ESSURE
Report
- Report Number
- 2951250-2016-02319
- Event Type
- Injury
- Date Received
- October 26, 2016
- Date of Event
- August 1, 2005
- Report Date
- May 6, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12273369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA, WEIGHT GAIN, BREAST TENDERNESS, DYSLIPIDEMIA, URINARY INCONTINENCE, RIGHT UPPER QUADRANT PAIN, HEARTBURN, CHOLECYSTITIS, STRESS INCONTINENCE, FEMALE AND CYSTOCELE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: RIMANTADINE AND DICLOXACILLIN. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH, CERVICAL CANCER AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MOMETASONE FUROATE (ELOCON), PHENTERMINE, RIMANTADINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT). IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN/ BACK PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDE/URINARY TRACT/VAGINAL)-UTI"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES:URINE INCONTINENCE"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), ABDOMINAL PAIN LOWER ("PAINFUL CRAMPING"), GENITAL INFECTION FEMALE ("GENITAL INFECTION") WITH VAGINAL DISCHARGE, FATIGUE ("FATIGUE") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL DISTENSION ("STOMACH BLOAT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, HYPERSENSITIVITY, ABDOMINAL PAIN LOWER, GENITAL INFECTION FEMALE, BACK PAIN, FATIGUE, HEADACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL INFECTION FEMALE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: MOST IF NOT ALL SYMPTOMS WERE DECREASED FOLLOWING ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; PELVIC PAIN, MENORRHAGIA, URINARY INCONTINENCE, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: INFORMATION RECEIVED VIA SOCIAL MEDIA. EVENT" ABDOMINAL DISTENSION AND WEIGHT GAIN" WAS ADDED. PREVIOUSLY REPORTED EVENT" GENITAL BLEEDING" SERIOUSNESS CRITERIA UPDATED TO NON-SERIOUS. FOLLOW UP 6 AND 7 PROCESSES TOGETHER ON 20-MAR-2020: INFORMATION RECEIVED VIA SOCIAL MEDIA. NO NEW CLINICAL INFOMATION RECEIVED. 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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12273369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA, WEIGHT GAIN, BREAST TENDERNESS, DYSLIPIDEMIA, URINARY INCONTINENCE, RIGHT UPPER QUADRANT PAIN, HEARTBURN, CHOLECYSTITIS, STRESS INCONTINENCE, FEMALE AND CYSTOCELE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: RIMANTADINE AND DICLOXACILLIN. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH, CERVICAL CANCER AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MOMETASONE FUROATE (ELOCON), PHENTERMINE, RIMANTADINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT). IN (B)(6)2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN/ BACK PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADE/URINARY TRACT/VAGINAL)-UTI"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES:URINE INCONTINENCE"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6)2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), ABDOMINAL PAIN LOWER ("PAINFUL CRAMPING"), GENITAL INFECTION FEMALE ("GENITAL INFECTION") WITH VAGINAL DISCHARGE, FATIGUE ("FATIGUE") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL DISTENSION ("STOMACH BLOAT"), WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UNDERWENT URINARY BLADDER SUSPENSION ("BLADDER LIFTED"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE (ESS205) WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, HYPERSENSITIVITY, ABDOMINAL PAIN LOWER, GENITAL INFECTION FEMALE, BACK PAIN, FATIGUE, HEADACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN, WEIGHT INCREASED AND URINARY BLADDER SUSPENSION OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL INFECTION FEMALE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, URINARY BLADDER SUSPENSION, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: MOST IF NOT ALL SYMPTOMS WERE DECREASED FOLLOWING ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2005: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; PELVIC PAIN, MENORRHAGIA, URINARY INCONTINENCE, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA WAS RECEIVED. EVENT ADDED- BLADDER LIFTED. REPORTER WERE 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 ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12273369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA, WEIGHT GAIN, BREAST TENDERNESS, DYSLIPIDEMIA, URINARY INCONTINENCE, RIGHT UPPER QUADRANT PAIN, HEARTBURN, CHOLECYSTITIS, STRESS INCONTINENCE, FEMALE AND CYSTOCELE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: RIMANTADINE AND DICLOXACILLIN. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH, CERVICAL CANCER AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MOMETASONE FUROATE (ELOCON), PHENTERMINE, RIMANTADINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN/ BACK PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDE/URINARY TRACT/VAGINAL)-UTI"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES:URINE INCONTINENCE"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), ABDOMINAL PAIN LOWER ("PAINFUL CRAMPING"), GENITAL INFECTION FEMALE ("GENITAL INFECTION") WITH VAGINAL DISCHARGE, FATIGUE ("FATIGUE") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL DISTENSION ("STOMACH BLOAT"), WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UNDERWENT URINARY BLADDER SUSPENSION ("BLADDER LIFTED"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, HYPERSENSITIVITY, ABDOMINAL PAIN LOWER, GENITAL INFECTION FEMALE, BACK PAIN, FATIGUE, HEADACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN, WEIGHT INCREASED AND URINARY BLADDER SUSPENSION OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL INFECTION FEMALE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, URINARY BLADDER SUSPENSION, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: MOST IF NOT ALL SYMPTOMS WERE DECREASED FOLLOWING ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; PELVIC PAIN, MENORRHAGIA, URINARY INCONTINENCE, DYSPAREUNIA. LOT NUMBER: 12273369 MANUFACTURING DATE: 2005-03 EXPIRATION DATE: 2006-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-APR-2020: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12273369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA, WEIGHT GAIN, BREAST TENDERNESS, DYSLIPIDEMIA, URINARY INCONTINENCE, RIGHT UPPER QUADRANT PAIN, HEARTBURN, CHOLECYSTITIS, STRESS INCONTINENCE, FEMALE AND CYSTOCELE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: RIMANTADINE AND DICLOXACILLIN. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH, CERVICAL CANCER AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MOMETASONE FUROATE (ELOCON), PHENTERMINE, RIMANTADINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT). IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN/ BACK PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDE/URINARY TRACT/VAGINAL)-UTI"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES:URINE INCONTINENCE"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), ABDOMINAL PAIN LOWER ("PAINFUL CRAMPING"), GENITAL INFECTION FEMALE ("GENITAL INFECTION") WITH VAGINAL DISCHARGE, FATIGUE ("FATIGUE") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VULVOVAGINAL PAIN ("VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, HYPERSENSITIVITY, ABDOMINAL PAIN LOWER, GENITAL INFECTION FEMALE, BACK PAIN, FATIGUE, HEADACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL INFECTION FEMALE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: MOST IF NOT ALL SYMPTOMS WERE DECREASED FOLLOWING ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; PELVIC PAIN, MENORRHAGIA, URINARY INCONTINENCE, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-MAR-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12273369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: RIMANTADINE AND DICLOXACILLIN. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH, CERVICAL CANCER AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MOMETASONE FUROATE (ELOCON), PHENTERMINE, RIMANTADINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT). IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN/ BACK PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDE/URINARY TRACT/VAGINAL)-UTI"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES:URINE INCONTINENCE"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6)2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), ABDOMINAL PAIN LOWER ("PAINFUL CRAMPING"), GENITAL INFECTION FEMALE ("GENITAL INFECTION") WITH VAGINAL DISCHARGE, FATIGUE ("FATIGUE") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VULVOVAGINAL PAIN ("VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE (ESS205) WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, HYPERSENSITIVITY, ABDOMINAL PAIN LOWER, GENITAL INFECTION FEMALE, BACK PAIN, FATIGUE, HEADACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL INFECTION FEMALE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: MOST IF NOT ALL SYMPTOMS WERE DECREASED FOLLOWING ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2005: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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 15-FEB-2019: PFS RECEIVED. REPORTER'S INFORMATION AND LOT NUMBER WAS ADDED. EVENTS ADDED: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), UTI, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), URINE INCONTINENCE, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL PAIN. MEDICAL HISTORY AND CONCOMITANT DRUGS, 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.
FOLLOW UP 14-NOV-2016: QUALITY-SAFETY EVALUATION OF PTC PTC GLOBAL NUMBER: (B)(4). NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERTS) INSERTED AND EXPERIENCED PELVIC PAIN AND PERSISTENT BLEEDING. THESE EVENTS ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN AND CHANGES IN BLEEDING PATTERN, INCLUDING UNSCHEDULED AND HEAVY BLEEDING, MAY OCCUR WITHIN CONSUMERS UNDER ESSURE USE. THUS, BASED ON A POSITIVE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THESE BOTH EVENTS AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. OTHER NONSERIOUS EVENTS WERE REPORTED. A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO ACTIVE FOLLOW-UP IS ALLOWED AND FURTHER INFORMATION IS EXPECTED ONLY THROUGH LITIGATION PROCESS
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER ON 03-OCT-2016 IN THE UNITED STATES, ON BEHALF AN ADULT (>=18Y & <65Y) FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2005 FOR BIRTH CONTROL. IN OR AROUND 2013, THE PLAINTIFF BEGAN SUFFERING FROM EXCRUCIATING PELVIC AND ABDOMINAL PAIN, ALLERGIC REACTIONS, PAINFUL CRAMPING, DISCHARGE, INFECTION, PERSISTENT BLEEDING SEVERE BACK PAIN, FATIGUE, HEADACHES, AND MORE. THERE WAS NO INDICATION TO THE PLAINTIFF THAT THE SYMPTOMS WERE RELATED TO THE ESSURE DEVICE INSIDE HER BODY. ON OR ABOUT (B)(6) 2014, SHE WAS FORCED TO UNDERGO A SURGERY TO REMOVE THE ESSURE COILS, INCLUDING A HYSTERECTOMY. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERTS) INSERTED AND EXPERIENCED PELVIC PAIN AND PERSISTENT BLEEDING. THESE EVENTS ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN AND CHANGES IN BLEEDING PATTERN, INCLUDING UNSCHEDULED AND HEAVY BLEEDING, MAY OCCUR WITHIN CONSUMERS UNDER ESSURE USE. THUS, BASED ON A POSITIVE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THESE BOTH EVENTS AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. OTHER NONSERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. NO ACTIVE FOLLOW-UP IS ALLOWED AND FURTHER INFORMATION IS EXPECTED ONLY THROUGH LITIGATION PROCESS
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708335 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12273369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| ELOCON| ELOCON| ELOCON| ELOCON| ELOCON| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| PHENTERMINE| PHENTERMINE| PHENTERMINE| PHENTERMINE| PHENTERMINE| RIMANTADINE| RIMANTADINE| RIMANTADINE| RIMANTADINE| RIMANTADINE| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT |