ESSURE
Report
- Report Number
- 2951250-2017-02517
- Event Type
- Injury
- Date Received
- July 18, 2017
- Report Date
- February 11, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
CONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/ SEVERE PAIN"), FALLOPIAN TUBE PERFORATION ("THE PATIENTS ESSURE DEVICE WAS SUB SEROSAL AND WAS IN THE PROXIMAL SEGMENT OF HER LEFT FALLOPIAN TUBE AND THE BLIND-ENDING PORTION OF HER FALLOPIAN TUBE AND HAD PARTIALLY PERFORATED THE FALLOPIAN TUBE STUB FROM A PREVIOUS ECTOPIC EXCISION.") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. R12451361,L20227507) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 1 (DATE OF BIRTH : (B)(6) 2008), MISCARRIAGE, ECTOPIC PREGNANCY, PERITONEAL EFFUSION, SALPINGECTOMY, CARDIAC CATHETERIZATION, SPONTANEOUS ABORTION, SPASM OF MUSCLE, CHEST PAIN, ANXIETY, BIPOLAR DISORDER AND BIPOLAR DISORDER. CONCURRENT CONDITIONS INCLUDED OBESITY, PROCEDURAL BLEEDING AND FITZ-HUGH-CURTIS SYNDROME. FAMILY HISTORY INCLUDED UNSPECIFIED ESSENTIAL HYPERTENSION (MOTHER , FATHER MATERNAL AUNT,PATERNAL AUNT) AND HEART DISEASE, UNSPECIFIED (MATERNAL GRANDPARENTS, PATERNAL GRANDPARENTS, MATERNAL AUNT, PATERNAL AUNT). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FROM (B)(6) 2010 TO (B)(6) 2010, METHOCARBAMOL (ROBAXIN) FROM 2015 TO 2016, PROPRANOLOL SINCE 2013 AND RIZATRIPTAN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE"), MIGRAINE ("WORSENING OF HER MIGRAINE HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES") AND FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"), ERYTHEMA ("REDNESS / RASHES OR SKIN CONDITIONS :REDNESS"), PRURITUS ("ITCHING / RASHES OR SKIN CONDITIONS : ITCHING"), ALOPECIA ("HAIR LOSS") AND ACNE ("RASHES OR SKIN CONDITIONS : ACNE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), MENSTRUAL DISORDER ("ABNORMAL MENSES"), RASH ("TOPICAL RASHES"), HYPOAESTHESIA ("NUMBNESS OF FEET, HANDS, LIPS, FACE, AND TONGUE"), VAGINAL INFECTION ("VAGINAL INFECTION"), VISION BLURRED ("BLURRED VISION"), AMNESIA ("MEMORY LOSS"), RHINITIS ALLERGIC ("NASAL ALLERGIES"), ANAEMIA ("ANEMIA"), BREAST PAIN ("MASTALGIA"), DYSGEUSIA ("METALIC TASTE IN MOUTH"), DENTAL CARIES ("TOOTH DECAY"), TOOTH LOSS ("TOOTH LOSS/ HAD TO HAVE EIGHT TEETH EXTRACTED"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ATTENTION DEFICIT/HYPERACTIVITY DISORDER ("ADULT ONSET ATTENTION DEFICIT DISORDER"), FIBROMYALGIA ("FIBROMYALGIA"), HYPOAESTHESIA ORAL ("NUMBNESS OF FEET, HANDS, LIPS, FACE, AND TONGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)") AND NECK PAIN ("NECK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ROBOTIC HYSTERECTOMY BILATERAL SALPINGECTOMY CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, MIGRAINE, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, WEIGHT INCREASED, HYPOAESTHESIA, VAGINAL DISCHARGE, VAGINAL INFECTION, ALOPECIA, VISION BLURRED, AMNESIA, RHINITIS ALLERGIC, ANAEMIA, BREAST PAIN, DYSGEUSIA, DENTAL CARIES, TOOTH LOSS, DEPRESSION, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, FIBROMYALGIA AND HYPOAESTHESIA ORAL WAS RESOLVING, THE FALLOPIAN TUBE PERFORATION, HEADACHE, FATIGUE, VAGINAL HAEMORRHAGE AND NECK PAIN OUTCOME WAS UNKNOWN AND THE RASH, ERYTHEMA, PRURITUS AND ACNE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ACNE, ALOPECIA, AMNESIA, ANAEMIA, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, BACK PAIN, BREAST PAIN, DENTAL CARIES, DEPRESSION, DYSGEUSIA, DYSPAREUNIA, ERYTHEMA, FALLOPIAN TUBE PERFORATION, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, HYPOAESTHESIA ORAL, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NECK PAIN, PELVIC PAIN, PRURITUS, RASH, RHINITIS ALLERGIC, TOOTH LOSS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.5 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: FALLOPIAN TUBE PERFORATION, PELVIC PAIN BATCH NUMBER: 12451361 MAN DATE: JUL-2010 EXP DATE: JUN-2013 BATCH NUMBER: 20227507 MAN DATE: NOV-2009 (B)(6) 2009 EXP DATE: NOV-2012 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PTC ON (B)(6) 2018: PFS RECEIVED- NO NEW INFORMATION 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/ SEVERE PAIN"), FALLOPIAN TUBE PERFORATION ("THE PATIENTS ESSURE DEVICE WAS SUB SEROSAL AND WAS IN THE PROXIMAL SEGMENT OF HER LEFT FALLOPIAN TUBE AND THE BLIND-ENDING PORTION OF HER FALLOPIAN TUBE AND HAD PARTIALLY PERFORATED THE FALLOPIAN TUBE STUB FROM A PREVIOUS ECTOPIC EXCISION.") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. R12451361,L20227507) 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 "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 1 (DATE OF BIRTH : (B)(6) 2008), MISCARRIAGE, ECTOPIC PREGNANCY, PERITONEAL EFFUSION, SALPINGECTOMY, CARDIAC CATHETERIZATION, SPONTANEOUS ABORTION, SPASM OF MUSCLE, CHEST PAIN, ANXIETY AND BIPOLAR DISORDER. CONCURRENT CONDITIONS INCLUDED OBESITY, PROCEDURAL BLEEDING, FITZ-HUGH-CURTIS SYNDROME, MIGRAINE AND HEADACHE. FAMILY HISTORY INCLUDED UNSPECIFIED ESSENTIAL HYPERTENSION (MOTHER , FATHER MATERNAL AUNT,PATERNAL AUNT) AND HEART DISEASE, UNSPECIFIED (MATERNAL GRANDPARENTS, PATERNAL GRANDPARENTS, MATERNAL AUNT, PATERNAL AUNT). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2010 TO (B)(6) 2010, METHOCARBAMOL (ROBAXIN) FROM 2015 TO 2016, PROPRANOLOL SINCE 2013 AND RIZATRIPTAN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE"), MIGRAINE ("WORSENING OF HER MIGRAINE HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES") AND FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED ERYTHEMA ("REDNESS / RASHES OR SKIN CONDITIONS :REDNESS"), PRURITUS ("ITCHING / RASHES OR SKIN CONDITIONS : ITCHING"), ALOPECIA ("HAIR LOSS") AND ACNE ("RASHES OR SKIN CONDITIONS : ACNE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), MENSTRUAL DISORDER ("ABNORMAL MENSES"), RASH ("TOPICAL RASHES"), HYPOAESTHESIA ("NUMBNESS OF FEET, HANDS, LIPS, FACE, AND TONGUE"), VAGINAL INFECTION ("VAGINAL INFECTION"), VISION BLURRED ("BLURRED VISION"), AMNESIA ("MEMORY LOSS"), RHINITIS ALLERGIC ("NASAL ALLERGIES"), ANAEMIA ("ANEMIA"), BREAST PAIN ("MASTALGIA"), DYSGEUSIA ("METALIC TASTE IN MOUTH"), DENTAL CARIES ("TOOTH DECAY"), TOOTH LOSS ("TOOTH LOSS/ HAD TO HAVE EIGHT TEETH EXTRACTED"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ATTENTION DEFICIT/HYPERACTIVITY DISORDER ("ADULT ONSET ATTENTION DEFICIT DISORDER"), FIBROMYALGIA ("FIBROMYALGIA"), HYPOAESTHESIA ORAL ("NUMBNESS OF FEET, HANDS, LIPS, FACE, AND TONGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)") AND NECK PAIN ("NECK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ROBOTIC HYSTERECTOMY BILATERAL SALPINGECTOMY CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, MIGRAINE, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, WEIGHT INCREASED, HYPOAESTHESIA, VAGINAL DISCHARGE, VAGINAL INFECTION, ALOPECIA, VISION BLURRED, AMNESIA, RHINITIS ALLERGIC, ANAEMIA, BREAST PAIN, DYSGEUSIA, DENTAL CARIES, TOOTH LOSS, DEPRESSION, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, FIBROMYALGIA AND HYPOAESTHESIA ORAL WAS RESOLVING, THE FALLOPIAN TUBE PERFORATION, HEADACHE, FATIGUE, VAGINAL HAEMORRHAGE AND NECK PAIN OUTCOME WAS UNKNOWN AND THE RASH, ERYTHEMA, PRURITUS AND ACNE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ACNE, ALOPECIA, AMNESIA, ANAEMIA, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, BACK PAIN, BREAST PAIN, DENTAL CARIES, DEPRESSION, DYSGEUSIA, DYSPAREUNIA, ERYTHEMA, FALLOPIAN TUBE PERFORATION, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, HYPOAESTHESIA ORAL, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NECK PAIN, PELVIC PAIN, PRURITUS, RASH, RHINITIS ALLERGIC, TOOTH LOSS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.5 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: FALLOPIAN TUBE PERFORATION, PELVIC PAIN. BATCH NUMBER: 12451361, MAN DATE: JUL-2010, EXP DATE: JUN-2013. BATCH NUMBER: 20227507, MAN DATE: NOV-2009, EXP DATE: NOV-2012. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-FEB-2019: PFS RECEIVED. EVENT ADDED: SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST. MEDICAL HISTORY WAS ADDED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER 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 ("SEVERE PELVIC PAIN/ SEVERE PAIN"), FALLOPIAN TUBE PERFORATION ("THE PATIENTS ESSURE DEVICE WAS SUB SEROSAL AND WAS IN THE PROXIMAL SEGMENT OF HER LEFT FALLOPIAN TUBE AND THE BLIND-ENDING PORTION OF HER FALLOPIAN TUBE AND HAD PARTIALLY PERFORATED THE FALLOPIAN TUBE STUB FROM A PREVIOUS ECTOPIC EXCISION.") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. (RIGHT) 12451361, (LEFT) 20227507) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 1 (DATE OF BIRTH : (B)(6) 2008), MISCARRIAGE, ECTOPIC PREGNANCY, PERITONEAL FLUID PROTEIN ABNORMAL, SALPINGECTOMY, CARDIAC CATHETERIZATION, SPONTANEOUS ABORTION, SPASM OF MUSCLE, CHEST PAIN, ANXIETY, BIPOLAR DISORDER AND BIPOLAR DISORDER. CONCURRENT CONDITIONS INCLUDED OBESITY, PROCEDURAL BLEEDING AND FITZ-HUGH-CURTIS SYNDROME. FAMILY HISTORY INCLUDED UNSPECIFIED ESSENTIAL HYPERTENSION (MOTHER , FATHER MATERNAL AUNT,PATERNAL AUNT) AND HEART DISEASE, UNSPECIFIED (MATERNAL GRANDPARENTS, PATERNAL GRANDPARENTS, MATERNAL AUNT, PATERNAL AUNT). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) ON (B)(6) 2010, METHOCARBAMOL (ROBAXIN) FROM 2015 TO 2016, PROPRANOLOL SINCE 2013 AND RIZATRIPTAN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE"), MIGRAINE ("WORSENING OF HER MIGRAINE HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES") AND FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"), ERYTHEMA ("REDNESS / RASHES OR SKIN CONDITIONS:REDNESS"), PRURITUS ("ITCHING / RASHES OR SKIN CONDITIONS: ITCHING"), ALOPECIA ("HAIR LOSS") AND ACNE ("RASHES OR SKIN CONDITIONS: ACNE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), MENSTRUAL DISORDER ("ABNORMAL MENSES"), RASH ("TOPICAL RASHES"), HYPOAESTHESIA ("NUMBNESS OF FEET, HANDS, LIPS, FACE, AND TONGUE"), VAGINAL INFECTION ("VAGINAL INFECTION"), VISION BLURRED ("BLURRED VISION"), AMNESIA ("MEMORY LOSS"), RHINITIS ALLERGIC ("NASAL ALLERGIES"), ANAEMIA ("ANEMIA"), BREAST PAIN ("MASTALGIA"), DYSGEUSIA ("METALIC TASTE IN MOUTH"), DENTAL CARIES ("TOOTH DECAY"), TOOTH LOSS ("TOOTH LOSS/ HAD TO HAVE EIGHT TEETH EXTRACTED"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ATTENTION DEFICIT/HYPERACTIVITY DISORDER ("ADULT ONSET ATTENTION DEFICIT DISORDER"), FIBROMYALGIA ("FIBROMYALGIA"), HYPOAESTHESIA ORAL ("NUMBNESS OF FEET, HANDS, LIPS, FACE, AND TONGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)") AND NECK PAIN ("NECK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ROBOTIC HYSTERECTOMY BILATERAL AND SALPINGECTOMY, CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, MIGRAINE, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, WEIGHT INCREASED, HYPOAESTHESIA, VAGINAL DISCHARGE, VAGINAL INFECTION, ALOPECIA, VISION BLURRED, AMNESIA, RHINITIS ALLERGIC, ANAEMIA, BREAST PAIN, DYSGEUSIA, DENTAL CARIES, TOOTH LOSS, DEPRESSION, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, FIBROMYALGIA, HYPOAESTHESIA ORAL AND GENITAL HAEMORRHAGE WAS RESOLVING, THE FALLOPIAN TUBE PERFORATION, HEADACHE, FATIGUE, VAGINAL HAEMORRHAGE AND NECK PAIN OUTCOME WAS UNKNOWN AND THE RASH, ERYTHEMA, PRURITUS AND ACNE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ACNE, ALOPECIA, AMNESIA, ANAEMIA, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, BACK PAIN, BREAST PAIN, DENTAL CARIES, DEPRESSION, DYSGEUSIA, DYSPAREUNIA, ERYTHEMA, FALLOPIAN TUBE PERFORATION, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, HYPOAESTHESIA ORAL, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NECK PAIN, PELVIC PAIN, PRURITUS, RASH, RHINITIS ALLERGIC, TOOTH LOSS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.5 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: FALLOPIAN TUBE PERFORATION, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PLAINTIFF FACT SHEET & MEDICAL RECORD RECEIVED. EVENTS ACNE, HEADACHE, FATIGUE, ABNORMAL BLEEDING, VAGINAL BLEEDING, FALLOPIAN TUBE PERFORATION WERE ADDED. LOT NUMBER ADDED. LAB DATA UPDATED. CONCOMITANT ,HISTORICAL CONDITION & DRUG ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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/ SEVERE PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), MIGRAINE ("WORSENING OF HER MIGRAINE HEADACHES"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), MENSTRUAL DISORDER ("ABNORMAL MENSES"), WEIGHT INCREASED ("WEIGHT GAIN"), RASH ("TOPICAL RASHES"), ERYTHEMA ("REDNESS "), PRURITUS ("ITCHING"), HYPOAESTHESIA ("NUMBNESS OF FEET, HANDS, LIPS, FACE, AND TONGUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), ALOPECIA ("HAIR LOSS"), VISION BLURRED ("BLURRED VISION"), AMNESIA ("MEMORY LOSS"), RHINITIS ALLERGIC ("NASAL ALLERGIES"), ANAEMIA ("ANEMIA"), BREAST PAIN ("MASTALGIA"), DYSGEUSIA ("METALIC TASTE IN MOUTH"), DENTAL CARIES ("TOOTH DECAY"), TOOTH LOSS ("TOOTH LOSS/ HAD TO HAVE EIGHT TEETH EXTRACTED"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ATTENTION DEFICIT/HYPERACTIVITY DISORDER ("ADULT ONSET ATTENTION DEFICIT DISORDER") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A BILATERAL SALPINGECTOMY, DURING WHICH BOTH OF HER FALLOPIAN TUBES WERE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, MIGRAINE, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, WEIGHT INCREASED, RASH, ERYTHEMA, PRURITUS, HYPOAESTHESIA, VAGINAL DISCHARGE, VAGINAL INFECTION, ALOPECIA, VISION BLURRED, AMNESIA, RHINITIS ALLERGIC, ANAEMIA, BREAST PAIN, DYSGEUSIA, DENTAL CARIES, TOOTH LOSS, DEPRESSION, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND FIBROMYALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, AMNESIA, ANAEMIA, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, BACK PAIN, BREAST PAIN, DENTAL CARIES, DEPRESSION, DYSGEUSIA, DYSPAREUNIA, ERYTHEMA, FIBROMYALGIA, HYPOAESTHESIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, PRURITUS, RASH, RHINITIS ALLERGIC, TOOTH LOSS, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 502047 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | R12451361,L20227507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| PROPRANOLOL| PROPRANOLOL| PROPRANOLOL| RIZATRIPTAN| RIZATRIPTAN| RIZATRIPTAN| ROBAXIN| ROBAXIN| ROBAXIN |