ESSURE
Report
- Report Number
- 2951250-2017-10937
- Event Type
- Injury
- Date Received
- December 20, 2017
- Date of Event
- February 22, 2010
- Report Date
- May 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("ESSURE WAS FORCED INTO THE LEFT TUBE AFTER THE KIT DIDN'T WORK/ PERFORATION OF LEFT FALLOPIAN TUBE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (BLEEDING FOR FIRST COUPLE OF MONTHS)") IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 1242099/ 685782) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (B)(6) 2000; (B)(6) 2002 AND (B)(6) 2009, ABORTION AND MENARCHE. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, IRREGULAR PERIODS, OBESITY, OVARIAN CYST, LATEX ALLERGY, SHORT OF BREATH, ALLERGIC REACTION TO ANALGESICS, HIGH CHOLESTEROL, NEPHROLITHIASIS, SEASONAL ALLERGY AND OVARIAN CYST. FAMILY HISTORY INCLUDED SEIZURES (MOTHER), DIABETES (GRANDPARENTS AND MATERNAL GRANDMOTHER), AIDS (MOTHER), MENTAL DISORDER NOS (MOTHER), HEART DISEASE, UNSPECIFIED (GRANDPARENTS), HYPERTENSION (GRANDPARENTS) AND DEPRESSIVE DISORDER (FATHER). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. IN MARCH 2010, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("HEAVIER PERIODS"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), OOPHORECTOMY ("LEFT OVARY REMOVED"), WEIGHT INCREASED ("WEIGHT GAIN"), LOSS OF LIBIDO ("LOSE OF SEX DRIVE") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). IN MARCH 2010, THE PATIENT UNDERWENT GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("HEAVIER PERIODS"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), OOPHORECTOMY ("LEFT OVARY REMOVED"), WEIGHT INCREASED ("WEIGHT GAIN"), LOSS OF LIBIDO ("LOSE OF SEX DRIVE") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). IN 2010, THE PATIENT EXPERIENCED HEADACHE ("HEAD PAIN- CONSISTENT AND CHRONIC HEADACHE"). IN 2014, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). IN APRIL 2015, THE PATIENT EXPERIENCED STRESS ("DEVICE FORCED IN CAUSING MENTAL STRESS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH OXYCODONE, HYDROCODONE AND SURGERY (LEFT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MIGRAINE, BACK PAIN, MENORRHAGIA, DYSPAREUNIA, OOPHORECTOMY, WEIGHT INCREASED, LOSS OF LIBIDO, HORMONE LEVEL ABNORMAL, HEADACHE, ANXIETY, DEPRESSION AND STRESS HAD NOT RESOLVED AND THE COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, LOSS OF LIBIDO, MENORRHAGIA, MIGRAINE, OOPHORECTOMY, STRESS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PFS- SHE DID NOT EXPERIENCED ANY COMPLICATIONS OF YOUR PREGNANCY OR DELIVERY.SHE DID NOT CLAIM ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. CURRENT WEIGHT: 223 LBS. MR -3 COILS REMAINING VISIBLE IN THE UTERINE CAVITY ON THE R, AND 4 COILS REMAINING VISIBLE IN THE UTERINE CAVITY ON THE L. PATIENT TOLERATED INSERTION WELL. ACCORDING TO MR, LEFT ESSURE DEVICE WAS REMOVED ON 01 MAY 2015 AND RIGHT ESSURE DEVICE WAS REMOVED ON (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON 1-MAY-2015: NEGATIVE . BATCH NUMBER: 1242099 EXPIRATION DATE: 2012/07 MANUFACTURE DATE: 2009/11 . BATCH NUMBER: 685782 EXPIRATION DATE: 2012/10 MANUFACTURE DATE: 2009/10 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUN-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 FALLOPIAN TUBE PERFORATION ('ESSURE WAS FORCED INTO THE LEFT TUBE AFTER THE KIT DIDN'T WORK/ PERFORATION OF LEFT FALLOPIAN TUBE') AND DEVICE DISLOCATION ('MIGRATION') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 1242099, 685782) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 2000; (B)(6) 2002 AND (B)(6) 2009.), ABORTION AND MENARCHE. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, IRREGULAR PERIODS, OBESITY, OVARIAN CYST, LATEX ALLERGY, SHORT OF BREATH, ALLERGIC REACTION TO ANALGESICS, HIGH CHOLESTEROL, NEPHROLITHIASIS, SEASONAL ALLERGY, OVARIAN CYST, CHRONIC UTI, CALCULUS OF KIDNEY, CERVICALGIA AND PALPITATIONS. FAMILY HISTORY INCLUDED SEIZURES (MOTHER), DIABETES (GRANDPARENTS AND MATERNAL GRANDMOTHER), AIDS (MOTHER), MENTAL DISORDER (MOTHER), HEART DISEASE, UNSPECIFIED (GRANDPARENTS), HYPERTENSION (GRANDPARENTS) AND DEPRESSIVE DISORDER (FATHER). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. IN (B)(6) 2010, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (BLEEDING FOR FIRST COUPLE OF MONTHS)"), MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("HEAVIER PERIODS"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND LOSS OF LIBIDO ("LOSE OF SEX DRIVE"), UNDERWENT OOPHORECTOMY ("LEFT OVARY REMOVED") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). IN 2010, THE PATIENT EXPERIENCED HEADACHE ("HEAD PAIN- CONSISTENT AND CHRONIC HEADACHE"). IN 2014, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED STRESS ("DEVICE FORCED IN CAUSING MENTAL STRESS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH HYDROCODONE, OXYCODONE AND SURGERY (LEFT SALPINGECTOMY, DEVICE REMOVAL AND ESURE REMOVAL DONE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MIGRAINE, BACK PAIN, MENORRHAGIA, DYSPAREUNIA, OOPHORECTOMY, WEIGHT INCREASED, LOSS OF LIBIDO, HORMONE LEVEL ABNORMAL, HEADACHE, ANXIETY, DEPRESSION AND STRESS HAD NOT RESOLVED AND THE DEVICE DISLOCATION AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, LOSS OF LIBIDO, MENORRHAGIA, MIGRAINE, OOPHORECTOMY, STRESS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PFS- SHE DID NOT EXPERIENCED ANY COMPLICATIONS OF YOUR PREGNANCY OR DELIVERY.SHE DID NOT CLAIM ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. CURRENT WEIGHT: 223 LBS MR -3 COILS REMAINING VISIBLE IN THE UTERINE CAVITY ON THE R, AND 4 COILS REMAINING VISIBLE IN THE UTERINE CAVITY ON THE L. PATIENT TOLERATED INSERTION WELL. ACCORDING TO MR, LEFT ESSURE DEVICE WAS REMOVED ON (B)(6) 2015 AND RIGHT ESSURE DEVICE WAS REMOVED ON (B)(6) 2015. REMOVAL DATE PROVIDED AS (B)(6) 2015 - LEFT SALPINGECTOMY, (B)(6) 2015 - REMOVAL OF RIGHT ESSURE COIL (PFS). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2015: RESULTS: NEGATIVE. BATCH NUMBER: 1242099 EXPIRATION DATE: 2012/07 MANUFACTURE DATE: 2009/11. BATCH NUMBER: 685782 EXPIRATION DATE: 2012/10 MANUFACTURE DATE: 2009/10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAY-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 FALLOPIAN TUBE PERFORATION ('ESSURE WAS FORCED INTO THE LEFT TUBE AFTER THE KIT DIDN'T WORK/ PERFORATION OF LEFT FALLOPIAN TUBE') AND DEVICE DISLOCATION ('MIGRATION') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 1242099/ 685782) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (B)(6) 2000; (B)(6) 2002 AND (B)(6)2009.), ABORTION AND MENARCHE. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, IRREGULAR PERIODS, OBESITY, OVARIAN CYST, LATEX ALLERGY, SHORT OF BREATH, ALLERGIC REACTION TO ANALGESICS, HIGH CHOLESTEROL, NEPHROLITHIASIS, SEASONAL ALLERGY, OVARIAN CYST, CHRONIC UTI, CALCULUS OF KIDNEY, CERVICALGIA AND PALPITATIONS. FAMILY HISTORY INCLUDED SEIZURES (MOTHER), DIABETES (GRANDPARENTS AND MATERNAL GRANDMOTHER), AIDS (MOTHER), MENTAL DISORDER (MOTHER), HEART DISEASE, UNSPECIFIED (GRANDPARENTS), HYPERTENSION (GRANDPARENTS) AND DEPRESSIVE DISORDER (FATHER). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. IN (B)(6) 2010, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (BLEEDING FOR FIRST COUPLE OF MONTHS)"), MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("HEAVIER PERIODS"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND LOSS OF LIBIDO ("LOSE OF SEX DRIVE"), UNDERWENT OOPHORECTOMY ("LEFT OVARY REMOVED") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). IN 2010, THE PATIENT EXPERIENCED HEADACHE ("HEAD PAIN- CONSISTENT AND CHRONIC HEADACHE"). IN 2014, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED STRESS ("DEVICE FORCED IN CAUSING MENTAL STRESS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH HYDROCODONE, OXYCODONE AND SURGERY (LEFT SALPINGECTOMY, DEVICE REMOVAL AND ESURE REMOVAL DONE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MIGRAINE, BACK PAIN, MENORRHAGIA, DYSPAREUNIA, OOPHORECTOMY, WEIGHT INCREASED, LOSS OF LIBIDO, HORMONE LEVEL ABNORMAL, HEADACHE, ANXIETY, DEPRESSION AND STRESS HAD NOT RESOLVED AND THE DEVICE DISLOCATION AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, LOSS OF LIBIDO, MENORRHAGIA, MIGRAINE, OOPHORECTOMY, STRESS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PFS- SHE DID NOT EXPERIENCED ANY COMPLICATIONS OF YOUR PREGNANCY OR DELIVERY. SHE DID NOT CLAIM ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. CURRENT WEIGHT: 223 LBS. MR -3 COILS REMAINING VISIBLE IN THE UTERINE CAVITY ON THE R, AND 4 COILS REMAINING VISIBLE IN THE UTERINE CAVITY ON THE L. PATIENT TOLERATED INSERTION WELL. ACCORDING TO MR, LEFT ESSURE DEVICE WAS REMOVED ON (B)(6) 2015 AND RIGHT ESSURE DEVICE WAS REMOVED ON (B)(6) 2015. REMOVAL DATE PROVIDED AS (B)(6) 2015 - LEFT SALPINGECTOMY, (B)(6) 2015 - REMOVAL OF RIGHT ESSURE COIL (PFS) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2015: RESULTS: NEGATIVE. BATCH NUMBER: 1242099 EXPIRATION DATE: 2012/07 MANUFACTURE DATE: 2009/11 . BATCH NUMBER: 685782 EXPIRATION DATE: 2012/10 MANUFACTURE DATE: 2009/10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PIF RECEIVED: EVENT MIGRATION ADDED. REPORTER INFORMATION ADDED. EVENT GENITAL HAEMORRHAGE UPDATED AS MEDICALLY NON-SIGNIFICANT. 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 FALLOPIAN TUBE PERFORATION ("ESSURE WAS FORCED INTO THE LEFT TUBE AFTER THE KIT DIDN'T WORK/ PERFORATION OF LEFT FALLOPIAN TUBE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (BLEEDING FOR FIRST COUPLE OF MONTHS)") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 1242099/685782) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 2000; (B)(6) 2002 AND (B)(6) 2009.), ABORTION AND MENARCHE. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, IRREGULAR PERIODS, OBESITY, OVARIAN CYST, LATEX ALLERGY, SHORT OF BREATH, ALLERGIC REACTION TO ANALGESICS, HIGH CHOLESTEROL, NEPHROLITHIASIS AND SEASONAL ALLERGY. FAMILY HISTORY INCLUDED SEIZURES (MOTHER), DIABETES (GRANDPARENTS AND MATERNAL GRANDMOTHER), AIDS (MOTHER), MENTAL DISORDER NOS (MOTHER), HEART DISEASE, UNSPECIFIED (GRANDPARENTS), HYPERTENSION (GRANDPARENTS) AND DEPRESSIVE DISORDER (FATHER). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. IN 2010, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK PAIN") AND HEADACHE ("HEAD PAIN- CONSISTENT AND CHRONIC HEADACHE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVIER PERIODS"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), OOPHORECTOMY ("LEFT OVARY REMOVED"), WEIGHT INCREASED ("WEIGHT GAIN"), LOSS OF LIBIDO ("LOSE OF SEX DRIVE"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION") AND STRESS ("DEVICE FORCED IN CAUSING MENTAL STRESS"). THE PATIENT WAS TREATED WITH OXYCODONE, HYDROCODONE AND SURGERY (LEFT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MIGRAINE, BACK PAIN, MENORRHAGIA, DYSPAREUNIA, OOPHORECTOMY, WEIGHT INCREASED, LOSS OF LIBIDO, HORMONE LEVEL ABNORMAL, HEADACHE, ANXIETY, DEPRESSION AND STRESS HAD NOT RESOLVED AND THE COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, LOSS OF LIBIDO, MENORRHAGIA, MIGRAINE, OOPHORECTOMY, STRESS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PFS- SHE DID NOT EXPERIENCED ANY COMPLICATIONS OF YOUR PREGNANCY OR DELIVERY.SHE DID NOT CLAIM ALLERGIC TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. (B)(6). MR -3 COILS REMAINING VISIBLE IN THE UTERINE CAVITY ON THE R, AND 4 COILS REMAINING VISIBLE IN THE UTERINE CAVITY ON THE L. PATIENT TOLERATED INSERTION WELL. ACCORDING TO MR, LEFT ESSURE DEVICE WAS REMOVED ON (B)(6) 2015 AND RIGHT ESSURE DEVICE WAS REMOVED ON (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2015: NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-NOV-2017: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED- REPORTER ADDED, ALL RELEVANT MEDICAL HISTORY, CONCURRENT CONDITION, CONCOMITANT MEDICATION, TREATMENT DRUG ADDED. CASE IS NOW VALID. SPECIFIC EVENTS ADDED. EVENT SEVERE AND PERMANENT INJURIES WAS DELETED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. INCIDENT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 915111 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 1242099, 685782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA |