ESSURE
Report
- Report Number
- 2951250-2016-02330
- Event Type
- Injury
- Date Received
- October 27, 2016
- Date of Event
- May 1, 2016
- Report Date
- July 26, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN; SHARP PELVIC STABBING PAINS/ PELVIC PAIN / PELVIC REGION PAIN/STABBING PAIN"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE PELVIS"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)/HEAVY CLOTS") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D19663) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 4 AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM (B)(6) 2016 TO (B)(6) 2016 FOR PELVIC PAIN, MIGRAINE AND HEADACHE, ANTIBIOTICS FOR URINARY TRACT INFECTION AS WELL AS DICYCLOVERINE HYDROCHLORIDE (BENTYL) AND NORETHISTERONE (MINI-PILL). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("LIGHT VAGINAL BLEEDING / ABNORMAL BLEEDING (VAGINAL)"), 2 MONTHS 21 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY BLEEDING WITH LARGE CLOTS / HEAVIER PERIODS/ HEAVY MENSTRUAL CYCLES / ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/SEVERE CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES") AND DYSCHEZIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DIFFICULTY DEFECATING"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT") AND VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING, STOMACH BLOATING/ PAINFUL STOMACH BLOATING") WITH ABDOMINAL PAIN UPPER AND ABDOMINAL RIGIDITY AND GASTROINTESTINAL DISORDER ("GI SYSTEM PROBLEMS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE") WITH PRURITUS GENITAL, VULVOVAGINAL RASH, PRURITUS, VULVOVAGINAL ERYTHEMA, GENITAL RASH AND RASH, MEDICAL DEVICE PAIN ("LOT OF PAIN / STABBING PAIN FROM COILS"), ARTHRALGIA ("LOT OF JOINT PAIN"), POLYMENORRHOEA ("ONE TO TWO MONTH MENSTRUAL CYCLE"), MENSTRUAL DISORDER ("HEAVY CLOTS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING, SEVERE CRAMPING / ABDOMINAL PAIN"), PAIN IN EXTREMITY ("LEG PAIN"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). THE PATIENT WAS TREATED WITH DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE), HYDROXYZINE HYDROCHLORIDE (VISTARIL), SIMETICONE (SIMETHICONE), TRIAMCINOLONE ACETONIDE AND SURGERY (BILATERAL SALPINGECTOMY WITH ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MOOD SWINGS, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED AND DYSCHEZIA HAD RESOLVED, THE ABDOMINAL DISTENSION, GASTROINTESTINAL DISORDER, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, POLYMENORRHOEA, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE MEDICAL DEVICE PAIN, MENSTRUAL DISORDER AND ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, GASTROINTESTINAL DISORDER AND VAGINAL HAEMORRHAGE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSCHEZIA, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MEDICAL DEVICE PAIN, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, NERVOUS SYSTEM DISORDER, PAIN IN EXTREMITY, PELVIC PAIN, POLYMENORRHOEA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: THE DEVICE WAS DEPLOYED AND WHEN ROLLED BACK THERE WAS NOTED TO BE 1 COIL EXTENDING FROM THE TUBAL OSTIA. THE PATIENT'S APPENDIX WAS IDENTIFIED AND FOUND TO BE NORMAL. HER LIVER MARGINS BOTH LEFT AND RIGHT WERE FOUND TO BE NORMAL. THE INNER ESSURE COILS WERE REMOVED THEN THE OUTER ESSURE COIL WAS EASILY IDENTIFIED AND THEN GRASPED WITH GENTLE TRACTION REMOVED FROM THE TUBAL STUMP. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 49.9 KG/SQM. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2016: NORMAL POST-OP EXAMINATION. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: HSG FAILED BECAUSE SHE HAD LIGHT VAGINAL BLEEDING. ULTRASOUND SCAN - ON (B)(6) 2016: ESSURE DEVICES IN FALLOPIAN TUBES, NO PATHOLOGY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, ABDOMINAL DISTENSION, PRURITUS, RASH, SUSPECTED ALLERGY TO METAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-APR-2019: QUALITY-SAFETY EVALUATION OF PTC.FOLLOW UP 20 AND 21 PROCESSED TOGETHER. INCIDENT: 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 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 ("PELVIC PAIN; SHARP PELVIC STABBING PAINS/ PELVIC PAIN / PELVIC REGION PAIN"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE PELVIS"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D19663) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 4 AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM MAY 2016 TO OCTOBER 2016 FOR PELVIC PAIN, MIGRAINE AND HEADACHE, ANTIBIOTICS FOR URINARY TRACT INFECTION AS WELL AS DICYCLOVERINE HYDROCHLORIDE (BENTYL) AND NORETHISTERONE (MINI-PILL). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN MAY 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("LIGHT VAGINAL BLEEDING / ABNORMAL BLEEDING (VAGINAL)"), 2 MONTHS 21 DAYS AFTER INSERTION OF ESSURE. IN MAY 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN MAY 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY BLEEDING WITH LARGE CLOTS / HEAVIER PERIODS/ HEAVY MENSTRUAL CYCLES / ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN JUNE 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES") AND DYSCHEZIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DIFFICULTY DEFECATING"). IN JULY 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT") AND VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING, STOMACH BLOATING/ PAINFUL STOMACH BLOATING") WITH ABDOMINAL PAIN UPPER AND ABDOMINAL RIGIDITY AND GASTROINTESTINAL DISORDER ("GI SYSTEM PROBLEMS"). IN AUGUST 2016, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN SEPTEMBER 2016, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE") WITH PRURITUS GENITAL, VULVOVAGINAL RASH, PRURITUS, VULVOVAGINAL ERYTHEMA, GENITAL RASH AND RASH, MEDICAL DEVICE PAIN ("LOT OF PAIN / STABBING PAIN FROM COILS"), ARTHRALGIA ("LOT OF JOINT PAIN"), POLYMENORRHOEA ("ONE TO TWO MONTH MENSTRUAL CYCLE"), MENSTRUAL DISORDER ("HEAVY CLOTS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING, SEVERE CRAMPING / ABDOMINAL PAIN"), PAIN IN EXTREMITY ("LEG PAIN"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). THE PATIENT WAS TREATED WITH DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE), HYDROXYZINE HYDROCHLORIDE (VISTARIL), SIMETICONE (SIMETHICONE), TRIAMCINOLONE ACETONIDE AND SURGERY (BOTH FALLOPIAN TUBES AND ESSURE WERE REMOVED, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MOOD SWINGS, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED AND DYSCHEZIA HAD RESOLVED, THE ABDOMINAL DISTENSION, GASTROINTESTINAL DISORDER, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, POLYMENORRHOEA, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE MEDICAL DEVICE PAIN, MENSTRUAL DISORDER AND ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, GASTROINTESTINAL DISORDER AND VAGINAL HAEMORRHAGE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSCHEZIA, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MEDICAL DEVICE PAIN, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, NERVOUS SYSTEM DISORDER, PAIN IN EXTREMITY, PELVIC PAIN, POLYMENORRHOEA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE DEVICE WAS DEPLOYED AND WHEN ROLLED BACK THERE WAS NOTED TO BE 1 COIL EXTENDING FROM THE TUBAL OSTIA. THE PATIENT'S APPENDIX WAS IDENTIFIED AND FOUND TO BE NORMAL. HER LIVER MARGINS BOTH LEFT AND RIGHT WERE FOUND TO BE NORMAL. THE INNER ESSURE COILS WERE REMOVED THEN THE OUTER ESSURE COIL WAS EASILY IDENTIFIED AND THEN GRASPED WITH GENTLE TRACTION REMOVED FROM THE TUBAL STUMP. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 49.9 KG/SQM. GYNAECOLOGICAL EXAMINATION - ON 07-JUN-2016: ASSESSMENT: NORMAL. RESULTS: NORMAL POST-OP EXAMINATION. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: RESULTS: HSG FAILED BECAUSE SHE HAD LIGHT VAGINAL BLEEDING. ULTRASOUND SCAN - ON (B)(6) 2016: RESULTS: ESSURE DEVICES IN FALLOPIAN TUBES, NO PATHOLOGY. AFTER VISIT (B)(6) 2016 (ON UNSPECIFIED DATE), GYNAECOLOGICAL EXAMINATION AT DOCTOR'S OFFICE: IMPROVED RASH SINCE STARTING TOPICAL MEDICATION,NOW IT ONLY ITCHED ACROSS THE PUBIS AND DOWN THE GROIN AREA, INTO THIGH AREA, ERYTHEMA IN THE INGUINAL SPACE, NEAR BOTH LABIA, PUBIS HAD A RAISED, POPULAR RASH CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, ABDOMINAL DISTENSION, PRURITUS, RASH, ALLERGY TO METAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JAN-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. LOT NUMBER ADDED. EVENTS ADDED FROM PFS- HORMONAL CHANGES DESCRIBE: HOT FLASHES, MOOD SWINGS, ABNORMAL BLEEDING (GENERAL), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES, MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE PELVIS, NAUSEA, NEUROLOGICAL CONDITIONS OR PROBLEMS, DEVICE BREAKAGE, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PERFORATION (FALLOPIAN TUBE(S)), VISION/EYE PROBLEMS TYPE: BLURRED VISION, WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DIFFICULTY DEFECATING, DID NOT UNDERGO CONFIRMATION TEST. OUTCOME OF EVENT MENORRHAGIA, VAGINAL HAEMORRHAGE, HEADACHE, PELVIC PAIN WERE UPDATED. PREVIOUS SECOND EVENT MENORRHAGIA WAS DELETED. REPORTER INFORMATION, PLAINTIFF NAME, CONCOMITANT DRUG, MEDICAL HISTORY 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 ('PELVIC PAIN; SHARP PELVIC STABBING PAINS/ PELVIC PAIN / PELVIC REGION PAIN/STABBING PAIN'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE PELVIS'), FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S))') AND DEVICE BREAKAGE ('DEVICE BREAKAGE') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D19663) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 4 AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM (B)(6) 2016 TO (B)(6) 2016 FOR PELVIC PAIN, MIGRAINE AND HEADACHE, ANTIBIOTICS FOR URINARY TRACT INFECTION AS WELL AS DICYCLOVERINE HYDROCHLORIDE (BENTYL) AND NORETHISTERONE (MINI-PILL). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("LIGHT VAGINAL BLEEDING / ABNORMAL BLEEDING (VAGINAL)"), 2 MONTHS 21 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY BLEEDING WITH LARGE CLOTS / HEAVIER PERIODS/ HEAVY MENSTRUAL CYCLES / ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/SEVERE CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES") AND DYSCHEZIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DIFFICULTY DEFECATING"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT") AND VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING, STOMACH BLOATING/ PAINFUL STOMACH BLOATING") WITH ABDOMINAL PAIN UPPER AND ABDOMINAL RIGIDITY AND GASTROINTESTINAL DISORDER ("GI SYSTEM PROBLEMS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)/HEAVY CLOTS"), ALLERGY TO METALS ("PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE") WITH PRURITUS GENITAL, VULVOVAGINAL RASH, PRURITUS, VULVOVAGINAL ERYTHEMA, GENITAL RASH AND RASH, MEDICAL DEVICE PAIN ("LOT OF PAIN / STABBING PAIN FROM COILS"), ARTHRALGIA ("LOT OF JOINT PAIN"), POLYMENORRHOEA ("ONE TO TWO MONTH MENSTRUAL CYCLE"), MENSTRUAL DISORDER ("HEAVY CLOTS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING, SEVERE CRAMPING / ABDOMINAL PAIN"), PAIN IN EXTREMITY ("LEG PAIN"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). THE PATIENT WAS TREATED WITH DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE), HYDROXYZINE HYDROCHLORIDE (VISTARIL), SIMETICONE (SIMETHICONE), TRIAMCINOLONE ACETONIDE AND SURGERY (BILATERAL SALPINGECTOMY WITH ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MOOD SWINGS, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED AND DYSCHEZIA HAD RESOLVED, THE ABDOMINAL DISTENSION, GASTROINTESTINAL DISORDER, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, POLYMENORRHOEA, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE MEDICAL DEVICE PAIN, MENSTRUAL DISORDER AND ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, GASTROINTESTINAL DISORDER AND VAGINAL HAEMORRHAGE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSCHEZIA, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MEDICAL DEVICE PAIN, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, NERVOUS SYSTEM DISORDER, PAIN IN EXTREMITY, PELVIC PAIN, POLYMENORRHOEA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE DEVICE WAS DEPLOYED AND WHEN ROLLED BACK THERE WAS NOTED TO BE 1 COIL EXTENDING FROM THE TUBAL OSTIA. THE PATIENT'S APPENDIX WAS IDENTIFIED AND FOUND TO BE NORMAL. HER LIVER MARGINS BOTH LEFT AND RIGHT WERE FOUND TO BE NORMAL. THE INNER ESSURE COILS WERE REMOVED THEN THE OUTER ESSURE COIL WAS EASILY IDENTIFIED AND THEN GRASPED WITH GENTLE TRACTION REMOVED FROM THE TUBAL STUMP. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 49.9 KG/SQM. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2016: NORMAL POST-OP EXAMINATION. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: HSG FAILED BECAUSE SHE HAD LIGHT VAGINAL BLEEDING. ULTRASOUND SCAN - ON (B)(6) 2016: ESSURE DEVICES IN FALLOPIAN TUBES, NO PATHOLOGY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, ABDOMINAL DISTENSION, PRURITUS, RASH, SUSPECTED ALLERGY TO METAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUL-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 PELVIC PAIN ('PELVIC PAIN; SHARP PELVIC STABBING PAINS/ PELVIC PAIN / PELVIC REGION PAIN/STABBING PAIN'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE PELVIS'), FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S))') AND DEVICE BREAKAGE ('DEVICE BREAKAGE') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D19663) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 4 AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM (B)(6) 2016 TO (B)(6) 2016 FOR PELVIC PAIN, MIGRAINE AND HEADACHE, ANTIBIOTICS FOR URINARY TRACT INFECTION AS WELL AS DICYCLOVERINE HYDROCHLORIDE (BENTYL) AND NORETHISTERONE (MINI-PILL). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("LIGHT VAGINAL BLEEDING / ABNORMAL BLEEDING (VAGINAL)"), 2 MONTHS 21 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY BLEEDING WITH LARGE CLOTS / HEAVIER PERIODS/ HEAVY MENSTRUAL CYCLES / ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/SEVERE CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES") AND DYSCHEZIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DIFFICULTY DEFECATING"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT") AND VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING, STOMACH BLOATING/ PAINFUL STOMACH BLOATING") WITH ABDOMINAL PAIN UPPER AND ABDOMINAL RIGIDITY AND GASTROINTESTINAL DISORDER ("GI SYSTEM PROBLEMS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)/HEAVY CLOTS"), ALLERGY TO METALS ("PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE") WITH PRURITUS GENITAL, VULVOVAGINAL RASH, PRURITUS, VULVOVAGINAL ERYTHEMA, GENITAL RASH AND RASH, MEDICAL DEVICE PAIN ("LOT OF PAIN / STABBING PAIN FROM COILS"), ARTHRALGIA ("LOT OF JOINT PAIN"), POLYMENORRHOEA ("ONE TO TWO MONTH MENSTRUAL CYCLE"), MENSTRUAL DISORDER ("HEAVY CLOTS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING, SEVERE CRAMPING / ABDOMINAL PAIN"), PAIN IN EXTREMITY ("LEG PAIN"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). THE PATIENT WAS TREATED WITH DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE), HYDROXYZINE HYDROCHLORIDE (VISTARIL), SIMETICONE (SIMETHICONE), TRIAMCINOLONE ACETONIDE AND SURGERY (BILATERAL SALPINGECTOMY WITH ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MOOD SWINGS, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED AND DYSCHEZIA HAD RESOLVED, THE ABDOMINAL DISTENSION, GASTROINTESTINAL DISORDER, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, POLYMENORRHOEA, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE MEDICAL DEVICE PAIN, MENSTRUAL DISORDER AND ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, GASTROINTESTINAL DISORDER AND VAGINAL HAEMORRHAGE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSCHEZIA, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MEDICAL DEVICE PAIN, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, NERVOUS SYSTEM DISORDER, PAIN IN EXTREMITY, PELVIC PAIN, POLYMENORRHOEA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: THE DEVICE WAS DEPLOYED AND WHEN ROLLED BACK THERE WAS NOTED TO BE 1 COIL EXTENDING FROM THE TUBAL OSTIA. THE PATIENT'S APPENDIX WAS IDENTIFIED AND FOUND TO BE NORMAL. HER LIVER MARGINS BOTH LEFT AND RIGHT WERE FOUND TO BE NORMAL. THE INNER ESSURE COILS WERE REMOVED THEN THE OUTER ESSURE COIL WAS EASILY IDENTIFIED AND THEN GRASPED WITH GENTLE TRACTION REMOVED FROM THE TUBAL STUMP. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 49.9 KG/SQM. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2016: NORMAL POST-OP EXAMINATION. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: HSG FAILED BECAUSE SHE HAD LIGHT VAGINAL BLEEDING. ULTRASOUND SCAN - ON (B)(6) 2016: ESSURE DEVICES IN FALLOPIAN TUBES, NO PATHOLOGY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, ABDOMINAL DISTENSION, PRURITUS, RASH, SUSPECTED ALLERGY TO METAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS IS A RETENTION CASE. ALL THE INFORMATION FROM DELETION CASE-(B)(4) (DUPLICATE) INCLUDING REFERENCES HAS BEEN TRANSFERRED TO THIS CASE. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 PELVIC PAIN ("PELVIC PAIN; SHARP PELVIC STABBING PAINS/ PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING WITH LARGE CLOTS") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 4. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 2 MONTHS 20 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("LIGHT VAGINAL BLEEDING"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING, STOMACH BLOATING/ PAINFUL STOMACH BLOATING") WITH ABDOMINAL PAIN UPPER AND ABDOMINAL RIGIDITY AND GASTROINTESTINAL DISORDER ("GI SYSTEM PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE") WITH PRURITUS GENITAL, VULVOVAGINAL RASH, PRURITUS, VULVOVAGINAL ERYTHEMA, GENITAL RASH AND RASH, MEDICAL DEVICE PAIN ("LOT OF PAIN / STABBING PAIN FROM COILS"), ARTHRALGIA ("LOT OF JOINT PAIN"), FATIGUE ("FATIGUE"), POLYMENORRHOEA ("ONE TO TWO MONTH MENSTRUAL CYCLE"), MENSTRUAL DISORDER ("HEAVY CLOTS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING, SEVERE CRAMPING"), PAIN IN EXTREMITY ("LEG PAIN"), MENORRHAGIA ("HEAVIER PERIODS/ HEAVY MENSTRUAL CYCLES"), HEADACHE ("HEADACHES") AND ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE") WITH PRURITUS GENITAL, VULVOVAGINAL RASH, PRURITUS, VULVOVAGINAL ERYTHEMA, GENITAL RASH AND RASH, MEDICAL DEVICE PAIN ("LOT OF PAIN / STABBING PAIN FROM COILS"), ARTHRALGIA ("LOT OF JOINT PAIN"), FATIGUE ("FATIGUE"), POLYMENORRHOEA ("ONE TO TWO MONTH MENSTRUAL CYCLE"), MENSTRUAL DISORDER ("HEAVY CLOTS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING, SEVERE CRAMPING"), PAIN IN EXTREMITY ("LEG PAIN"), MENORRHAGIA ("HEAVIER PERIODS/ HEAVY MENSTRUAL CYCLES"), HEADACHE ("HEADACHES") AND ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"). THE PATIENT WAS TREATED WITH HYDROXYZINE HYDROCHLORIDE (VISTARIL), TRIAMCINOLONE ACETONIDE, DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE), DIMETICONE, ACTIVATED (SIMETHICONE) AND SURGERY (BOTH FALLOPIAN TUBES AND ESSURE WERE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MEDICAL DEVICE PAIN, MENSTRUAL DISORDER AND ABDOMINAL PAIN HAD NOT RESOLVED AND THE GENITAL HAEMORRHAGE, ABDOMINAL DISTENSION, GASTROINTESTINAL DISORDER, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, POLYMENORRHOEA, PAIN IN EXTREMITY, MENORRHAGIA, HEADACHE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, HEADACHE, MEDICAL DEVICE PAIN, MENORRHAGIA, MENSTRUAL DISORDER, PAIN IN EXTREMITY, PELVIC PAIN AND POLYMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, ARTHRALGIA, FATIGUE, GASTROINTESTINAL DISORDER AND VAGINAL HAEMORRHAGE WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2016: NORMAL POST-OP EXAMINATION (NORMAL) HYSTEROSALPINGOGRAM, ON (B)(6) 2016: HSG FAILED BECAUSE SHE HAD LIGHT VAGINAL BLEEDING ULTRASOUND SCAN, ON (B)(6) 2016: ESSURE DEVICES IN FALLOPIAN TUBES, NO PATHOLOGY AFTER VISIT (B)(6) 2016 (ON UNSPECIFIED DATE), GYNAECOLOGICAL EXAMINATION AT DOCTOR'S OFFICE: IMPROVED RASH SINCE STARTING TOPICAL MEDICATION,NOW IT ONLY ITCHED ACROSS THE PUBIS AND DOWN THE GROIN AREA, INTO THIGH AREA, ERYTHEMA IN THE INGUINAL SPACE, NEAR BOTH LABIA, PUBIS HAD A RAISED, POPULAR RASH. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-DEC-2017: LEGAL COMPLAINT RECEIVED: REPORTER INFORMATION UPDATED. ESSURE STOP DATE UPDATED FROM (B)(6) 2016. EVENTS PELVIC PAIN, PAINFUL STOMACH BLOATING, HEAVY MENSTRUAL CYCLES, SEVERE ITCHING WERE CLUBBED WITH PREVIOUSLY REPORTED EVENTS. EVENTS HEAVY BLEEDING WITH LARGE CLOTS, SEVERE ABDOMINAL CRAMPING WERE NEWLY ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA AG, (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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.
FOLLOW UP 04-NOV-2016: QUALITY-SAFETY EVALUATION OF PTC GLOBAL NUMBER: (B)(4). SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. FOLLOW-UP FROM 10-NOV-2016: NO FURTHER FOLLOW-UP WILL BE PURSUED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED PELVIC PAIN AND PHYSICIAN THINKS SHE WILL HAVE TO REMOVE ESSURE. UPON FOLLOW UP RECEIPT, CASE BECAME LEGAL. PELVIC PAIN IS ANTICIPATED IN ESSURE REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC PAIN MAY OCCUR. IN THIS CASE, EVENT STARTED AROUND 4 MONTHS AFTER ESSURE INSERTION. ALSO PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE, WITH ITCHING ERYTHEMA AND RASH IN PUBIC AREA AND RASH AND ITCHING IN GENITAL AREA AMONGST NON SERIOUS EVENTS. CONSIDERING EVENT'S NATURE AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT, AS DEVICE REMOVAL WILL BE REQUIRED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-DEC-2016: INFORMATION FROM LAWYER: IN (B)(6) 2016, BOTH OF CLIENT'S FALLOPIAN TUBES AND THE ESSURE WERE REMOVED, AND SHE CONTINUES HAVING PELVIC PAIN, SEVERE CRAMPING, STABBING PAIN, AND HEAVY CLOTS, THOSE EVENTS WERE CONSIDERED RELATED TO ESSURE, OUTCOME OF THE OTHER EVENTS UNKNOWN, REMEDIAL DRUGS FOR BLOATING AND GENITAL RASH SPECIALISED COMPANY. CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED PELVIC PAIN. UPON FOLLOW UP RECEIPT, CASE BECAME LEGAL. IT WAS REPORTED THAT BOTH FALLOPIAN TUBES AND ESSURE WERE REMOVED. PELVIC PAIN IS ANTICIPATED IN ESSURE REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC PAIN MAY OCCUR. IN THIS CASE, EVENT STARTED AROUND 4 MONTHS AFTER ESSURE INSERTION. ALSO PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE, WITH ITCHING ERYTHEMA AND RASH IN PUBIC AREA AND RASH AND ITCHING IN GENITAL AREA AMONGST NON SERIOUS EVENTS. CONSIDERING EVENT'S NATURE AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT BECAUSE DEVICE REMOVAL WAS REQUIRED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON 05-OCT-2016 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. ON (B)(6) 2016 ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) WAS INSERTED FOR PERMANENT STERILIZATION. ON (B)(6) 2016 THE PATIENT HAD A NORMAL POST-OP EXAM. ON (B)(6) 2016 HSG (HYSTEROSALPINGOGRAM) WAS ATTEMPTED BUT HSG FAILED BECAUSE PATIENT HAD LIGHT VAGINAL BLEEDING. THE PHYSICIAN WAS GOING TO SEND PATIENT FOR REPEAT HSG BUT PATIENT RETURN TO DOCTOR'S OFFICE INSTEAD DUE TO PROBLEMS WITH ESSURE. ON (B)(6) 2016 THE PATIENT WAS COMPLAINING OF BLOATING AND GI SYSTEM PROBLEMS. BENTAL WAS PRESCRIBED AND SHE WAS TO TAKE OVER-THE-COUNTER SIMETHICONE. ON (B)(6) 2016 THE PATIENT WENT TO THE ER (EMERGENCY ROOM) COMPLAINING OF PELVIC PAIN, GENITAL ITCHING, PROBLEMS WITH HER BIRTH CONTROL AND VAGINAL RASH. ULTRASOUND WAS PERFORMED AND SHOWED ESSURE DEVICES IN FALLOPIAN TUBES. NO OTHER PATHOLOGY NOTED BY ER. PATIENT WAS GIVEN A TOPICAL CREAM FOR THE RASH AND ORAL VISTARIL. AT THE TIME OF THIS REPORT IT ONLY ITCHED ACROSS THE PUBIS AND DOWN THE GROIN AREA, INTO THIGH AREA. EXAM SHOWED ERYTHEMA IN THE INGUINAL SPACE, NEAR BOTH LABIA. PUBIS HAD A RAISED POPULAR RASH. ACCORDING TO THE PHYSICIAN, THE PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE AND THINKS SHE WILL HAVE TO REMOVE ESSURE DEVICES. THE OUTCOME OF EVENTS IS NOT RECOVERED. ESSURE WAS ONGOING AT THE TIME OF THIS REPORT. FOLLOW-UP RECEIVED ON 07-OCT-2016 CONSUMER STATED THAT SHE HAD A LOT OF SIDE EFFECTS. SHE HAD LOT OF PAIN, RASH AND ITCHING BETWEEN HER THIGHS AND PRIVATE AREA (HAIR AROUND PRIVATE PART), A LOT OF JOINT PAIN AND STABBING PAIN FROM COILS, FATIGUE. SHE ALSO STATED THAT SHE IS VERY LIMITED AND MISERABLE BECAUSE OF ESSURE. PHYSICIAN TOLD TO CONSUMER THAT HER ESSURE COILS WILL BE REMOVED. FOLLOW UP INFORMATION RECEIVED ON 12-OCT-2016 FROM PATIENT: SHE HAD 04 CHILDREN. ON (B)(6) 2016 THE ESSURE PROCEDURE WAS PERFORMED. SINCE THE PROCEDURE, SHE WAS EXPERIENCING ONE TO TWO-MONTH MENSTRUAL CYCLE, HEAVY CLOTS, SEVERE ABDOMINAL CRAMPING AND PELVIC PAIN, STOMACH BLOATING WHICH IS HARD AND PAINFUL, SHARP PELVIC STABBING PAINS, LEG PAIN, HEAVIER PERIODS, SEVERE ITCHING, HEADACHES AND FATIGUE. IN (B)(6) 2016 SHE WAS BROUGHT TO THE EMERGENCY ROOM BECAUSE OF SEVERE PELVIC PAIN AND SEVERE ITCHING. SHE WAS PRESCRIBED HYDROXYZINE HCL 25MG ORAL TABLET AND TRIAMCINOLONE ACETONIDE 0.1% TOPICAL OINTMENT WHICH SHE TOOK AND APPLIED EVERY DAY. THE PAIN DID NOT SUBSIDE AS IT WAS SO INTENSE AND PERSISTENT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED PELVIC PAIN AND PHYSICIAN THINKS SHE WILL HAVE TO REMOVE ESSURE. UPON FOLLOW UP RECEIPT, CASE BECAME LEGAL. PELVIC PAIN IS ANTICIPATED IN ESSURE REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC PAIN MAY OCCUR. IN THIS CASE, EVENT STARTED AROUND 4 MONTHS AFTER ESSURE INSERTION. ALSO PATIENT SEEMS TO BE HAVING AN ALLERGIC REACTION TO ESSURE, WITH ITCHING ERYTHEMA AND RASH IN PUBIC AREA AND RASH AND ITCHING IN GENITAL AREA AMONGST NON SERIOUS EVENTS. CONSIDERING EVENT'S NATURE AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT, AS DEVICE REMOVAL WILL BE REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713312 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D19663 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| BENTYL| BENTYL| BENTYL| BENTYL| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| MINI-PILL| MINI-PILL| MINI-PILL| MINI-PILL |