ESSURE
Report
- Report Number
- 2951250-2019-07421
- Event Type
- Injury
- Date Received
- September 20, 2019
- Date of Event
- June 9, 2015
- 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (MENORRHAGIA)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C40241) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, MULTIPLE CESAREAN SECTIONS (3 CESAREAN SECTIONS CESAREAN SECTION - 2014, CESAREAN SECTION - 2011, CESAREAN SECTION ¿ 2001), RECURRENT ABORTION (4 MISCARRIAGES), APPENDECTOMY, THYROIDECTOMY, TUBAL LIGATION, ACUTE CHOLECYSTITIS, GALLSTONES, INJURY (ORGANS, SUCH AS BOWEL, BLADDER AND BLOOD VESSELS), ADENOMYOSIS (ADENOMYOSIS WITH NRL ADX AND ESSURE COILS- OFFERED LAP B SALPINGECTOMY VS HYST) AND SUBMUCOUS LEIOMYOMA OF UTERUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVA RING FROM 2012 TO 2013 AND MIRENA IN 2010. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"). IN 2017, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION : VAGINAL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS)"), BACK PAIN ("PAIN- BACK"), FIBROMYALGIA ("AUTOIMMUNE DIAGNOSED- FIBROMYALGIA"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MOOD SWINGS ("MOOD SWINGS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ANXIETY ("ANXIETY"), PELVIC PAIN ("PELVIC PAIN"), ARTHRALGIA ("JOINT PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, METRORRHAGIA, ALOPECIA, MIGRAINE AND HEADACHE HAD RESOLVED, THE DYSMENORRHOEA, DYSPAREUNIA, FIBROMYALGIA, VAGINAL HAEMORRHAGE, MOOD SWINGS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, ANXIETY, WEIGHT INCREASED, PELVIC PAIN AND FATIGUE OUTCOME WAS UNKNOWN AND THE BACK PAIN, ARTHRALGIA AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR OTHER INJURIES/SYMPT.? YES LEFT SIDE- 1 TRAILING COIL, RIGHT SIDE- 4 TRAILING COILS . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33 KG/SQM. COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2015: GALLSTONE WITHOUT CT EVIDENCE OF ACUTE CHOLECYSTITIS. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION ESSURE INSERTION WAS A SUCCESS WITH FULL BLOCKAGE. IMAGING PROCEDURE - ON (B)(6) 2015: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) : BILATERAL OCCLUSION. BATCH NO C40241 PRODUCTION DATE 02-04-2014 EXPIRATION DATE 30-04-2017. 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 MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (MENORRHAGIA)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C40241) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, MULTIPLE CESAREAN SECTIONS (3 CESAREAN SECTIONS CESAREAN SECTION - 2014 CESAREAN SECTION - 2011 CESAREAN SECTION ¿ 2001), MISCARRIAGE (4 MISCARRIAGES), APPENDECTOMY, THYROIDECTOMY, TUBAL LIGATION, ACUTE CHOLECYSTITIS, GALLSTONES, INJURY (ORGANS, SUCH AS BOWEL, BLADDER AND BLOOD VESSELS), ADENOMYOSIS (ADENOMYOSIS WITH NRL ADX AND ESSURE COILS- OFFERED LAP B SALPINGECTOMY VS HYST) AND FIBROIDS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVA RING FROM 2012 TO 2013 AND MIRENA IN 2010. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ALOPECIA ("HAIR LOSS"). IN JUNE 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"). IN 2017, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION : VAGINAL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS)"), BACK PAIN ("PAIN- BACK"), FIBROMYALGIA ("AUTOIMMUNE DIAGNOSED- FIBROMYALGIA"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MOOD SWINGS ("MOOD SWINGS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ANXIETY ("ANXIETY"), PELVIC PAIN ("PELVIC PAIN"), ARTHRALGIA ("JOINT PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, METRORRHAGIA, ALOPECIA, MIGRAINE AND HEADACHE HAD RESOLVED, THE DYSMENORRHOEA, DYSPAREUNIA, FIBROMYALGIA, VAGINAL HAEMORRHAGE, MOOD SWINGS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, ANXIETY, WEIGHT INCREASED, PELVIC PAIN AND FATIGUE OUTCOME WAS UNKNOWN AND THE BACK PAIN, ARTHRALGIA AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR OTHER INJURIES/SYMPTOM.? YES LEFT SIDE- 1 TRAILING COIL, RIGHT SIDE- 4 TRAILING COILS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33 KG/SQM. COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2015: GALLSTONE WITHOUT CT EVIDENCE OF ACUTE CHOLECYSTITIS. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION ESSURE INSERTION WAS A SUCCESS WITH FULL BLOCKAGE. IMAGING PROCEDURE - ON (B)(6) 2015: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) : BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. NEW EVENTS-" ABNORMAL BLEEDING (VAGINAL), HORMONAL CHANGES DESCRIBE: MOOD SWINGS, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL, PARAMENIA (INABILITY TO HAVE SEXUAL INTERCOURSE), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, FATIGUE AND WEIGHT GAIN, ABDOMINAL PAIN, JOINT PAIN", MEDICAL HISTORY, LOT NUMBER AND LAB DATA 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-CONFORMANCE'S 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 MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS)"), BACK PAIN ("PAIN- BACK"), FIBROMYALGIA ("AUTOIMMUNE DIAGNOSED- FIBROMYALGIA"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINE") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (SALPING. (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, METRORRHAGIA, ALOPECIA, MIGRAINE AND HEADACHE HAD RESOLVED AND THE DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN AND FIBROMYALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FIBROMYALGIA, HEADACHE, MENORRHAGIA, METRORRHAGIA AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR OTHER INJURIES/SYMPT.? YES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2015: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) : BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED: INCIDENT CATEGORY UPDATED PREVIOUSLY REPORTED EVENT INJURY TO HERSELF REPLACED BY NEW EVENTS DYSMENORRHEA (CRAMPING), PAIN- BACK, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), AUTOIMMUNE DIAGNOSED- FIBROMYALGIA, BLADDER/URINARY PROBLEMS, HAIR LOSS, MIGRAINE AND HEADACHES. OUTCOME FOR THE EVENTS MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS) AND BLADDER/URINARY PROBLEMS UPDATED TO RECOVERED / RESOLVED. REPORTER INFORMATION, PRODUCT INDICATION, INSERTION AND REMOVAL DATES UPDATED. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 892367 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C40241 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | DEPO PROVERA| DEPO PROVERA| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL] |