ESSURE
Report
- Report Number
- 2951250-2017-01870
- Event Type
- Injury
- Date Received
- April 27, 2017
- Date of Event
- April 1, 2005
- Report Date
- June 24, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / RIGHT LOWER QUADRANT PAIN"), DEVICE DISLOCATION ("RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE."), DYSMENORRHOEA ("DYSMENORRHEA"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE SYMPTOMS/AUTOIMMUNE-TYPE SYMPTOMS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: BEFORE ESSURE, PLAINTIFF HAD NOT EXPERIENCED THE REPORTED COMBINATION OF SYMPTOMS WHILE NOT ON BIRTH CONTROL. HER MENSTRUAL PERIODS WERE NORMAL AND SHE HAD NO PROBLEM WITH GOING ABOUT HER DAILY LIFE. CONCOMITANT PRODUCTS INCLUDED EUGYNON (SEASONALE). ON AN UNKNOWN DATE, THE PATIENT STARTED DEPO-PROVERA AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPY, INTERMITTENT LOWER ABDOMINAL PAIN"). ON (B)(6) 2004, 24 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH METRORRHAGIA. ON (B)(6) 2005, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2007, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("HYPERTHYROIDISM") WITH TRICHORRHEXIS, MOOD SWINGS AND ANXIETY. ON (B)(6) 2007, THE PATIENT EXPERIENCED TENDONITIS ("LEFT WRIST TENDONITIS") WITH PAIN IN EXTREMITY, SENSORY DISTURBANCE AND PERIPHERAL SWELLING. IN (B)(6) 2010, THE PATIENT EXPERIENCED THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR FALLING OUT/SEVERE HAIR LOSS") AND ABDOMINAL PAIN UPPER ("CRAMPING STOMACH PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ACARODERMATITIS ("SCABIES") WITH RASH PAPULAR. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC CONTACT DERMATITIS SECONDARY TO NICKEL OR METALS") AND ACNE CYSTIC ("CYSTIC ACNE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP") AND CERVICITIS ("ACUTE CHRONIC CERVICITIS"). THE PATIENT WAS TREATED WITH IBUPROFEN, VICODIN, HYDROMORPHONE HYDROCHLORIDE (DILAUDID), PERMETHRIN (ELIMITE), SURGERY (LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006), SURGERY (UNDERWENT LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON OR AROUND (B)(6) 2006) AND SURGERY (LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSFUNCTIONAL UTERINE BLEEDING, AUTOIMMUNE DISORDER, MENORRHAGIA, WEIGHT FLUCTUATION, DYSPAREUNIA, VAGINAL INFECTION, ARTHRALGIA, FATIGUE, ABDOMINAL PAIN LOWER, HYPERTHYROIDISM, THE LAST EPISODE OF ABDOMINAL PAIN, TENDONITIS, ALOPECIA, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ADENOMYOSIS, CERVICAL POLYP, CERVICITIS, ALLERGY TO METALS AND ACNE CYSTIC OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ACNE CYSTIC, ADENOMYOSIS, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, CERVICAL POLYP, CERVICITIS, DEVICE DISLOCATION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HYPERTHYROIDISM, MENORRHAGIA, PELVIC PAIN, TENDONITIS, VAGINAL INFECTION, WEIGHT FLUCTUATION, THE FIRST EPISODE OF ABDOMINAL PAIN, THE SECOND EPISODE OF ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER TO BE RELATED TO ESSURE (ESS205). NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PLAINTIFF FALLOPIAN TUBES, ESSURE COILS AND OVARIES WERE NOT REMOVED. HER SYMPTOMS PERSISTED DESPITE CONSTANT TREATMENT AND MEDICINAL THERAPY. DIAGNOSTIC RESULTS: ON OR AROUND (B)(6) 2005, PLAINTIFF UNDERWENT A HSG, WHICH SHOWED BILATERAL TUBAL OCCLUSION. IT ALSO SHOWED THAT THE RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE. PLAINTIFF UNDERWENT A SECOND HSG STUDY ON OR AROUND (B)(6) 2005, WHICH INDICATED THAT THE ESSURE COILS WERE UNCHANGED AND HER FALLOPIAN TUBES WERE OCCLUDED BILATERALLY. ON (B)(6) 2006, PLAINTIFF PATHOLOGY REPORT REVEALED ADENOMYOSIS, A SMALL BENIGN ENDOCERVICAL POLYP AND ACUTE CHRONIC CERVICITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JUN-2018: SUMMONS RECEIVED. REPORTER'S INFORMATION WAS ADDED. EVENTS ADDED: ALLERGIC CONTACT DERMATITIS SECONDARY TO NICKEL OR METALS, CYSTIC ACNE. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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 PAIN ('PELVIC PAIN / RIGHT LOWER QUADRANT PAIN'), DEVICE DISLOCATION ('RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE.') AND DYSMENORRHOEA ('DYSMENORRHEA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: BEFORE ESSURE, PLAINTIFF HAD NOT EXPERIENCED THE REPORTED COMBINATION OF SYMPTOMS WHILE NOT ON BIRTH CONTROL. HER MENSTRUAL PERIODS WERE NORMAL AND SHE HAD NO PROBLEM WITH GOING ABOUT HER DAILY LIFE. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (SEASONALE) AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPY, INTERMITTENT LOWER ABDOMINAL PAIN"). ON (B)(6) 2004, THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") WITH METRORRHAGIA, 24 DAYS AFTER INSERTION OF ESSURE (ESS205). ON (B)(6) 2005, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2007, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("HYPERTHYROIDISM") WITH TRICHORRHEXIS, MOOD SWINGS AND ANXIETY. ON (B)(6) 2007, THE PATIENT EXPERIENCED TENDONITIS ("LEFT WRIST TENDONITIS") WITH PAIN IN EXTREMITY, SENSORY DISTURBANCE AND PERIPHERAL SWELLING. IN (B)(6) 2010, THE PATIENT EXPERIENCED THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR FALLING OUT/SEVERE HAIR LOSS") AND ABDOMINAL PAIN UPPER ("CRAMPING STOMACH PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ACARODERMATITIS ("SCABIES") WITH RASH PAPULAR. ON (B)(6) 2017, THE PATIENT EXPERIENCED DERMATITIS CONTACT ("ALLERGIC CONTACT DERMATITIS SECONDARY TO NICKEL OR METALS") AND ACNE CYSTIC ("CYSTIC ACNE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER ("AUTOIMMUNE SYMPTOMS/AUTOIMMUNE-TYPE SYMPTOMS"), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP"), CERVICITIS ("ACUTE CHRONIC CERVICITIS"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND HYPERSENSITIVITY ("HYPERSENSITIVITY "). THE PATIENT WAS TREATED WITH HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), HYDROMORPHONE HYDROCHLORIDE (DILAUDID), IBUPROFEN, PERMETHRIN (ELIMITE) AND SURGERY (LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006, LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006 AND UNDERWENT LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON OR AROUND (B)(6) 2006). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSFUNCTIONAL UTERINE BLEEDING, AUTOIMMUNE DISORDER, MENORRHAGIA, WEIGHT FLUCTUATION, DYSPAREUNIA, VAGINAL INFECTION, ARTHRALGIA, FATIGUE, ABDOMINAL PAIN LOWER, HYPERTHYROIDISM, THE LAST EPISODE OF ABDOMINAL PAIN, TENDONITIS, ALOPECIA, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ADENOMYOSIS, CERVICAL POLYP, CERVICITIS, DERMATITIS CONTACT, ACNE CYSTIC, MIGRAINE, HEADACHE AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ACNE CYSTIC, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, CERVICAL POLYP, CERVICITIS, DERMATITIS CONTACT, DEVICE DISLOCATION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HYPERSENSITIVITY, HYPERTHYROIDISM, MENORRHAGIA, MIGRAINE, PELVIC PAIN, TENDONITIS, VAGINAL INFECTION, WEIGHT FLUCTUATION, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: PLAINTIFF FALLOPIAN TUBES, ESSURE COILS AND OVARIES WERE NOT REMOVED. HER SYMPTOMS PERSISTED DESPITE CONSTANT TREATMENT AND MEDICINAL THERAPY. SHE HAD HYSTERECTOMY BUT STILL HAS ESSURE DEVICES IMPLANTED DIAGNOSTIC RESULTS: ON OR AROUND (B)(6) 2005, PLAINTIFF UNDERWENT A HSG, WHICH SHOWED BILATERAL TUBAL OCCLUSION. IT ALSO SHOWED THAT THE RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE. PLAINTIFF UNDERWENT A SECOND HSG STUDY ON OR AROUND (B)(6) 2005, WHICH INDICATED THAT THE ESSURE COILS WERE UNCHANGED AND HER FALLOPIAN TUBES WERE OCCLUDED BILATERALLY. ON (B)(6) 2006, PLAINTIFF PATHOLOGY REPORT REVEALED ADENOMYOSIS, A SMALL BENIGN ENDOCERVICAL POLYP AND ACUTE CHRONIC CERVICITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2020: PIF RECEIVED- NEW EVENT MIGRAINE, HEADACHE AND HYPERSENSITIVITY WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / RIGHT LOWER QUADRANT PAIN'), DEVICE DISLOCATION ('RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE.') AND DYSMENORRHOEA ('DYSMENORRHEA') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: BEFORE ESSURE, PLAINTIFF HAD NOT EXPERIENCED THE REPORTED COMBINATION OF SYMPTOMS WHILE NOT ON BIRTH CONTROL. HER MENSTRUAL PERIODS WERE NORMAL AND SHE HAD NO PROBLEM WITH GOING ABOUT HER DAILY LIFE. ON OR AROUND (B)(6) 2005, PLAINTIFF UNDERWENT A HSG, WHICH SHOWED BILATERAL TUBAL OCCLUSION. IT ALSO SHOWED THAT THE RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE. PLAINTIFF UNDERWENT A SECOND HSG STUDY ON OR AROUND (B)(6) 2005, WHICH INDICATED THAT THE ESSURE COILS WERE UNCHANGED AND HER FALLOPIAN TUBES WERE OCCLUDED BILATERALLY. ON (B)(6) 2006, PLAINTIFF PATHOLOGY REPORT REVEALED ADENOMYOSIS, A SMALL BENIGN ENDOCERVICAL POLYP AND ACUTE CHRONIC CERVICITIS. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (SEASONAL) AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPY, INTERMITTENT LOWER ABDOMINAL PAIN"). ON (B)(6) 2004, THE PATIENT EXPERIENCED ABNORMAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") WITH INTERMENSTRUAL BLEEDING, 24 DAYS AFTER INSERTION OF ESSURE (ESS205). ON (B)(6) 2005, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2007, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("HYPERTHYROIDISM") WITH TRICHORRHEXIS, MOOD SWINGS AND ANXIETY. ON (B)(6) 2007, THE PATIENT EXPERIENCED TENDONITIS ("LEFT WRIST TENDONITIS") WITH PAIN IN EXTREMITY, SENSORY DISTURBANCE AND PERIPHERAL SWELLING. IN (B)(6) 2010, THE PATIENT EXPERIENCED THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR FALLING OUT/SEVERE HAIR LOSS") AND ABDOMINAL PAIN UPPER ("CRAMPING STOMACH PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ACARODERMATITIS ("SCABIES") WITH RASH PAPULAR. ON (B)(6) 2017, THE PATIENT EXPERIENCED DERMATITIS CONTACT ("ALLERGIC CONTACT DERMATITIS SECONDARY TO NICKEL OR METALS") AND ACNE CYSTIC ("CYSTIC ACNE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER ("AUTOIMMUNE SYMPTOMS/AUTOIMMUNE-TYPE SYMPTOMS"), HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP"), CERVICITIS ("ACUTE CHRONIC CERVICITIS"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND HYPERSENSITIVITY ("HYPERSENSITIVITY "). THE PATIENT WAS TREATED WITH HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), HYDROMORPHONE HYDROCHLORIDE (DILAUDID), IBUPROFEN, PERMETHRIN (ELIMITE) AND SURGERY (LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006, LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006 AND UNDERWENT LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON OR AROUND (B)(6) 2006). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, ABNORMAL UTERINE BLEEDING, AUTOIMMUNE DISORDER, HEAVY MENSTRUAL BLEEDING, WEIGHT FLUCTUATION, DYSPAREUNIA, VAGINAL INFECTION, ARTHRALGIA, FATIGUE, ABDOMINAL PAIN LOWER, HYPERTHYROIDISM, THE LAST EPISODE OF ABDOMINAL PAIN, TENDONITIS, ALOPECIA, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ADENOMYOSIS, CERVICAL POLYP, CERVICITIS, DERMATITIS CONTACT, ACNE CYSTIC, MIGRAINE, HEADACHE AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ABNORMAL UTERINE BLEEDING, ACARODERMATITIS, ACNE CYSTIC, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, CERVICAL POLYP, CERVICITIS, DERMATITIS CONTACT, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPERSENSITIVITY, HYPERTHYROIDISM, MIGRAINE, PELVIC PAIN, TENDONITIS, VAGINAL INFECTION, WEIGHT FLUCTUATION, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE (ESS205). NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PLAINTIFF FALLOPIAN TUBES, ESSURE COILS AND OVARIES WERE NOT REMOVED. HER SYMPTOMS PERSISTED DESPITE CONSTANT TREATMENT AND MEDICINAL THERAPY. SHE HAD HYSTERECTOMY BUT STILL HAS ESSURE DEVICES IMPLANTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: RESULTS: BILATERAL TUBAL OCCLUSION; ON (B)(6) 2005: RESULTS: COILS WERE UNCHANGED. PATHOLOGY TEST - ON (B)(6) 2006: RESULTS: ADENOMYOSIS, A SMALL BENIGN ENDOCERVICAL POLYP. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUN-2021: MR RECEIVED: REPORTER INFORMATION, PATIENT DOB ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / RIGHT LOWER QUADRANT PAIN'), DEVICE DISLOCATION ('RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE.') AND DYSMENORRHOEA ('DYSMENORRHEA') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: BEFORE ESSURE, PLAINTIFF HAD NOT EXPERIENCED THE REPORTED COMBINATION OF SYMPTOMS WHILE NOT ON BIRTH CONTROL. HER MENSTRUAL PERIODS WERE NORMAL AND SHE HAD NO PROBLEM WITH GOING ABOUT HER DAILY LIFE. ON OR AROUND (B)(6) 2005, PLAINTIFF UNDERWENT A HSG, WHICH SHOWED BILATERAL TUBAL OCCLUSION. IT ALSO SHOWED THAT THE RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE. PLAINTIFF UNDERWENT A SECOND HSG STUDY ON OR AROUND (B)(6) 2005, WHICH INDICATED THAT THE ESSURE COILS WERE UNCHANGED AND HER FALLOPIAN TUBES WERE OCCLUDED BILATERALLY. ON (B)(6) 2006, PLAINTIFF PATHOLOGY REPORT REVEALED ADENOMYOSIS, A SMALL BENIGN ENDOCERVICAL POLYP AND ACUTE CHRONIC CERVICITIS. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (SEASONALE) AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPY, INTERMITTENT LOWER ABDOMINAL PAIN"). ON (B)(6) 2004, THE PATIENT EXPERIENCED ABNORMAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") WITH INTERMENSTRUAL BLEEDING, 24 DAYS AFTER INSERTION OF ESSURE (ESS205). ON (B)(6) 2005, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2007, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("HYPERTHYROIDISM") WITH TRICHORRHEXIS, MOOD SWINGS AND ANXIETY. ON (B)(6) 2007, THE PATIENT EXPERIENCED TENDONITIS ("LEFT WRIST TENDONITIS") WITH PAIN IN EXTREMITY, SENSORY DISTURBANCE AND PERIPHERAL SWELLING. IN (B)(6) 2010, THE PATIENT EXPERIENCED THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR FALLING OUT/SEVERE HAIR LOSS") AND ABDOMINAL PAIN UPPER ("CRAMPING STOMACH PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ACARODERMATITIS ("SCABIES") WITH RASH PAPULAR. ON (B)(6) 2017, THE PATIENT EXPERIENCED DERMATITIS CONTACT ("ALLERGIC CONTACT DERMATITIS SECONDARY TO NICKEL OR METALS") AND ACNE CYSTIC ("CYSTIC ACNE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER ("AUTOIMMUNE SYMPTOMS/AUTOIMMUNE-TYPE SYMPTOMS"), HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP"), CERVICITIS ("ACUTE CHRONIC CERVICITIS"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND HYPERSENSITIVITY ("HYPERSENSITIVITY "). THE PATIENT WAS TREATED WITH HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), HYDROMORPHONE HYDROCHLORIDE (DILAUDID), IBUPROFEN, PERMETHRIN (ELIMITE) AND SURGERY (LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006, LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006 AND UNDERWENT LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON OR AROUND (B)(6), 2006). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, ABNORMAL UTERINE BLEEDING, AUTOIMMUNE DISORDER, HEAVY MENSTRUAL BLEEDING, WEIGHT FLUCTUATION, DYSPAREUNIA, VAGINAL INFECTION, ARTHRALGIA, FATIGUE, ABDOMINAL PAIN LOWER, HYPERTHYROIDISM, THE LAST EPISODE OF ABDOMINAL PAIN, TENDONITIS, ALOPECIA, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ADENOMYOSIS, CERVICAL POLYP, CERVICITIS, DERMATITIS CONTACT, ACNE CYSTIC, MIGRAINE, HEADACHE AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ABNORMAL UTERINE BLEEDING, ACARODERMATITIS, ACNE CYSTIC, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, CERVICAL POLYP, CERVICITIS, DERMATITIS CONTACT, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPERSENSITIVITY, HYPERTHYROIDISM, MIGRAINE, PELVIC PAIN, TENDONITIS, VAGINAL INFECTION, WEIGHT FLUCTUATION, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: PLAINTIFF FALLOPIAN TUBES, ESSURE COILS AND OVARIES WERE NOT REMOVED. HER SYMPTOMS PERSISTED DESPITE CONSTANT TREATMENT AND MEDICINAL THERAPY. SHE HAD HYSTERECTOMY BUT STILL HAS ESSURE DEVICES IMPLANTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: RESULTS: BILATERAL TUBAL OCCLUSION; ON (B)(6) 2005: RESULTS: COILS WERE UNCHANGED. PATHOLOGY TEST - ON (B)(6) 2006: RESULTS: ADENOMYOSIS, A SMALL BENIGN ENDOCERVICAL POLYP. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2021: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / RIGHT LOWER QUADRANT PAIN"), DYSMENORRHOEA ("DYSMENORRHEA"), DEVICE DISLOCATION ("RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE.") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE SYMPTOMS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: BEFORE ESSURE, PLAINTIFF HAD NOT EXPERIENCED THE REPORTED COMBINATION OF SYMPTOMS WHILE NOT ON BIRTH CONTROL. HER MENSTRUAL PERIODS WERE NORMAL AND SHE HAD NO PROBLEM WITH GOING ABOUT HER DAILY LIFE. CONCURRENT CONDITIONS INCLUDED DERMATITIS DUE TO METALS (IT CAUSES SWELLING AND IRRITATION TO HER SKIN.). CONCOMITANT PRODUCTS INCLUDED EUGYNON (SEASONAL). ON AN UNKNOWN DATE, THE PATIENT STARTED DEPO-PROVERA AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPY, INTERMITTENT LOWER ABDOMINAL PAIN"). ON (B)(6) 2004, 24 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") WITH METRORRHAGIA. ON (B)(6) 2005, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2007, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("HYPERTHYROIDISM") WITH TRICHORRHEXIS, MOOD SWINGS AND ANXIETY. ON (B)(6) 2007, THE PATIENT EXPERIENCED TENDONITIS ("LEFT WRIST TENDONITIS") WITH PAIN IN EXTREMITY, SENSORY DISTURBANCE AND PERIPHERAL SWELLING. IN (B)(6) 2010, THE PATIENT EXPERIENCED THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR FALLING OUT") AND ABDOMINAL PAIN UPPER ("CRAMPING STOMACH PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ACARODERMATITIS ("SCABIES") WITH RASH PAPULAR. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP") AND CERVICITIS ("ACUTE CHRONIC CERVICITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP") AND CERVICITIS ("ACUTE CHRONIC CERVICITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP") AND CERVICITIS ("ACUTE CHRONIC CERVICITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP") AND CERVICITIS ("ACUTE CHRONIC CERVICITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP") AND CERVICITIS ("ACUTE CHRONIC CERVICITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP") AND CERVICITIS ("ACUTE CHRONIC CERVICITIS"). THE PATIENT WAS TREATED WITH IBUPROFEN, VICODIN, HYDROMORPHONE HYDROCHLORIDE (DILAUDID), PERMETHRIN (ELIMITE), SURGERY (LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006) AND SURGERY (LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, MENORRHAGIA, WEIGHT FLUCTUATION, DYSPAREUNIA, VAGINAL INFECTION, ARTHRALGIA, FATIGUE, ABDOMINAL PAIN LOWER, DYSFUNCTIONAL UTERINE BLEEDING, HYPERTHYROIDISM, THE LAST EPISODE OF ABDOMINAL PAIN, TENDONITIS, ALOPECIA, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ADENOMYOSIS, CERVICAL POLYP AND CERVICITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, CERVICAL POLYP, CERVICITIS, DEVICE DISLOCATION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HYPERTHYROIDISM, MENORRHAGIA, PELVIC PAIN, TENDONITIS, VAGINAL INFECTION, WEIGHT FLUCTUATION, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: PLAINTIFF FALLOPIAN TUBES, ESSURE COILS AND OVARIES WERE NOT REMOVED. HER SYMPTOMS PERSISTED DESPITE CONSTANT TREATMENT AND MEDICINAL THERAPY. DIAGNOSTIC RESULTS: ON OR AROUND (B)(6) 2005, PLAINTIFF UNDERWENT A HSG, WHICH SHOWED BILATERAL TUBAL OCCLUSION. IT ALSO SHOWED THAT THE RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE. PLAINTIFF UNDERWENT A SECOND HSG STUDY ON OR AROUND (B)(6) 2005, WHICH INDICATED THAT THE ESSURE COILS WERE UNCHANGED AND HER FALLOPIAN TUBES WERE OCCLUDED BILATERALLY. ON (B)(6) 2006, PLAINTIFF PATHOLOGY REPORT REVEALED ADENOMYOSIS, A SMALL BENIGN ENDOCERVICAL POLYP AND ACUTE CHRONIC CERVICITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-NOV-2017: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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 PAIN ("PELVIC PAIN / RIGHT LOWER QUADRANT PAIN"), DYSMENORRHOEA ("DYSMENORRHEA"), DEVICE DISLOCATION ("RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE.") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE SYMPTOMS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: BEFORE ESSURE, PLAINTIFF HAD NOT EXPERIENCED THE REPORTED COMBINATION OF SYMPTOMS WHILE NOT ON BIRTH CONTROL. HER MENSTRUAL PERIODS WERE NORMAL AND SHE HAD NO PROBLEM WITH GOING ABOUT HER DAILY LIFE. CONCURRENT CONDITIONS INCLUDED ALLERGY (IT CAUSES SWELLING AND IRRITATION TO HER SKIN.). CONCOMITANT PRODUCTS INCLUDED EUGYNON (SEASONALE). ON AN UNKNOWN DATE, THE PATIENT STARTED DEPO-PROVERA AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPY, INTERMITTENT LOWER ABDOMINAL PAIN"). ON (B)(6) 2004, 24 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") WITH METRORRHAGIA. ON (B)(6) 2005, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2007, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("HYPERTHYROIDISM") WITH TRICHORRHEXIS, MOOD SWINGS AND ANXIETY. ON (B)(6) 2007, THE PATIENT EXPERIENCED TENDONITIS ("LEFT WRIST TENDONITIS") WITH PAIN IN EXTREMITY, SENSORY DISTURBANCE AND PERIPHERAL SWELLING. IN (B)(6) 2010, THE PATIENT EXPERIENCED THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR FALLING OUT") AND ABDOMINAL PAIN UPPER ("CRAMPING STOMACH PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ACARODERMATITIS ("SCABIES") WITH RASH PRURITIC. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ADENOMYOSIS ("ADENOMYOSIS"), CERVICAL POLYP ("ENDOCERVICAL POLYP") AND CERVICITIS ("ACUTE CHRONIC CERVICITIS"). THE PATIENT WAS TREATED WITH IBUPROFEN, VICODIN, HYDROMORPHONE HYDROCHLORIDE (DILAUDID), PERMETHRIN (ELIMITE), SURGERY (LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2006). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, MENORRHAGIA, WEIGHT FLUCTUATION, DYSPAREUNIA, VAGINAL INFECTION, ARTHRALGIA, FATIGUE, ABDOMINAL PAIN LOWER, DYSFUNCTIONAL UTERINE BLEEDING, HYPERTHYROIDISM, THE LAST EPISODE OF ABDOMINAL PAIN, TENDONITIS, ALOPECIA, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ADENOMYOSIS, CERVICAL POLYP AND CERVICITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ACARODERMATITIS, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, CERVICAL POLYP, CERVICITIS, DEVICE DISLOCATION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HYPERTHYROIDISM, MENORRHAGIA, PELVIC PAIN, TENDONITIS, VAGINAL INFECTION, WEIGHT FLUCTUATION, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: PLAINTIFF FALLOPIAN TUBES, ESSURE COILS AND OVARIES WERE NOT REMOVED. HER SYMPTOMS PERSISTED DESPITE CONSTANT TREATMENT AND MEDICINAL THERAPY. DIAGNOSTIC RESULTS: ON OR AROUND (B)(6) 2005, PLAINTIFF UNDERWENT A HSG, WHICH SHOWED BILATERAL TUBAL OCCLUSION. IT ALSO SHOWED THAT THE RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE. PLAINTIFF UNDERWENT A SECOND HSG STUDY ON OR AROUND (B)(6) 2005, WHICH INDICATED THAT THE ESSURE COILS WERE UNCHANGED AND HER FALLOPIAN TUBES WERE OCCLUDED BILATERALLY. ON (B)(6) 2006, PLAINTIFF PATHOLOGY REPORT REVEALED ADENOMYOSIS, A SMALL BENIGN ENDOCERVICAL POLYP AND ACUTE CHRONIC CERVICITIS. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2004 AND REPORTED ADVERSE EVENTS INCLUDING PELVIC PAIN / RIGHT LOWER QUADRANT PAIN, DYSMENORRHOEA AND THE RIGHT ESSURE COIL HAD ADVANCED OR MIGRATED DEEPER INTO THE FALLOPIAN TUBE. ON (B)(6) 2006 SHE UNDERWENT A HYSTERECTOMY. ESSURE WAS NOT REMOVED. UNSATISFACTORY ESSURE LOCATION (INCLUDING DISTAL LOCATION INTO THE FALLOPIAN TUBE) IS A POSSIBLE COMPLICATION OF ESSURE PROCEDURE. DEPENDING ON DEVICE LOCATION PATIENT MAY HAD PAIN AS A RESULT. ADDITIONALLY, PELVIC PAIN AND DYSMENORRHEA ARE HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS PARTICULAR CASE, THE EXACT MECHANISM OF UNSATISFACTORY ESSURE LOCATION WAS NOT KNOWN. REGARDING PATIENT'S PAIN, SHE HAD ADENOMYOSIS WHICH COULD HAVE BEEN A CONTRIBUTORY ROLE IN HER SYMPTOMS. THE PATIENT ALSO REPORTED AUTOIMMUNE SYMPTOMS. 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 |
|---|---|---|---|---|---|---|---|
| 309041 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| SEASONAL [ETHINYLESTRADIOL,LEVONORGESTREL])| SEASONALE| SEASONALE| SEASONALE| SEASONALE| SEASONALE| SEASONAL [ETHINYLESTRADIOL,LEVONORGESTREL]) |