ESSURE
Report
- Report Number
- 2951250-2021-01689
- Event Type
- Injury
- Date Received
- May 7, 2021
- Date of Event
- February 1, 2018
- Report Date
- May 14, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND HEAVY MENSTRUAL BLEEDING ('CONTINUOUS BLEEDING THROUGHOUT THE MONTH EXCEPT FOR 4-5 DAYS / VAGINAL BLEEDING') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 060141-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SMOKER, OBESITY, IRREGULAR MENSTRUAL CYCLE, PARITY 2 (NO C-SECTIONS), GRAVIDA II, VAGINAL POLYP (10MM, REMOVED AT ESSURE INSERTION), LUMBALGIA, ANEMIA (TREATED WITH FERO-GRADUMET), HERNIATED DISC, MIGRAINE WITHOUT AURA, UTERINE ABRASION AND CHOLECYSTECTOMY. NO NICKEL/METALS ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: MIRENA FROM 2014 TO (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) FOR CONTRACEPTION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED ENDOMETRIAL DISORDER ("ENDOMETRIAL BIOPSY ABNORMAL"). ON (B)(6) 2017, THE PATIENT EXPERIENCED SUPRAPUBIC PAIN ("SUPRAPUBIC PAIN") AND DIARRHOEA ("DIARRHEA"), 1 YEAR 3 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2018, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("ABDOMINAL PAIN IN BOTH ILIAC FOSSAE"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), BREAST DISCOMFORT ("BREAST DISCOMFORT"), GROIN PAIN ("BILATERAL INGUINAL PAIN THAT WORSENS DURING THE BLEEDING") AND DYSMENORRHOEA ("BILATERAL INGUINAL PAIN THAT WORSENS DURING THE BLEEDING"). ON (B)(6) 2020, THE PATIENT EXPERIENCED PRURITUS ("GENERALIZED ITCHING") AND RASH ("GENERALIZED RASH"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("MYOMA IS SLIGHTLY LARGER") AND EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). THE PATIENT WAS TREATED WITH DESOGESTREL (CERAZETTE), PETHIDINE HYDROCHLORIDE (DOLANTINE), RANITIDINE, LEVONORGESTREL (MIRENA), SURGERY (TOTAL HISTERECTOMY AND BILATERAL SALPINGECTOMY, OVARIES WERE PRESERVED) AND ENDOMETRIAL ASPIRATE (ABUNDANT MATERIAL). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, BREAST DISCOMFORT, GROIN PAIN, UTERINE LEIOMYOMA, ENDOMETRIAL DISORDER, SUPRAPUBIC PAIN, DYSMENORRHOEA, DIARRHOEA, CERVICITIS, PRURITUS AND RASH OUTCOME WAS UNKNOWN AND THE HEAVY MENSTRUAL BLEEDING AND INTERMENSTRUAL BLEEDING HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BREAST DISCOMFORT, CERVICITIS, DIARRHOEA, DYSMENORRHOEA, ENDOMETRIAL DISORDER, GROIN PAIN, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, PELVIC PAIN, PRURITUS, RASH, SUPRAPUBIC PAIN AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WAS EASY, 2 VISIBLE RINGS ON RIGHT SIDE, 3 ON LEFT. ON REMOVAL PROCEDURE, PATIENT WAS DISCHARGED FROM HOSPITAL ON THE SECOND POSTOPERATIVE DAY. A MIRENA CASE WAS CREATED FOR THIS PATIENT ((B)(6)). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.6 KG/SQM. ALLERGY TEST: (B)(6) 2020: SENSITIZATION TO ESSURE IS RULED OUT AT PRESENT. BIOPSY ENDOMETRIUM: IN (B)(6) 2017: ABNORMAL, NO MALIGNANCY. ULTRASOUND ABDOMEN: ON (B)(6) 2017: IT WAS NOT POSSIBLE TO VISUALIZE THE APPENDIX, NOR FREE FLUID. NEGATIVE ULTRASOUND BLUMBERG. ON (B)(6) 2017: IT WAS NOT POSSIBLE TO VISUALIZE THE APPENDIX, NOR FREE FLUID. NEGATIVE ULTRASOUND BLUMBERG. LIVER OF NORMAL MORPHOLOGY WITH DIFFUSE INCREASE IN ECHOGENICITY PROBABLY RELATED TO STEATOSIS, WITHOUT EVIDENCE OF FOCAL LESIONS. POST-SURGICAL ABSENCE OF GALLBLADDER. PANCREATIC AREA AND UPPER RETROPERITONEUM NOT VISUALIZED BY INTERPOSITION OF GAS. SPLEEN WITHOUT ALTERATIONS. BOTH KIDNEYS WITHOUT SIGNIFICANT ALTERATIONS. NO OBSTRUCTIVE UROPATHY DATA. URINARY BLADDER NOT REPLENISHED, NOT ASSESSABLE. UTERUS AND RIGHT OVARY WITHOUT SIGNIFICANT ALTERATIONS. LEFT OVARY NOT VISUALIZED. ULTRASOUND SCAN: ON (B)(6) 2017: UTERUS WITH ENDOMETRIUM OF 14 MM. INTRAMURAL MYOMA ON THE POSTERIOR FACE OF 45 * 57 MM. NORMAL VISIBLE OVARIES. ESSURES WELL PLACED. ULTRASOUND SCAN VAGINA: ON (B)(6) 2016: UTERUS WITH MYOMA ON THE POSTERIOR-FUNDUS, INTRAMURAL 43X40 MM. BOTH NORMALLY-INSERTED ESSURE DEVICES ARE SEEN. NORMAL OVARIES.; ON (B)(6) 2019: UTERUS WITH CAVITATED ENDOMETRIUM. FUNDUS INTRAMURAL MYOMA 51 * 54 * 54. NORMAL OVARIES. ESSURES WELL PLACED.; ON (B)(6) 2019: UTERUS WITH INTRAMURAL MYOMA ON THE POSTERIOR SIDE OF 68X59. NORMALLY INSERTED IUD. BOTH OVARIES VISIBLE, ECHOGRAPHICALLY NORMAL. NORMALLY-INSERTED ESSURES. THIS LOT NUMBER 060141 IS INVALID. 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 11-MAY-2021: QUALITY SAFETY EVALUATION OF PTC WE RECEIVED AN INVALID LOT NUMBER. 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 PELVIC PAIN ('PELVIC PAIN') AND HEAVY MENSTRUAL BLEEDING ('CONTINUOUS BLEEDING THROUGHOUT THE MONTH EXCEPT FOR 4-5 DAYS / VAGINAL BLEEDING') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 060141) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SMOKER, OBESITY, IRREGULAR MENSTRUAL CYCLE, PARITY 2 (NO C-SECTIONS), GRAVIDA II, VAGINAL POLYP (10MM, REMOVED AT ESSURE INSERTION), LUMBALGIA, ANEMIA (TREATED WITH FERO-GRADUMET), HERNIATED DISC, MIGRAINE WITHOUT AURA, UTERINE ABRASION AND CHOLECYSTECTOMY. NO NICKEL/METALS ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: MIRENA FROM (B)(6) TO (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) FOR CONTRACEPTION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) , THE PATIENT EXPERIENCED ENDOMETRIAL DISORDER ("ENDOMETRIAL BIOPSY ABNORMAL"). ON (B)(6) 2017, THE PATIENT EXPERIENCED SUPRAPUBIC PAIN ("SUPRAPUBIC PAIN") AND DIARRHOEA ("DIARRHEA"), 1 YEAR 3 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2018, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("ABDOMINAL PAIN IN BOTH ILIAC FOSSAE"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), BREAST DISCOMFORT ("BREAST DISCOMFORT"), GROIN PAIN ("BILATERAL INGUINAL PAIN THAT WORSENS DURING THE BLEEDING") AND DYSMENORRHOEA ("BILATERAL INGUINAL PAIN THAT WORSENS DURING THE BLEEDING"). ON (B)(6) 2020, THE PATIENT EXPERIENCED PRURITUS ("GENERALIZED ITCHING") AND RASH ("GENERALIZED RASH"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("MYOMA IS SLIGHTLY LARGER") AND EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). THE PATIENT WAS TREATED WITH DESOGESTREL (CERAZETTE), PETHIDINE HYDROCHLORIDE (DOLANTINE), RANITIDINE, LEVONORGESTREL (MIRENA), SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, OVARIES WERE PRESERVED) AND ENDOMETRIAL ASPIRATE (ABUNDANT MATERIAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, BREAST DISCOMFORT, GROIN PAIN, UTERINE LEIOMYOMA, ENDOMETRIAL DISORDER, SUPRAPUBIC PAIN, DYSMENORRHOEA, DIARRHOEA, CERVICITIS, PRURITUS AND RASH OUTCOME WAS UNKNOWN AND THE HEAVY MENSTRUAL BLEEDING AND INTERMENSTRUAL BLEEDING HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BREAST DISCOMFORT, CERVICITIS, DIARRHOEA, DYSMENORRHOEA, ENDOMETRIAL DISORDER, GROIN PAIN, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, PELVIC PAIN, PRURITUS, RASH, SUPRAPUBIC PAIN AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WAS EASY, 2 VISIBLE RINGS ON RIGHT SIDE, 3 ON LEFT. ON REMOVAL PROCEDURE, PATIENT WAS DISCHARGED FROM HOSPITAL ON THE SECOND POSTOPERATIVE DAY. A MIRENA CASE WAS CREATED FOR THIS PATIENT (2021-137647). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) . ALLERGY TEST - ON (B)(6) 2020: SENSITIZATION TO ESSURE IS RULED OUT AT PRESENT.. BIOPSY ENDOMETRIUM - IN (B)(6) : ABNORMAL, NO MALIGNANCY. ULTRASOUND ABDOMEN - ON (B)(6) 2017: IT WAS NOT POSSIBLE TO VISUALIZE THE APPENDIX, NOR FREE FLUID. NEGATIVE ULTRASOUND BLUMBERG.; ON (B)(6) 2017: IT WAS NOT POSSIBLE TO VISUALIZE THE APPENDIX, NOR FREE FLUID. NEGATIVE ULTRASOUND BLUMBERG. LIVER OF NORMAL MORPHOLOGY WITH DIFFUSE INCREASE IN ECHOGENICITY PROBABLY RELATED TO STEATOSIS, WITHOUT EVIDENCE OF FOCAL LESIONS. POST-SURGICAL ABSENCE OF GALLBLADDER. PANCREATIC AREA AND UPPER RETROPERITONEUM NOT VISUALIZED BY INTERPOSITION OF GAS. SPLEEN WITHOUT ALTERATIONS. BOTH KIDNEYS WITHOUT SIGNIFICANT ALTERATIONS. NO OBSTRUCTIVE UROPATHY DATA. URINARY BLADDER NOT REPLENISHED, NOT ASSESSABLE. UTERUS AND RIGHT OVARY WITHOUT SIGNIFICANT ALTERATIONS. LEFT OVARY NOT VISUALIZED.. ULTRASOUND SCAN - ON (B)(6) 2017: UTERUS WITH ENDOMETRIUM OF 14 MM. INTRAMURAL MYOMA ON THE POSTERIOR FACE OF 45 * 57 MM. NORMAL VISIBLE OVARIES. ESSURES WELL PLACED.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: UTERUS WITH MYOMA ON THE POSTERIOR-FUNDUS, INTRAMURAL 43X40 MM. BOTH NORMALLY-INSERTED ESSURE DEVICES ARE SEEN. NORMAL OVARIES.; ON (B)(6) 2019: UTERUS WITH CAVITATED ENDOMETRIUM. FUNDUS INTRAMURAL MYOMA 51 * 54 * 54. NORMAL OVARIES. ESSURES WELL PLACED.; ON (B)(6) 2019: UTERUS WITH INTRAMURAL MYOMA ON THE POSTERIOR SIDE OF 68X59. NORMALLY INSERTED IUD. BOTH OVARIES VISIBLE, ECHOGRAPHICALLY NORMAL. NORMALLY-INSERTED ESSURES.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-MAY-2021: MEDICAL RECORDS RECEIVED. INFORMATION ADDED: REPORTERS (CASE IS NOW MEDICALLY CONFIRMED), PATIENT¿S AGE, MEDICAL HISTORY, LAB DATA, ESSURE INSERTION/REMOVAL DATES, INDICATION AND LOT NUMBER, CONCOMITANT AND TREATMENT DRUG, EVENTS (PELVIC PAIN, ENDOMETRIAL BIOPSY ABNORMAL, CONTINUOUS BLEEDING THROUGHOUT THE MONTH EXCEPT FOR 4-5 DAYS, ABDOMINAL PAIN IN BOTH ILIAC FOSSAE, METRORRHAGIA, BREAST DISCOMFORT, BILATERAL INGUINAL PAIN THAT WORSENS DURING THE BLEEDING, MYOMA IS SLIGHTLY LARGER, SUPRAPUBIC PAIN, DYSMENORRHEA, DIARRHEA, CHRONIC CERVICITIS, GENERALIZED ITCHING AND RASH), MIRENA ADDED AS HISTORICAL DRUG AND TREATMENT DRUG, EVENT "DAMAGES" WAS DELETED. CASE WAS UPGRADED TO SERIOUS INCIDENT. ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PTC. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 687839 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 060141-INVALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | CERAZETTE [DESOGESTREL]| CERAZETTE [DESOGESTREL] |