ESSURE
Report
- Report Number
- 2951250-2017-10897
- Event Type
- Injury
- Date Received
- December 19, 2017
- Date of Event
- November 1, 2014
- Report Date
- April 18, 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
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE MISSING COIL"), PELVIC PAIN ("PAIN/ SEVERE PAIN/PELVIC AREA PAIN(SHARP, STABBING)/ PAIN/ SEVERE PAIN"), PLACENTA PRAEVIA ("PLACENTA PREVIA STAGE 4") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("BECAME PREGNANT/UNINTENDED PREGNANCY/FOUR MONTHS PREGNANT/ I WAS FOUR MONTHS PREGNANT AND HAD A CHECK UP WITH PHYSICIAN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTIES WITH PLACEMENT ON ONE SIDE", DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST-NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2, LIVE BIRTH IN 2010, LIVE BIRTH ON (B)(6) 2012, FATIGUE, WEIGHT GAIN, PHARYNGITIS, OVERWEIGHT, HYPOTHYROIDISM, CONSTIPATION, VITAMIN B COMPLEX DEFICIENCY, ADJUSTMENT DISORDER, DEPRESSED MOOD, HYPERLIPIDEMIA, PAIN IN LIMB, ACUTE UPPER RESPIRATORY TRACT INFECTION, FEVER, PAIN IN THORACIC SPINE, COCCYX PAIN, NECK PAIN, ALLERGIC RHINITIS DUE TO POLLEN, DIFFICULTY IN WALKING, PREGNANCY TERMINATION, PREGNANCY, BODY MASS INDEX NORMAL AND ENDOSCOPY ON (B)(6) 2014. SHE DID NOT EXPERIENCE A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT. (B)(6) 2015: PRIMARY LOW TRANSVERSE CSECTION VIA PFANNENSTIEL - FINDINGS: MALE INFANT IN CEPHALIC PRESENTATION. PEDIATRICS PRESENT AT DELIVERY. APGAR¿S 9 AND 9. WEIGHT 6 POUNDS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEXAPRO, ONDANSETRON AND ADIPEX. CONCURRENT CONDITIONS INCLUDED ALCOHOL USE, TOBACCO USER, EX-SMOKER, DYSPHAGIA, GASTRITIS, HIATAL HERNIA, GASTRIC DISORDER, URINARY TRACT INFECTION, LYMPHADENITIS AND WEIGHT GAIN. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. IN 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"), THE FIRST EPISODE OF DYSMENORRHOEA ("MENSTRUAL PAIN"), ANXIETY ("ANXIETY") AND MIGRAINE ("MIGRAINES/ FREQUENT MIGRAINES"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED THE SECOND EPISODE OF DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ MENSTRUAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ UNABLE TO HAVE INTERCOURSE WITHOUT PAIN") AND ABDOMINAL DISTENSION ("BLOATING"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2014, THE PATIENT EXPERIENCED HEADACHE ("HEAD PAIN"). IN 2015, THE PATIENT EXPERIENCED VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY") AND INCONTINENCE ("INCONTINENCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PLACENTA PRAEVIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), PANIC ATTACK ("PANIC ATTACKS/PANIC DISORDER"), POLYMENORRHOEA ("MENSTRUATION ON A TOO-FREQUENT BASIS / MENSTRUAL FREQUENCY") AND GASTROINTESTINAL DISORDER ("BOWEL ISSUES"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ALPRAZOLAM (XANAX), FLUOXETINE HYDROCHLORIDE (PROZAC) AND SURGERY (C-SECTION AND ESSURE WAS REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, PLACENTA PRAEVIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, THE LAST EPISODE OF DYSMENORRHOEA, ABDOMINAL PAIN, DEPRESSION, WEIGHT FLUCTUATION, DYSPAREUNIA, ANXIETY, MIGRAINE, PANIC ATTACK, VITAMIN D DEFICIENCY, ABDOMINAL DISTENSION, POLYMENORRHOEA, GASTROINTESTINAL DISORDER AND HEADACHE OUTCOME WAS UNKNOWN AND THE FATIGUE AND WEIGHT INCREASED HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, INCONTINENCE, MIGRAINE, PANIC ATTACK, PELVIC PAIN, PLACENTA PRAEVIA, POLYMENORRHOEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, VITAMIN D DEFICIENCY, WEIGHT FLUCTUATION, WEIGHT INCREASED, THE FIRST EPISODE OF DYSMENORRHOEA AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT: 123 SHE WAS FOUR MONTHS PREGNANT AND HAD A CHECK UP WITH DOCTOR. DATE NOT RECALLED. LIVE BIRTH. PATIENT HAD USED BCP, SPORADICALLY AS A BIRTH CONTROL FOLLOWING ESSURE PLACEMENT. DISCREPANCY TO BE NOTED: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. CURRENT WEIGHT 148. THE DATE PATIENT LEARNED OF THE PERFORATION SUSPECTED, UNDERGOING TESTING. DISCREPANCY TO BE NOTED AS REMOVAL SCHEDULED: REASON(S) FOR REMOVAL AS OF APRIL 2019, I ANTICIPATE BEING SCHEDULED SOON FOR ESSURE REMOVAL SURGERY, AS MARCH 2019 TESTING SHOWS ONE MISSING COIL; SURGEON AND DATE TBD; PAIN AND OTHER SYMPTOMS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24 KG/SQM. ENDOSCOPY - ON 22-DEC-2014: RESULTS: IRRITABLE BOWEL SYNDROME. 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. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED LACK OF EFFICACY AND THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, A LACK OF EFFICACY AND 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-APR-2019: PFS RECEIVED: EVENTS: HEADACHE AND DEVICE DISLOCATION WERE ADDED. PLAINTIFFS ADDRESS DETAILS WERE UPDATED. MEDICAL HISTORY WERE ADDED. REPORTER CAUSALITY COMMENTS WERE 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 PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/ SEVERE PAIN/ PELVIC AREA PAIN (SHARP, STABBING)/ PAIN/ SEVERE PAIN"), PLACENTA PRAEVIA ("PLACENTA PREVIA STAGE 4") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("BECAME PREGNANT/ UNINTENDED PREGNANCY/ FOUR MONTHS PREGNANT/ I WAS FOUR MONTHS PREGNANT AND HAD A CHECK UP WITH PHYSICIAN") IN A FEMALE PATIENT (GRAVIDA 5, PARA 3) WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE DIFFICULT TO USE "DIFFICULTIES WITH PLACEMENT ON ONE SIDE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2, LIVE BIRTH IN (B)(6), LIVE BIRTH ON (B)(6), FATIGUE, WEIGHT GAIN, PHARYNGITIS, OVERWEIGHT, HYPOTHYROIDISM, CONSTIPATION, VITAMIN B COMPLEX DEFICIENCY, ADJUSTMENT DISORDER, DEPRESSED MOOD, HYPERLIPIDEMIA, PAIN IN LIMB, ACUTE UPPER RESPIRATORY TRACT INFECTION, FEVER, PAIN IN THORACIC SPINE, COCCYX PAIN, NECK PAIN, ALLERGIC RHINITIS DUE TO POLLEN AND DIFFICULTY IN WALKING. SHE DID NOT EXPERIENCE A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ADIPEX AND LEXAPRO. CONCURRENT CONDITIONS INCLUDED ALCOHOL USE, TOBACCO USER, EX-SMOKER, DYSPHAGIA, GASTRITIS, HIATAL HERNIA AND STOMACH DISCOMFORT. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. IN 2014, 109 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ MENSTRUAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("DEPRESSION"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ UNABLE TO HAVE INTERCOURSE WITHOUT PAIN"), THE SECOND EPISODE OF DYSMENORRHOEA ("MENSTRUAL PAIN"), ANXIETY ("ANXIETY") AND MIGRAINE ("MIGRAINES/ FREQUENT MIGRAINES"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2015, THE PATIENT EXPERIENCED VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), INCONTINENCE ("INCONTINENCE") AND ABDOMINAL DISTENSION ("BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PLACENTA PRAEVIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), PANIC ATTACK ("PANIC ATTACKS/ PANIC DISORDER"), WEIGHT INCREASED ("WEIGHT GAIN"), POLYMENORRHOEA ("MENSTRUATION ON A TOO-FREQUENT BASIS"), ABDOMINAL DISCOMFORT ("BOWEL ISSUES") AND INVESTIGATION NONCOMPLIANCE ("DID YOU UNDERGO AN ESSURE CONFIRMATION TEST-NO"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH FLUOXETINE HYDROCHLORIDE (PROZAC), ALPRAZOLAM (XANAX), SURGERY (ESSURE WAS REMOVED) AND SURGERY (C-SECTION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PLACENTA PRAEVIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABDOMINAL PAIN, DEPRESSION, WEIGHT FLUCTUATION, DYSPAREUNIA, THE LAST EPISODE OF DYSMENORRHOEA, ANXIETY, MIGRAINE, PANIC ATTACK, VITAMIN D DEFICIENCY, ABDOMINAL DISTENSION, ABDOMINAL DISCOMFORT AND INVESTIGATION NONCOMPLIANCE OUTCOME WAS UNKNOWN AND THE FATIGUE AND WEIGHT INCREASED HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSPAREUNIA, FATIGUE, INCONTINENCE, INVESTIGATION NONCOMPLIANCE, MIGRAINE, PANIC ATTACK, PELVIC PAIN, PLACENTA PRAEVIA, POLYMENORRHOEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, VITAMIN D DEFICIENCY, WEIGHT FLUCTUATION, WEIGHT INCREASED, THE FIRST EPISODE OF DYSMENORRHOEA AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT: (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ENDOSCOPY - ON (B)(6) 2014: IRRITABLE BOWEL SYNDROME. 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. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED LACK OF EFFICACY AND THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, A LACK OF EFFICACY AND 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-NOV-2017: NEW REPORTER¿S ADDED. HISTORICAL CONDITIONS AND DRUGS ADDED. CONCOMITANT CONDITIONS ADDED. NEW EVENTS ADDED: MENSTRUATION ON A TOO-FREQUENT BASIS, BOWEL ISSUES, DIFFICULTIES WITH PLACEMENT ON ONE SIDE, SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. 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 PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/ SEVERE PAIN/PELVIC AREA PAIN (SHARP, STABBING)"), PLACENTA PRAEVIA ("PLACENTA PREVIA STAGE 4") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("BECAME PREGNANT/UNINTENDED PREGNANCY/FOUR MONTHS PREGNANT") IN A FEMALE PATIENT (GRAVIDA 5, PARA 3) WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2, LIVE BIRTH IN (B)(6), LIVE BIRTH ON (B)(6), FATIGUE AND WEIGHT GAIN. SHE DID NOT EXPERIENCE A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. IN 2014, 109 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("DEPRESSION"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), THE FIRST EPISODE OF DYSMENORRHOEA ("MENSTRUAL PAIN"), ANXIETY ("ANXIETY") AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2015, THE PATIENT EXPERIENCED VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), INCONTINENCE ("INCONTINENCE") AND ABDOMINAL DISTENSION ("BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PLACENTA PRAEVIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THE SECOND EPISODE OF DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), FATIGUE ("FATIGUE"), PANIC ATTACK ("PANIC ATTACKS/PANIC DISORDER") AND WEIGHT INCREASED ("WEIGHT GAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH FLUOXETINE HYDROCHLORIDE (PROZAC), ALPRAZOLAM (XANAX), SURGERY (ESSURE WAS REMOVED) AND SURGERY (C-SECTION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PLACENTA PRAEVIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, THE LAST EPISODE OF DYSMENORRHOEA, ABDOMINAL PAIN, DEPRESSION, WEIGHT FLUCTUATION, DYSPAREUNIA, ANXIETY, MIGRAINE, PANIC ATTACK, VITAMIN D DEFICIENCY AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN AND THE FATIGUE AND WEIGHT INCREASED HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSPAREUNIA, FATIGUE, INCONTINENCE, MIGRAINE, PANIC ATTACK, PELVIC PAIN, PLACENTA PRAEVIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, VITAMIN D DEFICIENCY, WEIGHT FLUCTUATION, WEIGHT INCREASED, THE FIRST EPISODE OF DYSMENORRHOEA AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ENDOSCOPY - ON (B)(6) 2014: IRRITABLE BOWEL SYNDROME. 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. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED LACK OF EFFICACY AND THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, A LACK OF EFFICACY AND 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: EVENTS ADDED-PLACENTA PREVIA STAGE 4, MENSTRUAL PAIN, ANXIETY, MIGRAINES/HEAD PAIN (MIGRAINE), PANIC ATTACKS, VITAMIN D DEFICIENCY, INCONTINENCE, PAIN/ SEVERE PAIN/ SEVERE PAIN/PELVIC AREA PAIN(SHARP, STABBING), BLOATING AND WEIGHT GAIN. HISTORICAL CONDITIONS, LAB DATA AND TREATMENT DRUGS ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA (B)(4), (B)(6), 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. 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 |
|---|---|---|---|---|---|---|---|
| 910272 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS |