ESSURE
Report
- Report Number
- 2951250-2019-04792
- Event Type
- Injury
- Date Received
- August 14, 2019
- Date of Event
- January 1, 2016
- Report Date
- April 27, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('ONE OF THE COILS PUNCTURED WHERE EVER IT WAS NEXT TO MY TUBE') AND PELVIC PAIN ('PAIN STABBING PELVIC PAIN') IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D01971) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SKIN CANCER. PATIENT HAD DONE ENDOMETRIAL BIOPSY FOR PAIN AND COLONOSCOPY FOR GASTROINTESTINAL CONDITIONS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: LEENA FROM 2010 TO (B)(6)2014, NUVARING FROM 2009 TO 2010, IUD NOS FROM 2008 TO 2009 AND MICROGESTIN FE. CONCURRENT CONDITIONS INCLUDED AUDITORY DISORDER, DIZZY, MALIGNANT MELANOMA, BASAL CELL CARCINOMA, CONJUNCTIVITIS, HYPERPLASIA, UTERINE LEIOMYOMA, ENDOMETRIAL METAPLASIA, BODY MASS INDEX NORMAL AND HEADACHE. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE SINCE (B)(6)2017. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) / SPOTTING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/IRREGULAR BLEEDING, SPOTTING"), ABDOMINAL PAIN ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:BLOATING"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), AUTOIMMUNE HYPOTHYROIDISM ("AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPOTHYROIDISM"), THYROID MASS ("AUTOIMMUNE DISORDER TYPE OF DISORDER:3 THYROID NODULES"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:NAUSEA"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), EYE PAIN ("VISION/EYE PROBLEMS TYPE: EYE PAIN"), OCULAR HYPERAEMIA ("VISION/EYE PROBLEMS TYPE: EYE REDNESS"), PHOTOPHOBIA ("VISION/EYE PROBLEMS TYPE:SENSITIVITY TO LIGHT"), LACRIMATION INCREASED ("VISION/EYE PROBLEMS TYPE:WATERY EYES"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ARTHRALGIA ("PAIN JOINT PAIN: HIP, KNEES"), NECK PAIN ("NECK PAIN") AND MUSCULOSKELETAL PAIN ("SHOULDER PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6)2018, THE PATIENT EXPERIENCED DRUG HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: ALLERGIC REACTION TO LIDOCAINE") AND TOOTHACHE ("DENTAL PROBLEMS / DENTAL PAIN"), 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PANIC REACTION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:PANIC"), HYPERLIPIDAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE:HYPERLIPIDEMIA"), MENSTRUATION IRREGULAR ("IRREGULAR BLEEDING"), FALLOPIAN TUBE CYST ("TUBAL CYSTS") AND CERVIX INFLAMMATION ("INFLAMED CERVIX") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE LEIOMYOMA AND FALLOPIAN TUBE CYST OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DRUG HYPERSENSITIVITY, BACK PAIN, ABDOMINAL DISTENSION, DYSMENORRHOEA, DYSPAREUNIA, PANIC REACTION, DEPRESSION, ANXIETY, AUTOIMMUNE HYPOTHYROIDISM, THYROID MASS, MIGRAINE, HYPERLIPIDAEMIA, NAUSEA, TOOTHACHE, VISION BLURRED, EYE PAIN, OCULAR HYPERAEMIA, PHOTOPHOBIA, LACRIMATION INCREASED, WEIGHT INCREASED, FATIGUE, ALOPECIA, ARTHRALGIA, NECK PAIN, MUSCULOSKELETAL PAIN AND MENSTRUATION IRREGULAR HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE HYPOTHYROIDISM, BACK PAIN, CERVIX INFLAMMATION, DEPRESSION, DRUG HYPERSENSITIVITY, DYSMENORRHOEA, DYSPAREUNIA, EYE PAIN, FALLOPIAN TUBE CYST, FALLOPIAN TUBE PERFORATION, FATIGUE, HYPERLIPIDAEMIA, LACRIMATION INCREASED, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MUSCULOSKELETAL PAIN, NAUSEA, NECK PAIN, OCULAR HYPERAEMIA, PANIC REACTION, PELVIC PAIN, PHOTOPHOBIA, THYROID MASS, TOOTHACHE, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: ESSURE DEVICES WERE PLACED IN STANDARD FASHION INTO THE BILATERAL TUBAL OSTIA WITH VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 3 COILS LEFT: 2 COILS. CURRENT WEIGHT 168 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2015: RESULTS: TOTAL BILATERAL OCCLUSION. SUCCESSFUL, NO LONGER NEED OTHER BIRTH CONTROL.; ON (B)(6) 2015: SUCCESSFUL. NO LONGER NEED OTHER BIRTH CONTROL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: EYE REDNESS, PHOTOPHOBIA, LACRIMATION INCREASED, EYE PAIN, PELVIC PAIN, HYPOTHYROIDISM, ABNORMAL VAGINAL BLEEDING, DYSMENORRHEA, ENDOMETRIAL BIOPSY. BATCH NO D01971, PRODUCTION DATE 2014-08-23, EXPIRATION DATE 2017-08-31. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: CONTENT FROM SOCIAL MEDIA RECEIVED: EVENTS WERE ADDED: FALLOPIAN TUBE PERFORATION, CERVIX INFLAMMATION, UTERINE LEIOMYOMA, FALLOPIAN TUBE CYST. REPORTER WAS ADDED. 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 PELVIC PAIN ('PAIN STABBING PELVIC PAIN') IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D01971) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SKIN CANCER. PATIENT HAD DONE ENDOMETRIAL BIOPSY FOR PAIN AND COLONOSCOPY FOR GASTROINTESTINAL CONDITIONS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: LEENA FROM 2010 TO (B)(6) 2014, NUVARING FROM 2009 TO 2010, IUD NOS FROM 2008 TO 2009 AND MICROGESTIN FE. CONCURRENT CONDITIONS INCLUDED AUDITORY DISORDER, DIZZY, MALIGNANT MELANOMA, BASAL CELL CARCINOMA, CONJUNCTIVITIS, HYPERPLASIA, UTERINE LEIOMYOMA, ENDOMETRIAL METAPLASIA, BODY MASS INDEX NORMAL AND HEADACHE. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE SINCE (B)(6) 2017. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:BLOATING"), HYPOTHYROIDISM ("AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPOTHYROIDISM"), THYROID MASS ("AUTOIMMUNE DISORDER TYPE OF DISORDER:3 THYROID NODULES"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:NAUSEA"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), EYE PAIN ("VISION/EYE PROBLEMS TYPE: EYE PAIN"), OCULAR HYPERAEMIA ("VISION/EYE PROBLEMS TYPE: EYE REDNESS"), PHOTOPHOBIA ("VISION/EYE PROBLEMS TYPE:SENSITIVITY TO LIGHT"), LACRIMATION INCREASED ("VISION/EYE PROBLEMS TYPE:WATERY EYES"), ARTHRALGIA ("PAIN JOINT PAIN: HIP, KNEES"), NECK PAIN ("NECK PAIN") AND MUSCULOSKELETAL PAIN ("SHOULDER PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) / SPOTTING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/IRREGULAR BLEEDING, SPOTTING"), DRUG HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: ALLERGIC REACTION TO LIDOCAINE"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PANIC REACTION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:PANIC"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), HYPERLIPIDAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE:HYPERLIPIDEMIA"), TOOTHACHE ("DENTAL PROBLEMS / DENTAL PAIN"), FATIGUE ("FATIGUE"), ALOPECIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:HAIR LOSS") AND MENSTRUATION IRREGULAR ("IRREGULAR BLEEDING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DRUG HYPERSENSITIVITY, ABDOMINAL PAIN, BACK PAIN, ABDOMINAL DISTENSION, DYSMENORRHOEA, DYSPAREUNIA, PANIC REACTION, DEPRESSION, ANXIETY, HYPOTHYROIDISM, THYROID MASS, MIGRAINE, HYPERLIPIDAEMIA, NAUSEA, TOOTHACHE, VISION BLURRED, EYE PAIN, OCULAR HYPERAEMIA, PHOTOPHOBIA, LACRIMATION INCREASED, WEIGHT INCREASED, FATIGUE, ALOPECIA, ARTHRALGIA, NECK PAIN, MUSCULOSKELETAL PAIN AND MENSTRUATION IRREGULAR HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DRUG HYPERSENSITIVITY, DYSMENORRHOEA, DYSPAREUNIA, EYE PAIN, FATIGUE, HYPERLIPIDAEMIA, HYPOTHYROIDISM, LACRIMATION INCREASED, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MUSCULOSKELETAL PAIN, NAUSEA, NECK PAIN, OCULAR HYPERAEMIA, PANIC REACTION, PELVIC PAIN, PHOTOPHOBIA, THYROID MASS, TOOTHACHE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: ESSURE DEVICES WERE PLACED IN STANDARD FASHION INTO THE BILATERAL TUBAL OSTIA WITH VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 3 COILS LEFT: 2 COILS. CURRENT WEIGHT 168 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. SUCCESSFUL, NO LONGER NEED OTHER BIRTH CONTROL.; ON (B)(6) 2015: SUCCESSFUL. NO LONGER NEED OTHER BIRTH CONTROL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: EYE REDNESS, PHOTOPHOBIA, LACRIMATION INCREASED, EYE PAIN, PELVIC PAIN, HYPOTHYROIDISM, ABNORMAL VAGINAL BLEEDING, DYSMENORRHEA, ENDOMETRIAL BIOPSY. BATCH NO D01971, PRODUCTION DATE 2014-08-23, EXPIRATION DATE 2017-08-31. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-AUG-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 PELVIC PAIN ('PAIN STABBING PELVIC PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D01971) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SKIN CANCER. PATIENT HAD DONE ENDOMETRIAL BIOPSY FOR PAIN AND COLONOSCOPY FOR GASTROINTESTINAL CONDITIONS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: LEENA FROM 2010 TO (B)(6) 2014, NUVARING FROM 2009 TO 2010, IUD NOS FROM 2008 TO 2009 AND MICROGESTIN FE. CONCURRENT CONDITIONS INCLUDED AUDITORY DISORDER, DIZZY, MALIGNANT MELANOMA, BASAL CELL CARCINOMA, CONJUNCTIVITIS, HYPERPLASIA, UTERINE LEIOMYOMA, ENDOMETRIAL METAPLASIA, BODY MASS INDEX NORMAL AND HEADACHE. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE SINCE (B)(6) 2017. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:BLOATING"), HYPOTHYROIDISM ("AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPOTHYROIDISM"), THYROID MASS ("AUTOIMMUNE DISORDER TYPE OF DISORDER:3 THYROID NODULES"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:NAUSEA"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), EYE PAIN ("VISION/EYE PROBLEMS TYPE: EYE PAIN"), OCULAR HYPERAEMIA ("VISION/EYE PROBLEMS TYPE: EYE REDNESS"), PHOTOPHOBIA ("VISION/EYE PROBLEMS TYPE:SENSITIVITY TO LIGHT"), LACRIMATION INCREASED ("VISION/EYE PROBLEMS TYPE:WATERY EYES"), ARTHRALGIA ("PAIN JOINT PAIN: HIP, KNEES"), NECK PAIN ("NECK PAIN") AND MUSCULOSKELETAL PAIN ("SHOULDER PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) / SPOTTING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/IRREGULAR BLEEDING, SPOTTING"), DRUG HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: ALLERGIC REACTION TO LIDOCAINE"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PANIC REACTION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:PANIC"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), HYPERLIPIDAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: HYPERLIPIDEMIA"), TOOTHACHE ("DENTAL PROBLEMS / DENTAL PAIN"), FATIGUE ("FATIGUE"), ALOPECIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: HAIR LOSS") AND MENSTRUATION IRREGULAR ("IRREGULAR BLEEDING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DRUG HYPERSENSITIVITY, ABDOMINAL PAIN, BACK PAIN, ABDOMINAL DISTENSION, DYSMENORRHOEA, DYSPAREUNIA, PANIC REACTION, DEPRESSION, ANXIETY, HYPOTHYROIDISM, THYROID MASS, MIGRAINE, HYPERLIPIDAEMIA, NAUSEA, TOOTHACHE, VISION BLURRED, EYE PAIN, OCULAR HYPERAEMIA, PHOTOPHOBIA, LACRIMATION INCREASED, WEIGHT INCREASED, FATIGUE, ALOPECIA, ARTHRALGIA, NECK PAIN, MUSCULOSKELETAL PAIN AND MENSTRUATION IRREGULAR HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DRUG HYPERSENSITIVITY, DYSMENORRHOEA, DYSPAREUNIA, EYE PAIN, FATIGUE, HYPERLIPIDAEMIA, HYPOTHYROIDISM, LACRIMATION INCREASED, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MUSCULOSKELETAL PAIN, NAUSEA, NECK PAIN, OCULAR HYPERAEMIA, PANIC REACTION, PELVIC PAIN, PHOTOPHOBIA, THYROID MASS, TOOTHACHE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: ESSURE DEVICES WERE PLACED IN STANDARD FASHION INTO THE BILATERAL TUBAL OSTIA WITH VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 3 COILS LEFT: 2 COILS. CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. SUCCESSFUL, NO LONGER NEED OTHER BIRTH CONTROL.; ON (B)(6) 2015: SUCCESSFUL. NO LONGER NEED OTHER BIRTH CONTROL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: EYE REDNESS, PHOTOPHOBIA, LACRIMATION INCREASED, EYE PAIN, PELVIC PAIN, HYPOTHYROIDISM, ABNORMAL VAGINAL BLEEDING, DYSMENORRHEA, ENDOMETRIAL BIOPSY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-AUG-2019: PFS AND MR WAS RECEIVED. CASE BECOME INCIDENT. LOT NUMBER WAS ADDED. PREVIOUSLY ADDED INJURY NOS WAS REPLACED BY ABNORMAL BLEEDING (VAGINAL) AND NEW EVENTS ABNORMAL BLEEDING (MENORRHAGIA), ENDOMETRIAL BIOPSY, COLONOSCOPY, ALLERGIC REACTION TO LIDOCAINE, ANXIETY, PANIC, DEPRESSION, HYPOTHYROIDISM, 3 THYROID NODULES, MIGRAINES / HEADACHES, HYPERLIPIDEMIA, NAUSEA, DENTAL PROBLEMS, DYSMENORRHEA, DYSPAREUNIA, BLURRED VISION, EYE PAIN, EYE REDNESS, SENSITIVITY TO LIGHT, WATERY EYES, WEIGHT GAIN, FATIGUE, BLOATING, HAIR LOSS, PELVIC PAIN, JOINT PAIN, LOWER BACK PAIN, NECK AND SHOULDER PAIN WERE ADDED. NEW REPORTERS WERE ADDED. PATIENT DEMOGRAPHIC WAS ADDED. EVENT ONSET DATES WERE ADDED. CONCOMITANT AND HISTORICAL CONDITIONS WERE ADDED. CONCOMITANT AND HISTORICAL DRUGS WERE ADDED. LAB DATA 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 688638 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D01971 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other| R | LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE |