ESSURE
Report
- Report Number
- 2951250-2019-04406
- Event Type
- Injury
- Date Received
- August 5, 2019
- Date of Event
- September 1, 2013
- Report Date
- August 22, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN (CONSTANT PELVIC PAIN)/ LOWER ABDOMINAL (PELVIC PAIN)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)/ SEVERE/ ABNORMAL BLEEDING (NOT MENSTRUAL)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B42242) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SPINAL CORPECTOMY (ANTERIOR CERVICAL CORPECTOMY SPINE SURGERY.) IN OCTOBER 2012, SPINAL CORPECTOMY (ANTERIOR CERVICAL CORPECTOMY SPINE SURGERY.) IN APRIL 2012 AND POST COITAL BLEEDING. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, BACK PAIN, SHORTNESS OF BREATH, URINARY INCONTINENCE, TIREDNESS, ENDOMETRIAL THICKENING, STRESS INCONTINENCE, CHRONIC CERVICITIS, ADENOMYOSIS, UTERINE BLEEDING, ENDOMETRIOSIS AND PELVIC ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORETHISTERONE ACETATE (LOESTRIN) FROM MAY 2012 TO FEBRUARY 2013 FOR CONTRACEPTION AS WELL AS DICYCLOVERIN HYDROCHLORIDE (DICYCLOMINE) SINCE 2006 TO MARCH 2017, LEVOTHYROXINE SODIUM (SYNTHROID) SINCE 2003, LISINOPRIL SINCE 2013, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NORETHISTERONE (CAMILA) FROM APRIL 2013 TO JUNE 2013, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM JULY 2013 TO NOVEMBER 2013 AND PROGESTERONE FROM NOVEMBER 2014 TO MAY 2015. IN SEPTEMBER 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/ PERSISTENT INCREASED MENSTRUAL FLOW"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ SEVERE MENSTRUAL CRAMPS"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), FATIGUE ("FATIGUE") AND GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: DECREASED") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("UNABLE TO PLACE COILS IN FIRST OFFICE VISIT"), ABDOMINAL PAIN ("ABDOMINAL PAIN/ ABDOMINAL CRAMPING") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL (PELVIC PAIN)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HORMONE LEVEL ABNORMAL, DYSMENORRHOEA, VULVOVAGINAL PAIN, FATIGUE, GASTROINTESTINAL DISORDER, WEIGHT INCREASED, COMPLICATION OF DEVICE INSERTION, ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF ESSURE INSERTION (PER PFS) - (B)(6) 2013 AND (B)(6) 2013. THE PHYSICIAN WAS UNABLE TO PLACE COILS IN FIRST OFFICE VISIT ON (B)(6) 2013. PATIENT STATED THAT MOST, IF NOT ALL (UNSPECIFIED) OF HER SYMPTOMS, IMPROVED SOON THEREAFTER ESSURE REMOVAL. CURRENT WEIGHT 175 LBS. 6 COILS ON RIGHT, 4 COILS ON LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.2 KG/SQM. HYSTEROSALPINGOGRAM - IN DECEMBER 2013: TOTAL BILATERAL OCCLUSION.. PATHOLOGY TEST - ON (B)(6) 2015: ENDOMETRIAL BIOPSY DISORDERED POLYPOID ENDOMETRIUM. NEGATIVE FOR ENDOMETRITIS, HYPERPLASIA AND NEOPLASM; ON (B)(6) 2015: CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. BASAL ENDOMETRIUM. ADENOMYOSIS BILATERAL FALLOPIAN TUBES WITH ESSURE-TYPE LUMINAL DEVICES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: DYSMENORRHEA, MENORRHAGIA EXPIRATION DATE: 01-06-2016 IN THIS FOLLOW UP. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: MR RECEIVED: NEW EVENTS- ABDOMINAL PAIN, LOWER ABDOMINAL PAIN WERE ADDED. REPORTERS, MEDICAL HISTORY, CONCOMITANT CONDITIONS AND DRUGS WERE 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 NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN (CONSTANT PELVIC PAIN)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B42242) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SPINAL CORPECTOMY (ANTERIOR CERVICAL CORPECTOMY SPINE SURGERY.) IN (B)(6) 2012 AND SPINAL CORPECTOMY (ANTERIOR CERVICAL CORPECTOMY SPINE SURGERY.) IN (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORETHISTERONE ACETATE (LOESTRIN) FROM (B)(6) 2012 TO (B)(6) 2013 FOR CONTRACEPTION AS WELL AS DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE) SINCE 2006 TO (B)(6) 2017, LEVOTHYROXINE SODIUM (SYNTHROID) SINCE 2003, LISINOPRIL SINCE 2013, NORETHISTERONE (CAMILA) FROM (B)(6) 2013 TO (B)(6) 2013, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2013 TO (B)(6) 2013 AND PROGESTERONE FROM (B)(6) 2014 TO (B)(6) 2015. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), FATIGUE ("FATIGUE") AND GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: DECREASED") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("UNABLE TO PLACE COILS IN FIRST OFFICE VISIT"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HORMONE LEVEL ABNORMAL, DYSMENORRHOEA, VULVOVAGINAL PAIN, FATIGUE, GASTROINTESTINAL DISORDER, WEIGHT INCREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF ESSURE INSERTION (PER PFS) - (B)(6) 2013 AND (B)(6) 2013. THE PHYSICIAN WAS UNABLE TO PLACE COILS IN FIRST OFFICE VISIT ON (B)(6) 2013. PATIENT STATED THAT MOST, IF NOT ALL (UNSPECIFIED) OF HER SYMPTOMS, IMPROVED SOON THEREAFTER ESSURE REMOVAL. CURRENT WEIGHT 175 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.2 KG/SQM. 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 7-AUG-2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN (CONSTANT PELVIC PAIN)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B42242) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SPINAL CORPECTOMY (ANTERIOR CERVICAL CORPECTOMY SPINE SURGERY.) IN (B)(6) 2012 AND SPINAL CORPECTOMY (ANTERIOR CERVICAL CORPECTOMY SPINE SURGERY.) IN (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL; NORETHISTERONE ACETATE (LOESTRIN) FROM (B)(6) 2012 TO (B)(6) 2013 FOR CONTRACEPTION AS WELL AS DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE) SINCE 2006 TO (B)(6) 2017, LEVOTHYROXINE SODIUM (SYNTHROID) SINCE 2003, LISINOPRIL SINCE 2013, NORETHISTERONE (CAMILA) FROM (B)(6) 2013 TO (B)(6) 2013, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2013 TO (B)(6) 2013 AND PROGESTERONE FROM (B)(6) 2014 TO (B)(6) 2015. 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), FATIGUE ("FATIGUE") AND GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: DECREASED") AND WEIGHT INCREASED ("WEIGHT GAIN").ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("UNABLE TO PLACE COILS IN FIRST OFFICE VISIT"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HORMONE LEVEL ABNORMAL, DYSMENORRHOEA, VULVOVAGINAL PAIN, FATIGUE, GASTROINTESTINAL DISORDER, WEIGHT INCREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF ESSURE INSERTION (PER PFS) - (B)(6) 2013 AND (B)(6) 2013. THE PHYSICIAN WAS UNABLE TO PLACE COILS IN FIRST OFFICE VISIT ON (B)(6) 2013. PATIENT STATED THAT MOST, IF NOT ALL (UNSPECIFIED) OF HER SYMPTOMS, IMPROVED SOON THEREAFTER ESSURE REMOVAL. CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). HYSTEROSALPINGOGRAM - IN (B)(6) 2013: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUL-2019: PFS RECEIVED : ESSURE REMOVAL ADDED, LOT NUMBER WAS PROVIDED. EVENT INJURY WAS UPDATED TO PELVIC PAIN. NEW EVENTS - ABNORMAL BLEEDING (GENERAL), HORMONAL CHANGES DESCRIBE: DECREASED, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION, WEIGHT GAIN, VAGINAL PAIN. REPORTERS, CONCOMITANT DRUG, MEDICAL HISTORY AND LAB RESULTS WERE ADDED. PATIENT DEMOGRAPHICS WERE ADDED. ON 31-JUL-2019: FOLLOW UP 1 AND 2 PROCESSED TOGETHER. INFORMATION REGARDING INSERTION PROCEDURE AND CONCOMITANT DRUGS WERE PROVIDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653286 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B42242 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | CAMILA| CAMILA| CAMILA| DEPO PROVERA| DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]| DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]| DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]| LISINOPRIL| LISINOPRIL| LISINOPRIL| LOESTRIN| LOESTRIN| LOESTRIN| NORETHINDRONE ACETATE| NORETHINDRONE ACETATE| NORETHINDRONE ACETATE| PROGESTERONE| PROGESTERONE| PROGESTERONE| SYNTHROID| SYNTHROID| SYNTHROID |