ESSURE
Report
- Report Number
- 2951250-2019-05957
- Event Type
- Injury
- Date Received
- September 10, 2019
- Date of Event
- November 1, 2013
- Report Date
- October 1, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEED') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B26272) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSPAREUNIA, ABDOMINAL BLOATING, MENSES LACK OF, DYSMENORRHOEA, POLYCYSTIC OVARY, PAIN OVARIAN, UPPER ABDOMINAL PAIN, CONSTIPATION, FATIGUE, HOT FLASHES, WEIGHT GAIN, NOCTURNAL URINARY FREQUENCY, URINE INCONTINENCE, LIBIDO DECREASED, NOSE BLEED, SINUS PAIN, TENDERNESS, SKIN DRY, ACNE, COLD INTOLERANCE, MOOD SWINGS, GAS, HEARTBURN, GASTRITIS, HIATAL HERNIA, BILIOUS GASTRIC DRAINAGE, LOWER ABDOMINAL PAIN, STRESS URINARY INCONTINENCE, MENSES IRREGULAR, DELAYED PERIOD, UTERINE BLEEDING, POLYCYSTIC OVARY, UTERINE FIBROIDS AND UTERINE ABLATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: MIRENA IUD FROM 2008 TO AUGUST 2013; FOR FREQUENCY, URGENCY: AZO; FOR SLEEP: XANAX; FOR AN UNREPORTED INDICATION: ACIPHEX FROM OCTOBER 2012 TO NOVEMBER 2012, PROTON PUMP INHIBITORS AND METAMUCIL ABOUT 3-4 TIMES A WEEK. CONCURRENT CONDITIONS INCLUDED GERD, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, MIGRAINE, TENDENCY TO BRUISE EASILY, HEADACHE, DIARRHEA, LEIOMYOMA AND BLEED IN LUTEAL CYST. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM AUGUST 2013 TO NOVEMBER 2016 FOR CONTRACEPTION, CLARITHROMYCIN (MACROBID) FOR UTI, METRONIDAZOLE (METROGEL) FOR VAGINAL INFECTION AS WELL AS AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) SINCE 2009, DICHLORALPHENAZONE;ISOMETHEPTENE;PARACETAMOL (MIDRIN) FROM JANUARY 2014 TO DECEMBER 2015, FLUOXETINE HYDROCHLORIDE (PROZAC) FROM SEPTEMBER 2016 TO DECEMBER 2016 AND VALACICLOVIR HYDROCHLORIDE (VALTREX) FROM JULY 2013 TO DECEMBER 2016. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN NOVEMBER 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS- UTI/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN DECEMBER 2013, THE PATIENT EXPERIENCED DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH") AND ANXIETY ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), 2 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED BY HYST. (FULL),SALPING. (BILATERAL) ON (B)(6) 2018-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED, THE DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE VAGINAL INFECTION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- PAIN AND BLEEDING, BLADDER/URINARY PROBLEM. ESSURE INSERTION DATE AS : (B)(6) 2013 AND (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CULTURE URINE - ON (B)(6) 2016: MULTIPLE ORGANISMS PRESENT EACH LESS THAN 10,000 CFU/ML. THESE ORGANISMS, COMMONLY FOUND ON EXTERNAL AND INTERNAL GENITALIA, ARE CONSIDERED TO BE COLONIZERS.. ENDOSCOPY - ON (B)(6) 2012: IMPRESSION: 1. CLASS A ESOPHAGITIS WITH AN IRREGULAR Z LINE, STATUS POST BIOPSIES. 2 . SMALL HIATAL HERNIA . 3. GASTRITIS STATUS POST BIOPSIES. 4. BILIOUS FLUID IN THE STOMACH. 5. NORMAL DUODENUM.. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED/TEST BILATERAL OCCLUSION.. ULTRASOUND ABDOMEN - ON (B)(6) 2012: 1. POST CHOLECYSTECTOMY . 2 . ULTRASOUND OF THE RIGHT UPPER QUADRANT OTHERWISE UNREMARKABLE . 3. IF CLINICALLY INDICATED, CT OF THE ABDOMEN AND PELVIS IS SUGGESTED FOR FURTHER R EVALUATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, URINARY TRACT INFECTION, PELVIC PAIN AND GENITAL BLEEDING, VAGINAL HEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS AND MR RECEIVED- LOT NUMBER WAS ADDED. NEW EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT, VAGINAL , PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH WERE ADDED. EVENTS ONSET DATE WERE ADDED. CONCOMITANT DRUGS, LAB DATA AND MEDICAL HISTORY WERE ADDED .PATIENT¿S HEIGHT WAS ADDED. NEW REPORTERS WERE ADDED. 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-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEED') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B26272) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSPAREUNIA, ABDOMINAL BLOATING, MENSES LACK OF, DYSMENORRHOEA, POLYCYSTIC OVARY, PAIN OVARIAN, UPPER ABDOMINAL PAIN, CONSTIPATION, FATIGUE, HOT FLASHES, WEIGHT GAIN, NOCTURNAL URINARY FREQUENCY, URINE INCONTINENCE, LIBIDO DECREASED, NOSE BLEED, SINUS PAIN, TENDERNESS, SKIN DRY, ACNE, COLD INTOLERANCE, MOOD SWINGS, GAS, HEARTBURN, GASTRITIS, HIATAL HERNIA, BILIOUS GASTRIC DRAINAGE, CRAMP IN LOWER ABDOMEN, STRESS URINARY INCONTINENCE, MENSES IRREGULAR, DELAYED PERIOD, UTERINE BLEEDING, POLYCYSTIC OVARY, UTERINE FIBROIDS AND UTERINE ABLATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: MIRENA IUD FROM 2008 TO AUGUST 2013; FOR FREQUENCY, URGENCY: AZO; FOR SLEEP: XANAX; FOR AN UNREPORTED INDICATION: ACIPHEX FROM OCTOBER 2012 TO NOVEMBER 2012, PROTON PUMP INHIBITORS AND METAMUCIL ABOUT 3-4 TIMES A WEEK. CONCURRENT CONDITIONS INCLUDED GERD, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, MIGRAINE, TENDENCY TO BRUISE EASILY, HEADACHE, DIARRHEA, LEIOMYOMA NOS AND BLEED IN LUTEAL CYST. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM AUGUST 2013 TO NOVEMBER 2016 FOR CONTRACEPTION, CLARITHROMYCIN (MACROBID) FOR UTI, METRONIDAZOLE (METROGEL) FOR VAGINAL INFECTION AS WELL AS AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) SINCE 2009, FLUOXETINE HYDROCHLORIDE (PROZAC) FROM SEPTEMBER 2016 TO DECEMBER 2016 AND VALACICLOVIR HYDROCHLORIDE (VALTREX) FROM JULY 2013 TO DECEMBER 2016. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN NOVEMBER 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS- UTI/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"). IN DECEMBER 2013, THE PATIENT EXPERIENCED DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH") AND ANXIETY ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), 2 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED BY HYST. (FULL),SALPING. (BILATERAL) ON (B)(6) 2018-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND URINARY TRACT INFECTION HAD RESOLVED, THE DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE VAGINAL INFECTION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- PAIN AND BLEEDING, BLADDER/URINARY PROBLEM. ESSURE INSERTION DATE AS : (B)(6) 2013 AND (B)(6) 2013. CONCOMITANT DRUG INCLUDES MIDRIN DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CULTURE URINE - ON (B)(6) 2016: MULTIPLE ORGANISMS PRESENT EACH LESS THAN 10,000 CFU/ML. THESE ORGANISMS, COMMONLY FOUND ON EXTERNAL AND INTERNAL GENITALIA, ARE CONSIDERED TO BE COLONIZERS.. ENDOSCOPY - ON (B)(6) 2012: IMPRESSION: 1. CLASS A ESOPHAGITIS WITH AN IRREGULAR Z LINE, STATUS POST BIOPSIES. 2 . SMALL HIATAL HERNIA . 3. GASTRITIS STATUS POST BIOPSIES. 4. BILIOUS FLUID IN THE STOMACH. 5. NORMAL DUODENUM.. HYSTEROSALPINGOGRAM - ON (B)(6) 2014 ULTRASOUND ABDOMEN - ON (B)(6) 2012: 1. POST CHOLECYSTECTOMY . 2 . ULTRASOUND OF THE RIGHT UPPER QUADRANT OTHERWISE UNREMARKABLE . 3. IF CLINICALLY INDICATED, CT OF THE ABDOMEN AND PELVIS IS SUGGESTED FOR FURTHER R EVALUATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, URINARY TRACT INFECTION, PELVIC PAIN AND GENITAL BLEEDING, VAGINAL HEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF PTC. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, 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"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS- UTI"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED BY HYST. (FULL), SALPING. (BILATERAL) ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN AND URINARY TRACT INFECTION HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, GENITAL HAEMORRHAGE, PELVIC PAIN, PSYCHOLOGICAL TRAUMA AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLEEDING, BLADDER/URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2014: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED/TEST BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED: CASE BECAME INCIDENT. PRODUCT INFORMATION ADDED. EVENT WAS ADDED- ABDOMINAL PAIN, GEN. ABNORMAL BLEED, PSYCH INJURY, BLADDER/URINARY PROBLEMS URINARY TRACT INFECTION. PATIENT DETAILS AND REPORTER INFORMATION WAS ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE HAVE CONDUCTED 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 778153 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B26272 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | ADDERALL| ADDERALL| DEPO PROVERA| DEPO PROVERA| MACROBID [CLARITHROMYCIN]| MACROBID [CLARITHROMYCIN]| METROGEL| METROGEL| PROZAC| PROZAC| VALTREX| VALTREX |