ESSURE
Report
- Report Number
- 2951250-2017-08889
- Event Type
- Injury
- Date Received
- November 27, 2017
- Report Date
- August 18, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN: PELVIC"), GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING") AND MYOCARDIAL INFARCTION ("HEART ATTACKS") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE, FALLOPIAN TUBES" ON (B)(6) 2012. THE PATIENT'S MEDICAL HISTORY INCLUDED TUBAL LIGATION ON (B)(6) 2012, FIBROIDS, PELVIC PAIN FEMALE, ECZEMA, HEADACHE AND BODY MASS INDEX NORMAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR IRREGULAR BLEEDING: TRINESSA; FOR PREVENT PREGNANCY: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED GRAVES' DISEASE AND CERVICITIS. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRIN), ATORVASTATIN SINCE (B)(6) 2015, BISOPROLOL SINCE (B)(6) 2010, CLOPIDOGREL SINCE (B)(6) 2015, FLUCONAZOLE, HYDROCODONE BITARTRATE;PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), IBUPROFEN SINCE 2003, LEVOTHYROXINE SINCE (B)(6) 2017, METOPROLOL TARTRATE AND THIAMAZOLE (METHIMAZOLE) FROM (B)(6) 2010 TO (B)(6) 2012. IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH ("SKIN RASHES"). IN 2013, THE PATIENT EXPERIENCED ECZEMA ("ECZEMA"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), ALLERGY TO METALS ("SYMPTOMS OF NICKEL ALLERGY"), ADHESION ("ADHESIONS"), DYSMENORRHOEA ("PAINFUL MENSTRUATION"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), HYPERTENSION ("HIGH BLOOD PRESSURE"), ALOPECIA ("HAIR LOSS"), PREMENSTRUAL SYNDROME ("ENHANCED PMS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE FIBROMA ("FIBROID TUMORS"), OVARIAN NEOPLASM ("OVARIAN TUMOR") AND UTERINE LEIOMYOMA ("TUMOR / TERATOMA / CANCER TYPE:FIBROIDS"). THE PATIENT WAS TREATED WITH ETHINYLESTRADIOL;NORGESTIMATE (TRI-SPRINTEC) AND SURGERY (TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/OOPHORECTOMY WITH REMOVAL OF THE ESSURE DEVICE AND TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/LEFT OOPHORECTOMY WITH REMOVAL OF THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUATION IRREGULAR, FIBROMA, FATIGUE, ADHESION, DYSMENORRHOEA, ANXIETY, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, HYPERTENSION, ALOPECIA, PREMENSTRUAL SYNDROME, MIGRAINE, HEADACHE, NAUSEA, ECZEMA, OVARIAN NEOPLASM, VAGINAL DISCHARGE, WEIGHT INCREASED, MYOCARDIAL INFARCTION, UTERINE LEIOMYOMA AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADHESION, ALLERGY TO METALS, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FIBROMA, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MYOCARDIAL INFARCTION, NAUSEA, OVARIAN NEOPLASM, PELVIC PAIN, PREMENSTRUAL SYNDROME, RASH, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 147 LBS. SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF ABNORMAL, HEAVY BLEEDING, IRREGULAR MENSTRUATION, FIBROID TUMORS, SYMPTOMS OF NICKEL ALLERGY, FATIGUE, ADHESIONS, AND PAINFUL MENSTRUATION, AMONG OTHER SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.6 KG/SQM. HYSTEROSALPINGOGRAM - IN 2012: RESULTS: CONFIRMED PROPER PLACEMENT. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: GENITAL BLEEDING, FIBROIDS, DYSMENORRHEA, MENORRHAGIA." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-APR-2019: REPORTER INFORMATION WAS ADDED. THIS CASE CONCERNS 41 YEAR OLD PATIENT. HER DEMOGRAPHIC WAS UPDATED. HER HISTORICAL CONDITION/MEDICATION AND CONCURRENT MEDICATION WERE ADDED. LAB DATA WAS ADDED. ESSURE INDICATION WAS AMENDED. ESSURE INSERTION AND REMOVAL DATE WERE UPDATED. ESSURE LOT NUMBER WAS ADDED. HER TREATMENT AND CONCOMITANT MEDICATIONS WERE ADDED. PER PLAINTIFF FACT SHEET FOLLOWING EVENTS : PAIN: PELVIC, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), HIGH BLOOD PRESSURE, FAILURE TO OCCLUDE, FALLOPIAN TUBES, HAIR LOSS, ENHANCED PMS (PREMENSTRUAL SYNDROME), MIGRAINES, HEADACHES, NAUSEA, ECZEMA, TUMOR / TERATOMA / CANCER TYPE: FIBROIDS, OVARIAN TUMOR, VAGINAL DISCHARGE, WEIGHT GAIN ,SKIN RASHES AND HEART ATTACKS WERE 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-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: PELVIC"), GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING") AND MYOCARDIAL INFARCTION ("HEART ATTACKS") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE, FALLOPIAN TUBES" ON (B)(6) 2012. THE PATIENT'S MEDICAL HISTORY INCLUDED TUBAL LIGATION ON (B)(6) 2012, FIBROIDS, PELVIC PAIN FEMALE, ECZEMATOUS RASH, HEADACHE AND BODY MASS INDEX NORMAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR IRREGULAR BLEEDING: TRINESSA; FOR PREVENT PREGNANCY: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED GRAVES' DISEASE AND CERVICITIS. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRIN), ATORVASTATIN SINCE (B)(6) 2015, BISOPROLOL SINCE MARCH 2010, CLOPIDOGREL SINCE SEPTEMBER 2015, FLUCONAZOLE, HYDROCODONE BITARTRATE;PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), IBUPROFEN SINCE 2003, LEVOTHYROXINE SINCE JUNE 2017, METOPROLOL TARTRATE AND THIAMAZOLE (METHIMAZOLE) FROM MARCH 2010 TO MARCH 2012. IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH ("SKIN RASHES"). IN 2013, THE PATIENT EXPERIENCED ECZEMA ("ECZEMA"). IN (B)(6)2015, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), ALLERGY TO METALS ("SYMPTOMS OF NICKEL ALLERGY"), ADHESION ("ADHESIONS"), DYSMENORRHOEA ("PAINFUL MENSTRUATION"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), HYPERTENSION ("HIGH BLOOD PRESSURE"), ALOPECIA ("HAIR LOSS"), PREMENSTRUAL SYNDROME ("ENHANCED PMS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE FIBROMA ("FIBROID TUMORS"), OVARIAN NEOPLASM ("OVARIAN TUMOR") AND UTERINE LEIOMYOMA ("TUMOR / TERATOMA / CANCER TYPE:FIBROIDS"). THE PATIENT WAS TREATED WITH ETHINYLESTRADIOL;NORGESTIMATE (TRI-SPRINTEC) AND SURGERY (TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/OOPHORECTOMY WITH REMOVAL OF THE ESSURE DEVICE AND TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/LEFT OOPHORECTOMY WITH REMOVAL OF THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MYOCARDIAL INFARCTION, MENSTRUATION IRREGULAR, FIBROMA, ALLERGY TO METALS, FATIGUE, ADHESION, DYSMENORRHOEA, ANXIETY, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, HYPERTENSION, ALOPECIA, PREMENSTRUAL SYNDROME, MIGRAINE, HEADACHE, NAUSEA, ECZEMA, OVARIAN NEOPLASM, VAGINAL DISCHARGE, WEIGHT INCREASED, UTERINE LEIOMYOMA AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADHESION, ALLERGY TO METALS, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FIBROMA, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MYOCARDIAL INFARCTION, NAUSEA, OVARIAN NEOPLASM, PELVIC PAIN, PREMENSTRUAL SYNDROME, RASH, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 147 LBS. SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF ABNORMAL, HEAVY BLEEDING, IRREGULAR MENSTRUATION, FIBROID TUMORS, SYMPTOMS OF NICKEL ALLERGY, FATIGUE, ADHESIONS, AND PAINFUL MENSTRUATION, AMONG OTHER SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.6 KG/SQM. HYSTEROSALPINGOGRAM - IN 2012: RESULTS: CONFIRMED PROPER PLACEMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: GENITAL BLEEDING, FIBRIODS, DYSMENORRHEA, MENORRHAGIA." LOT NUMBER:882184. MANUFACTURE DATE:2011-07, EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-APR-2019: QUALITY SAFETY EVALUATION OF PTC. 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-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 PERFORATION ('MIGRATION OR PERFORATION'), PELVIC PAIN ('PAIN: PELVIC'), GENITAL HEMORRHAGE ('ABNORMAL, HEAVY BLEEDING') AND MYOCARDIAL INFARCTION ('HEART ATTACKS') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE, FALLOPIAN TUBES" ON (B)(6) 2012. THE PATIENT'S MEDICAL HISTORY INCLUDED TUBAL LIGATION ON (B)(6) 2012, FIBROIDS, PELVIC PAIN FEMALE, ECZEMATOUS RASH, HEADACHE AND BODY MASS INDEX NORMAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR IRREGULAR BLEEDING: TRINESSA; FOR PREVENT PREGNANCY: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED GRAVES' DISEASE AND CERVICITIS. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRIN), ATORVASTATIN SINCE (B)(6) 2015, BISOPROLOL SINCE (B)(6) 2010, CLOPIDOGREL SINCE (B)(6) 2015, FLUCONAZOLE, HYDROCODONE BITARTRATE;PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), IBUPROFEN SINCE 2003, LEVOTHYROXINE SINCE (B)(6) 2017, METOPROLOL TARTRATE AND THIAMAZOLE (METHIMAZOLE) FROM (B)(6) 2010 TO (B)(6) 2012. IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH ("SKIN RASHES"). IN 2013, THE PATIENT EXPERIENCED ECZEMA ("ECZEMA"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), ALLERGY TO METALS ("SYMPTOMS OF NICKEL ALLERGY"), ADHESION ("ADHESIONS"), DYSMENORRHOEA ("PAINFUL MENSTRUATION"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), HYPERTENSION ("HIGH BLOOD PRESSURE"), ALOPECIA ("HAIR LOSS"), PREMENSTRUAL SYNDROME ("ENHANCED PMS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE FIBROMA ("FIBROID TUMORS"), OVARIAN NEOPLASM ("OVARIAN TUMOR") AND UTERINE LEIOMYOMA ("TUMOR / TERATOMA / CANCER TYPE:FIBROIDS"). THE PATIENT WAS TREATED WITH ETHINYLESTRADIOL;NORGESTIMATE (TRI-SPRINTEC) AND SURGERY (TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/OOPHORECTOMY WITH REMOVAL OF THE ESSURE DEVICE AND TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/LEFT OOPHORECTOMY WITH REMOVAL OF THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PERFORATION, PELVIC PAIN, GENITAL HEMORRHAGE, MYOCARDIAL INFARCTION, MENSTRUATION IRREGULAR, FIBROMA, ALLERGY TO METALS, FATIGUE, ADHESION, DYSMENORRHOEA, ANXIETY, DEPRESSION, VAGINAL HEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, HYPERTENSION, ALOPECIA, PREMENSTRUAL SYNDROME, MIGRAINE, HEADACHE, NAUSEA, ECZEMA, OVARIAN NEOPLASM, VAGINAL DISCHARGE, WEIGHT INCREASED, UTERINE LEIOMYOMA AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADHESION, ALLERGY TO METALS, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FIBROMA, GENITAL HEMORRHAGE, HEADACHE, HYPERTENSION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MYOCARDIAL INFARCTION, NAUSEA, OVARIAN NEOPLASM, PELVIC PAIN, PERFORATION, PREMENSTRUAL SYNDROME, RASH, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 147 LBS. SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF ABNORMAL, HEAVY BLEEDING, IRREGULAR MENSTRUATION, FIBROID TUMORS, SYMPTOMS OF NICKEL ALLERGY, FATIGUE, ADHESIONS, AND PAINFUL MENSTRUATION, AMONG OTHER SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.6 KG/SQM. HYSTEROSALPINGOGRAM - IN 2012: RESULTS: CONFIRMED PROPER PLACEMENT. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: GENITAL BLEEDING, FIBRIODS, DYSMENORRHEA, MENORRHAGIA." LOT NUMBER:882184. MANUFACTURE DATE:2011-07, EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-MAR-2020: PIF RECEIVED: EVENT MIGRATION/ PERFORATION WAS ADDED. REPORTER INFORMATION WAS 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('MIGRATION OR PERFORATION'), PELVIC PAIN ('PAIN: PELVIC'), GENITAL HAEMORRHAGE ('ABNORMAL, HEAVY BLEEDING') AND MYOCARDIAL INFARCTION ('HEART ATTACKS') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE, FALLOPIAN TUBES" ON (B)(6) 2012. THE PATIENT'S MEDICAL HISTORY INCLUDED TUBAL LIGATION ON (B)(6) 2012, FIBROIDS, PELVIC PAIN FEMALE, ECZEMATOUS RASH, HEADACHE AND BODY MASS INDEX NORMAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR IRREGULAR BLEEDING: TRINESSA; FOR PREVENT PREGNANCY: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED GRAVES' DISEASE AND CERVICITIS. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRIN), ATORVASTATIN SINCE (B)(6) 2015, BISOPROLOL SINCE (B)(6) 2010, CLOPIDOGREL SINCE (B)(6) 2015, FLUCONAZOLE, HYDROCODONE BITARTRATE;PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), IBUPROFEN SINCE 2003, LEVOTHYROXINE SINCE (B)(6) 2017, METOPROLOL TARTRATE AND THIAMAZOLE (METHIMAZOLE) FROM (B)(6) 2010 TO (B)(6) 2012. IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH ("SKIN RASHES"). IN 2013, THE PATIENT EXPERIENCED ECZEMA ("ECZEMA"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), ALLERGY TO METALS ("SYMPTOMS OF NICKEL ALLERGY"), ADHESION ("ADHESIONS"), DYSMENORRHOEA ("PAINFUL MENSTRUATION"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), HYPERTENSION ("HIGH BLOOD PRESSURE"), ALOPECIA ("HAIR LOSS"), PREMENSTRUAL SYNDROME ("ENHANCED PMS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE FIBROMA ("FIBROID TUMORS"), OVARIAN NEOPLASM ("OVARIAN TUMOR") AND UTERINE LEIOMYOMA ("TUMOR / TERATOMA / CANCER TYPE:FIBROIDS"). THE PATIENT WAS TREATED WITH ETHINYLESTRADIOL;NORGESTIMATE (TRI-SPRINTEC) AND SURGERY (TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/OOPHORECTOMY WITH REMOVAL OF THE ESSURE DEVICE AND TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/LEFT OOPHORECTOMY WITH REMOVAL OF THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PERFORATION, PELVIC PAIN, GENITAL HAEMORRHAGE, MYOCARDIAL INFARCTION, MENSTRUATION IRREGULAR, FIBROMA, ALLERGY TO METALS, FATIGUE, ADHESION, DYSMENORRHOEA, ANXIETY, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, HYPERTENSION, ALOPECIA, PREMENSTRUAL SYNDROME, MIGRAINE, HEADACHE, NAUSEA, ECZEMA, OVARIAN NEOPLASM, VAGINAL DISCHARGE, WEIGHT INCREASED, UTERINE LEIOMYOMA AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADHESION, ALLERGY TO METALS, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FIBROMA, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MYOCARDIAL INFARCTION, NAUSEA, OVARIAN NEOPLASM, PELVIC PAIN, PERFORATION, PREMENSTRUAL SYNDROME, RASH, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 147 LBS. SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF ABNORMAL, HEAVY BLEEDING, IRREGULAR MENSTRUATION, FIBROID TUMORS, SYMPTOMS OF NICKEL ALLERGY, FATIGUE, ADHESIONS, AND PAINFUL MENSTRUATION, AMONG OTHER SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.6 KG/SQM. HYSTEROSALPINGOGRAM - IN 2012: RESULTS: CONFIRMED PROPER PLACEMENT.. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: GENITAL BLEEDING, FIBRIODS, DYSMENORRHEA, MENORRHAGIA." LOT NUMBER: 882184 MANUFACTURING DATE:2011-07 EXPIRATION DATE:2014-07. LOT NUMBER:882184 MANUFACTURE DATE:2011-07, EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2020: 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), FIBROMA ("FIBROID TUMORS"), ALLERGY TO METALS ("SYMPTOMS OF NICKEL ALLERGY"), FATIGUE ("FATIGUE"), ADHESION ("ADHESIONS"), DYSMENORRHOEA ("PAINFUL MENSTRUATION"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT A TOTAL HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICE.). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, MENSTRUATION IRREGULAR, FIBROMA, ADHESION, DYSMENORRHOEA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADHESION, ALLERGY TO METALS, ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, FIBROMA, GENITAL HAEMORRHAGE AND MENSTRUATION IRREGULAR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF ABNORMAL, HEAVY BLEEDING, IRREGULAR MENSTRUATION, FIBROID TUMORS, SYMPTOMS OF NICKEL ALLERGY, FATIGUE, ADHESIONS, AND PAINFUL MENSTRUATION, AMONG OTHER SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED PROPER PLACEMENT 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 |
|---|---|---|---|---|---|---|---|
| 839871 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | ASPIRIN [ACETYLSALICYLIC ACID]| ASPIRIN [ACETYLSALICYLIC ACID]| ASPIRIN [ACETYLSALICYLIC ACID]| ASPIRIN [ACETYLSALICYLIC ACID]| ATORVASTATIN| ATORVASTATIN| ATORVASTATIN| ATORVASTATIN| BISOPROLOL| BISOPROLOL| BISOPROLOL| BISOPROLOL| CLOPIDOGREL| CLOPIDOGREL| CLOPIDOGREL| CLOPIDOGREL| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| HYDROCODONE/ACETAMINOPHEN| HYDROCODONE/ACETAMINOPHEN| HYDROCODONE/ACETAMINOPHEN| HYDROCODONE/ACETAMINOPHEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| METHIMAZOLE| METHIMAZOLE| METHIMAZOLE| METHIMAZOLE| METOPROLOL TARTRATE| METOPROLOL TARTRATE| METOPROLOL TARTRATE| METOPROLOL TARTRATE |