ESSURE
Report
- Report Number
- 2951250-2017-00564
- Event Type
- Injury
- Date Received
- February 17, 2017
- Date of Event
- September 1, 2011
- Report Date
- January 6, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
CONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFECTION ("INFECTIONS"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE"), SALPINGITIS ("SALPINGITIS") AND PERIHEPATITIS ("FITZ-HUGH-CURTIS SYNDROME") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 622943) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY, PELVIC MASS SINCE (B)(6) 2011, PELVIC INFLAMMATORY DISEASE SINCE (B)(6) 2011, PERIHEPATITIS SINCE (B)(6) 2011, ENDOMETRIOSIS SINCE (B)(6) 2011, PELVIC INFLAMMATORY DISEASE SINCE (B)(6) 2011, PAINFUL HIPS, LOW BACK PAIN, VAGINAL DISCHARGE, SALPINGITIS, OOPHORITIS AND MENOPAUSAL. CONCOMITANT PRODUCTS INCLUDED METHOCARBAMOL SINCE JUNE 2011 AND NUVARING (NUVA). ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN APRIL 2007, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN JUNE 2007, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"). IN OCTOBER 2007, THE PATIENT EXPERIENCED MENTAL DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION"). IN OCTOBER 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN APRIL 2009, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT LOSS"). IN 2009, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN AUGUST 2010, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN SEPTEMBER 2011, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SUBOXONE, ANALGESICS, SURGERY (FULL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND BILATERAL OOPHORECTOMY), SURGERY (FULL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND BILATERAL OOPHORECTOMY) AND SURGERY (FULL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND BILATERAL OOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC INFECTION OUTCOME WAS UNKNOWN AND THE PELVIC INFLAMMATORY DISEASE, SALPINGITIS, PERIHEPATITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, WEIGHT DECREASED, MENTAL DISORDER, PELVIC PAIN AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENTAL DISORDER, PELVIC INFECTION, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERIHEPATITIS, SALPINGITIS, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: TOTAL BILATERAL OCCLUSION ON (B)(6) 2011, PROCEDURE: DIAGNOSTIC LAPAROSCOPY, ADHESIOLYSIS. OPERATIVE FINDINGS: THE APPARENT MASS WAS AN OVARY WITH A CORPUS LUTEUM WITH A DENSE ADHERENT FALLOPIAN TUBE PARTIALLY OCCLUDED WRAPPED AROUND THE OVARY. THIS WAS ON THE LEFT. THE RIGHT OVARY AND TUBE WERE ALSO DENSELY ADHERENT INTO THE CUL-DE-SAC. ON (B)(6) 2011, NOTES: LEFT FALLOPIAN TUBE APPEARS LIKE THERE WAS A PREVIOUS LIGATION PROCEDURE PERFORMED 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 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 INFECTION ('INFECTIONS'), PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), SALPINGITIS ('SALPINGITIS') AND PERIHEPATITIS ('FITZ-HUGH-CURTIS SYNDROME') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 622943) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY. STATE AND DATE OF DEATH OF PLAINTIFF: (B)(6) 2018, TN. ON (B)(6) 2011, PROCEDURE: DIAGNOSTIC LAPAROSCOPY, ADHESIOLYSIS. OPERATIVE FINDINGS: THE APPARENT MASS WAS AN OVARY WITH A CORPUS LUTEUM WITH A DENSE ADHERENT FALLOPIAN TUBE PARTIALLY OCCLUDED WRAPPED AROUND THE OVARY. THIS WAS ON THE LEFT. THE RIGHT OVARY AND TUBE WERE ALSO DENSELY ADHERENT INTO THE CUL-DE-SAC. ON (B)(6) 2011, NOTES: LEFT FALLOPIAN TUBE APPEARS LIKE THERE WAS A PREVIOUS LIGATION PROCEDURE PERFORMED. CONCURRENT CONDITIONS INCLUDED PELVIC INFLAMMATORY DISEASE SINCE (B)(6) 2011, PERIHEPATITIS SINCE (B)(6) 2011, ENDOMETRIOSIS SINCE (B)(6) 2011, PELVIC INFLAMMATORY DISEASE SINCE (B)(6) 2011, PELVIC MASS SINCE (B)(6) 2011, OBESITY, PAINFUL HIPS, LOW BACK PAIN, VAGINAL DISCHARGE, SALPINGITIS, OOPHORITIS AND MENOPAUSAL. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) FROM (B)(6) 2007 TO (B)(6) 2007 FOR CONTRACEPTION AS WELL AS METHOCARBAMOL SINCE (B)(6) 2011. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2007, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2007, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"). IN (B)(6) 2007, THE PATIENT EXPERIENCED DRUG DEPENDENCE ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ADDICTION TO PAIN MEDICATION"). IN (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2009, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). IN 2009, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2010, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH ANALGESICS, BUPRENORPHINE HYDROCHLORIDE;NALOXONE HYDROCHLORIDE (SUBOXONE), IBUPROFEN (MOTRIN), OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL (PERCOCET) AND SURGERY (FULL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND BILATERAL OOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC INFECTION OUTCOME WAS UNKNOWN AND THE PELVIC INFLAMMATORY DISEASE, SALPINGITIS, PERIHEPATITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, WEIGHT DECREASED, DRUG DEPENDENCE, PELVIC PAIN AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED DRUG DEPENDENCE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, PELVIC INFECTION, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERIHEPATITIS, SALPINGITIS, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: CURRENT WEIGHT: 165 LBS. RECEIVED TREATMENT FOR DYSPAREUNIA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, SALPINGITIS, FITZ-HUGH CURTIS SYNDROME, ADDICTION TO PAIN MEDICATION, DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: FOLLOW 7 AND 8 PROCESSED TOGETHER PFS RECEIVED: PREVIOUSLY ADDED MENTAL DISORDER WAS REPLACED WITH DRUG DEPENDENCE, TREATMENT DRUG, MEDICAL HISTORY WAS ADDED ON (B)(6) 2019: PFS RECEIVED: NO NEW INFORMATION. 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 INFECTION ("INFECTIONS"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE"), SALPINGITIS ("SALPINGITIS") AND PERIHEPATITIS ("FITZ-HUGH-CURTIS SYNDROME") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 622943) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED METHOCARBAMOL SINCE (B)(6) 2011. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2007, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND PELVIC PAIN ("PAIN"). IN 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2009, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT LOSS") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN 2010, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN SEPTEMBER 2011, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENTAL DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION"). THE PATIENT WAS TREATED WITH SUBOXONE, ANALGESICS, SURGERY (FULL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND BILATERAL OOPHORECTOMY), SURGERY (FULL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND BILATERAL OOPHORECTOMY) AND SURGERY (FULL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND BILATERAL OOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC INFECTION OUTCOME WAS UNKNOWN AND THE PELVIC INFLAMMATORY DISEASE, SALPINGITIS, PERIHEPATITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, WEIGHT DECREASED, MENTAL DISORDER, PELVIC PAIN AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENTAL DISORDER, PELVIC INFECTION, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERIHEPATITIS, SALPINGITIS, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.3 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PFS RECEIVED: NEW REPORTER, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT LOT NO, ONSET AND REMOVAL DATES UPDATED, TREATMENT DRUGS, HISTORICAL DRUGS AND CONDITIONS, CONCOMITANT DRUGS AND CONDITIONS, LAB DATA, NEW EVENTS DYSMENORRHEA, DYSPAREUNIA, FATIGUE, PELVIC INFLAMMATORY DISEASE, WEIGHT DECREASED, SALPINGITIS, PERIHEPATITIS, MENTAL DISORDER, PELVIC PAIN ADDED. OUTCOME FOR THE EVENTS DYSMENORRHEA, DYSPAREUNIA, FATIGUE, PELVIC INFLAMMATORY DISEASE, WEIGHT DECREASED, SALPINGITIS, PERIHEPATITIS, MENTAL DISORDER, PELVIC PAIN ADDED AS RECOVERED /RESOLVED. 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.
QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-FEB-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD INFECTIONS. SHE UNDERWENT A HYSTERECTOMY 5 YEARS AFTER INSERTION. AS LIMITED INFORMATION WAS PROVIDED IN THIS LEGAL CLAIM REGARDING THE EXACT NATURE OF THE INFECTIONS, THE EVENT WAS INTERPRETED AS PELVIC INFECTION IN A CONSERVATIVE APPROACH. PELVIC INFECTION IS AN ANTICIPATED EVENT IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. UPPER GENITAL TRACT INFECTIONS OCCUR WHEN MICROORGANISMS ASCEND FROM THE LOWER GENITAL TRACT, INFECTING THE UTERUS, FALLOPIAN TUBES AND OVARIES. WHILE ESSURE SYSTEM IS STERILE IT MAY, DUE TO A BACTERIAL CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTIONS AFTER INSERTION PROCEDURE. IN THE PRESENT CASE, THE EXACT TIME POINT OF THE INFECTIONS WAS NOT REPORTED. HYSTERECTOMY WAS DONE ONLY 5 YEARS AFTER INSERTION. DESPITE THE LIMITED INFORMATION PROVIDED, GIVEN THE NATURE OF THE REPORTED EVENT, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THE CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED WITH NEITHER COMPLAINT SAMPLE NOR VALID LOT NUMBER. THUS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE AS IT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFECTION ("INFECTIONS") IN A FEMALE PATIENT WHO RECEIVED ESSURE (ESS205) FOR CONTRACEPTION. IN (B)(6) 2007, THE PATIENT STARTED ESSURE (ESS205). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY IN 2012). ESSURE (ESS205) WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PELVIC INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC INFECTION TO BE RELATED TO ESSURE (ESS205). COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD INFECTIONS. SHE UNDERWENT A HYSTERECTOMY 5 YEARS AFTER INSERTION. AS LIMITED INFORMATION WAS PROVIDED IN THIS LEGAL CLAIM REGARDING THE EXACT NATURE OF THE INFECTIONS, THE EVENT WAS INTERPRETED AS PELVIC INFECTION IN A CONSERVATIVE APPROACH. PELVIC INFECTION IS AN ANTICIPATED EVENT IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. UPPER GENITAL TRACT INFECTIONS OCCUR WHEN MICROORGANISMS ASCEND FROM THE LOWER GENITAL TRACT, INFECTING THE UTERUS, FALLOPIAN TUBES AND OVARIES. WHILE ESSURE SYSTEM IS STERILE IT MAY, DUE TO A BACTERIAL CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTIONS AFTER INSERTION PROCEDURE. IN THE PRESENT CASE, THE EXACT TIME POINT OF THE INFECTIONS WAS NOT REPORTED. HYSTERECTOMY WAS DONE ONLY 5 YEARS AFTER INSERTION. DESPITE THE LIMITED INFORMATION PROVIDED, GIVEN THE NATURE OF THE REPORTED EVENT, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THE CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122951 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 622943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other| R | METHOCARBAMOL| METHOCARBAMOL| METHOCARBAMOL| NUVA| NUVARING |