION"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("GI CONDITIONS/ GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING") AND LYMPHADENOPATHY ("OTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: SWOLLEN GLANDS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN/ CHRONIC"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL INFECTION ("BLADDER OR URINARY PROBLEMS OR CHANGES URINARY STENT IMPLANTED DUE TO ABDOMINAL INFECTION"), 6 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBS"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND HEADACHE ("HEADACHES") AND UNDERWENT URETHRAL STENT INSERTION ("URINARY STENT IMPLANTED/ BLADDER OR URINARY PROBLEMS OR CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY. (FULL), SALPINGECTOMY (BILATERAL),(B)(6) 2018- ADDITIONAL SURGERIES). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, MENORRHAGIA, URETHRAL STENT INSERTION, VAGINAL HAEMORRHAGE AND ABDOMINAL INFECTION OUTCOME WAS UNKNOWN AND THE PELVIC INFECTION, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, MIGRAINE, HEADACHE, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, DYSGEUSIA, OVULATION PAIN AND LYMPHADENOPATHY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL INFECTION, ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DEVICE DISLOCATION, DYSGEUSIA, FATIGUE, HEADACHE, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, OVULATION PAIN, PELVIC INFECTION, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, URETHRAL STENT INSERTION, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR CHRONIC PAIN, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MIGRATION, BLADDER PROBS., URINARY PROBLEMS, OTHER, VAGINAL DISCHARGE, MIGRAINE, HEADACHES, FATIGUE, WEIGHT GAIN, GI CONDITIONS, METALLIC TASTE, TWINGES DURING OVULATION, PELVIC INFECTION, SWOLLEN GLANDS, URINARY STENT IMPLANTED. PLAINTIFF PERFORMED ADDITIONAL SURGERIES ON (B)(6) 2018 THE INTRODUCER WAS RETRACTED AND APPROXIMATELY 2 COILS WERE VISUALIZED. ATTENTION WAS THEN TURNED TO THE LEFT OSTIA WHERE A SIMILAR PROCEDURE WAS PERFORMED, UPON RETRACTION OF THE INTRODUCER, 3 COILS WERE VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.8 KG/SQM. COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2018: FINDINGS: THERE IS EVIDENCE OF TUBAL LIGATION CLIPS BILATERALLY. THERE MAY BE WALL THICKENING IN THE RECTUM. AN APPEARANCE OF A CORPUS LUTEAL CYST WITHIN THE RIGHT OVARY IS SUSPECTED MEASURING 2.1 CM. IMPRESSION: EXTENSIVE STRANDING OF THE FAT IN THE PELVIS SURROUNDING THE BLADDER WALL UTERUS AND RECTUM WITH SMALL AMOUNTS OF COMPLEX FLUID IN THE INTRAPERITONEAL AND EXTRA PERITONEAL SPACES OF THE PELVIS WITHOUT A WILL DEFINED DRAINABLE FLUID COLLECTION AT THIS TIME. CYSTOSCOPY - ON (B)(6) 2018: LEFT RETROGRADE PYELOGRAM, POSSIBLE LEFT URETEROSCOPY, POSSIBLE LEFT STENT INSERTION (LEFT). HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S): (UNSPECIFIED): BILATERAL OCCLUSION. MICRO INSERTS ARE IDENTIFIED WITHIN PROXIMAL RIGHT AND LEFT FALLOPIAN TUBES IN GOOD POSITION AND ALIGNMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC INFECTION, MIGRAINE, MENORRHAGIA, ABDOMINAL INFECTION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2019: PFS RECEIVED. INJURY NOS REPLACED WITH NEW EVENT PELVIC PAIN. NEW EVENTS ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, MIGRATION, BLADDER PROBS, URINARY PROBLEMS, VAGINAL DISCHARGE, MIGRAINE, HEADACHES, FATIGUE, WEIGHT GAIN, GI CONDITIONS, METALLIC TASTE, TWINGES DURING OVULATION, PELVIC INFECTION, SWOLLEN GLANDS WERE ADDED. LAB DATA, REPORTER¿S INFORMATION, PATIENT¿S DEMOGRAPHICS WERE ADDED. ON 20-SEP-2019: PFS+MR RECEIVED. LOT NUMBER ADDED. NEW EVENTS: ABNORMAL BLEEDING (VAGINAL), ABDOMINAL INFECTION, PELVIC INFLAMMATORY DISEASE, ATTEMPTED TO IMPLANT DEVICE MULTIPLE TIMES WERE ADDED. GI CONDITIONS UPDATED TO BLOATING, ONSET DATES FOR EVENTS ADDED. NEW REPORTERS, CONCOMITANT CONDITIONS AND LAB DATA 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-CONFORMANCE 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 |
|---|---|---|---|---|---|---|---|
| 974799 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 901330 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R |