ESSURE
Report
- Report Number
- 2951250-2017-02073
- Event Type
- Injury
- Date Received
- June 12, 2017
- Date of Event
- January 1, 2017
- Report Date
- March 20, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW (B)(4)) ON 30-MAY-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 13-JUN-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ CHRONIC PELVIC PAIN/ PAIN"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CAVITY") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SCABIES. CONCURRENT CONDITIONS INCLUDED DERMATITIS, UNSPECIFIED PRURITIC DISORDER, ECZEMA AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED ACETIC ACID, CHAPARRAL DANDELION BLEND, COLECALCIFEROL (VITAMIN D), EUCALYPTUS GLOBULUS OIL (EUCALYPTUS OIL), HERBAL PREPARATION, HYDROCORTISONE (HYDROCORTISON [HYDROCORTISONE]), HYDROXYZINE, IRON, MULTIVITAMINS, OLEA EUROPAEA LEAF EXTRACT (OLIVE LEAVES EXTRACT) AND ZINC. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH GENERALISED ("FULL BODY RASHES/ RASHES/ RASHES OR SKIN CONDITIONS TYPE: WHOLE BODY"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ALOPECIA ("LOST MOST OF MY NATURAL HAIR/ HAIR LOSS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, LIFE THREATENING AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENERALISED OEDEMA ("FLUID BUILD UP IN MY FACE, NECK, CHEST AND BACK/FLUID RETENSION IN MY LEGS AND ANKLE"), CYANOSIS ("OXYGEN DOES NOT FLOW PROPERLY IN MY SKIN"), SKIN DISCOLOURATION ("THE UPPER THIGH AND CHEST AND BACK SKIN HAS GOTTEN 2 SHADES DARKER"), HAEMOPTYSIS ("COUGHING UP BLOOD"), EPISTAXIS ("NOSE BLEEDS"), ABDOMINAL DISTENSION ("BLOATING") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2017 LAPAROSCOPIC REMOVAL OF ESSURE COIL; REMOVAL OF ESSURE COIL;) AND SURGERY (ON (B)(6) 2017 LAPAROSCOPIC REMOVAL OF ESSURE COIL; REMOVAL OF ESSURE COIL;). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALOPECIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL DISCHARGE AND WEIGHT INCREASED HAD RESOLVED AND THE DEVICE EXPULSION, GENITAL HAEMORRHAGE, RASH GENERALISED, GENERALISED OEDEMA, CYANOSIS, SKIN DISCOLOURATION, HAEMOPTYSIS, EPISTAXIS, ABDOMINAL DISTENSION, FEELING ABNORMAL, ALLERGY TO METALS, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, CYANOSIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EPISTAXIS, FEELING ABNORMAL, GENERALISED OEDEMA, GENITAL HAEMORRHAGE, HAEMOPTYSIS, MENORRHAGIA, PELVIC PAIN, RASH GENERALISED, SKIN DISCOLOURATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER LIFE WAS DESTROYED, SHE IS NOT ABLE TO WORK AND JUST APPLIED FOR DISABILITY. LIFE-THREATENING, DISABILITY/PERMANENT DAMAGE AND INTERVENTION WERE MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: NEW REPORTERS ADDED. CASE MEDICALLY CONFIRMED. PATIENT¿S DEMOGRAPHICS ADDED. HISTORICAL AND CONCOMITANT CONDITIONS ADDED. NEW EVENTS ADDED: ABNORMAL BLEEDING (VAGINAL), MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CAVITY, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, AND WEIGHT GAIN. 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.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5069501) ON 30-MAY-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-MAR-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("DEVICE BREAKAGE"), PELVIC PAIN ("PELVIC PAIN/ CHRONIC PELVIC PAIN/ PAIN"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CAVITY") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SCABIES, SKIN LESION, SKIN INFLAMMATION, VULVOVAGINITIS, UTERINE BLEEDING, UTERINE FIBROID, OVARIAN CYST (LEFT OVARY), UTERINE ENLARGEMENT AND HIVES. SURGICAL PATHOLOGY-CH REPORT FINAL DIAGNOSIS: SUBMITTED AS RIGHT ESSURE COIL: FOREIGN BODY CONSISTENT WITH ESSURE COIL (GROSS DIAGNOSIS ONLY), SUBMITTED AS LEFT ESSURE COIL: FOREIGN BODY CONSISTENT WITH ESSURE COIL (GROSS DIAGNOSIS ONLY), RIGHT FALLOPIAN TUBE SALPINGECTOMY: PLICAL FIBROSIS, LEFT FALLOPIAN TUBE SALPINGECTOMY: PLICAL FIBROSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM (B)(6) TO (B)(6) , NUVARING AND DIAZEPAM. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED CONTRACEPTION WITH DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED DERMATITIS, UNSPECIFIED PRURITIC DISORDER, ECZEMA, OVERWEIGHT, UTERINE ENLARGEMENT, PEMPHIGUS VULGARIS, BLISTERS, INFLAMMATION, FIBROSIS, PEMPHIGUS VULGARIS, HYPERPIGMENTATION SKIN, FATIGUE, PAIN ANKLE, BLISTERS, PRURITIC RASH AND SKIN DISORDER. CONCOMITANT PRODUCTS INCLUDED ACETIC ACID, EUCALYPTUS GLOBULUS OIL (EUCALYPTUS OIL), HERBAL EXTRACT NOS (CHAPARRAL DANDELION BLEND), HERBAL PREPARATION, HYDROCORTISONE (HYDROCORTISON), HYDROXYZINE, IBUPROFEN, IRON, OLEA EUROPAEA LEAF EXTRACT (OLIVE LEAVES EXTRACT), VITAMIN D NOS (VITAMIN D), VITAMINS NOS (MULTIVITAMINS) AND ZINC. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH GENERALISED ("FULL BODY RASHES/ RASHES/ RASHES OR SKIN CONDITIONS TYPE: WHOLE BODY"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ALOPECIA ("LOST MOST OF MY NATURAL HAIR/ HAIR LOSS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, LIFE THREATENING AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENERALISED OEDEMA ("FLUID BUILD UP IN MY FACE, NECK, CHEST AND BACK/FLUID RETENSION IN MY LEGS AND ANKLE"), CYANOSIS ("OXYGEN DOES NOT FLOW PROPERLY IN MY SKIN"), SKIN DISCOLOURATION ("THE UPPER THIGH AND CHEST AND BACK SKIN HAS GOTTEN 2 SHADES DARKER"), HAEMOPTYSIS ("COUGHING UP BLOOD"), EPISTAXIS ("NOSE BLEEDS"), ABDOMINAL DISTENSION ("BLOATING") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2017 LAPAROSCOPIC REMOVAL OF ESSURE COIL; REMOVAL OF ESSURE COIL;, ON (B)(6) 2017 LAPAROSCOPIC REMOVAL OF ESSURE COIL; REMOVAL OF RIGHT ESSURE COIL; AND ON (B)(6) 2017 LAPAROSCOPIC REMOVAL OF ESSURE COIL; REMOVAL OF RIGHT ESSURE COIL;). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, RASH GENERALISED, GENERALISED OEDEMA, CYANOSIS, SKIN DISCOLOURATION, HAEMOPTYSIS, EPISTAXIS, ABDOMINAL DISTENSION, FEELING ABNORMAL, ALLERGY TO METALS, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ALOPECIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL DISCHARGE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, CYANOSIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EPISTAXIS, FEELING ABNORMAL, GENERALISED OEDEMA, GENITAL HAEMORRHAGE, HAEMOPTYSIS, MENORRHAGIA, PELVIC PAIN, RASH GENERALISED, SKIN DISCOLOURATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER LIFE WAS DESTROYED, SHE IS NOT ABLE TO WORK AND JUST APPLIED FOR DISABILITY. LIFE-THREATENING, DISABILITY/PERMANENT DAMAGE AND INTERVENTION WERE MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. PATIENT DONE SCREENING FOR STD WHICH RESULTS ANEMIA, HSV-1 INFECTION, OVARIAN CYST, PEMPHIGUS VULGARIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. UTERUS: NORMAL FALLOPIAN TUBES: BOTH FALLOPIAN TUBES ARE CLOSED WITH ESSURES. MAMMOGRAM - ON AN UNKNOWN DATE: HEAVY MENSES. PREGNANCY TEST - ON (B)(6) 2013: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, VAGINAL DISCHARGE, MENORRHAGIA,ALLERGY TO METALS,RASH. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAR-2019: PFS RECEIVED PATIENT INFORMATION WAS ADDED. NEW EVENT ADDED DEVICE BREAKAGE ADDED. CONCOMITANT CONDITIONS ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5069501) ON 30-MAY-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 19-MAR-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("DEVICE BREAKAGE"), PELVIC PAIN ("PELVIC PAIN/ CHRONIC PELVIC PAIN/ PAIN"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CAVITY") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SCABIES, SKIN LESION, SKIN INFLAMMATION, VULVOVAGINITIS, UTERINE BLEEDING, UTERINE FIBROID, OVARIAN CYST (LEFT OVARY), UTERINE ENLARGEMENT AND HIVES. SURGICAL PATHOLOGY-CH REPORT FINAL DIAGNOSIS: 1. SUBMITTED AS RIGHT ESSURE COIL: FOREIGN BODY CONSISTENT WITH ESSURE COIL (GROSS DIAGNOSIS ONLY). 2. SUBMITTED AS LEFT ESSURE COIL: FOREIGN BODY CONSISTENT WITH ESSURE COIL (GROSS DIAGNOSIS ONLY). 3. RIGHT FALLOPIAN TUBE SALPINGECTOMY: PLICAL FIBROSIS. 4. LEFT FALLOPIAN TUBE SALPINGECTOMY: PLICAL FIBROSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM 2009 TO 2011, NUVARING AND DIAZEPAM. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED CONTRACEPTION WITH DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED DERMATITIS, UNSPECIFIED PRURITIC DISORDER, ECZEMA, OVERWEIGHT, UTERINE ENLARGEMENT, PEMPHIGUS VULGARIS, BLISTERS, INFLAMMATION, FIBROSIS, PEMPHIGUS VULGARIS, HYPERPIGMENTATION SKIN, FATIGUE, PAIN ANKLE, BLISTERS, PRURITIC RASH AND SKIN DISORDER. CONCOMITANT PRODUCTS INCLUDED ACETIC ACID, EUCALYPTUS GLOBULUS OIL (EUCALYPTUS OIL), HERBAL EXTRACT NOS (CHAPARRAL DANDELION BLEND), HERBAL PREPARATION, HYDROCORTISONE (HYDROCORTISON), HYDROXYZINE, IBUPROFEN, IRON, OLEA EUROPAEA LEAF EXTRACT (OLIVE LEAVES EXTRACT), VITAMIN D NOS (VITAMIN D), VITAMINS NOS (MULTIVITAMINS) AND ZINC. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH GENERALISED ("FULL BODY RASHES/ RASHES/ RASHES OR SKIN CONDITIONS TYPE: WHOLE BODY"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ALOPECIA ("LOST MOST OF MY NATURAL HAIR/ HAIR LOSS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, LIFE THREATENING AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENERALISED OEDEMA ("FLUID BUILD UP IN MY FACE, NECK, CHEST AND BACK/FLUID RETENSION IN MY LEGS AND ANKLE"), CYANOSIS ("OXYGEN DOES NOT FLOW PROPERLY IN MY SKIN"), SKIN DISCOLOURATION ("THE UPPER THIGH AND CHEST AND BACK SKIN HAS GOTTEN 2 SHADES DARKER"), HAEMOPTYSIS ("COUGHING UP BLOOD"), EPISTAXIS ("NOSE BLEEDS"), ABDOMINAL DISTENSION ("BLOATING") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2017 LAPAROSCOPIC REMOVAL OF ESSURE COIL; REMOVAL OF ESSURE COIL;, ON (B)(6) 2017 LAPAROSCOPIC REMOVAL OF ESSURE COIL; REMOVAL OF RIGHT ESSURE COIL; AND ON (B)(6) 2017 LAPAROSCOPIC REMOVAL OF ESSURE COIL; REMOVAL OF RIGHT ESSURE COIL;). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, RASH GENERALISED, GENERALISED OEDEMA, CYANOSIS, SKIN DISCOLOURATION, HAEMOPTYSIS, EPISTAXIS, ABDOMINAL DISTENSION, FEELING ABNORMAL, ALLERGY TO METALS, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ALOPECIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL DISCHARGE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, CYANOSIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EPISTAXIS, FEELING ABNORMAL, GENERALISED OEDEMA, GENITAL HAEMORRHAGE, HAEMOPTYSIS, MENORRHAGIA, PELVIC PAIN, RASH GENERALISED, SKIN DISCOLOURATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER LIFE WAS DESTROYED, SHE IS NOT ABLE TO WORK AND JUST APPLIED FOR DISABILITY. LIFE-THREATENING, DISABILITY/PERMANENT DAMAGE AND INTERVENTION WERE MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. PATIENT DONE SCREENING FOR STD WHICH RESULTS ANEMIA, HSV-1 INFECTION, OVARIAN CYST, PEMPHIGUS VULGARIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. UTERUS: NORMAL. FALLOPIAN TUBES: BOTH FALLOPIAN TUBES ARE CLOSED WITH ESSURES. MAMMOGRAM - ON AN UNKNOWN DATE: HEAVY MENSES. PREGNANCY TEST - ON (B)(6) 2013: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, VAGINAL DISCHARGE, MENORRHAGIA,ALLERGY TO METALS,RASH. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-MAR-2019: QUALITY-SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). INCIDENT- NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FOOD AND DRUG ADMINISTRATION (REFERENCE NUMBER: MW5069501) ON 30-MAY-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-SEP-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ACETIC ACID, CHAPARRAL DANDELION BLEND, CHOLECALCIFEROL (VITAMIN D), EUCALYPTUS GLOBULUS OIL (EUCALYPTUS OIL), HERBAL PREPARATION, HYDROCORTISONE (HYDROCORTISON [HYDROCORTISONE]), HYDROXYZINE, IRON, MULTIVITAMINS, OLEA EUROPAEA LEAF EXTRACT (OLIVE LEAVES EXTRACT) AND ZINC. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, LIFE THREATENING AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RASH GENERALISED ("FULL BODY RASHES/ RASHES"), ALOPECIA ("LOST MOST OF MY NATURAL HAIR/ HAIR LOSS"), GENERALISED OEDEMA ("FLUID BUILD UP IN MY FACE, NECK, CHEST AND BACK/FLUID RETENSION IN MY LEGS AND ANKLE"), CYANOSIS ("OXYGEN DOES NOT FLOW PROPERLY IN MY SKIN"), SKIN DISCOLOURATION ("THE UPPER THIGH AND CHEST AND BACK SKIN HAS GOTTEN 2 SHADES DARKER"), HAEMOPTYSIS ("COUGHING UP BLOOD"), EPISTAXIS ("NOSE BLEEDS"), MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"), ABDOMINAL DISTENSION ("BLOATING") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2017). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, RASH GENERALISED, ALOPECIA, GENERALISED OEDEMA, CYANOSIS, SKIN DISCOLOURATION, HAEMOPTYSIS, EPISTAXIS, MENORRHAGIA, ABDOMINAL DISTENSION AND FEELING ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, CYANOSIS, EPISTAXIS, FEELING ABNORMAL, GENERALISED OEDEMA, GENITAL HAEMORRHAGE, HAEMOPTYSIS, MENORRHAGIA, PELVIC PAIN, RASH GENERALISED AND SKIN DISCOLOURATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER LIFE WAS DESTROYED, SHE IS NOT ABLE TO WORK AND JUST APPLIED FOR DISABILITY. LIFE-THREATENING, DISABILITY/PERMANENT DAMAGE AND INTERVENTION WERE MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-SEP-2017: SUMMONS RECEIVED: REPORTER INFORMATION AND LAWYER ADDED, ESSURE INDICATION WAS UPDATED TO PERMANENT CONTRACEPTION, EVENTS EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION, BLOATING AND BRAIN FOG WERE ADDED AND NEWLY REPORTED EVENTS TERMS CHRONIC PELVIC PAIN, RASHES, HAIR LOSS CLUBBED WITH PREVIOUSLY REPORTED EVENTS. 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.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FOOD AND DRUG ADMINISTRATION (REFERENCE NUMBER: MW5069501) ON 30-MAY-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ACETIC ACID, CHAPARRAL DANDELION BLEND, CHOLECALCIFEROL (VITAMIN D), EUCALYPTUS GLOBULUS OIL (EUCALYPTUS OIL), HERBAL PREPARATION, HYDROCORTISONE (HYDROCORTISON [HYDROCORTISONE]), HYDROXYZINE, IRON, MULTIVITAMINS, OLEA EUROPAEA LEAF EXTRACT (OLIVE LEAVES EXTRACT) AND ZINC. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, LIFE THREATENING AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RASH GENERALISED ("FULL BODY RASHES"), ALOPECIA ("LOST MOST OF MY NATURAL HAIR"), GENERALISED OEDEMA ("FLUID BUILD UP IN MY FACE, NECK, CHEST AND BACK/FLUID RETENSION IN MY LEGS AND ANKLE"), CYANOSIS ("OXYGEN DOES NOT FLOW PROPERLY IN MY SKIN"), SKIN DISCOLOURATION ("THE UPPER THIGH AND CHEST AND BACK SKIN HAS GOTTEN 2 SHADES DARKER"), HAEMOPTYSIS ("COUGHING UP BLOOD") AND EPISTAXIS ("NOSE BLEEDS"). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, RASH GENERALISED, ALOPECIA, GENERALISED OEDEMA, CYANOSIS, SKIN DISCOLOURATION, HAEMOPTYSIS AND EPISTAXIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, CYANOSIS, EPISTAXIS, GENERALISED OEDEMA, GENITAL HAEMORRHAGE, HAEMOPTYSIS, PELVIC PAIN, RASH GENERALISED AND SKIN DISCOLOURATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED HER LIFE WAS DESTROYED, SHE IS NOT ABLE TO WORK AND JUST APPLIED FOR DISABILITY. LIFE-THREATENING, DISABILITY/PERMANENT DAMAGE AND INTERVENTION WERE MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. 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 |
|---|---|---|---|---|---|---|---|
| 415559 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Life Threatening| O| R| S | ACETIC ACID| ACETIC ACID| ACETIC ACID| ACETIC ACID (ACETIC ACID)| CHAPARRAL DANDELION BLEND| CHAPARRAL DANDELION BLEND| CHAPARRAL DANDELION BLEND| CHAPARRAL DANDELION BLEND| EUCALYPTUS OIL| EUCALYPTUS OIL| EUCALYPTUS OIL| EUCALYPTUS OIL (EUCALYPTUS GLOBULUS OIL)| HERBAL PREPARATION| HERBAL PREPARATION| HERBAL PREPARATION| HERBAL PREPARATION (HERBAL PREPARATION)| HYDROCORTISON [HYDROCORTISONE]| HYDROCORTISON [HYDROCORTISONE]| HYDROCORTISON [HYDROCORTISONE]| HYDROCORTISON [HYDROCORTISONE]| HYDROXYZINE| HYDROXYZINE| HYDROXYZINE| HYDROXYZINE (HYDROXYZINE)| IBUPROFEN| IBUPROFEN| IRON| IRON| IRON| IRON (IRON [IRON])| MULTIVITAMINS| MULTIVITAMINS (MULTIVITAMINS)| MULTIVITAMINS [VITAMINS NOS]| MULTIVITAMINS [VITAMINS NOS]| OLIVE LEAVES EXTRACT| OLIVE LEAVES EXTRACT| OLIVE LEAVES EXTRACT| OLIVE LEAVES EXTRACT (OLEA EUROPAEA LEAF EXTRACT)| VITAMIN D| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITMAIN D (COLECALCIFEROL)| ZINC| ZINC| ZINC| ZINC (ZINC [ZINC])| ACETIC ACID (ACETIC ACID)| CHAPARRAL DANDELION BLEND| EUCALYPTUS OIL (EUCALYPTUS GLOBULUS OIL)| HERBAL PREPARATION (HERBAL PREPARATION)| HYDROCORTISON [HYDROCORTISONE]| HYDROXYZINE (HYDROXYZINE)| IRON (IRON [IRON])| MULTIVITAMINS (MULTIVITAMINS)| OLIVE LEAVES EXTRACT (OLEA EUROPAEA LEAF EXTRACT)| VITMAIN D (COLECALCIFEROL)| ZINC (ZINC [ZINC]) |