ESSURE
Report
- Report Number
- 2951250-2017-03622
- Event Type
- Injury
- Date Received
- September 13, 2017
- Date of Event
- May 1, 2012
- Report Date
- August 15, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN/SEVERE DAILY PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969, 959209) INSERTED FOR FEMALE STERILIZATION. 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 PERFORM ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (3 LIVE BIRTH ON (B)(6) 2000, (B)(6) 2006 AND (B)(6) 2011)), PREMATURE LABOR AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED GENERAL ANESTHESIA, HEADACHE, DIZZINESS, FAINTING AND ENDOMETRIOSIS EXTERNA. FAMILY HISTORY INCLUDED DIABETES, BLOOD PRESSURE HIGH AND HEART DISORDER. CONCOMITANT PRODUCTS INCLUDED ANESTHETICS, GENERAL (GENERAL ANESTHESIA) FOR ANESTHESIA. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ALLERGY TO METALS ("NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION") AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("SEVERE DAILY VAGINAL PAIN") AND FEMALE STERILISATION ("TUBAL LIGATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (BILATERAL SALPINGECTOMY AND DILATION AND CURETTAGE), SURGERY (DILATION AND CURETTAGE, BILATERAL SALPINGECTOMY) AND SURGERY (DILATION AND CURETTAGE, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, FATIGUE, MIGRAINE, HEADACHE, DYSPAREUNIA AND ALLERGY TO METALS HAD NOT RESOLVED AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, HYPERSENSITIVITY AND FEMALE STERILISATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FEMALE STERILISATION, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT. SHE DID NOT CLAIM ESSURE WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE DID NOT ADVISED OF ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT AND ESSURE REMOVAL PROCEDURE. SHE DID SELF STUDY AND DISCOVERED THAT THE METAL IN ESSURE CAUSES THE REACTION TO HER PELVIC ORGANS. PELVIC PAIN, DYSMENORRHEA , SECONDARY TO THE ESSURE METAL REACTION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.6 KG/SQM. ON (B)(6) 2015, PATIENT HAD PATHOLOGICAL REPORT WAS GROSS DESCRIPTION: A. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "ECC." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF MULTIPLE FRAGMENTS OF TAN BROWN TISSUE AND BLOOD CLOTS MEASURING APPROXIMATELY 1.0 X 1.0 X 0.4 CM IN AGGREGATE. THE SPECIMEN IS SUBMITTED ENTIRELY IN ONE CASSETTE. B. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "EMC." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF MULTIPLE ARRANGEMENTS OF TAN-BROWN TISSUE AND BLOOD CLOTS MEASURING APPROXIMATELY 1 A X 1.3 X 0.5 CM IN AGGREGATE. THE SPECIMEN IS SUBMITTED ENTIRELY IN ONE CASSETTE. C. THE SPECIMEN IS LABELED WITH THE PATIENTS NAME,10 NUMBER AND "LEFT FALLOPIAN TUBE WITH ESSURE IMPLANT." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF A SEGMENT OF FALLOPIAN TUBE TISSUE WITH ATTACHED ESSURE DEVICE, MEASURING APPROXIMATELY 2.2 CM IN LENGTH X 0.5 CM IN DIAMETER. THE SPECIMEN IS SERIALLY SECTIONED AND SUBMITTED ENTIRELY IN ONE CASSELLE. ESSURE DEVICE, GROSS ONLY. D. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "RIGHT FALLOPIAN TUBE WITH ESSURE IMPLANT." THE SPECIMEN IS RECEIVED IN FORMALIN. AND IT CONSISTS OF A SHORT SEGMENT OF FALLOPIAN TUBE WITH ATTACHED AND SEPARATE SEGMENTS OF ESSURE DEVICE, MEASURING APPROXIMATELY 1.6 CM IN LENGTH X 0.5 EM IN DIAMETER_ THE SPECIMEN IS SERIALLY SECTIONED AND SUBMITTED ENTIRELY IN ONE CASSETTE. ESSURE DEVICE, GROSS ONLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: CONFIRMED PELVIC PAIN, DYSMENORRHEA AND MENORRHAGIA. LOT NUMBER: 940969 MAN DATE: 2012-01 EXP DATE: 2015-01 . LOT NUMBER: 959209 MAN DATE: 2012-03 EXP DATE: 2015-03 . 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. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN/SEVERE DAILY PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969, 959209) INSERTED FOR FEMALE STERILIZATION. 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 PERFORM ESSURE CONFIMAITON TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (3 LIVE BIRTH ON (26-JAN-2000, 27-OCT2006 AND 13OCT2011)), PREMATURE LABOR AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED GENERAL ANESTHESIA, HEADACHE, DIZZINESS, FAINTING AND ENDOMETRIOSIS EXTERNA. FAMILY HISTORY INCLUDED DIABETES, BLOOD PRESSURE HIGH AND HEART DISORDER. CONCOMITANT PRODUCTS INCLUDED ANESTHETICS, GENERAL (GENERAL ANESTHESIA) FOR ANESTHESIA. IN MAY 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON 18-MAY-2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSPAREUNIA ("DYSPARENURIA (PAINFUL SEXUAL INTERCOURSE)"), ALLERGY TO METALS ("NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION") AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("SEVERE DAILY VAGINAL PAIN") AND FEMALE STERILISATION ("TUBAL LIGATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (BILATERAL SALPINGECTOMY AND DILATION AND CURETTAGE), SURGERY (DILATION AND CURETTAGE, BILATERAL SAPLPINGECTOMY) AND SURGERY (DILATION AND CURETTAGE, BILATERAL SAPLPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, FATIGUE, MIGRAINE, HEADACHE, DYSPAREUNIA AND ALLERGY TO METALS HAD NOT RESOLVED AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, HYPERSENSITIVITY AND FEMALE STERILISATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FEMALE STERILISATION, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT. SHE DID NOT CLAIM ESSURE WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE DID NOT ADVISED OF ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT AND ESSURE REMOVAL PROCEDURE. SHE DID SELF STUDY AND DISCOVERED THAT THE METAL IN ESSURE CAUSES THE REACTION TO HER PELVIC ORGANS. PELVIC PAIN, DYSMENORRHEA , SECONDARY TO THE ESSURE METAL REACTION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.6 KG/SQM. ON (B)(6) 2015, PATIENT HAD PATHOLOGICAL REPORT WAS GROSS DESCRIPTION: A. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "ECC." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF MULTIPLE FRAGMENTS OF TAN BROWN TISSUE AND BLOOD CLOTS MEASURING APPROXIMATELY 1.0 X 1.0 X 0.4 CM IN AGGREGATE. THE SPECIMEN IS SUBMITTED ENTIRELY IN ONE CASSETTE. B. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "EMC." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF MULTIPLE ARRANGEMENTS OF TAN-BROWN TISSUE AND BLOOD CLOTS MEASURING APPROXIMATELY 1 A X 1.3 X 0.5 CM IN AGGREGATE. THE SPECIMEN IS SUBMITTED ENTIRELY IN ONE CASSETTE. C. THE SPECIMEN IS LABELED WITH THE PATIENTS NAME,10 NUMBER AND "LEFT FALLOPIAN TUBE WITH ESSURE IMPLANT." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF A SEGMENT OF FALLOPIAN TUBE TISSUE WITH ATTACHED ESSURE DEVICE, MEASURING APPROXIMATELY 2.2 CM IN LENGTH X 0.5 CM IN DIAMETER. THE SPECIMEN IS SERIALLY SECTIONED AND SUBMITTED ENTIRELY IN ONE CASSELLE. ESSURE DEVICE, GROSS ONLY. D. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "RIGHT FALLOPIAN TUBE WITH ESSURE IMPLANT." THE SPECIMEN IS RECEIVED IN FORMALIN. AND IT CONSISTS OF A SHORT SEGMENT OF FALLOPIAN TUBE WITH ATTACHED AND SEPARATE SEGMENTS OF ESSURE DEVICE, MEASURING APPROXIMATELY 1.6 CM IN LENGTH X 0.5 EM IN DIAMETER_ THE SPECIMEN IS SERIALLY SECTIONED AND SUBMITTED ENTIRELY IN ONE CASSETTE. ESSURE DEVICE, GROSS ONLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: CONFIRMED PELVIC PAIN, DYSMENORRHEA AND MENORRHAGIA. LOT NUMBER: 940969 MAN DATE: 2012-01 EXP DATE: 2015-01 . LOT NUMBER: 959209 MAN DATE: 2012-03 EXP DATE: 2015-03 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 ("PELVIC PAIN/PAIN/SEVERE DAILY PELVIC PAIN/ PAIN"), GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969, 959209) INSERTED FOR FEMALE STERILIZATION. 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 PERFORM ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (3 LIVE BIRTH ON ((B)(6) 2000, (B)(6) 2006 AND (B)(6) 2011)), PREMATURE LABOR AND VAGINAL DELIVERY. CONCURRENT CONDITIONS INCLUDED GENERAL ANESTHESIA, HEADACHE, DIZZINESS, FAINTING AND ENDOMETRIOSIS EXTERNA. FAMILY HISTORY INCLUDED DIABETES, BLOOD PRESSURE HIGH AND HEART DISORDER. CONCOMITANT PRODUCTS INCLUDED ANESTHETICS, GENERAL (GENERAL ANESTHESIA) FOR ANESTHESIA. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2012, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), MIGRAINE ("MIGRAINES"), ALLERGY TO METALS ("NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("DYSPARENURIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), THE FIRST EPISODE OF VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), THE SECOND EPISODE OF VULVOVAGINAL PAIN ("SEVERE DAILY VAGINAL PAIN"), FATIGUE ("FATIGUE") AND FEMALE STERILISATION ("TUBAL LIGATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (BILATERAL SALPINGECTOMY AND DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, ALLERGY TO METALS, HEADACHE, FATIGUE AND DYSPAREUNIA HAD NOT RESOLVED AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, HYPERSENSITIVITY, THE LAST EPISODE OF VULVOVAGINAL PAIN AND FEMALE STERILISATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FEMALE STERILISATION, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF VULVOVAGINAL PAIN AND THE SECOND EPISODE OF VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT. SHE DID NOT CLAIM ESSURE WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE DID NOT ADVISED OF ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT AND ESSURE REMOVAL PROCEDURE. SHE DID SELF STUDY AND DISCOVERED THAT THE METAL IN ESSURE CAUSES THE REACTION TO HER PELVIC ORGANS. PELVIC PAIN, DYSMENORRHEA , SECONDARY TO THE ESSURE METAL REACTION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.6 KG/SQM. ON (B)(6) 2015, PATIENT HAD PATHOLOGICAL REPORT WAS GROSS DESCRIPTION: A. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "ECC." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF MULTIPLE FRAGMENTS OF TAN BROWN TISSUE AND BLOOD CLOTS MEASURING APPROXIMATELY 1.0 X 1.0 X 0.4 CM IN AGGREGATE. THE SPECIMEN IS SUBMITTED ENTIRELY IN ONE CASSETTE. B. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "EMC." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF MULTIPLE ARRANGEMENTS OF TAN-BROWN TISSUE AND BLOOD CLOTS MEASURING APPROXIMATELY 1 A X 1.3 X 0.5 CM IN AGGREGATE. THE SPECIMEN IS SUBMITTED ENTIRELY IN ONE CASSETTE. C. THE SPECIMEN IS LABELED WITH THE PATIENTS NAME,10 NUMBER AND "LEFT FALLOPIAN TUBE WITH ESSURE IMPLANT." THE SPECIMEN IS RECEIVED IN FORMALIN, AND IT CONSISTS OF A SEGMENT OF FALLOPIAN TUBE TISSUE WITH ATTACHED ESSURE DEVICE, MEASURING APPROXIMATELY 2.2 CM IN LENGTH X 0.5 CM IN DIAMETER. THE SPECIMEN IS SERIALLY SECTIONED AND SUBMITTED ENTIRELY IN ONE CASSELLE. ESSURE DEVICE, GROSS ONLY. D. THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME,10 NUMBER AND "RIGHT FALLOPIAN TUBE WITH ESSURE IMPLANT." THE SPECIMEN IS RECEIVED IN FORMALIN. AND IT CONSISTS OF A SHORT SEGMENT OF FALLOPIAN TUBE WITH ATTACHED AND SEPARATE SEGMENTS OF ESSURE DEVICE, MEASURING APPROXIMATELY 1.6 CM IN LENGTH X 0.5 EM IN DIAMETER_ THE SPECIMEN IS SERIALLY SECTIONED AND SUBMITTED ENTIRELY IN ONE CASSETTE. ESSURE DEVICE, GROSS ONLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: CONFIRMED PELVIC PAIN, DYSMENORRHEA AND MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-FEB-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. EVENTS WERE ADDED PER PFS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), MIGRAINES / HEADACHES, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),SEVERE DAILY VAGINAL PAIN, FATIGUE AND SHE DID NOT PERFORM ESSURE CONFIRMATION TEST WERE ADDED. THE EVENT PAIN, SEVERE DAILY PELVIC PAIN WAS UPDATED. ESSURE WAS IMPLANTED FOR PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES. BATCH NUMBER WAS ADDED. PATIENT DEMOGRAPHICS, MEDICAL HISTORY, CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS WERE 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 ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2015, PLAINTIFF UNDERWENT ONE OR MORE SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, PELVIC PAIN AND VULVOVAGINAL 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 |
|---|---|---|---|---|---|---|---|
| 642095 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 940969, 959209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | GENERAL ANESTHESIA| GENERAL ANESTHESIA| GENERAL ANESTHESIA |