ESSURE
Report
- Report Number
- 2951250-2017-05911
- Event Type
- Injury
- Date Received
- November 1, 2017
- Date of Event
- November 1, 2012
- Report Date
- October 14, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("COILS WERE NOT INSERTED PROPERLY AND WERE POKING OUT OF THE FALLOPIAN TUBES") AND PELVIC PAIN ("SEVERE PELVIC PAIN/SHARP STABBING PAIN") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610 (VALID), 92703) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: TREATMENT NONCOMPLIANCE "DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING ESSURE PLACEMENT PROCEDURE" AND MEDICAL DEVICE MONITORING ERROR "ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6)1997), CARPAL TUNNEL SYNDROME, HYPOTHYROIDISM, HYPERTENSION, HYPOTHYROIDISM, TUBAL LIGATION AND SMOKER. SHE NEVER USED ALCOHOL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA IN 1995, SYNTHROID AND CODEINE. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DIZZINESS WITH CODEINE. CONCURRENT CONDITIONS INCLUDED OBESITY, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, LEUKORRHEA, HEADACHE, VAGINAL HYSTERECTOMY (REMOVAL OF BOTH FALLOPIAN TUBES AT SAME OPERATIVE EPISODE), THYROIDECTOMY, CHOLECYSTECTOMY, CESAREAN SECTION (CESAREAN DELIVERY), UTERINE PROLAPSE (WITHOUT MENTION OF VAGINAL WALL PROLAPSE), OBESITY AND GENERAL ANESTHESIA. FAMILY HISTORY INCLUDED TYPE II DIABETES MELLITUS, BLOOD PRESSURE HIGH (FATHER) AND HEART ATTACK. CONCOMITANT PRODUCTS INCLUDED HYDROCHLOROTHIAZIDE, LEVOTHYROXINE AND MULTIVITAMIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("UNUSUAL MENSTRUAL CYCLE"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND DYSMENORRHOEA ("UNUSUAL MENSTRUAL CRAMPING"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE") WITH RASH, WEIGHT INCREASED ("GAINED WEIGHT DUE TO THE LOW ENERGY WHEN ANY ACTIVITIES ARE BEING DONE BY THE PLAINTIFF"), INVESTIGATION NONCOMPLIANCE ("DID NOT UNDERGO AN ESSURE CONFIRMATION TEST"), ASTHENIA ("LOW ENERGY") AND DECREASED ACTIVITY ("LOW ENERGY LEVELS, RESULTING IN INACTIVITY"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY, VAGINAL WITH BILATERAL HEMISALPINGECTOMY) AND SURGERY (HYSTERECTOMY, VAGINAL WITH BILATERAL HEMISALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, INVESTIGATION NONCOMPLIANCE, DYSMENORRHOEA, MIGRAINE AND DECREASED ACTIVITY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, MENSTRUAL DISORDER, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALLERGY TO METALS, WEIGHT INCREASED AND ASTHENIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, DECREASED ACTIVITY, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, INVESTIGATION NONCOMPLIANCE, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS NOT ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. SHE DID NOT EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.3 KG/SQM. ULTRASOUND SCAN: IN 2013: COILS WERE NOT INSERTED PROPERLY AND WERE POKING O CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY. CONFIRMING CHRONIC PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. LAB DATA UPDATED. EVENTS: MIGRAINES, COILS WERE NOT INSERTED PROPERLY AND WERE POKING OUT OF THE FALLOPIAN TUBES, LOW ENERGY LEVELS, RESULTING IN INACTIVITY WERE NEWLY ADDED. INCIDENT. AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/SHARP STABBING PAIN") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610(VALID), 92703(INVALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I AND PARITY 1 ((B)(6) 1997). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA IN 1995 AND SYNTHROID. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENSTRUAL DISORDER ("UNUSUAL MENSTRUAL CYCLE"), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE") WITH RASH, WEIGHT INCREASED ("GAINED WEIGHT DUE TO THE LOW ENERGY WHEN ANY ACTIVITIES ARE BEING DONE BY THE PLAINTIFF"), INVESTIGATION NONCOMPLIANCE ("DID NOT UNDERGO AN ESSURE CONFIRMATION TEST"), TREATMENT NONCOMPLIANCE ("DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING ESSURE PLACEMENT PROCEDURE"), ASTHENIA ("LOW ENERGY") AND DYSMENORRHOEA ("UNUSUAL MENSTRUAL CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE.). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENSTRUAL DISORDER, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALLERGY TO METALS, WEIGHT INCREASED AND ASTHENIA HAD NOT RESOLVED AND THE INVESTIGATION NONCOMPLIANCE, TREATMENT NONCOMPLIANCE AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, DYSMENORRHOEA, DYSPAREUNIA, INVESTIGATION NONCOMPLIANCE, MENSTRUAL DISORDER, PELVIC PAIN, TREATMENT NONCOMPLIANCE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS NOT ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE SHE DID NOT EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.3 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-FEB-2018: QUALITY-SAFETY EVALUATION OF PTC. 92703 IS NOT A VALID ESSURE BATCH NUMBER. INCIDENT. AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/SHARP STABBING PAIN") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610(VALID), 92703) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY" ON (B)(6) 2012. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6) 1997), CARPAL TUNNEL SYNDROME, HYPOTHYROIDISM, HYPERTENSION, HYPOTHYROIDISM, TUBAL LIGATION AND SMOKER. SHE NEVER USED ALCOHOL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA IN 1995, SYNTHROID AND CODEINE. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DIZZINESS WITH CODEINE. CONCURRENT CONDITIONS INCLUDED OBESITY, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, LEUKORRHEA, HEADACHE, VAGINAL HYSTERECTOMY (REMOVAL OF BOTH FALLOPIAN TUBES AT SAME OPERATIVE EPISODE), THYROIDECTOMY, CHOLECYSTECTOMY, CESAREAN SECTION (CESAREAN DELIVERY), UTERINE PROLAPSE (WITHOUT MENTION OF VAGINAL WALL PROLAPSE), OBESITY AND GENERAL ANESTHESIA. FAMILY HISTORY INCLUDED TYPE II DIABETES MELLITUS, BLOOD PRESSURE HIGH (FATHER) AND HEART ATTACK. CONCOMITANT PRODUCTS INCLUDED HYDROCHLOROTHIAZIDE, LEVOTHYROXINE AND MULTIVITAMIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENSTRUAL DISORDER ("UNUSUAL MENSTRUAL CYCLE"), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE") WITH RASH, WEIGHT INCREASED ("GAINED WEIGHT DUE TO THE LOW ENERGY WHEN ANY ACTIVITIES ARE BEING DONE BY THE PLAINTIFF"), INVESTIGATION NONCOMPLIANCE ("DID NOT UNDERGO AN ESSURE CONFIRMATION TEST"), TREATMENT NONCOMPLIANCE ("DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING ESSURE PLACEMENT PROCEDURE"), ASTHENIA ("LOW ENERGY") AND DYSMENORRHOEA ("UNUSUAL MENSTRUAL CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, VAGINAL WITH BILATERAL HEMISALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENSTRUAL DISORDER, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALLERGY TO METALS, WEIGHT INCREASED AND ASTHENIA HAD NOT RESOLVED AND THE INVESTIGATION NONCOMPLIANCE, TREATMENT NONCOMPLIANCE AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, DYSMENORRHOEA, DYSPAREUNIA, INVESTIGATION NONCOMPLIANCE, MENSTRUAL DISORDER, PELVIC PAIN, TREATMENT NONCOMPLIANCE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS NOT ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE SHE DID NOT EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.3 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY. CONFIRMING CHRONIC PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-FEB-2018: MEDICAL RECORDS RECEIVED. NEW REPORTER, PATIENT RELEVANT, CONCURRENT CONDITION AND CONCOMITANT MEDICATIONS INCLUDING LEVOTHYROXINE, MULTIVITAMIN AND HYDROCHLOROTHIAZIDE WERE ADDED. EVENT ADDED PER MR: ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY. INCIDENT. AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('COILS WERE NOT INSERTED PROPERLY AND WERE POKING OUT OF THE FALLOPIAN TUBES'), EMBEDDED DEVICE ('MYOMETRIUM: ESSURE COIL IDENTIFIED') AND PELVIC PAIN ('SEVERE PELVIC PAIN/SHARP STABBING PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610(VALID), 92703, 927073) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: TREATMENT NONCOMPLIANCE "DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING ESSURE PLACEMENT PROCEDURE", MEDICAL DEVICE MONITORING ERROR "ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6)1997), CARPAL TUNNEL SYNDROME, HYPOTHYROIDISM, HYPERTENSION, HYPOTHYROIDISM, TUBAL LIGATION AND SMOKER. SHE NEVER USED ALCOHOL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA, SYNTHROID AND CODEINE. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DIZZINESS WITH CODEINE. CONCURRENT CONDITIONS INCLUDED OBESITY, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, LEUKORRHEA, HEADACHE, VAGINAL HYSTERECTOMY (REMOVAL OF BOTH FALLOPIAN TUBES AT SAME OPERATIVE EPISODE), THYROIDECTOMY, CHOLECYSTECTOMY, CESAREAN SECTION (CESAREAN DELIVERY), UTERINE PROLAPSE (WITHOUT MENTION OF VAGINAL WALL PROLAPSE), OBESITY, GENERAL ANESTHESIA AND CERVICITIS. FAMILY HISTORY INCLUDED TYPE II DIABETES MELLITUS, BLOOD PRESSURE HIGH (FATHER) AND HEART ATTACK. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID) AND VITAMINS NOS (MULTIVITAMIN). IN 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING"). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("UNUSUAL MENSTRUAL CYCLE"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND DYSMENORRHOEA ("UNUSUAL MENSTRUAL CRAMPING"). IN (B)(6)2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("MYOMETRIUM: ESSURE COIL IDENTIFIED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE") WITH RASH, ASTHENIA ("LOW ENERGY") AND DECREASED ACTIVITY ("LOW ENERGY LEVELS, RESULTING IN INACTIVITY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINED WEIGHT DUE TO THE LOW ENERGY WHEN ANY ACTIVITIES ARE BEING DONE BY THE PLAINTIFF"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, VAGINAL WITH BILATERAL HEMISALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, DEVICE EXPULSION, DYSMENORRHOEA, MIGRAINE AND DECREASED ACTIVITY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, MENSTRUAL DISORDER, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALLERGY TO METALS, WEIGHT INCREASED AND ASTHENIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, DECREASED ACTIVITY, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS NOT ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE SHE DID NOT EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.3 KG/SQM. ULTRASOUND SCAN - IN 2013: RESULTS: COILS WERE NOT INSERTED PROPERLY AND WERE POKING OUT OF FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY. CONFIRMING CHRONIC PELVIC PAIN, ABDOMINAL PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, DEVICE EXPULSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-OCT-2020: MEDICAL RECORDS RECEIVED. EVENT ADDED: MYOMETRIUM: ESSURE COIL IDENTIFIED. LOT NUMBER, CONCOMITANT DRUGS, AND MEDICAL HISTORY WERE ADDED. EVENT INVESTIGATION NONCOMPLIANCE UPDATED TO DEVICE MONITORING PROCEDURE NOT PERFORMED. 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 DEVICE DISLOCATION ('COILS WERE NOT INSERTED PROPERLY AND WERE POKING OUT OF THE FALLOPIAN TUBES'), EMBEDDED DEVICE ('MYOMETRIUM: ESSURE COIL IDENTIFIED') AND PELVIC PAIN ('SEVERE PELVIC PAIN/SHARP STABBING PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 92703-INV, 922610, 927073) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: TREATMENT NONCOMPLIANCE "DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING ESSURE PLACEMENT PROCEDURE", MEDICAL DEVICE MONITORING ERROR "ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 (B)(6) 1997), CARPAL TUNNEL SYNDROME, HYPOTHYROIDISM, HYPERTENSION, HYPOTHYROIDISM, TUBAL LIGATION AND SMOKER. SHE NEVER USED ALCOHOL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA, SYNTHROID AND CODEINE. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DIZZINESS WITH CODEINE. CONCURRENT CONDITIONS INCLUDED OBESITY, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, LEUKORRHEA, HEADACHE, VAGINAL HYSTERECTOMY (REMOVAL OF BOTH FALLOPIAN TUBES AT SAME OPERATIVE EPISODE), THYROIDECTOMY, CHOLECYSTECTOMY, CESAREAN SECTION (CESAREAN DELIVERY), UTERINE PROLAPSE (WITHOUT MENTION OF VAGINAL WALL PROLAPSE), OBESITY, GENERAL ANESTHESIA AND CERVICITIS. FAMILY HISTORY INCLUDED TYPE II DIABETES MELLITUS, BLOOD PRESSURE HIGH (FATHER) AND HEART ATTACK. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID) AND VITAMINS NOS (MULTIVITAMIN). IN 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("UNUSUAL MENSTRUAL CYCLE"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND DYSMENORRHOEA ("UNUSUAL MENSTRUAL CRAMPING"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("MYOMETRIUM: ESSURE COIL IDENTIFIED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE") WITH RASH, ASTHENIA ("LOW ENERGY") AND DECREASED ACTIVITY ("LOW ENERGY LEVELS, RESULTING IN INACTIVITY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINED WEIGHT DUE TO THE LOW ENERGY WHEN ANY ACTIVITIES ARE BEING DONE BY THE PLAINTIFF"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, VAGINAL WITH BILATERAL HEMISALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, DEVICE EXPULSION, DYSMENORRHOEA, MIGRAINE AND DECREASED ACTIVITY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, MENSTRUAL DISORDER, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALLERGY TO METALS, WEIGHT INCREASED AND ASTHENIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, DECREASED ACTIVITY, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS NOT ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. SHE DID NOT EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.3 KG/SQM. ULTRASOUND SCAN - IN 2013: RESULTS: COILS WERE NOT INSERTED PROPERLY AND WERE POKING OUT OF FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ESSURE AND NOVASURE THERMAL ABLATION PERFORMED ON SAME DAY. CONFIRMING CHRONIC PELVIC PAIN, ABDOMINAL PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, DEVICE EXPULSION. BATCH # 92703 IS INVALID. LOT NUMBER:922610 MANUFACTURE DATE:2011-11 EXPIRATION DATE:2014-11. LOT NUMBER:927073 MANUFACTURE DATE:2011-12 EXPIRATION DATE: 2014-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-OCT-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 ("SEVERE PELVIC PAIN/ SHARP STABBING PAIN") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 92703, 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I AND PARITY 1 ((B)(6)). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA IN 1995 AND SYNTHROID. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENSTRUAL DISORDER ("UNUSUAL MENSTRUAL CYCLE"), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE") WITH RASH, WEIGHT INCREASED ("GAINED WEIGHT DUE TO THE LOW ENERGY WHEN ANY ACTIVITIES ARE BEING DONE BY THE PLAINTIFF"), INVESTIGATION NON-COMPLIANCE ("DID NOT UNDERGO AN ESSURE CONFIRMATION TEST"), TREATMENT NONCOMPLIANCE ("DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING ESSURE PLACEMENT PROCEDURE"), ASTHENIA ("LOW ENERGY") AND DYSMENORRHOEA ("UNUSUAL MENSTRUAL CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE.). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENSTRUAL DISORDER, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALLERGY TO METALS, WEIGHT INCREASED AND ASTHENIA HAD NOT RESOLVED AND THE INVESTIGATION NONCOMPLIANCE, TREATMENT NONCOMPLIANCE AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, DYSMENORRHOEA, DYSPAREUNIA, INVESTIGATION NONCOMPLIANCE, MENSTRUAL DISORDER, PELVIC PAIN, TREATMENT NONCOMPLIANCE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS NOT ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. SHE DID NOT EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.3 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JAN-2018: REPORTERS ADDED, EVENT UNUSUAL MENSTRUAL CYCLE, CRAMPING, PAINFUL INTERCOURSE HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE, ARMS REGULARLY GET A RASH/ BACK REGULARLY GET A RASH/ LEGS REGULARLY GET A RASH THE PLAINTIFF ALSO HAS GAINED WEIGHT DUE TO THE LOW ENERGY WHEN ANY ACTIVITIES ARE BEING DONE BY THE PLAINTIFF, DID NOT UNDERGO AN ESSURE CONFIRMATION TEST, DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING ESSURE PLACEMENT PROCEDURE AND LOW ENERGY AND UNUSUAL MENSTRUAL CRAMPING WERE ADDED, PRODUCT STOP DATE AND LOT NUMBER ADDED. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON OR ABOUT (B)(6) 2013, PLAINTIFF UNDERWENT A HYSTERECTOMY TO REMOVE THE ESSURE DEVICE.). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 774021 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 92703-INV, 922610, 927073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| MULTIVITAMIN| MULTIVITAMIN| MULTIVITAMIN [VITAMINS NOS]| MULTIVITAMIN [VITAMINS NOS]| SYNTHROID| SYNTHROID |