ESSURE
Report
- Report Number
- 2951250-2020-08319
- Event Type
- Injury
- Date Received
- June 4, 2020
- Date of Event
- November 1, 2013
- Report Date
- August 14, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA ON (B)(6) 2012. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION/EMBEDDED COIL FROM HER UTERUS / PERFORATED UTERUS'), PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), ABDOMINAL INFECTION ('ONE OF THE ADHESIONS ON MY LIVER WAS STARTING TO GET INFECTED') AND PERIHEPATITIS ('FITZ-HUGH CURTIS SYNDROME') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE PHYSICAL PROPERTY ISSUE "ONE OF THE INSERTS TO BE IN A U SHAPE". THE PATIENT'S MEDICAL HISTORY INCLUDED LIVE BIRTH ON (B)(6) 2010, LIVE BIRTH ON (B)(6) 2010, LIVE BIRTH IN 2005, PARITY 3 AND MULTIGRAVIDA. *ON (B)(6) 2013, PATHOLOGY TEST FOR UTERUS AND BILATERAL FALLOPIAN TUBE REVEALED THAT UTERUS WAS WITH SEPARATELY SUBMITTED BILATERAL FALLOPIAN TUBES, LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. SURGICAL ABSENCE OF CERVIX AND ENDOCERVIX. BENIGN SECRETORY PATTERN ENDOMETRIUM. NORMAL MYOMETRIUM. NORMAL BILATERAL FALLOPIAN TUBE. FOR PELVIC PAIN, THE SPECIMEN WAS LABELLED ¿UTERUS¿. THE SPECIMENS CONSISTED OF 94 G COLLECTIVE WEIGHT MORSELIZED UTERUS (9X9X3 CM) IN AGGREGATE. ON SECTION THERE WAS IDENTIFIABLE ENDOMETNUM RANGING FROM 0.1 CO 0.4 CM IN THICKNESS. NO MASS LESIONS WERE IDENTIFIED GROSSLY. NO CERVICAL, OVARIAN OR FALLOPIAN TUBE TISSUE IS IDENTIFIED REPRESENTATIVE SECTION WERE SUBMITTED IN SIX CASSETTES. THE SPECIMEN WAS LABELED ¿BILATERAL FALLOPIAN TUBE. THE SPECIMEN CONSISTED OF PURPLE FALLOPIAN TUBE AND FIMBRIA (5.3 CM IN LENGTH X 0.5 CM IN DIAMETER) AND TWO ADDITIONAL SEGMENTS OF FALLOPIAN TUBE MEASURING 3.8CM IN LENGTH X 0.5CM IN DIAMETER. REPRESENTATIVE SECTIONS WERE SUBMITTED IN TWO CASSETTES. WHICH WERE PINT MENTIONED FALLOPIAN TUBE AND SECOND MENTIONED FALLOPIAN TUBE. A B. A FORMAL MICROSCOPIC EXAMINATION WAS PERFORMED. ON (B)(6) 2013, GENITAL CULTURE WAS DONE WHICH REVEALED CANDIDA ALBICANS MODERATE. FINAL CULTURE SHOWED NORMAL VAGINAL FLORA ALSO PRESENT. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY, IRREGULAR MENSTRUATION AND VAGINAL YEAST INFECTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PARAESTHESIA ("SHARP ELECTRICAL SENSATION"). IN JUNE 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES/CHRONIC HEADACHES"). IN JULY 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY MENSTRUAL CYCLES"). IN NOVEMBER 2012, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN/LOWER BACK PAIN RADIATING DOWN HER LEGS (AGGRAVATING LOWER BACK PAIN RADIATING TO HER JOINTS)"). IN DECEMBER 2012, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN/HIP AND JOINT PAIN (ACHY JOINTS)"). IN JANUARY 2013, THE PATIENT EXPERIENCED MUSCULAR WEAKNESS ("MUSCLES WEAKNESS"). IN MAY 2013, THE PATIENT EXPERIENCED VULVOVAGINAL BURNING SENSATION ("CONSTANT VAGINAL BURNING"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS ("MISCARRIAGE"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. IN NOVEMBER 2013, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FUNGAL INFECTION ("CHRONIC YEAST INFECTIONS"), ABDOMINAL ADHESIONS ("ABDOMINAL ADHESIONS"), PAIN ("MYSTERIOUS PAIN, HURT EVERYWHERE"), ABDOMINAL DISTENSION ("BLOATING"), ANXIETY ("ANXIETY") WITH IRRITABILITY, ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE") AND PELVIC DISCOMFORT ("PELVIC PRESSURE"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE MICRO-INSERT/UNINTENDED PREGNANCY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH REMOVAL OF ADHESIONS FROM LIVER AND ABDOMINAL WALLS AND SURGERY (ESSURE REMOVAL/PARTIAL HYSTERECTOMY WAS DONE AND REMOVAL OF ADHESIONS FROM LIVER AND ABDOMINAL WALLS DURING PARTIAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, ABDOMINAL INFECTION, FUNGAL INFECTION, ABDOMINAL ADHESIONS, PAIN, HEADACHE, BACK PAIN, ARTHRALGIA, WEIGHT INCREASED, ABDOMINAL DISTENSION, MENORRHAGIA, ANXIETY AND PELVIC DISCOMFORT HAD RESOLVED AND THE PELVIC INFLAMMATORY DISEASE, PERIHEPATITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, VULVOVAGINAL BURNING SENSATION, MUSCULAR WEAKNESS AND PARAESTHESIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL ADHESIONS, ABDOMINAL DISTENSION, ABDOMINAL INFECTION, ABORTION SPONTANEOUS, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, FUNGAL INFECTION, HEADACHE, MENORRHAGIA, MUSCULAR WEAKNESS, PAIN, PARAESTHESIA, PELVIC DISCOMFORT, PELVIC INFLAMMATORY DISEASE, PERIHEPATITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, VULVOVAGINAL BURNING SENSATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS IS A RETENTION CASE. ALL THE INFORMATION INCLUDING: EVENT- PELVIC INFLAMMATORY DISEASE, INTRA-ABDOMINAL INFECTION, PREGNANT WITH ESSURE MICRO-INSERT, MISCARRIAGE, FITZ-HUGH CURTIS SYNDROME, ABDOMINAL ADHESIONS, CHRONIC YEAST INFECTIONS, DEVICE INEFFECTIVE, GENERALIZED PAIN, HEADACHES, LOW BACK PAIN, ACHY JOINTS, WEIGHT GAIN, BLOATING, HEAVY MENSTRUAL CYCLES, ANXIETY, IRRITABILITY, CONSTANT VAGINAL BURNING, MUSCLES WEAKNESS, PELVIC PRESSURE, ALLERGIC TO NICKEL, ELECTRIC SENSATIONS AND PELVIC PAIN FEMALE. OUTCOME OF THE EVENT UTERINE PERFORATION WAS CHANGED TO RECOVERED FROM UNKNOWN. DATE OF EVENT UTERINE PERFORATION WAS ADDED. MEDICAL HISTORY, LAB DATA, REFERENCES DETAILS, REPORTER INFORMATION AND SOURCE DOCUMENTS WERE TRANSFERRED FROM DELETION CASE. LEGACY DEVICE REPORT NUM- 2951250-2015-01443- MEDWATCH 3500A MFR NUMBER. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FDA ON 01-JUN-2012. THE MOST RECENT INFORMATION WAS RECEIVED ON 05-AUG-2020. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION/EMBEDDED COIL FROM HER UTERUS / PERFORATED UTERUS') AND PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE PHYSICAL PROPERTY ISSUE "ONE OF THE INSERTS TO BE IN A U SHAPE". THE PATIENT'S MEDICAL HISTORY INCLUDED LIVE BIRTH ON (B)(6) 2010, LIVE BIRTH ON (B)(6) 2010, LIVE BIRTH IN 2005, PARITY 3 AND MULTIGRAVIDA. *ON (B)(6) 2013, PATHOLOGY TEST FOR UTERUS AND BILATERAL FALLOPIAN TUBE REVEALED THAT UTERUS WAS WITH SEPARATELY SUBMITTED BILATERAL FALLOPIAN TUBES, LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. SURGICAL ABSENCE OF CERVIX AND ENDOCERVIX. BENIGN SECRETORY PATTERN ENDOMETRIUM. NORMAL MYOMETRIUM. NORMAL BILATERAL FALLOPIAN TUBE. FOR PELVIC PAIN, THE SPECIMEN WAS LABELLED ¿UTERUS¿. THE SPECIMENS CONSISTED OF 94 G COLLECTIVE WEIGHT MORSELIZED UTERUS (9X9X3 CM) IN AGGREGATE. ON SECTION THERE WAS IDENTIFIABLE ENDOMETRIUM RANGING FROM 0.1 CO 0.4 CM IN THICKNESS. NO MASS LESIONS WERE IDENTIFIED GROSSLY. NO CERVICAL, OVARIAN OR FALLOPIAN TUBE TISSUE IS IDENTIFIED REPRESENTATIVE SECTION WERE SUBMITTED IN SIX CASSETTES. THE SPECIMEN WAS LABELED ¿BILATERAL FALLOPIAN TUBE. THE SPECIMEN CONSISTED OF PURPLE FALLOPIAN TUBE AND FIMBRIA (5.3 CM IN LENGTH X 0.5 CM IN DIAMETER) AND TWO ADDITIONAL SEGMENTS OF FALLOPIAN TUBE MEASURING 3.8CM IN LENGTH X 0.5CM IN DIAMETER. REPRESENTATIVE SECTIONS WERE SUBMITTED IN TWO CASSETTES. WHICH WERE PINT MENTIONED FALLOPIAN TUBE AND SECOND MENTIONED FALLOPIAN TUBE. A B. A FORMAL MICROSCOPIC EXAMINATION WAS PERFORMED. ON (B)(6) 2013, GENITAL CULTURE WAS DONE WHICH REVEALED CANDIDA ALBICANS MODERATE. FINAL CULTURE SHOWED NORMAL VAGINAL FLORA ALSO PRESENT. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY, IRREGULAR MENSTRUATION AND VAGINAL YEAST INFECTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PARAESTHESIA ("SHARP ELECTRICAL SENSATION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES/CHRONIC HEADACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY MENSTRUAL CYCLES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN/LOWER BACK PAIN RADIATING DOWN HER LEGS (AGGRAVATING LOWER BACK PAIN RADIATING TO HER JOINTS)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN/HIP AND JOINT PAIN (ACHY JOINTS)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MUSCULAR WEAKNESS ("MUSCLES WEAKNESS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VULVOVAGINAL BURNING SENSATION ("CONSTANT VAGINAL BURNING"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS ("MISCARRIAGE"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. IN (B)(6) 2013, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PERIHEPATITIS ("FITZ-HUGH CURTIS SYNDROME"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL INFECTION ("ONE OF THE ADHESIONS ON MY LIVER WAS STARTING TO GET INFECTED"), FUNGAL INFECTION ("CHRONIC YEAST INFECTIONS"), ABDOMINAL ADHESIONS ("ABDOMINAL ADHESIONS"), PAIN ("MYSTERIOUS PAIN, HURT EVERYWHERE"), ABDOMINAL DISTENSION ("BLOATING"), ANXIETY ("ANXIETY") WITH IRRITABILITY, ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE") AND PELVIC DISCOMFORT ("PELVIC PRESSURE"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE MICRO-INSERT/UNINTENDED PREGNANCY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH REMOVAL OF ADHESIONS FROM LIVER AND ABDOMINAL WALLS AND SURGERY (ESSURE REMOVAL/PARTIAL HYSTERECTOMY WAS DONE AND REMOVAL OF ADHESIONS FROM LIVER AND ABDOMINAL WALLS DURING PARTIAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, ABDOMINAL INFECTION, FUNGAL INFECTION, ABDOMINAL ADHESIONS, PAIN, HEADACHE, BACK PAIN, ARTHRALGIA, WEIGHT INCREASED, ABDOMINAL DISTENSION, MENORRHAGIA, ANXIETY AND PELVIC DISCOMFORT HAD RESOLVED AND THE PELVIC INFLAMMATORY DISEASE, PERIHEPATITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, VULVOVAGINAL BURNING SENSATION, MUSCULAR WEAKNESS AND PARAESTHESIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL ADHESIONS, ABDOMINAL DISTENSION, ABDOMINAL INFECTION, ABORTION SPONTANEOUS, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, FUNGAL INFECTION, HEADACHE, MENORRHAGIA, MUSCULAR WEAKNESS, PAIN, PARAESTHESIA, PELVIC DISCOMFORT, PELVIC INFLAMMATORY DISEASE, PERIHEPATITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, VULVOVAGINAL BURNING SENSATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-AUG-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 UTERINE PERFORATION ('PERFORATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "ONE OF THE INSERTS TO BE IN A U SHAPE". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE PERFORATION TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: NEW REPORTER, EVENT "PERFORATION " INSERTION AND REMOVAL DATE ADDED. PREVIOUSLY CODED EVENT DEVICE DISLOCATION UPDATED AS DEVICE SHAPE ALTERATION. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583138 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R |