ESSURE
Report
- Report Number
- 2951250-2016-02555
- Event Type
- Injury
- Date Received
- November 17, 2016
- Date of Event
- July 1, 2012
- Report Date
- April 20, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE DEVICE WAS NOT VISIBLE ACCORDING TO DOCTOR DURING HYSTERECTOMY/REMOVAL OF UTERUS OR FALLOPIAN TUBES'), PELVIC PAIN ('SEVERE AND CHRONIC PELVIC PAIN / PAIN/PAIN RIGHT SIDE PELVIC PAIN'), GENITAL HAEMORRHAGE ('EXCESSVIE BLEEDING AFTER ESSURE DEVICE') AND UTERINE HAEMORRHAGE ('ABNORMAL UTERINE BLEEDING') IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901326) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 1 (((B)(6) 1991)), UTERINE DILATION AND CURETTAGE AND NASAL OPERATION. ON (B)(6) 2012, HYSTEROSALPINGOGRAM TEST SHOWED, NO OPACIFICATION OF THE FALLOPIAN TUBES, EITHER SIDE; ESSURE DEVICES IN PLACE. ON (B)(6) 2014, ABDOMEN ULTRASOUND SHOWED, PATIENT IS STATUS POST ESSURE PROCEDURE WITH INSERTS IDENTIFIED IN THE PELVIC REGIONS. ON (B)(6) 2016, SURGICAL PATHOLOGICAL REPORT SHOWED, UTERUS 1 CERVIX, BILATERAL TUBES". THE SPECIMEN CONSISTS OF A UTERUS ATTACHED TO A CERVIX AND BILATERAL FALLOPIAN TUBES. THE SPECIMEN WEIGHS 135 GM THE UTERUS MEASURES 10.0 CM. FROM THE CERVIX TO THE TOP OF THE FUNDUS, 3.5 CM. FROM EIGHT TO LEFT, AND 4.2 CM. IN ANTERIOPOSTERIOR" DIAMETER. 2. THE SEROSAL SURFACE IS SMOOTH AND SHINY. THE CERVICAL OS IS PATENT MEASURING 1.3 CM. THE UTERU5 IS BIVALVED. THE CERVIX IS UNREMARKABLE. THE ENDOMETRIUM IS RED, SORT, AND APPEARS ATROPHIC WITH A SMALL STENOTIC AREA THAT SUGGSSTIVE OR ABLATION THERAPY. 3. THE MYOMETRIUM MEASURES 2.2 CM. IN AVERAGE THICKNESS, THE UTERUS IS SECTIONED REVEALING A TRABECULATED MYOMETRIUM (MINIMAL DISSECTION WAS PERFORMED PER PATIENT ACCOMPANYING REQUEST TO PRESERVE ANATOMY) THE ATTACHED RIGHT FALLOPIAN TUBE MEASURES 9.0 CM. IN LENGTH AND 0.5 CM. IN AVERAGE DIAMETER IT IS ATTACHED TO A FIMBRIAE. THE SEROSAL SURFACE APPEARS UNREMARKABLE. 4. THE FALLOPIAN TUBE IS SERIALLY SECTIONED IN 4 MM INTERVALS. THERE IS A METALLIC EMBEDDED TUBULAR HARD"1ARE PRESENT NEAR THE CORNUA. IT MEASURES APPROXIMATELY 2.5 CM. IN LENGTH THE REMINDER OF THE FALLOPIAN TUBE IS UNREMARKABLE. THE HARDWARE IS LEFT EMBEDDED WITHIN THE TISSUE FAR PRESERVATION. 5. THE ATTACHED LEFT FALLOPIAN TUBE MEASURES A. 8 CM. IN LENGTH WITH 0.7 CM. AVERAGE DIAMETER. RIGHT IS ATTACHED TO A FIMBRIA. IT HAS A SMOOTH SEROSAL SURFACE AND IS ATTACHED TO THE PARATUBAL CYSTS. THE CYSTS MEASURE 0.5 AND 0.1 CM. THEY ARE FILLED WITH SEROUS FLUID AND HAVE A SMOOTH LINING. THE FALLOPIAN TUBE IS SERIALLY SECTIONED IN 4 MM INTERVALS. 6. THERE IS A METALLIC EMBEDDED TUBULAR HARDCARE PRESENT NEAR THE CORNUA. IT MEASURE AS APPROXIMATELY 2.0 CM. IN LENGTH. THE REMAINDER OF THE FALLOPIAN TUBE IS UNREMARKABLE. THE HARDWARE IS LEFT EMBEDDED WITHIN THE TISSUE FOR PRESERVATION. REPRESENTATIVE SECTIONS ARE SUBMITTED IN EIGHT CASSETTES. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: BIRTH CONTROL PILL; FOR EYELASHES: LATISSE; FOR AN UNREPORTED INDICATION: CARBOCAINE HCL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH CARBOCAINE HCL. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, PREMENSTRUAL SYNDROME, HEADACHE, EX-SMOKER, ALCOHOL USE, BLOATING, CRAMP IN LOWER ABDOMEN, BREAST TENDERNESS, EXHAUSTION, MENOMETRORRHAGIA, RIGHT LOWER QUADRANT PAIN, HEMORRHOIDS, CONSTIPATION, MENSTRUAL MIGRAINE AND DYSFUNCTIONAL UTERINE BLEEDING. FAMILY HISTORY INCLUDED HEART DISEASE, UNSPECIFIED (MOTHER, GRAND MOTHER (MATERNAL), GRAND MOTHER (PATERNAL)), HYPERTENSION (MOTHER, GRAND MOTHER (MATERNAL)), DIABETES (MOTHER, GRAND MOTHER (MATERNAL)), STROKE (GRAND MOTHER (MATERNAL)), BREAST CANCER (GRAND MOTHER (MATERNAL)), COLON CANCER (GRAND MOTHER (MATERNAL), GRANDFATHER PATERNAL)) AND MALIGNANT NEOPLASM OF BODY OF UTERUS (AUNT). CONCOMITANT PRODUCTS INCLUDED BIMATOPROST (LATISSE), BUTALBITAL SINCE (B)(6) 2014, ESCITALOPRAM SINCE (B)(6) 2016, ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LOMEDIA 24 FE), ETHINYLESTRADIOL;LEVONORGESTREL (TRIVORA) AND HYDROCODONE SINCE (B)(6) 2016. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), HYPERSENSITIVITY ("ALLERGIC REACTIONS / ALLERGIC OR HYPERSENSITIVITY REACTION/ALLERGY TO ALL") WITH URTICARIA, SKIN ODOUR ABNORMAL AND RASH, HEADACHE ("HEADACHES") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("SEVERE DEPRESSION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES ; MOOD SWINGS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL AND EXCESSIVE BLEEDING DURING MENSES / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS-SCAR TISSUE BREAKING THROUGH WALLS OF UTERUS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED OVARIAN CYST ("CYST ON OVARY"), 3 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE AND CHRONIC BACK PAIN"), ABDOMINAL DISTENSION ("BLOATING"), HOT FLUSH ("HOT FLASHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ADNEXA UTERI PAIN ("SEVERE OVARIAN PAIN AROUND THE TIME OF MENSES"), PROCEDURAL PAIN ("PROCEDURE/PLACEMENT OF COILS WAS EXTREMELY PAINFUL") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH BUPROPION HYDROCHLORIDE (WELLBUTRIN), CONTRACEPTIVES, CORTISONE, DIPHENHYDRAMINE HYDROCHLORIDE, SUPPLEMENT AND DIET, SURGERY (ABLATION, TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) BILATERAL SALPINGECTOMY AND A TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY,ULTRASOUND), TOPICAL CREAMS AND CORTISONE AND MULTIVITAMINS. ESSURE WAS REMOVED ON (B)(6) 2016. IN 2013, THE WEIGHT INCREASED HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, UTERINE HAEMORRHAGE, BACK PAIN, MENORRHAGIA, ABDOMINAL DISTENSION, FATIGUE, MIGRAINE, HYPERSENSITIVITY, MOOD SWINGS, HOT FLUSH, VAGINAL HAEMORRHAGE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, ADENOMYOSIS, OVARIAN CYST, DEPRESSION, ADNEXA UTERI PAIN AND PROCEDURAL PAIN HAD RESOLVED AND THE FEELING ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ADENOMYOSIS, ADNEXA UTERI PAIN, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, MOOD SWINGS, OVARIAN CYST, PELVIC PAIN, PROCEDURAL PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PATIENT HAD ULTRASOUND SHOWS UTERUS AND OVARIES, THERE IS SMALL ECHOGENIC FOCUS SEEN IN THE ENDOMETRIUM, NEAR THE FUNDUS, WITH A QUESTION THAT WEATHER IT IS A PORTION OF THE ESSURE INSERT SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: SATISFACTORY PLACEMENT AND FULL OCCLUSION OF BOTH. HYSTEROSALPINGOGRAM TEST SHOWED, NO OPACIFICATION OF THE FALLOPIAN TUBES, EITHER SIDE; ESSURE DEVICES IN PLACE. PATHOLOGY TEST - IN (B)(6) 2016: UTERUS 1 CERVIX, BILATERAL TUBES". THE SPECIMEN CONSISTS OF A UTERUS ATTACHED TO A CERVIX AND BILATERAL FALLOPIAN TUBES. THE SPECIMEN WEIGHS 135 GM THE UTERUS MEASURES 10.0 CM. FROM THE CERVIX TO THE TOP OF THE FUNDUS, 3.5 CM. FROM EIGHT TO LEFT, AND 4.2 CM. IN ANTERIOPOSTERIOR" DIAMETER. 2. THE SEROSAL SURFACE IS SMOOTH AND SHINY. THE CERVICAL OS IS PATENT MEASURING 1.3 CM. THE UTERU5 IS BIVALVED. THE CERVIX IS UNREMARKABLE. THE ENDOMETRIUM IS RED, SORT, AND APPEARS ATROPHIC WITH A SMALL STENOTIC AREA THAT SUGGSSTIVE OR ABLATION THERAPY. 3. THE MYOMETRIUM MEASURES 2.2 CM. IN AVERAGE THICKNESS, THE UTERUS IS SECTIONED REVEALING A TRABECULATED MYOMETRIUM (MINIMAL DISSECTION WAS PERFORMED PER PATIENT ACCOMPANYING REQUEST TO PRESERVE ANATOMY) THE ATTACHED RIGHT FALLOPIAN TUBE MEASURES 9.0 CM. IN LENGTH AND 0.5 CM. IN AVERAGE DIAMETER IT IS ATTACHED TO A FIMBRIAE. THE SEROSAL SURFACE APPEARS UNREMARKABLE. 4. THE FALLOPIAN TUBE IS SERIALLY SECTIONED IN 4 MM INTERVALS. THERE IS A METALLIC EMBEDDED TUBULAR HARD"1ARE PRESENT NEAR THE CORNUA. IT MEASURES APPROXIMATELY 2.5 CM. IN LENGTH THE REMINDER OF THE FALLOPIAN TUBE IS UNREMARKABLE. THE HARDWARE IS LEFT EMBEDDED WITHIN THE TISSUE FAR PRESERVATION. 5. THE ATTACHED LEFT FALLOPIAN TUBE MEASURES A. 8 CM. IN LENGTH WITH 0.7 CM. AVERAGE DIAMETER. RIGHT IS ATTACHED TO A FIMBRIA. IT HAS A SMOOTH SEROSAL SURFACE AND IS ATTACHED TO THE PARATUBAL CYSTS. THE CYSTS MEASURE 0.5 AND 0.1 CM. THEY ARE FILLED WITH SEROUS FLUID AND HAVE A SMOOTH LINING. THE FALLOPIAN TUBE IS SERIALLY SECTIONED IN 4 MM INTERVALS. 6. THERE IS A METALLIC EMBEDDED TUBULAR HARDCARE PRESENT NEAR THE CORNUA. IT MEASURE AS APPROXIMATELY 2.0 CM. IN LENGTH. THE REMAINDER OF THE FALLOPIAN TUBE IS UNREMARKABLE. THE HARDWARE IS LEFT EMBEDDED WITHIN THE TISSUE FOR PRESERVATION. REPRESENTATIVE SECTIONS ARE SUBMITTED IN EIGHT CASSETTES. ULTRASOUND ABDOMEN - ON (B)(6) 2014: PATIENT IS STATUS POST ESSURE PROCEDURE WITH INSERTS IDENTIFIED IN THE PELVIC REGIONS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: UTERINE HAEMORRHAGE (CONFIRMING GENITAL HAEMORRHAGE), PROCEDURAL PAIN, URTICARIA, PELVIC PAIN, OVARIAN CYST, MIGRAINE, WEIGHT GAIN, ABDOMINAL DISTENSION, ADNEXA UTERI PAIN, MOOD SWINGS, MIGRAINES, HEADACHES, MENORRHAGIA, DYSMENORRHEA". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED- NEW EVENT BRAIN FOG AND REPOTER WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE DEVICE WAS NOT VISIBLE ACCORDING TO DOCTOR DURING HYSTERECTOMY/REMOVAL OF UTERUS OR FALLOPIAN TUBES"), PELVIC PAIN ("SEVERE AND CHRONIC PELVIC PAIN / PAIN/PAIN RIGHT SIDE PELVIC PAIN"), GENITAL HAEMORRHAGE ("EXCESSVIE BLEEDING AFTER ESSURE DEVICE") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901326) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 1 (((B)(6) 1991)), UTERINE DILATION AND CURETTAGE AND NASAL OPERATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: BIRTH CONTROL PILL; FOR EYELASHES: LATISSE; FOR AN UNREPORTED INDICATION: CARBOCAINE HCL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH CARBOCAINE HCL. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, PREMENSTRUAL SYNDROME, HEADACHE, EX-SMOKER, ALCOHOL USE, BLOATING, CRAMP IN LOWER ABDOMEN, BREAST TENDERNESS, EXHAUSTION AND MENOMETRORRHAGIA. FAMILY HISTORY INCLUDED HEART DISEASE, UNSPECIFIED (MOTHER, GRAND MOTHER (MATERNAL), GRAND MOTHER (PATERNAL)), HYPERTENSION (MOTHER, GRAND MOTHER (MATERNAL)), DIABETES (MOTHER, GRAND MOTHER (MATERNAL)), STROKE (GRAND MOTHER (MATERNAL)), BREAST CANCER (GRAND MOTHER (MATERNAL)), COLON CANCER (GRAND MOTHER (MATERNAL), GRANDFATHER PATERNAL)) AND MALIGNANT NEOPLASM OF BODY OF UTERUS (AUNT). CONCOMITANT PRODUCTS INCLUDED BUTALBITAL SINCE (B)(6) 2014, ESCITALOPRAM SINCE (B)(6) 2016 AND HYDROCODONE SINCE (B)(6) 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DEPRESSION ("SEVERE DEPRESSION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HYPERSENSITIVITY ("ALLERGIC REACTIONS / ALLERGIC OR HYPERSENSITIVITY REACTION") WITH URTICARIA, PAROSMIA AND RASH AND HEADACHE ("HEADACHES"). IN 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL AND EXCESSIVE BLEEDING DURING MENSES / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS-SCAR TISSUE BREAKING THROUGH WALLS OF UTERUS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE AND CHRONIC BACK PAIN"), ABDOMINAL DISTENSION ("BLOATING"), MOOD SWINGS ("HORMONAL CHANGES ; MOOD SWINGS"), HOT FLUSH ("HOT FLASHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), OVARIAN CYST ("CYST ON OVARY"), ADNEXA UTERI PAIN ("SEVERE OVARIAN PAIN AROUND THE TIME OF MENSES") AND PROCEDURAL PAIN ("PROCEDURE/PLACEMENT OF COILS WAS EXTREMELY PAINFUL"). THE PATIENT WAS TREATED WITH DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL), BUPROPION (WELLBUTRIN), CONTRACEPTIVES NOS, SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) BILATERAL SALPINGECTOMY), SURGERY (A TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY), AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, UTERINE HAEMORRHAGE, BACK PAIN, MENORRHAGIA, ABDOMINAL DISTENSION, FATIGUE, WEIGHT INCREASED, MIGRAINE, HYPERSENSITIVITY, MOOD SWINGS, HOT FLUSH, VAGINAL HAEMORRHAGE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, ADENOMYOSIS, OVARIAN CYST, DEPRESSION, ADNEXA UTERI PAIN AND PROCEDURAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ADENOMYOSIS, ADNEXA UTERI PAIN, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, MOOD SWINGS, OVARIAN CYST, PELVIC PAIN, PROCEDURAL PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD ULTRASOUND SHOWS UTERUS AND OVARIES, THERE IS SMALL ECHOGENIC FOCUS SEEN IN THE ENDOMETRIUM, NEAR THE FUNDUS, WITH A QUESTION THAT WEATHER IT IS A PORTION OF THE ESSURE INSERT SEEN . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: SATISFACTORY PLACEMENT AND FULL OCCLUSION OF BOTH ON (B)(6) 2012, HYSTEROSALPINGOGRAM TEST SHOWED, NO OPACIFICATION OF THE FALLOPIAN TUBES, EITHER SIDE; ESSURE DEVICES IN PLACE. ON (B)(6) 2014, ABDOMEN ULTRASOUND SHOWED, PATIENT IS STATUS POST ESSURE PROCEDURE WITH INSERTS IDENTIFIED IN THE PELVIC REGIONS. ON (B)(6) 2016, SURGICAL PATHOLOGICAL REPORT SHOWED, UTERUS 1 CERVIX, BILATERAL TUBES". THE SPECIMEN CONSISTS OF A UTERUS ATTACHED TO A CERVIX AND BILATERAL FALLOPIAN TUBES. THE SPECIMEN WEIGHS 135 GM THE UTERUS MEASURES 10.0 CM. FROM THE CERVIX TO THE TOP OF THE FUNDUS, 3.5 CM. FROM EIGHT TO LEFT, AND 4.2 CM. IN ANTERIOPOSTERIOR" DIAMETER. THE SEROSAL SURFACE IS SMOOTH AND SHINY. THE CERVICAL OS IS PATENT MEASURING 1.3 CM. THE UTERU5 IS BIVALVED. THE CERVIX IS UNREMARKABLE. THE ENDOMETRIUM IS RED, SORT, AND APPEARS ATROPHIC WITH A SMALL STENOTIC AREA THAT SUGGSSTIVE OR ABLATION THERAPY. THE MYOMETRIUM MEASURES 2.2 CM. IN AVERAGE THICKNESS, THE UTERUS IS SECTIONED REVEALING A TRABECULATED MYOMETRIUM (MINIMAL DISSECTION WAS PERFORMED PER PATIENT ACCOMPANYING REQUEST TO PRESERVE ANATOMY) THE ATTACHED RIGHT FALLOPIAN TUBE MEASURES 9.0 CM. IN LENGTH AND 0.5 CM. IN AVERAGE DIAMETER IT IS ATTACHED TO A FIMBRIAE. THE SEROSAL SURFACE APPEARS UNREMARKABLE. THE FALLOPIAN TUBE IS SERIALLY SECTIONED IN 4 MM INTERVALS. THERE IS A METALLIC EMBEDDED TUBULAR HARD"1ARE PRESENT NEAR THE CORNUA. IT MEASURES APPROXIMATELY 2.5 CM. IN LENGTH THE REMINDER OF THE FALLOPIAN TUBE IS UNREMARKABLE. THE HARDWARE IS LEFT EMBEDDED WITHIN THE TISSUE FAR PRESERVATION. THE ATTACHED LEFT FALLOPIAN TUBE MEASURES A. 8 CM. IN LENGTH WITH 0.7 CM. AVERAGE DIAMETER. RIGHT IS ATTACHED TO A FIMBRIA. IT HAS A SMOOTH SEROSAL SURFACE AND IS ATTACHED TO THE PARATUBAL CYSTS. THE CYSTS MEASURE 0.5 AND 0.1 CM. THEY ARE FILLED WITH SEROUS FLUID AND HAVE A SMOOTH LINING. THE FALLOPIAN TUBE IS SERIALLY SECTIONED IN 4 MM INTERVALS. THERE IS A METALLIC EMBEDDED TUBULAR HARDCARE PRESENT NEAR THE CORNUA. IT MEASURE AS APPROXIMATELY 2.0 CM. IN LENGTH. THE REMAINDER OF THE FALLOPIAN TUBE IS UNREMARKABLE. THE HARDWARE IS LEFT EMBEDDED WITHIN THE TISSUE FOR PRESERVATION. REPRESENTATIVE SECTIONS ARE SUBMITTED IN EIGHT CASSETTES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: UTERINE HAEMORRHAGE (CONFIRMING GENITAL HAEMORRHAGE), PROCEDURAL PAIN, URTICARIA, PELVIC PAIN, OVARIAN CYST, MIGRAINE, WEIGHT GAIN, ABDOMINAL DISTENSION, ADNEXA UTERI PAIN, MOOD SWINGS". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-FEB-2018: PFS RECEIVED - NEW EVENTS, "HORMONAL CHANGES ; MOOD SWINGS, HOT FLASHES, ABNORMAL BLEEDING (VAGINAL), METALLIC ODOR ON PALMS OF HANDS, HIVES DAY OF IMPLANT, CRUSTY RASH FROM WEARING RINGS, HEADACHES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ADENOMYOSIS-SCAR TISSUE BREAKING THROUGH WALLS OF UTERUS, CYST ON OVARY, SEVERE DEPRESSION, SEVERE OVARIAN PAIN AROUND THE TIME OF MENSES, EXCESSIVE BLEEDING AFTER ESSURE DEVICE, PROCEDURE/PLACEMENT OF COILS WAS EXTREMELY PAINFUL AND ABNORMAL UTERINE BLEEDING" WERE ADDED. LOT NUMBER WAS ADDED. NEW REPORTER WERE ADDED. HISTORICAL AND CONCOMITANT CONDITIONS AND TREATMENT MEDICATION WERE ADDED. LAB DATA WERE ADDED. ¿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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE DEVICE WAS NOT VISIBLE ACCORDING TO DOCTOR DURING HYSTERECTOMY/REMOVAL OF UTERUS OR FALLOPIAN TUBES"), PELVIC PAIN ("SEVERE AND CHRONIC PELVIC PAIN / PAIN/PAIN RIGHT SIDE PELVIC PAIN"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING AFTER ESSURE DEVICE") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901326) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 1 (((B)(6) 1991)), UTERINE DILATION AND CURETTAGE AND NASAL OPERATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: BIRTH CONTROL PILL; FOR EYELASHES: LATISSE; FOR AN UNREPORTED INDICATION: CARBOCAINE HCL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH CARBOCAINE HCL. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, PREMENSTRUAL SYNDROME, HEADACHE, EX-SMOKER, ALCOHOL USE, BLOATING, CRAMP IN LOWER ABDOMEN, BREAST TENDERNESS, EXHAUSTION AND MENOMETRORRHAGIA. FAMILY HISTORY INCLUDED HEART DISEASE, UNSPECIFIED (MOTHER, GRAND MOTHER (MATERNAL), GRAND MOTHER (PATERNAL)), HYPERTENSION (MOTHER, GRAND MOTHER (MATERNAL)), DIABETES (MOTHER, GRAND MOTHER (MATERNAL)), STROKE (GRAND MOTHER (MATERNAL)), BREAST CANCER (GRAND MOTHER (MATERNAL)), COLON CANCER (GRAND MOTHER (MATERNAL), GRANDFATHER PATERNAL)) AND MALIGNANT NEOPLASM OF BODY OF UTERUS (AUNT). CONCOMITANT PRODUCTS INCLUDED BUTALBITAL SINCE (B)(6) 2014, ESCITALOPRAM SINCE (B)(6) 2016 AND HYDROCODONE SINCE (B)(6) 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), MOOD SWINGS ("HORMONAL CHANGES ; MOOD SWINGS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DEPRESSION ("SEVERE DEPRESSION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HYPERSENSITIVITY ("ALLERGIC REACTIONS / ALLERGIC OR HYPERSENSITIVITY REACTION") WITH URTICARIA, SKIN ODOUR ABNORMAL AND RASH AND HEADACHE ("HEADACHES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL AND EXCESSIVE BLEEDING DURING MENSES / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS-SCAR TISSUE BREAKING THROUGH WALLS OF UTERUS"). ON (B)(6) 2016, 3 YEARS 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED OVARIAN CYST ("CYST ON OVARY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE AND CHRONIC BACK PAIN"), ABDOMINAL DISTENSION ("BLOATING"), HOT FLUSH ("HOT FLASHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ADNEXA UTERI PAIN ("SEVERE OVARIAN PAIN AROUND THE TIME OF MENSES") AND PROCEDURAL PAIN ("PROCEDURE/PLACEMENT OF COILS WAS EXTREMELY PAINFUL"). THE PATIENT WAS TREATED WITH DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL), BUPROPION (WELLBUTRIN), CONTRACEPTIVES NOS, SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) BILATERAL SALPINGECTOMY), SURGERY (A TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. IN 2013, THE WEIGHT INCREASED HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, UTERINE HAEMORRHAGE, BACK PAIN, MENORRHAGIA, ABDOMINAL DISTENSION, FATIGUE, MIGRAINE, HYPERSENSITIVITY, MOOD SWINGS, HOT FLUSH, VAGINAL HAEMORRHAGE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, ADENOMYOSIS, OVARIAN CYST, DEPRESSION, ADNEXA UTERI PAIN AND PROCEDURAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ADENOMYOSIS, ADNEXA UTERI PAIN, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, MOOD SWINGS, OVARIAN CYST, PELVIC PAIN, PROCEDURAL PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD ULTRASOUND SHOWS UTERUS AND OVARIES, THERE IS SMALL ECHOGENIC FOCUS SEEN IN THE ENDOMETRIUM, NEAR THE FUNDUS, WITH A QUESTION THAT WEATHER IT IS A PORTION OF THE ESSURE INSERT SEEN DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: SATISFACTORY PLACEMENT AND FULL OCCLUSION OF BOTH ON (B)(6) 2012, HYSTEROSALPINGOGRAM TEST SHOWED, NO OPACIFICATION OF THE FALLOPIAN TUBES, EITHER SIDE; ESSURE DEVICES IN PLACE. ON (B)(6) 2014, ABDOMEN ULTRASOUND SHOWED, PATIENT IS STATUS POST ESSURE PROCEDURE WITH INSERTS IDENTIFIED IN THE PELVIC REGIONS. ON (B)(6) 2016, SURGICAL PATHOLOGICAL REPORT SHOWED, UTERUS 1 CERVIX, BILATERAL TUBES". THE SPECIMEN CONSISTS OF A UTERUS ATTACHED TO A CERVIX AND BILATERAL FALLOPIAN TUBES. THE SPECIMEN WEIGHS 135 GM THE UTERUS MEASURES 10.0 CM. FROM THE CERVIX TO THE TOP OF THE FUNDUS, 3.5 CM. FROM EIGHT TO LEFT, AND 4.2 CM. IN ANTERIOPOSTERIOR" DIAMETER. 2. THE SEROSAL SURFACE IS SMOOTH AND SHINY. THE CERVICAL OS IS PATENT MEASURING 1.3 CM. THE UTERU5 IS BIVALVED. THE CERVIX IS UNREMARKABLE. THE ENDOMETRIUM IS RED, SORT, AND APPEARS ATROPHIC WITH A SMALL STENOTIC AREA THAT SUGGESTIVE OR ABLATION THERAPY. 3. THE MYOMETRIUM MEASURES 2.2 CM. IN AVERAGE THICKNESS, THE UTERUS IS SECTIONED REVEALING A TRABECULATED MYOMETRIUM (MINIMAL DISSECTION WAS PERFORMED PER PATIENT ACCOMPANYING REQUEST TO PRESERVE ANATOMY) THE ATTACHED RIGHT FALLOPIAN TUBE MEASURES 9.0 CM. IN LENGTH AND 0.5 CM. IN AVERAGE DIAMETER IT IS ATTACHED TO A FIMBRIAE. THE SEROSAL SURFACE APPEARS UNREMARKABLE. 4. THE FALLOPIAN TUBE IS SERIALLY SECTIONED IN 4 MM INTERVALS. THERE IS A METALLIC EMBEDDED TUBULAR HARD" ARE PRESENT NEAR THE CORNUA. IT MEASURES APPROXIMATELY 2.5 CM. IN LENGTH THE REMINDER OF THE FALLOPIAN TUBE IS UNREMARKABLE. THE HARDWARE IS LEFT EMBEDDED WITHIN THE TISSUE FAR PRESERVATION. 5. THE ATTACHED LEFT FALLOPIAN TUBE MEASURES A. 8 CM. IN LENGTH WITH 0.7 CM. AVERAGE DIAMETER. RIGHT IS ATTACHED TO A FIMBRIA. IT HAS A SMOOTH SEROSAL SURFACE AND IS ATTACHED TO THE PARATUBAL CYSTS. THE CYSTS MEASURE 0.5 AND 0.1 CM. THEY ARE FILLED WITH SEROUS FLUID AND HAVE A SMOOTH LINING. THE FALLOPIAN TUBE IS SERIALLY SECTIONED IN 4 MM INTERVALS. 6. THERE IS A METALLIC EMBEDDED TUBULAR HARDCARE PRESENT NEAR THE CORNUA. IT MEASURE AS APPROXIMATELY 2.0 CM. IN LENGTH. THE REMAINDER OF THE FALLOPIAN TUBE IS UNREMARKABLE. THE HARDWARE IS LEFT EMBEDDED WITHIN THE TISSUE FOR PRESERVATION. REPRESENTATIVE SECTIONS ARE SUBMITTED IN EIGHT CASSETTES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: UTERINE HAEMORRHAGE (CONFIRMING GENITAL HAEMORRHAGE), PROCEDURAL PAIN, URTICARIA, PELVIC PAIN, OVARIAN CYST, MIGRAINE, WEIGHT GAIN, ABDOMINAL DISTENSION, ADNEXA UTERI PAIN, MOOD SWINGS". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-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.
QUALITY-SAFETY EVALUATION OF PTC: PTC GLOBAL NUMBER (B)(4). 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. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-DEC-2016: QUALITY SAFETY EVALUATION OF PTC RECEIVED. COMPANY CAUSALITY COMMENT: A FEMALE PLAINTIFF HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WAS EXPERIENCING SEVERE AND CHRONIC PELVIC PAIN SOMETIME POST INSERTION. SHE UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY 4 YEARS AFTER PLACEMENT. THIS EVENT IS ANTICIPATED ACCORDING TO ESSURE REFERENCE SAFETY INFORMATION. CONSIDERING THE IMPLIED TEMPORAL RELATIONSHIP AND THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSAL RELATIONSHIP CANNOT BE EXCLUDED. SINCE A SURGICAL INTERVENTION WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE, A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF AN ADULT FEMALE PLAINTIFF IN UNITED STATES ON 27-OCT-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2012 FOR PERMANENT CONTRACEPTION. ON OR ABOUT (B)(6) 2012, PLAINTIFF HAD A HYSTEROSALPINGOGRAM (HSG) TEST THAT CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. SHE REPORTED TO HER HEALTHCARE PROVIDER THAT SHE WAS EXPERIENCING SEVERE AND CHRONIC PELVIC AND BACK PAIN, ABNORMAL AND EXCESSIVE BLEEDING DURING MENSES, BLOATING, FATIGUE, WEIGHT GAIN, MIGRAINES, AND ALLERGIC REACTIONS. ON OR ABOUT (B)(6) 2016, SHE SAW HER PHYSICIAN AND UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY. COMPANY CAUSALITY COMMENT:A FEMALE PLAINTIFF HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WAS EXPERIENCING SEVERE AND CHRONIC PELVIC PAIN SOMETIME POST INSERTION. SHE UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY 4 YEARS AFTER PLACEMENT. THIS EVENT IS ANTICIPATED ACCORDING TO ESSURE REFERENCE SAFETY INFORMATION. CONSIDERING THE IMPLIED TEMPORAL RELATIONSHIP AND THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSAL RELATIONSHIP CANNOT BE EXCLUDED. SINCE A SURGICAL INTERVENTION WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. TECHNICAL ANALYSIS HAS BEEN REQUESTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760954 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 901326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other| R | BUTALBITAL| BUTALBITAL| BUTALBITAL| ESCITALOPRAM| ESCITALOPRAM| ESCITALOPRAM| HYDROCODONE| HYDROCODONE| HYDROCODONE| LATISSE| LOMEDIA 24 FE| TRIVORA |