BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6518084 · Received April 25, 2017

    Report

    Report Number
    2951250-2017-01608
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    October 1, 2013
    Report Date
    January 2, 2020
    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

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED POLYNEUROPATHY SINCE 2011 AND CERVICAL DYSPLASIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) SINCE (B)(6)2013 AND ORAL CONTRACEPTIVE NOS SINCE (B)(6)2009 FOR BIRTH CONTROL AS WELL AS OXYCOCET (PERCOCET) SINCE 2011. 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), PELVIC ADHESIONS ("ADHESIONS"), CYST ("CYSTS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON(B)(6) 2016/OOPHORECTOMY (ONE SIDE REMOVAL OF OVARY)). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE PELVIC ADHESIONS AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYST, PELVIC ADHESIONS AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLAINTIFF FACT SHEET RECEIVED. NEW REPORTER, PATIENT DEMOGRAPHIC DETAILS, CONCOMITANT CONDITION, ESSURE LOT NUMBER AND STOP DATE, CONCOMITANT DRUG WAS ADDED. EVENT WAS ADDED: LOWER ABDOMINAL PAIN. EVENT OUTCOME WAS ADDED: PELVIC PAIN, LOWER ABDOMINAL PAIN WAS 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 IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED POLYNEUROPATHY SINCE 2011 AND CERVICAL DYSPLASIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) SINCE (B)(6) 2013 AND ORAL CONTRACEPTIVE NOS SINCE (B)(6) 2009 FOR BIRTH CONTROL AS WELL AS OXYCOCET (PERCOCET) SINCE 2011. 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), PELVIC ADHESIONS ("ADHESIONS"), CYST ("CYSTS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016/OOPHORECTOMY (ONE SIDE REMOVAL OF OVARY)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE PELVIC ADHESIONS AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYST, PELVIC ADHESIONS AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT. 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 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 IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED POLYNEUROPATHY SINCE 2011 AND CERVICAL DYSPLASIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE (B)(6) 2013 AND ORAL CONTRACEPTIVE NOS SINCE 2009 FOR BIRTH CONTROL AS WELL AS AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) SINCE 2011. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("ADHESIONS") AND CYST ("CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016/OOPHORECTOMY (ONE SIDE REMOVAL OF OVARY)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE PELVIC ADHESIONS, CYST, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYST, DYSMENORRHOEA, DYSPAREUNIA, PELVIC ADHESIONS AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2013: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-DEC-2019: PFS RECEIVED. REPORTER INFORMATION, CONCOMITANT DRUG, LAB DATA ADDED. EVENTS: DYSMENORRHEA, DYSPAREUNIA ADDED. INCIDENT: 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.

    Additional Manufacturer Narrative · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A 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), PELVIC ADHESIONS ("ADHESIONS") AND CYST ("CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC ADHESIONS AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYST, PELVIC ADHESIONS AND PELVIC PAIN TO BE RELATED TO ESSURE. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. A PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2013 AND REPORTED PELVIC PAIN ("CHRONIC PELVIC PAIN"). ON (B)(6) 2016 PLAINTIFF UNDERWENT SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). PELVIC PAIN IS HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS CASE NO ALTERNATIVE EXPLANATION WAS GIVEN FOR THIS EVENT. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A 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), PELVIC ADHESIONS ("ADHESIONS") AND CYST ("CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC ADHESIONS AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYST, PELVIC ADHESIONS AND PELVIC PAIN TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2013 AND REPORTED PELVIC PAIN ("CHRONIC PELVIC PAIN"). ON (B)(6) 2016 PLAINTIFF UNDERWENT SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). PELVIC PAIN IS HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS CASE NO ALTERNATIVE EXPLANATION WAS GIVEN FOR THIS EVENT. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300198 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822374

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| R ADDERALL| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| PERCOCET| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]