ESSURE
Report
- Report Number
- 2951250-2019-11965
- Event Type
- Injury
- Date Received
- December 5, 2019
- Date of Event
- December 1, 2013
- Report Date
- March 26, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) / ABNORMAL BLEEDING (MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A68805) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NECK PAIN, SHOULDER PAIN, RECTAL BLEEDING, DIARRHEA AND HEMORRHOIDS. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID;HYDROCODONE BITARTRATE (LORTAB ASA) SINCE 2011, FOLIC ACID SINCE 2012, KETOROLAC SINCE 2018, LAMOTRIGINE (LAMICTAL) FROM 2015 TO 2017, MINERALS NOS;VITAMINS NOS (PRENATAL VITAMINS) FROM 2012 TO 2013, MISOPROSTOL (CYTOTEC) SINCE 2018, OXYCODONE SINCE 2011, SALBUTAMOL (ALBUTEROL HFA) AND ZOLPIDEM TARTRATE (AMBIEN) FROM 2013 TO 2018. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ADENOMYOSIS ("FOCAL ADENOMYOSIS") AND WAS FOUND TO HAVE LEIOMYOMA ("LEIOMYOMA"). IN (B)(6) 2017, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS / BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS / BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), LIBIDO DECREASED ("HORMONAL CHANGES DESCRIBE: DECREASED SEX DRIVE"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY"), BACK PAIN ("LOW BACK PAIN") AND SCIATICA ("SCIATIC NERVE PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL), HYSTERECTOMY (FULL) AND ABLATION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND SCIATICA HAD RESOLVED AND THE MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHOEA, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, WEIGHT INCREASED, LIBIDO DECREASED, ADENOMYOSIS, LEIOMYOMA, PSYCHOLOGICAL TRAUMA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, LEIOMYOMA, LIBIDO DECREASED, MENORRHAGIA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, SCIATICA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE IMPLANT DATE (B)(6) 2013 AND (B)(6) 2013. PLAINTIFF RECEIVED TREATMENT FOR EVENTS PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), WEIGHT GAIN, FOCAL ADENOMYOSIS, DECREASED SEX DRIVE AND LEIOMYOMA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2013: BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-FEB-2020: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. LOT NUMBER ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL), LOW BACK PAIN, SCIATIC NERVE PAIN. OUTCOME OF EVENT PELVIC PAIN WERE UPDATED. ONSET DATE OF EVENT MENORRHAGIA, URINARY TRACT DISORDER, BLADDER DISORDER, DYSMENORRHOEA, PELVIC PAIN, LEIOMYOMA, ADENOMYOSIS WERE UPDATED. REPORTER INFORMATION, AKA NAME, MEDICAL HISTORY, CONCOMITANT DRUG, LAB DATA 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 ('PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) / ABNORMAL BLEEDING (MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A68805-INV) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NECK PAIN, SHOULDER PAIN, RECTAL BLEEDING, DIARRHEA AND HEMORRHOIDS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FOR BIRTH CONTROL AS WELL AS ACETYLSALICYLIC ACID;HYDROCODONE BITARTRATE (LORTAB ASA) SINCE 2011, FOLIC ACID SINCE 2012, KETOROLAC SINCE 2018, LAMOTRIGINE (LAMICTAL) FROM 2015 TO 2017, MINERALS NOS;VITAMINS NOS (PRENATAL VITAMINS) FROM 2012 TO 2013, MISOPROSTOL (CYTOTEC) SINCE 2018, OXYCODONE SINCE 2011, SALBUTAMOL (ALBUTEROL HFA) AND ZOLPIDEM TARTRATE (AMBIEN) FROM 2013 TO 2018. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ADENOMYOSIS ("FOCAL ADENOMYOSIS") AND WAS FOUND TO HAVE LEIOMYOMA ("LEIOMYOMA"). IN (B)(6) 2017, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS / BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS / BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), LIBIDO DECREASED ("HORMONAL CHANGES DESCRIBE: DECREASED SEX DRIVE"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY"), BACK PAIN ("LOW BACK PAIN") AND SCIATICA ("SCIATIC NERVE PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL), HYSTERECTOMY (FULL) AND ABLATION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND SCIATICA HAD RESOLVED AND THE MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHOEA, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, WEIGHT INCREASED, LIBIDO DECREASED, ADENOMYOSIS, LEIOMYOMA, PSYCHOLOGICAL TRAUMA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, LEIOMYOMA, LIBIDO DECREASED, MENORRHAGIA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, SCIATICA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE IMPLANT DATE (B)(6) 2013. PLAINTIFF RECEIVED TREATMENT FOR EVENTS PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), WEIGHT GAIN, FOCAL ADENOMYOSIS, DECREASED SEX DRIVE AND LEIOMYOMA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON(B)(6) 2013: BILATERAL OCCLUSION. THE LOT NUMBER REPORTED (A68805) IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-MAR-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). ON 4-MAR-2020: PFS RECEIVED: CONCOMITANT DRUG ADDED. FU 4 AND 5 PROCESSED TOGETHER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), LIBIDO DECREASED ("DECREASED SEX DRIVE"), ADENOMYOSIS ("FOCAL ADENOMYOSIS") AND PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND LEIOMYOMA ("LEIOMYOMA"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL), HYSTERECTOMY (FULL) AND ABLATION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHOEA, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, WEIGHT INCREASED, LIBIDO DECREASED, ADENOMYOSIS, LEIOMYOMA AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, LEIOMYOMA, LIBIDO DECREASED, MENORRHAGIA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE IMPLANT DATE (B)(6) 2013 AND (B)(6) 2013. PLAINTIFF RECEIVED TREATMENT FOR EVENTS PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), WEIGHT GAIN, FOCAL ADENOMYOSIS, DECREASED SEX DRIVE AND LEIOMYOMA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-NOV-2019: PLAINTIFF FACT SHEET RECEIVED. EVENT INJURY WAS UPDATED TO EVENTS: PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), URINARY PROBLEMS, BLADDER PROBLEMS, BLADDER INFECTION, UTI, VAGINAL INFECTION, WEIGHT GAIN, FOCAL ADENOMYOSIS, DECREASED SEX DRIVE AND LEIOMYOMA. ESSURE REMOVAL; DETAILS 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 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1210319 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A68805-INV | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | ALBUTEROL HFA| ALBUTEROL HFA| AMBIEN| AMBIEN| CYTOTEC| CYTOTEC| DEPO PROVERA| FOLIC ACID| FOLIC ACID| KETOROLAC| KETOROLAC| LAMICTAL| LAMICTAL| LORTAB ASA| LORTAB ASA| NSAIDS| OXYCODONE| OXYCODONE| PRENATAL VITAMINS [MINERALS NOS,VITAMINS NOS]| PRENATAL VITAMINS [MINERALS NOS,VITAMINS NOS] |