ESSURE
Report
- Report Number
- 2951250-2017-09636
- Event Type
- Injury
- Date Received
- December 4, 2017
- Date of Event
- January 1, 2013
- Report Date
- July 20, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5032892) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 31-MAY-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("EXTREME/ SEVERE / CHRONIC PELVIC PAIN") AND SJOGREN'S SYNDROME ("WORSENED SJOGREN'S SYNDROME") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SJOGREN'S SYNDROME, ENDOMETRIOSIS (IN 2005 OR 2006), CHOLECYSTECTOMY (EXPERIENCED PAIN ON MY SIDE. HAD DEVELOPED GALLSTONES) IN 2010, GALLSTONES, MULTIGRAVIDA, PARITY 3 (((B)(6) 2000, (B)(6) 2006 AND (B)(6) 2009).) AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ALESSE IN 2009. CONCURRENT CONDITIONS INCLUDED AUTOIMMUNE DISORDER AND RETROVERTED UTERUS. CONCOMITANT PRODUCTS INCLUDED HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL) SINCE 2008. IN 2011, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("GASTROINTESTINAL ISSUES") AND ABDOMINAL DISTENSION ("SEVERE BLOATING"). IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PARAESTHESIA, HYPOAESTHESIA, PAIN AND FATIGUE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FEELING ABNORMAL ("BRAIN FOG"), ALOPECIA ("HAIR LOSS"), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUAL CYCLE"), HEADACHE ("HEADACHES"), BACK PAIN ("LOWER BACK PAIN") AND DEPRESSION ("DEPRESSION") WITH ANXIETY AND MOOD SWINGS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED PSYCHIATRIC AND /OR PSYCHOLOGICAL CONDITIONS") AND TREATMENT NONCOMPLIANCE ("SHE DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WAS PERFORMED). ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2016, THE PELVIC PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE SJOGREN'S SYNDROME, FEELING ABNORMAL, ALOPECIA, GASTROINTESTINAL DISORDER, ABDOMINAL DISTENSION, MENTAL DISORDER, MENORRHAGIA, HEADACHE, BACK PAIN, DEPRESSION AND TREATMENT NONCOMPLIANCE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR TREATMENT NONCOMPLIANCE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACK PAIN, DEPRESSION, FEELING ABNORMAL, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, MENTAL DISORDER, PELVIC PAIN AND SJOGREN'S SYNDROME TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE DID NOT CLAIM HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. CHRONIC PAIN WAS GONE AFTER ABOUT A MONTH AFTER REMOVAL. SHE DID NOT ADVISED OF ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. SHE DID NOT RETAIN THE ESSURE OR ANY PORTION OF IT. DIAGNOSTIC RESULTS: DATE NOT SPECIFIED: HSG: BLOCKAGE OF OVARIES WAS CONFIRMED (AS REPORTED) THREE MONTHS LATER THE ESSURE PLACEMENT. ON (B)(6) 2011: HYSTEROSALPINGOGRAM (TEST 1 ), ON (B)(6) 2013: HYSTEROSALPINGOGRAM (TEST 2) S AND I INJECTION HYSTEROSONOGRAPHY, SINOGRAFIN IONIC. CONTRAST: HSG/HSG CATHETER- CATHERIZATION OF FALL TUBE W/HSG. LOTS OF SONOGRAMS DONE TO DETERMINE POSSIBLE CAUSE OF PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAY-2018: QUALITY-SAFETY EVALUATION OF PTC. 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.
INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5032892) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 25-JUN-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("EXTREME/ SEVERE / CHRONIC PELVIC PAIN/CHRONIC PELVIC PAIN") AND SJOGREN'S SYNDROME ("WOESENED SJOGREN'S SYNDROME/SJOGREN¿S SYNDROME") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: TREATMENT NONCOMPLIANCE "SHE DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SJOGREN'S SYNDROME, ENDOMETRIOSIS (IN 2005 OR 2006), CHOLECYSTECTOMY (EXPERIENCED PAIN ON MY SIDE. HAD DEVELOPED GALLSTONES) IN 2010, GALLSTONES, MULTIGRAVIDA, PARITY 3 ((B)(6) 2000, (B)(6) 2006 AND (B)(6) 2009).) AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ALESSE IN 2009. CONCURRENT CONDITIONS INCLUDED AUTOIMMUNE DISORDER AND RETROVERTED UTERUS. CONCOMITANT PRODUCTS INCLUDED HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL) SINCE 2008. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PARAESTHESIA, HYPOAESTHESIA, PAIN AND FATIGUE, FEELING ABNORMAL ("BRAIN FOG/BRAIN FOG"), ALOPECIA ("HAIR LOSS/HAIR LOSS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL ISSUES/GASTROINTESTINAL ISSUES"), ABDOMINAL DISTENSION ("SEVERE BLOATING/SEVERE BLOATING"), MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED PSYCHIATRIC AND /OR PSYCHOLOGICAL CONDITIONS"), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUAL CYCLE"), HEADACHE ("HEADACHES"), BACK PAIN ("LOWER BACK PAIN"), DEPRESSION ("DEPRESSION") WITH ANXIETY AND MOOD SWINGS AND ENDOMETRIOSIS ("WORSENING OF ENDOMETRIOSIS/WORSENING OF ENDOMETRIOSIS"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WAS PERFORMED). ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2016, THE PELVIC PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE SJOGREN'S SYNDROME, FEELING ABNORMAL, ALOPECIA, GASTROINTESTINAL DISORDER, ABDOMINAL DISTENSION, MENTAL DISORDER, MENORRHAGIA, HEADACHE, BACK PAIN, DEPRESSION, ENDOMETRIOSIS AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, BACK PAIN, DEPRESSION, ENDOMETRIOSIS, FEELING ABNORMAL, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, MENTAL DISORDER, PELVIC PAIN AND SJOGREN'S SYNDROME TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE DID NOT CLAIM HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE.CHRONIC PAIN WAS GONE AFTER ABOUT A MONTH AFTER REMOVAL.SHE DID NOT ADVISED OF ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE.SHE DID NOT RETAIN THE ESSURE OR ANY PORTION OF IT. DIAGNOSTIC RESULTS: DATE NOT SPECIFIED: HSG: BLOCKAGE OF OVARIES WAS CONFIRMED (AS REPORTED) THREE MONTHS LATER THE ESSURE PLACEMENT. ON (B)(6) 2011: HYSTEROSALPINGOGRAM (TEST 1 ), ON (B)(6) 2013: HYSTEROSALPINGOGRAM (TEST 2)S AND I INJECTION HYSTEROSONOGRAPHY, SINOGRAFIN IONIC CONTRAST- HSG/HSG CATHETER- CATHERIZATION OF FALL TUBE W/HSG.LOTS OF SONOGRAMS DONE TO DETERMINE POSSIBLE CAUSE OF PELVIC PAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENTS PER PFS: WORSENING OF ENDOMETRIOSIS AND JOINT PAIN WERE ADDED, EVENT ONSET DATE WAS UPDATED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FOOD AND DRUG ADMINISTRATION (REFERENCE NUMBER: MW5032892) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 15-NOV-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("EXTREME/ SEVERE / CHRONIC PELVIC PAIN") AND SJOGREN'S SYNDROME ("WORSENED SJOGREN'S SYNDROME") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SJOGREN'S SYNDROME, ENDOMETRIOSIS (IN 2005 OR 2006), CHOLECYSTECTOMY (EXPERIENCED PAIN ON MY SIDE. HAD DEVELOPED GALLSTONES) IN 2010, GALLSTONES, MULTIGRAVIDA, PARITY 3 ((B)(6) 2000, (B)(6) 2006 AND (B)(6) 2009).) AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ALESSE IN 2009. CONCURRENT CONDITIONS INCLUDED AUTOIMMUNE DISORDER AND RETROVERTED UTERUS. CONCOMITANT PRODUCTS INCLUDED HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL) IN 2008. IN 2011, 30 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("GASTROINTESTINAL ISSUES") AND ABDOMINAL DISTENSION ("SEVERE BLOATING"). IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PARAESTHESIA, HYPOAESTHESIA, PAIN AND FATIGUE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FEELING ABNORMAL ("BRAIN FOG"), ALOPECIA ("HAIR LOSS"), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUAL CYCLE"), HEADACHE ("HEADACHES"), BACK PAIN ("LOWER BACK PAIN") AND DEPRESSION ("DEPRESSION") WITH ANXIETY AND MOOD SWINGS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED PSYCHIATRIC AND /OR PSYCHOLOGICAL CONDITIONS") AND TREATMENT NONCOMPLIANCE ("SHE DID NOT USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WAS PERFORMED). ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2016, THE PELVIC PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE SJOGREN'S SYNDROME, FEELING ABNORMAL, ALOPECIA, GASTROINTESTINAL DISORDER, ABDOMINAL DISTENSION, MENTAL DISORDER, MENORRHAGIA, HEADACHE, BACK PAIN, DEPRESSION AND TREATMENT NONCOMPLIANCE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACK PAIN, DEPRESSION, FEELING ABNORMAL, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, MENTAL DISORDER, PELVIC PAIN AND SJOGREN'S SYNDROME TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR TREATMENT NONCOMPLIANCE WITH ESSURE. THE REPORTER COMMENTED: SHE DID NOT CLAIM HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. CHRONIC PAIN WAS GONE AFTER ABOUT A MONTH AFTER REMOVAL. SHE DID NOT ADVISED OF ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. SHE DID NOT RETAIN THE ESSURE OR ANY PORTION OF IT. DIAGNOSTIC RESULTS: DATE NOT SPECIFIED: HSG: BLOCKAGE OF OVARIES WAS CONFIRMED (AS REPORTED) THREE MONTHS LATER THE ESSURE PLACEMENT. ON (B)(6) 2011: HYSTEROSALPINGOGRAM (TEST 1 ), ON (B)(6) 2013: HYSTEROSALPINGOGRAM (TEST 2)S AND I INJECTION HYSTEROSONOGRAPHY, SINOGRAFIN IONIC. CONTRAST- HSG/HSG CATHETER- CATHETERIZATION OF FALL TUBE W/HSG. LOTS OF SONOGRAMS DONE TO DETERMINE POSSIBLE CAUSE OF PELVIC PAIN. 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. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. 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 EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: EVENTS ¿TINGLING SENSATIONS, NUMBNESS, GASTROINTESTINAL ISSUES, SEVERE BLOATING, ESSURE CAUSED OR AGGRAVATED PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITIONS, WORSENED SJOGRENS SYNDROME TREATMENT NON COMPLIANCE, ARE ADDED. LOT NUMBER (863581) ADDED. EVENTS PELVIC PAIN, BRAIN FOG , BODY ACHES/PAIN, CHRONIC FATIGUE, HAIR LOSS, MOOD SWINGS, ANXIETY ARE UPDATED. HISTORICAL CONDITION CHOLECYSTECTOMY, PREGNANCIES-3, LIVE BIRTHS-3, SJOGRENS SYNDROME, ENDOMETRIOSIS ADDED. HISTORICAL DRUG (ALESSE) ADDED. CONCOMITANT MEDICATION PLAQUENIL ADDED. PRODUCT STOP DATE UPDATED, LAB DATA UPDATED. REPORTER CAUSALITY COMMENT UPDATED. REPORTER AND PATIENT INFORMATION UPDATED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), 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. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858640 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | PLAQUENIL| PLAQUENIL| PLAQUENIL| PLAQUENIL |