ESSURE
Report
- Report Number
- 2951250-2016-00718
- Event Type
- Injury
- Date Received
- May 27, 2016
- Date of Event
- January 1, 2011
- Report Date
- December 30, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 836495) INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 2, AUTOIMMUNE DISORDER, DYSMENORRHEA AND RASH. CONCURRENT CONDITIONS INCLUDED OBESITY. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), ALOPECIA ("HAIR LOSS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), MENORRHAGIA ("ABNORMAL BLEEDING ((VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING ((VAGINAL, MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SKIN DISORDER ("AUTOIMMUNE DISORDER: SKIN CONDITIONS"), PSORIASIS ("AUTOIMMUNE DISORDER:PSORIASIS"), ROSACEA ("AUTOIMMUNE DISORDER: ROSACEA"), FATIGUE ("FATIGUE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), RASH ("AUTOIMMUNE DISORDER: RASHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), THE FIRST EPISODE OF ABDOMINAL DISTENSION ("FEELING EXTREEMELY BLOATED/UNCOMFORTABLE BLOATED FEELING IN MY STOMACH WHICH ONLY GETS WORSE THROUGHOUT THE DAY"), THE SECOND EPISODE OF ABDOMINAL DISTENSION ("FEELING EXTREEMELY BLOATED"), ABDOMINAL PAIN LOWER ("CRAMPING") AND COMPLICATION ASSOCIATED WITH DEVICE ("DEVICE COMPLICATIONS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTORNY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, SKIN DISORDER, PSORIASIS, ROSACEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, RASH AND COMPLICATION ASSOCIATED WITH DEVICE OUTCOME WAS UNKNOWN AND THE ALOPECIA, DYSPAREUNIA, THE LAST EPISODE OF ABDOMINAL DISTENSION AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, COMPLICATION ASSOCIATED WITH DEVICE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, PSORIASIS, RASH, ROSACEA, SKIN DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF ABDOMINAL DISTENSION AND THE SECOND EPISODE OF ABDOMINAL DISTENSION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION CURRENT WEIGHT 160 LBS. QUALITY-SAFETY EVALUATION OF PTC: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENTS IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2018: THE CASE (B)(4) (MFR# 2951250-2017-07084) WAS IDENTIFIED AS A FOLLOW UP OF THIS CASE. THEREFORE, THE CASE (B)(4) WAS DELETED FROM ARGUS DATABASE. CONSUMER'S AND REPORTER'S INFORMATION WERE UPDATED. NEW REPORTERS ADDED. PATIENT'S RELEVANT HISTORY WAS ADDED (INITIAL, BMI, DOB, LAB TEST); LOT NUMBER RECEIVED. START AND STOP DATES WERE UPDATED. THE PREVIOUS EVENT: "DEVICE REMOVED" WAS UPDATED TO "PAIN" (PELVIC PAIN FEMALE); NEW EVENTS ADDED: ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, 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.
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: FDA-2014-N-0736-0700) ON 21-AUG-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 05-OCT-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 836495) INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 2, AUTOIMMUNE DISORDER, DYSMENORRHEA AND RASH. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), ALOPECIA ("HAIR LOSS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), MENORRHAGIA ("ABNORMAL BLEEDING ((VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING ((VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SKIN DISORDER ("AUTOIMMUNE DISORDER: SKIN CONDITIONS"), PSORIASIS ("AUTOIMMUNE DISORDER:PSORIASIS"), ROSACEA ("AUTOIMMUNE DISORDER: ROSACEA"), FATIGUE ("FATIGUE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), RASH ("AUTOIMMUNE DISORDER: RASHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), THE FIRST EPISODE OF ABDOMINAL DISTENSION ("FEELING EXTREEMELY BLOATED/UNCOMFORTABLE BLOATED FEELING IN MY STOMACH WHICH ONLY GETS WORSE THROUGHOUT THE DAY"), THE SECOND EPISODE OF ABDOMINAL DISTENSION ("FEELING EXTREEMELY BLOATED"), ABDOMINAL PAIN LOWER ("CRAMPING") AND COMPLICATION ASSOCIATED WITH DEVICE ("DEVICE COMPLICATIONS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTORNY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, SKIN DISORDER, PSORIASIS, ROSACEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, RASH AND COMPLICATION ASSOCIATED WITH DEVICE OUTCOME WAS UNKNOWN AND THE ALOPECIA, DYSPAREUNIA, THE LAST EPISODE OF ABDOMINAL DISTENSION AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, COMPLICATION ASSOCIATED WITH DEVICE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, PSORIASIS, RASH, ROSACEA, SKIN DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF ABDOMINAL DISTENSION AND THE SECOND EPISODE OF ABDOMINAL DISTENSION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION CURRENT WEIGHT 160 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-OCT-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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER:(B)(4)) ON (B)(6) 2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 14-NOV-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 836495) INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2, AUTOIMMUNE DISORDER, DYSMENORRHEA AND RASH. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED LORCASERIN HYDROCHLORIDE (BELVIQ). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), SKIN DISORDER ("AUTOIMMUNE DISORDER: SKIN CONDITIONS"), ALOPECIA ("HAIR LOSS"), ROSACEA ("AUTOIMMUNE DISORDER: ROSACEA"), FATIGUE ("FATIGUE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), MENORRHAGIA ("ABNORMAL BLEEDING ((VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING ((VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PSORIASIS ("AUTOIMMUNE DISORDER:PSORIASIS"), RASH ("AUTOIMMUNE DISORDER: RASHES"), THE FIRST EPISODE OF ABDOMINAL DISTENSION ("FEELING EXTREEMELY BLOATED/UNCOMFORTABLE BLOATED FEELING IN MY STOMACH WHICH ONLY GETS WORSE THROUGHOUT THE DAY"), THE SECOND EPISODE OF ABDOMINAL DISTENSION ("FEELING EXTREEMELY BLOATED"), ABDOMINAL PAIN LOWER ("CRAMPING"), COMPLICATION ASSOCIATED WITH DEVICE ("DEVICE COMPLICATIONS") AND MOOD ALTERED ("EMOTIONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTORNY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, SKIN DISORDER, PSORIASIS, ROSACEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, RASH, COMPLICATION ASSOCIATED WITH DEVICE, MOOD ALTERED AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE ALOPECIA, FATIGUE, DYSPAREUNIA, THE LAST EPISODE OF ABDOMINAL DISTENSION AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, COMPLICATION ASSOCIATED WITH DEVICE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MOOD ALTERED, PELVIC PAIN, PSORIASIS, RASH, ROSACEA, SKIN DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL DISTENSION AND THE SECOND EPISODE OF ABDOMINAL DISTENSION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 160 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION; IN 2011: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-NOV-2018: PLAINTIFF FACT SHEET RECEIVED: EVENTS: EMOTIONAL CHANGES, WEIGHT GAIN. EVENT ONSET DATE AND OUTCOME WERE 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 (FDA, REFERENCE NUMBER: (B)(4)) ON 21-AUG-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 03-DEC-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 836495) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2, AUTOIMMUNE DISORDER, DYSMENORRHEA AND RASH. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED LORCASERIN HYDROCHLORIDE (BELVIQ). IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), SKIN DISORDER ("AUTOIMMUNE DISORDER: SKIN CONDITIONS"), ALOPECIA ("HAIR LOSS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES / EMOTIONAL CHANGES") AND ABDOMINAL DISTENSION ("FEELING EXTREMELY BLOATED/UNCOMFORTABLE BLOATED FEELING IN MY STOMACH WHICH ONLY GETS WORSE THROUGHOUT THE DAY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING ((VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING ((VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND BACK PAIN ("LOW BACK PAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ROSACEA ("AUTOIMMUNE DISORDER: ROSACEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PSORIASIS ("AUTOIMMUNE DISORDER:PSORIASIS"), RASH ("AUTOIMMUNE DISORDER: RASHES"), ABDOMINAL PAIN LOWER ("CRAMPING"), COMPLICATION ASSOCIATED WITH DEVICE ("DEVICE COMPLICATIONS"), FEELING ABNORMAL ("BRAIN FOG") AND MEMORY IMPAIRMENT ("FORGETFULLNESS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTORNY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MOOD ALTERED, SKIN DISORDER, PSORIASIS, ROSACEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, RASH, COMPLICATION ASSOCIATED WITH DEVICE, WEIGHT INCREASED, BACK PAIN AND MEMORY IMPAIRMENT OUTCOME WAS UNKNOWN AND THE ALOPECIA, FATIGUE, DYSPAREUNIA, ABDOMINAL DISTENSION AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, COMPLICATION ASSOCIATED WITH DEVICE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, MEMORY IMPAIRMENT, MENORRHAGIA, MOOD ALTERED, PELVIC PAIN, PSORIASIS, RASH, ROSACEA, SKIN DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 160 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31 KG/SQM. HYSTEROSALPINGOGRAM IN 2011: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2015: IMPRESSION SATISFACTORY POSITIONING OF THE ESSURE DEVICES, AND SATISFACTORY OCCLUSION OF BOTH FALLOPIAN TUBES RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY, CONSUMER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS AND SOCIAL MEDIA RECEIVED: EVENTS: LOW BACK PAIN, BRAIN FOG, FORGETFULNESS WERE ADDED. EVENT ONSET DATE 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.
(B)(4). IT REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE IN UNITED STATES WHO HAD ESSURE(FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2011 FOR BIRTH CONTROL. CONSUMER'S HISTORY INCLUDED PARITY 2. CONSUMER REPORTED THAT SHE WAKES UP EVERYDAY WITH AN UNCOMFORTABLE BLOATED FEELING IN HER STOMACH WHICH ONLY GETS WORSE THROUGHOUT THE DAY . FOLLOW-UP RECEIVED ON 04-OCT-2015 WITH THE FINAL PTC ((B)(4)) INVESTIGATION RESULT: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. FINAL RISK CLASSIFICATION: RISK CATEGORY V. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. FOLLOW-UP INFORMATION RECEIVED ON 04-MAY-2016 AND CASE WAS UPGRADED TO INCIDENT. A LEGAL CLAIM WAS RECEIVED. THE PLAINTIFF WAS IMPLANTED WITH ESSURE AND SUBSEQUENTLY HAD THE DEVICE REMOVED DUE TO COMPLICATIONS. FOLLOW-UP RECEIVED ON 23-MAY-2016: QUALITY SAFETY EVALUATION OF PTC WAS UPDATED WITHOUT MAJOR CHANGES. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS RECEIVED FROM A FEMALE CONSUMER/PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) REMOVED DUE TO COMPLICATIONS. THIS EVENT IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. THIS CASE WAS RECEIVED WITH LIMITED INFORMATION. INITIALLY, CONSUMER REPORTED A BLOATED FEELING IN HER STOMACH. LATER, A LEGAL CLAIM WAS RECEIVED. IT INCLUDED SEVERAL PLAINTIFFS AND THE ADVERSE EVENTS/COMPLICATIONS EACH INDIVIDUAL PLAINTIFF EXPERIENCED WERE NOT SPECIFIED. DESPITE OF THE LACK OF DETAILS FOR A COMPREHENSIVE CAUSALITY ASSESSMENT; CONSIDERING ESSURE REMOVAL WAS REQUIRED, CAUSALITY WITH THE SUSPECT DEVICE CANNOT BE EXCLUDED. THEREFORE, THIS CASE WAS UPGRADED TO INCIDENT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340780 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 836495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | BELVIQ| BELVIQ| BELVIQ |