ESSURE
Report
- Report Number
- 2951250-2017-05333
- Event Type
- Injury
- Date Received
- October 24, 2017
- Date of Event
- May 1, 2005
- Report Date
- June 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN PELVIC AREA") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO: 12266501) 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 VAGINAL DELIVERY (2), MULTIPLE SCLEROSIS, SEIZURE, PERSONALITY DISORDER, ALLERGIC REACTION TO ANALGESICS, BRADYCARDIA, ASTHMA AND FIBROMYALGIA. CONCURRENT CONDITIONS INCLUDED MALPOSITION OF UTERUS, LEG PAIN, BACK PAIN, LIPIDS INCREASED, OVARIAN CYST, DIABETES MELLITUS, DECREASED APPETITE AND WEIGHT LOSS. CONCOMITANT PRODUCTS INCLUDED AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLENE) SINCE JANUARY 2007, AMLODIPINE SINCE JANUARY 2007, FINGOLIMOD HYDROCHLORIDE (GILENYA) SINCE JANUARY 2015, INTERFERON BETA-1A (AVONEX) FROM JANUARY 2003 TO JANUARY 2015, LISINOPRIL SINCE JANUARY 2007, METFORMIN SINCE JANUARY 2007 AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITIONS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITIONS: MENTAL ANGUISH"), 3 DAYS AFTER INSERTION OF ESSURE (ESS205). ON (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION ("INFECTIONS") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ENDOMETRIAL ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY AND DYSPAREUNIA HAD RESOLVED AND THE INFECTION AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSPAREUNIA, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: NO COILS DEMONSTRATED ON THE LEFT, 2 COILS DEMONSTRATED ON THE RIGHT. DISCREPANCY NOTED THAT YOU HAVE NOT HAD YOUR ESSURE REMOVED, ARE YOU CURRENTLY PLANNING FOR ESSURE REMOVAL-NO. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JAN-2019: NEW PFS RECEIVED. OUTCOME UPDATED FOR EVENT PELVIC PAIN, VAGINAL BLEEDING, MENORRHAGIA, DYSPAREUNIA, DEPRESSION & ANXIETY. HISTORICAL CONDITIONS & CONCOMITANT MEDICATION ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12266501) 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 PAST MEDICAL HISTORY INCLUDED VAGINAL DELIVERY (2), MULTIPLE SCLEROSIS, SEIZURE, DEPRESSION, PERSONALITY DISORDER, ALLERGIC REACTION TO ANALGESICS, BRADYCARDIA, ASTHMA AND FIBROMYALGIA. CONCURRENT CONDITIONS INCLUDED MALPOSITION OF UTERUS, LEG PAIN, BACK PAIN, LIPIDS INCREASED, OVARIAN CYST, DIABETES MELLITUS, DECREASED APPETITE AND WEIGHT LOSS. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN APRIL 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION ("INFECTIONS") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY) AND SURGERY (UNDERWENT ENDOMETRIAL ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA, INFECTION, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSPAREUNIA, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: NO COILS DEMONSTRATED ON THE LEFT, 2 COILS DEMONSTRATED ON THE RIGHT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL PROBLEM). 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 / PAIN") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12266501) 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 PAST MEDICAL HISTORY INCLUDED VAGINAL DELIVERY (2), MULTIPLE SCLEROSIS, SEIZURE, DEPRESSION, PERSONALITY DISORDER, DRUG HYPERSENSITIVITY, BRADYCARDIA, ASTHMA AND FIBROMYALGIA. CONCURRENT CONDITIONS INCLUDED MALPOSITION OF UTERUS, LEG PAIN, BACK PAIN, LIPIDS INCREASED, OVARIAN CYST, DIABETES MELLITUS, DECREASED APPETITE AND WEIGHT LOSS. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION ("INFECTIONS") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY) AND SURGERY (UNDERWENT ENDOMETRIAL ABLATION). ESSURE (ESS205) WAS REMOVED ON 24-MAR-2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA, INFECTION, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSPAREUNIA, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: NO COILS DEMONSTRATED ON THE LEFT, 2 COILS DEMONSTRATED ON THE RIGHT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUN-2018: EVENTS- "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DEPRESSION, MENTAL ANGUISH, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST.", LOT NUMBER, REPORTER ADDED FROM PFS. CONCOMITTANT AND HISTORICAL CONDITION ADDEDFROM MEDICAL RECORD. 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 / PAIN PELVIC AREA') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12266501) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED FAMOTIDINE. 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 VAGINAL DELIVERY (2), SEIZURE, PERSONALITY DISORDER, ALLERGIC REACTION TO ANALGESICS, BRADYCARDIA, ASTHMA AND FIBROMYALGIA. CONCURRENT CONDITIONS INCLUDED GERD SINCE (B)(6) 2015, HYPERTENSION SINCE (B)(6) 2007, MULTIPLE SCLEROSIS, MALPOSITION OF UTERUS, LEG PAIN, BACK PAIN, LIPIDS INCREASED, OVARIAN CYST, DIABETES MELLITUS, DECREASED APPETITE AND WEIGHT LOSS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2005 TO (B)(6) 2005 FOR BIRTH CONTROL AS WELL AS AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLENE) SINCE (B)(6) 2007, AMLODIPINE SINCE (B)(6) 2007, FINGOLIMOD HYDROCHLORIDE (GILENYA) SINCE (B)(6) 2015, INTERFERON BETA-1A (AVONEX) FROM (B)(6) 2003 TO (B)(6) 2015, LISINOPRIL SINCE (B)(6) 2007, METFORMIN SINCE (B)(6) 2007 AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITIONS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITIONS: MENTAL ANGUISH"), 4 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT STARTED FAMOTIDINE AT AN UNSPECIFIED DOSE AND FREQUENCY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION ("INFECTIONS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEM/UTI"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEM"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ENDOMETRIAL ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, DYSPAREUNIA, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE INFECTION AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSPAREUNIA, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: NO COILS DEMONSTRATED ON THE LEFT, 2 COILS DEMONSTRATED ON THE RIGHT. DISCREPANCY NOTED THAT YOU HAVE NOT HAD YOUR ESSURE REMOVED, ARE YOU CURRENTLY PLANNING FOR ESSURE REMOVAL-NO. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. ADDED NEW EVENT BLADDER PROBLEM , URINARY PROBLEM , BLADDER INFECTION ,VAGINAL INFECTION , UTI ,VAGINAL DISCHARGE WERE ADDED. 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 PELVIC PAIN ('SEVERE PELVIC PAIN / PAIN PELVIC AREA') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12266501) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED FAMOTIDINE. 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 VAGINAL DELIVERY (2), SEIZURE, PERSONALITY DISORDER, ALLERGIC REACTION TO ANALGESICS, BRADYCARDIA, ASTHMA AND FIBROMYALGIA. CONCURRENT CONDITIONS INCLUDED GERD SINCE (B)(6) 2015, HYPERTENSION SINCE (B)(6) 2007, MULTIPLE SCLEROSIS, MALPOSITION OF UTERUS, LEG PAIN, BACK PAIN, LIPIDS INCREASED, OVARIAN CYST, DIABETES MELLITUS, DECREASED APPETITE AND WEIGHT LOSS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2005 TO (B)(6) 2005 FOR BIRTH CONTROL AS WELL AS AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLENE) SINCE (B)(6) 2007, AMLODIPINE SINCE (B)(6) 2007, FINGOLIMOD HYDROCHLORIDE (GILENYA) SINCE (B)(6) 2015, INTERFERON BETA-1A (AVONEX) FROM (B)(6) 2003 TO (B)(6) 2015, LISINOPRIL SINCE (B)(6) 2007, METFORMIN SINCE (B)(6) 2007 AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITIONS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITIONS: MENTAL ANGUISH"), 4 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT STARTED FAMOTIDINE AT AN UNSPECIFIED DOSE AND FREQUENCY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION ("INFECTIONS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEM/UTI"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEM"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ENDOMETRIAL ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, DYSPAREUNIA, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE INFECTION AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSPAREUNIA, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: NO COILS DEMONSTRATED ON THE LEFT, 2 COILS DEMONSTRATED ON THE RIGHT. DISCREPANCY NOTED THAT YOU HAVE NOT HAD YOUR ESSURE REMOVED, ARE YOU CURRENTLY PLANNING FOR ESSURE REMOVAL-NO. LOT NUMBER: 12266501 MANUFACTURING DATE: 2004-10 EXPIRATION DATE: 2005-12 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY-SAFETY EVALUATION OF PTC A TECHNICAL INVESTIGATION WAS 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 PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFECTION ("INFECTIONS") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY DUE TO COMPLICATIONS FROM ESSURE DEVICE). ESSURE (ESS205) WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, INFECTION AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED INFECTION, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). 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 |
|---|---|---|---|---|---|---|---|
| 751867 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12266501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| AMITRIPTYLENE| AMITRIPTYLENE| AMITRIPTYLENE| AMLODIPINE| AMLODIPINE| AMLODIPINE| AVONEX| AVONEX| AVONEX| DEPO PROVERA| DEPO PROVERA| GILENYA| GILENYA| GILENYA| GILENYA| GILENYA| LISINOPRIL| LISINOPRIL| LISINOPRIL| METFORMIN| METFORMIN| METFORMIN |