ESSURE
Report
- Report Number
- 2951250-2016-02183
- Event Type
- Injury
- Date Received
- October 13, 2016
- Date of Event
- October 1, 2004
- Report Date
- March 22, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: PS/CV/SHC/36189) ON 14-SEP-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 23-OCT-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEMORRHAGES'), PELVIC PAIN ('INTENSE PELVIC PAIN /TOO MUCH PAIN'), PRURITUS ('"UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING / ESSURE CAUSES A LOT OF ITCHING'), DISABILITY ('THE PATIENT COMMENTED THAT SHE WAS INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS'), UTERINE LEIOMYOMA ('MYOMATOUS UTERUS'), ANAEMIA ('ANEMIA'), HIATUS HERNIA ('HIATAL HERNIA') AND ARTHROPATHY ('DEFORMITIES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 AND OVERWEIGHT (BMI 28.9). CONCURRENT CONDITIONS INCLUDED DRUG HYPERSENSITIVITY. ON (B)(6)2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6)2004, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRURITUS (SERIOUSNESS CRITERION HOSPITALIZATION), INFECTION (""UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING / ESSURE CAUSES A LOT OF INFECTION"), DYSMENORRHOEA ("PAINFUL MENSTRUAL PERIODS/ TOO MUCH PAIN"), THE FIRST EPISODE OF MENSTRUAL DISORDER ("BAD SMELL DURING MENSTRUATION"), THE SECOND EPISODE OF MENSTRUAL DISORDER ("BLOOD CLOTS"), CYST ("CYSTS AS A CONSEQUENCE OF THE BLEEDING"), HEADACHE ("HEADACHE"), PERIPHERAL SWELLING ("LEG SWELLING"), FATIGUE ("TIREDNESS"), ANAEMIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST PAIN ("BREASTS PAIN"), INFLAMMATION ("ABDOMINAL INFLAMMATION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6)2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABUNDANT MENSTRUATION (WHICH LASTED BETWEEN 20 AND 25 DAYS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISABILITY (SERIOUSNESS CRITERION DISABILITY), PROCEDURAL PAIN ("TERRIBLE PAIN AFTER ESSURE REMOVAL PROCEDURE"), DEPRESSED MOOD ("FEELS SAD"), RESTLESS LEGS SYNDROME ("RESTLESS LEGS SYNDROME"), MENTAL DISORDER ("SHE IS NOT FEELING FINE PSYCHOLOGICALLY DUE TO THE PROCEDURE"), HIATUS HERNIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FLUID RETENTION ("LIQUID RETENTION"), BONE PAIN ("PAIN IN BONES"), PAIN IN EXTREMITY ("PAIN IN HANDS") AND ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE UTERINE LEIOMYOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CONTRACEPTIVES, INTRAVAGINAL CONTRACEPTIVES, PRAMIPEXOLE AND SURGERY (FALLOPIAN TUBES REMOVED DUE TO THE DEVICE; SURGERY SIMILAR TO A C-SECTION). ESSURE (ESS205) WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, PRURITUS, INFECTION, DISABILITY, UTERINE LEIOMYOMA, MENORRHAGIA, PROCEDURAL PAIN, DEPRESSED MOOD, RESTLESS LEGS SYNDROME, DYSMENORRHOEA, THE LAST EPISODE OF MENSTRUAL DISORDER, CYST, HEADACHE, PERIPHERAL SWELLING, FATIGUE, ANAEMIA, INFLAMMATION, ALOPECIA, HIATUS HERNIA, FLUID RETENTION, BONE PAIN, PAIN IN EXTREMITY AND ARTHROPATHY HAD RESOLVED, THE BREAST PAIN OUTCOME WAS UNKNOWN AND THE MENTAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANAEMIA, ARTHROPATHY, BONE PAIN, BREAST PAIN, CYST, DEPRESSED MOOD, DISABILITY, DYSMENORRHOEA, FATIGUE, FLUID RETENTION, GENITAL HAEMORRHAGE, HEADACHE, HIATUS HERNIA, INFECTION, INFLAMMATION, MENORRHAGIA, MENTAL DISORDER, PAIN IN EXTREMITY, PELVIC PAIN, PERIPHERAL SWELLING, PROCEDURAL PAIN, PRURITUS, RESTLESS LEGS SYNDROME, UTERINE LEIOMYOMA, THE FIRST EPISODE OF MENSTRUAL DISORDER AND THE SECOND EPISODE OF MENSTRUAL DISORDER TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE CONSUMER IS CONSIDERING A LAWSUIT. SHE MADE A POST IN CROP SCIENCE LINKEDIN CHANNEL REFERRING THAT SHE IS A WOMAN WITHOUT UTERUS THAT WILL UNDERGO A SECOND SURGERY WITH THE CONSEQUENCES THAT THIS ENTAILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-OCT-2019: SERIOUSNESS CRITERION HOSPITALIZATION WAS CONSIDERED FOR THE EVENT PRURITUS, WHICH BECAME INCIDENT. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE HAVE CONDUCTED A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 14-SEP-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 14-FEB-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEMORRHAGES'), PELVIC PAIN ('INTENSE PELVIC PAIN /TOO MUCH PAIN'), PRURITUS ('"UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING / ESSURE CAUSES A LOT OF ITCHING'), DISABILITY ('THE PATIENT COMMENTED THAT SHE WAS INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS'), UTERINE LEIOMYOMA ('MYOMATOUS UTERUS'), ANAEMIA ('ANEMIA'), HIATUS HERNIA ('HIATAL HERNIA') AND ARTHROPATHY ('DEFORMITIES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 AND OVERWEIGHT (BMI 28.9). CONCURRENT CONDITIONS INCLUDED DRUG HYPERSENSITIVITY. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRURITUS (SERIOUSNESS CRITERION HOSPITALIZATION), DEVICE RELATED INFECTION (""UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING / ESSURE CAUSES A LOT OF INFECTION"), DYSMENORRHOEA ("PAINFUL MENSTRUAL PERIODS/ TOO MUCH PAIN"), THE FIRST EPISODE OF MENSTRUAL DISORDER ("BAD SMELL DURING MENSTRUATION"), THE SECOND EPISODE OF MENSTRUAL DISORDER ("BLOOD CLOTS"), CYST ("CYSTS AS A CONSEQUENCE OF THE BLEEDING"), HEADACHE ("HEADACHE"), PERIPHERAL SWELLING ("LEG SWELLING"), FATIGUE ("TIREDNESS"), ANAEMIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST PAIN ("BREASTS PAIN"), INFLAMMATION ("ABDOMINAL INFLAMMATION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABUNDANT MENSTRUATION (WHICH LASTED BETWEEN 20 AND 25 DAYS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISABILITY (SERIOUSNESS CRITERION DISABILITY), PROCEDURAL PAIN ("TERRIBLE PAIN AFTER ESSURE REMOVAL PROCEDURE"), DEPRESSED MOOD ("FEELS SAD"), RESTLESS LEGS SYNDROME ("RESTLESS LEGS SYNDROME"), MENTAL DISORDER ("SHE IS NOT FEELING FINE PSYCHOLOGICALLY DUE TO THE PROCEDURE"), HIATUS HERNIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FLUID RETENTION ("LIQUID RETENTION"), BONE PAIN ("PAIN IN BONES"), PAIN IN EXTREMITY ("PAIN IN HANDS"), ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTION "), PERIPROSTHETIC METALLOSIS ("METALLOSIS ") AND MYALGIA ("MUSCULAR PAIN ") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CONTRACEPTIVES, INTRAVAGINAL CONTRACEPTIVES, PRAMIPEXOLE AND SURGERY (SUBTOTAL HYSTERECTOMY SURGERY WITH DOUBLE BILATERAL SALPINGECTOMY BY LAPAROTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, PRURITUS, DEVICE RELATED INFECTION, DISABILITY, UTERINE LEIOMYOMA, MENORRHAGIA, PROCEDURAL PAIN, DEPRESSED MOOD, RESTLESS LEGS SYNDROME, DYSMENORRHOEA, THE LAST EPISODE OF MENSTRUAL DISORDER, CYST, HEADACHE, PERIPHERAL SWELLING, FATIGUE, ANAEMIA, INFLAMMATION, ALOPECIA, HIATUS HERNIA, FLUID RETENTION, BONE PAIN, PAIN IN EXTREMITY AND ARTHROPATHY HAD RESOLVED, THE BREAST PAIN, HYPERSENSITIVITY, PERIPROSTHETIC METALLOSIS AND MYALGIA OUTCOME WAS UNKNOWN AND THE MENTAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANAEMIA, ARTHROPATHY, BONE PAIN, BREAST PAIN, CYST, DEPRESSED MOOD, DEVICE RELATED INFECTION, DISABILITY, DYSMENORRHOEA, FATIGUE, FLUID RETENTION, GENITAL HAEMORRHAGE, HEADACHE, HIATUS HERNIA, HYPERSENSITIVITY, INFLAMMATION, MENORRHAGIA, MENTAL DISORDER, MYALGIA, PAIN IN EXTREMITY, PELVIC PAIN, PERIPHERAL SWELLING, PERIPROSTHETIC METALLOSIS, PROCEDURAL PAIN, PRURITUS, RESTLESS LEGS SYNDROME, UTERINE LEIOMYOMA, THE FIRST EPISODE OF MENSTRUAL DISORDER AND THE SECOND EPISODE OF MENSTRUAL DISORDER TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE CONSUMER IS CONSIDERING A LAWSUIT. SHE MADE A POST IN CROP SCIENCE LINKEDIN CHANNEL REFERRING THAT SHE IS A WOMAN WITHOUT UTERUS THAT WILL UNDERGO A SECOND SURGERY WITH THE CONSEQUENCES THAT THIS ENTAILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-FEB-2020: LEGAL CLAIM RECEIVED, LAWYER ADDED AS REPORTER. PATIENT¿S INITIALS UPDATED. EVENTS ADDED: ALLERGIC REACTION, METALLOSSIS, MUSCULAR PAIN. ESSURE REMOVAL SURGERY SPECIFIED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 14-SEP-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 14-FEB-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEMORRHAGES'), PELVIC PAIN ('INTENSE PELVIC PAIN /TOO MUCH PAIN'), PRURITUS ('"UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING / ESSURE CAUSES A LOT OF ITCHING'), DISABILITY ('THE PATIENT COMMENTED THAT SHE WAS INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS'), UTERINE LEIOMYOMA ('MYOMATOUS UTERUS'), ANAEMIA ('ANEMIA'), HIATUS HERNIA ('HIATAL HERNIA') AND ARTHROPATHY ('DEFORMITIES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 AND OVERWEIGHT (BMI 28.9). CONCURRENT CONDITIONS INCLUDED DRUG HYPERSENSITIVITY. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRURITUS (SERIOUSNESS CRITERION HOSPITALIZATION), DEVICE RELATED INFECTION (""UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING / ESSURE CAUSES A LOT OF INFECTION"), DYSMENORRHOEA ("PAINFUL MENSTRUAL PERIODS/ TOO MUCH PAIN"), THE FIRST EPISODE OF MENSTRUAL DISORDER ("BAD SMELL DURING MENSTRUATION"), THE SECOND EPISODE OF MENSTRUAL DISORDER ("BLOOD CLOTS"), CYST ("CYSTS AS A CONSEQUENCE OF THE BLEEDING"), HEADACHE ("HEADACHE"), PERIPHERAL SWELLING ("LEG SWELLING"), FATIGUE ("TIREDNESS"), ANAEMIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST PAIN ("BREASTS PAIN"), INFLAMMATION ("ABDOMINAL INFLAMMATION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABUNDANT MENSTRUATION (WHICH LASTED BETWEEN 20 AND 25 DAYS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISABILITY (SERIOUSNESS CRITERION DISABILITY), PROCEDURAL PAIN ("TERRIBLE PAIN AFTER ESSURE REMOVAL PROCEDURE"), DEPRESSED MOOD ("FEELS SAD"), RESTLESS LEGS SYNDROME ("RESTLESS LEGS SYNDROME"), MENTAL DISORDER ("SHE IS NOT FEELING FINE PSYCHOLOGICALLY DUE TO THE PROCEDURE"), HIATUS HERNIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FLUID RETENTION ("LIQUID RETENTION"), BONE PAIN ("PAIN IN BONES"), PAIN IN EXTREMITY ("PAIN IN HANDS"), ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTION "), PERIPROSTHETIC METALLOSIS ("METALLOSIS ") AND MYALGIA ("MUSCULAR PAIN ") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CONTRACEPTIVES, INTRAVAGINAL CONTRACEPTIVES, PRAMIPEXOLE AND SURGERY (SUBTOTAL HYSTERECTOMY SURGERY WITH DOUBLE BILATERAL SALPINGECTOMY BY LAPAROTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, PRURITUS, DEVICE RELATED INFECTION, DISABILITY, UTERINE LEIOMYOMA, MENORRHAGIA, PROCEDURAL PAIN, DEPRESSED MOOD, RESTLESS LEGS SYNDROME, DYSMENORRHOEA, THE LAST EPISODE OF MENSTRUAL DISORDER, CYST, HEADACHE, PERIPHERAL SWELLING, FATIGUE, ANAEMIA, INFLAMMATION, ALOPECIA, HIATUS HERNIA, FLUID RETENTION, BONE PAIN, PAIN IN EXTREMITY AND ARTHROPATHY HAD RESOLVED, THE BREAST PAIN, HYPERSENSITIVITY, PERIPROSTHETIC METALLOSIS AND MYALGIA OUTCOME WAS UNKNOWN AND THE MENTAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANAEMIA, ARTHROPATHY, BONE PAIN, BREAST PAIN, CYST, DEPRESSED MOOD, DEVICE RELATED INFECTION, DISABILITY, DYSMENORRHOEA, FATIGUE, FLUID RETENTION, GENITAL HAEMORRHAGE, HEADACHE, HIATUS HERNIA, HYPERSENSITIVITY, INFLAMMATION, MENORRHAGIA, MENTAL DISORDER, MYALGIA, PAIN IN EXTREMITY, PELVIC PAIN, PERIPHERAL SWELLING, PERIPROSTHETIC METALLOSIS, PROCEDURAL PAIN, PRURITUS, RESTLESS LEGS SYNDROME, UTERINE LEIOMYOMA, THE FIRST EPISODE OF MENSTRUAL DISORDER AND THE SECOND EPISODE OF MENSTRUAL DISORDER TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE CONSUMER IS CONSIDERING A LAWSUIT. SHE MADE A POST IN CROP SCIENCE LINKEDIN CHANNEL REFERRING THAT SHE IS A WOMAN WITHOUT UTERUS THAT WILL UNDERGO A SECOND SURGERY WITH THE CONSEQUENCES THAT THIS ENTAILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-FEB-2020: LEGAL CLAIM RECEIVED, LAWYER ADDED AS REPORTER. PATIENT¿S INITIALS UPDATED. EVENTS ADDED: ALLERGIC REACTION, METALLOSSIS, MUSCULAR PAIN. ESSURE REMOVAL SURGERY SPECIFIED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: PS/CV/SHC/36189) ON (B)(6) 2016. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEMORRHAGES'), PELVIC PAIN ('INTENSE PELVIC PAIN /TOO MUCH PAIN'), PRURITUS ('"UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING / ESSURE CAUSES A LOT OF ITCHING'), DISABILITY ('THE PATIENT COMMENTED THAT SHE WAS INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS'), UTERINE LEIOMYOMA ('MYOMATOUS UTERUS'), ANAEMIA ('ANEMIA'), HIATUS HERNIA ('HIATAL HERNIA') AND ARTHROPATHY ('DEFORMITIES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 AND OVERWEIGHT (BMI 28.9). CONCURRENT CONDITIONS INCLUDED DRUG HYPERSENSITIVITY. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRURITUS (SERIOUSNESS CRITERION HOSPITALIZATION), DEVICE RELATED INFECTION (""UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING / ESSURE CAUSES A LOT OF INFECTION"), DYSMENORRHOEA ("PAINFUL MENSTRUAL PERIODS/ TOO MUCH PAIN"), THE FIRST EPISODE OF MENSTRUAL DISORDER ("BAD SMELL DURING MENSTRUATION"), THE SECOND EPISODE OF MENSTRUAL DISORDER ("BLOOD CLOTS"), CYST ("CYSTS AS A CONSEQUENCE OF THE BLEEDING"), HEADACHE ("HEADACHE"), PERIPHERAL SWELLING ("LEG SWELLING"), FATIGUE ("TIREDNESS"), ANAEMIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST PAIN ("BREASTS PAIN"), INFLAMMATION ("ABDOMINAL INFLAMMATION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABUNDANT MENSTRUATION (WHICH LASTED BETWEEN 20 AND 25 DAYS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISABILITY (SERIOUSNESS CRITERION DISABILITY), PROCEDURAL PAIN ("TERRIBLE PAIN AFTER ESSURE REMOVAL PROCEDURE"), DEPRESSED MOOD ("FEELS SAD"), RESTLESS LEGS SYNDROME ("RESTLESS LEGS SYNDROME"), MENTAL DISORDER ("SHE IS NOT FEELING FINE PSYCHOLOGICALLY DUE TO THE PROCEDURE"), HIATUS HERNIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FLUID RETENTION ("LIQUID RETENTION"), BONE PAIN ("PAIN IN BONES"), PAIN IN EXTREMITY ("PAIN IN HANDS"), ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTION"), PERIPROSTHETIC METALLOSIS ("METALLOSIS") AND MYALGIA ("MUSCULAR PAIN") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CONTRACEPTIVES, INTRAVAGINAL CONTRACEPTIVES, PRAMIPEXOLE AND SURGERY (SUBTOTAL HYSTERECTOMY SURGERY WITH DOUBLE BILATERAL SALPINGECTOMY BY LAPAROTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, PRURITUS, DEVICE RELATED INFECTION, DISABILITY, UTERINE LEIOMYOMA, MENORRHAGIA, PROCEDURAL PAIN, DEPRESSED MOOD, RESTLESS LEGS SYNDROME, DYSMENORRHOEA, THE LAST EPISODE OF MENSTRUAL DISORDER, CYST, HEADACHE, PERIPHERAL SWELLING, FATIGUE, ANAEMIA, INFLAMMATION, ALOPECIA, HIATUS HERNIA, FLUID RETENTION, BONE PAIN, PAIN IN EXTREMITY AND ARTHROPATHY HAD RESOLVED, THE BREAST PAIN, HYPERSENSITIVITY, PERIPROSTHETIC METALLOSIS AND MYALGIA OUTCOME WAS UNKNOWN AND THE MENTAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANAEMIA, ARTHROPATHY, BONE PAIN, BREAST PAIN, CYST, DEPRESSED MOOD, DEVICE RELATED INFECTION, DISABILITY, DYSMENORRHOEA, FATIGUE, FLUID RETENTION, GENITAL HAEMORRHAGE, HEADACHE, HIATUS HERNIA, HYPERSENSITIVITY, INFLAMMATION, MENORRHAGIA, MENTAL DISORDER, MYALGIA, PAIN IN EXTREMITY, PELVIC PAIN, PERIPHERAL SWELLING, PERIPROSTHETIC METALLOSIS, PROCEDURAL PAIN, PRURITUS, RESTLESS LEGS SYNDROME, UTERINE LEIOMYOMA, THE FIRST EPISODE OF MENSTRUAL DISORDER AND THE SECOND EPISODE OF MENSTRUAL DISORDER TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE CONSUMER IS CONSIDERING A LAWSUIT. SHE MADE A POST IN CROP SCIENCE LINKEDIN CHANNEL REFERRING THAT SHE IS A WOMAN WITHOUT UTERUS THAT WILL UNDERGO A SECOND SURGERY WITH THE CONSEQUENCES THAT THIS ENTAILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-MAY-2020: QUALITY-SAFETY EVALUATION OF PTC 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4) ON 14-SEP-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 15-MAY-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('INTENSE PELVIC PAIN /TOO MUCH PAIN, DISABLING'), GENITAL HAEMORRHAGE ('HEMORRHAGES') AND PRURITUS ('ESSURE CAUSES A LOT OF ITCHING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 (2 NATURAL DELIVERIES). CONCURRENT CONDITIONS INCLUDED OVERWEIGHT (BMI 28.9) AND DRUG HYPERSENSITIVITY (ALLERGY TO ACETYLSALICYLIC ACID). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRURITUS (SERIOUSNESS CRITERION HOSPITALIZATION), DYSMENORRHOEA ("PAINFUL MENSTRUAL PERIODS/ TOO MUCH PAIN"), MENSTRUAL DISORDER ("BAD SMELL DURING MENSTRUATION"), DEVICE RELATED INFECTION ("ESSURE CAUSES A LOT OF INFECTION"), INFLAMMATION ("ABDOMINAL INFLAMMATION"), HEADACHE ("HEADACHE"), BREAST PAIN ("BREASTS PAIN"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), ALOPECIA ("HAIR LOSS"), CYST ("CYSTS AS A CONSEQUENCE OF THE BLEEDING"), PERIPHERAL SWELLING ("LEG SWELLING") AND FATIGUE ("TIREDNESS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABUNDANT MENSTRUATION (WHICH LASTED BETWEEN 20 AND 25 DAYS)/ BLOOD CLOTS WITH MENSES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ALLERGIC REACTION"), PROCEDURAL PAIN ("TERRIBLE PAIN AFTER ESSURE REMOVAL PROCEDURE"), RESTLESS LEGS SYNDROME ("RESTLESS LEGS SYNDROME"), ARTHROPATHY ("DEFORMITIES"), MYALGIA ("MUSCULAR PAIN"), PAIN IN EXTREMITY ("PAIN IN HANDS"), BONE PAIN ("PAIN IN BONES"), FLUID RETENTION ("LIQUID RETENTION"), HIATUS HERNIA ("HIATAL HERNIA"), PERIPROSTHETIC METALLOSIS ("METALLOSIS") AND DEPRESSED MOOD ("FEELS SAD") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("MYOMATOUS UTERUS"). THE PATIENT WAS TREATED WITH CONTRACEPTIVES, INTRAVAGINAL CONTRACEPTIVES, PRAMIPEXOLE AND SURGERY (SUBTOTAL HYSTERECTOMY SURGERY WITH BILATERAL SALPINGECTOMY BY LAPAROTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, PRURITUS, MENORRHAGIA, DYSMENORRHOEA, MENSTRUAL DISORDER, DEVICE RELATED INFECTION, INFLAMMATION, PROCEDURAL PAIN, HEADACHE, UTERINE LEIOMYOMA, IRON DEFICIENCY ANAEMIA, ALOPECIA, RESTLESS LEGS SYNDROME, ARTHROPATHY, PAIN IN EXTREMITY, BONE PAIN, CYST, PERIPHERAL SWELLING, FLUID RETENTION, FATIGUE, HIATUS HERNIA AND DEPRESSED MOOD HAD RESOLVED AND THE HYPERSENSITIVITY, BREAST PAIN, MYALGIA AND PERIPROSTHETIC METALLOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ARTHROPATHY, BONE PAIN, BREAST PAIN, CYST, DEPRESSED MOOD, DEVICE RELATED INFECTION, DYSMENORRHOEA, FATIGUE, FLUID RETENTION, GENITAL HAEMORRHAGE, HEADACHE, HIATUS HERNIA, HYPERSENSITIVITY, INFLAMMATION, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MENSTRUAL DISORDER, MYALGIA, PAIN IN EXTREMITY, PELVIC PAIN, PERIPHERAL SWELLING, PERIPROSTHETIC METALLOSIS, PROCEDURAL PAIN, PRURITUS, RESTLESS LEGS SYNDROME AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE IS NOT FEELING FINE PSYCHOLOGICALLY DUE TO THE PROCEDURE AND IS CONSIDERING A LAWSUIT. SHE MADE A POST IN CROP SCIENCE LINKEDIN CHANNEL REFERRING THAT SHE IS A WOMAN WITHOUT UTERUS THAT WILL UNDERGO A SECOND SURGERY WITH THE CONSEQUENCES THAT THIS ENTAILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAR-2021: HA REFERENCE NUMBER ADDED. 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 CASE WAS REPORTED VIA REGULATORY AUTHORITY (B)(6) (REFERENCE NUMBER: (B)(4)) ON 21-NOV-2016 AND WAS FORWARDED TO BAYER ON 22-NOV-2016. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("HEMORRHAGES"), PELVIC PAIN ("INTENSE PELVIC PAIN /TOO MUCH PAIN"), DISABILITY ("THE PATIENT COMMENTED THAT SHE WAS INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS"), UTERINE LEIOMYOMA ("MYOMATOUS UTERUS"), ANAEMIA ("ANEMIA"), HIATUS HERNIA ("HIATAL HERNIA") AND ARTHROPATHY ("DEFORMITIES") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 2 AND OVERWEIGHT (BMI 28.9). CONCURRENT CONDITIONS INCLUDED DRUG HYPERSENSITIVITY. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL PERIODS/ TOO MUCH PAIN"), THE FIRST EPISODE OF MENSTRUAL DISORDER ("BAD SMELL DURING MENSTRUATION"), THE SECOND EPISODE OF MENSTRUAL DISORDER ("BLOOD CLOTS"), CYST ("CYSTS AS A CONSEQUENCE OF THE BLEEDING"), HEADACHE ("HEADACHE"), PERIPHERAL SWELLING ("LEG SWELLING"), INFECTION (""UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING"), PRURITUS (""UNMANIFESTED" INFECTIONS CHARACTERIZED BY ITCHING"), FATIGUE ("TIREDNESS"), ANAEMIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST PAIN ("BREASTS PAIN"), INFLAMMATION ("ABDOMINAL INFLAMMATION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABUNDANT MENSTRUATION (WHICH LASTED BETWEEN 20 AND 25 DAYS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISABILITY (SERIOUSNESS CRITERION DISABILITY), UTERINE LEIOMYOMA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("TERRIBLE PAIN AFTER ESSURE REMOVAL PROCEDURE"), DEPRESSED MOOD ("FEELS SAD"), RESTLESS LEGS SYNDROME ("RESTLESS LEGS SYNDROME"), MENTAL DISORDER ("SHE IS NOT FEELING FINE PSYCHOLOGICALLY DUE TO THE PROCEDURE"), HIATUS HERNIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FLUID RETENTION ("LIQUID RETENTION"), BONE PAIN ("PAIN IN BONES"), PAIN IN EXTREMITY ("PAIN IN HANDS") AND ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CONTRACEPTIVES NOS, INTRAVAGINAL CONTRACEPTIVES, PRAMIPEXOLE AND SURGERY (FALLOPIAN TUBES REMOVED DUE TO THE DEVICE; SURGERY SIMILAR TO A C-SECTION). ESSURE (ESS205) WAS REMOVED ON (B)(6)-2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, DISABILITY, UTERINE LEIOMYOMA, MENORRHAGIA, PROCEDURAL PAIN, DEPRESSED MOOD, RESTLESS LEGS SYNDROME, DYSMENORRHOEA, THE LAST EPISODE OF MENSTRUAL DISORDER, CYST, HEADACHE, PERIPHERAL SWELLING, INFECTION, PRURITUS, FATIGUE, ANAEMIA, INFLAMMATION, ALOPECIA, HIATUS HERNIA, FLUID RETENTION, BONE PAIN, PAIN IN EXTREMITY AND ARTHROPATHY HAD RESOLVED, THE BREAST PAIN OUTCOME WAS UNKNOWN AND THE MENTAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANAEMIA, ARTHROPATHY, BONE PAIN, BREAST PAIN, CYST, DEPRESSED MOOD, DISABILITY, DYSMENORRHOEA, FATIGUE, FLUID RETENTION, GENITAL HAEMORRHAGE, HEADACHE, HIATUS HERNIA, INFECTION, INFLAMMATION, MENORRHAGIA, MENTAL DISORDER, PAIN IN EXTREMITY, PELVIC PAIN, PERIPHERAL SWELLING, PROCEDURAL PAIN, PRURITUS, RESTLESS LEGS SYNDROME, UTERINE LEIOMYOMA, THE FIRST EPISODE OF MENSTRUAL DISORDER AND THE SECOND EPISODE OF MENSTRUAL DISORDER TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE CONSUMER IS CONSIDERING A LAWSUIT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.9 KG/SQM. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE GLOBAL SAFETY DATABASE WAS PERFORMED ON 23-JAN-2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM (PT): GENITAL HAEMORRHAGE: 762 CASES. PELVIC PAIN: (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JAN-2018: REPORT RETRIEVED FROM TV NEWS PROGRAM TITLED (B)(6) EVENTS "HIATAL HERNIA, LIQUID RETENTION, PAIN IN BONES, PAIN IN HANDS, DEFORMITIES, MYOMATOUS UTERUS" WERE ADDED. IMPORTANT EVENTS WERE CONSIDERED AS MEDICALLY SIGNIFICANT. EVENTS "MYOMATOUS UTERUS AND TOO MUCH PAIN" WERE TICKED AS SERIOUS DUE TO INTERVENTION REQUIRED. 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.
THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS AND OVERWEIGHT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2017: CASE CORRECTION: COMPANY CAUSALITY COMMENT UPDATED. EVENTS TERRIBLE PAIN AFTER ESSURE REMOVAL PROCEDURE, RESTLESS LEGS SYNDROME, BLOOD CLOTS, INTENSE PELVIC PAIN, AND ANEMIA ARE NON-SERIOUS. ON 30-JAN-2017: CODING CORRECTION. COMPANY CAUSALITY COMMENT: THIS POTENTIAL LEGAL NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) PLACED MORE THAN 10 YEARS PRIOR TO THE REPORT. SINCE ESSURE INSERTION, SHE HAD HEMORRHAGES (INTERPRETED AS GENITAL BLEEDING). SHE WAS ALSO INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS. SHE HAD TO USE OTHER CONTRACEPTIVES SIMULTANEOUSLY WITH ESSURE IN ORDER TO CONTROL THE HEMORRHAGES. CONSUMER HAD HER FALLOPIAN TUBES REMOVED DUE TO THE DEVICE. BOTH EVENTS RESOLVED. GENITAL BLEEDING IS ANTICIPATED WHILE DISABILITY IS UNANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THE NATURE OF THE EVENT GENITAL BLEEDING AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. IN CONTRAST, THE EXACT REASON FOR THE INCAPACITATING CONDITION WAS NOT PROVIDED. THEREFORE, CAUSALITY BETWEEN DISABILITY AND ESSURE CANNOT BE ASSESSED. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT.
FOLLOW-UP RECEIVED ON 21-NOV-2016: REGULATORY AUTHORITY NUMBER WAS RECEIVED ((B)(4)). COMPANY CAUSALITY COMMENT: THIS POTENTIAL LEGAL NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) PLACED MORE THAN 10 YEARS AGO. SINCE ESSURE INSERTION, SHE HAD HEMORRHAGES (INTERPRETED AS GENITAL BLEEDING). SHE WAS ALSO INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS. SHE HAD TO USE OTHER CONTRACEPTIVES SIMULTANEOUSLY WITH ESSURE IN ORDER TO CONTROL THE HEMORRHAGES. A PROCEDURE WAS THEN NEEDED AND CONSUMER HAD HER FALLOPIAN TUBES REMOVED DUE TO THE DEVICE. GENITAL BLEEDING IS LISTED WHILE DISABILITY IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE MAY CAUSE BLEEDINGS AND THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. IN CONTRAST, THE REASON FOR THE INCAPACITATING CONDITION WAS NOT PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO ASSESS THE DISABILITY AT THIS TIME. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION HAS BEEN REQUESTED.
THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE, A SEARCH IN THE GLOBAL SAFETY DATABASE WAS PERFORMED ON 09-MAR-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM (PT): GENITAL HAEMORRHAGE: 526 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. 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 BATCH 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 21-FEB-2017: QUALITY SAFETY EVALUATION OF PTC. ON 2-MAR-2017: UPDATED QUALITY-SAFETY EVALUATION RECEIVED. COMPANY CAUSALITY COMMENT: THIS POTENTIAL LEGAL NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) PLACED MORE THAN 10 YEARS PRIOR TO THE REPORT. SINCE ESSURE INSERTION, SHE HAD HEMORRHAGES (INTERPRETED AS GENITAL BLEEDING). SHE WAS ALSO INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS. SHE HAD TO USE OTHER CONTRACEPTIVES SIMULTANEOUSLY WITH ESSURE IN ORDER TO CONTROL THE HEMORRHAGES. TWELVE YEARS AFTER INSERTION HER FALLOPIAN TUBES WERE REMOVED DUE TO THE DEVICE. BOTH EVENTS RESOLVED. GENITAL BLEEDING IS ANTICIPATED WHILE DISABILITY IS UNANTICIPATED IN THE REFERENCE SAFETY INFORMATION OF ESSURE. CONSIDERING THE NATURE OF THE EVENT GENITAL BLEEDING AND THE LACK OF ALTERNATIVE EXPLANATIONS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. IN CONTRAST, THE EXACT REASON FOR THE INCAPACITATING CONDITION WAS NOT PROVIDED. THEREFORE, A CAUSAL RELATIONSHIP BETWEEN DISABILITY AND ESSURE CANNOT BE ASSESSED. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. NUMEROUS OTHER EVENTS WERE ALSO REPORTED (NON-SERIOUS). AN UPDATED PRODUCT TECHNICAL ANALYSIS RESULTED IN AN UNCONFIRMED QUALITY DEFECT, AS LOT NUMBER AND COMPLAINT SAMPLE WERE NOT AVAILABLE.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM AN ADULT FEMALE CONSUMER IN (B)(6) ON 14-SEP-2016 WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) PLACED MORE THAN 10 YEARS AGO AS CONTRACEPTIVE. SINCE ESSURE INSERTION, SHE HAS PRESENTED EVENTS SUCH AS HEMORRHAGES, ABUNDANT MENSTRUATION, FEELING SAD, AND RESTLESS LEGS SYNDROME. IN ADDITION, CONSUMER INFORMED THAT WAS INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS. CONSUMER ALSO INFORMED THAT SHE HAD TO USE OTHER CONTRACEPTIVES SIMULTANEOUSLY WITH ESSURE IN ORDER TO CONTROL THE HEMORRHAGES. A PROCEDURE WAS THEN NEEDED AND CONSUMER HAD HER FALLOPIAN TUBES REMOVED DUE TO THE DEVICE. AFTER ESSURE REMOVAL, SHE EXPERIENCED TERRIBLE PAIN. THE CONSUMER IS CONSIDERING A LAWSUIT. ALL THE EVENTS WERE CONSIDERED AS RELATED BY CONSUMER. COMPANY CAUSALITY COMMENT: THIS POTENTIAL LEGAL NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) PLACED MORE THAN 10 YEARS AGO. SINCE ESSURE INSERTION, SHE HAD HEMORRHAGES (INTERPRETED AS GENITAL BLEEDING). SHE WAS ALSO INCAPACITATED WHEN SHE USED TO BE AUTONOMOUS. SHE HAD TO USE OTHER CONTRACEPTIVES SIMULTANEOUSLY WITH ESSURE IN ORDER TO CONTROL THE HEMORRHAGES. A PROCEDURE WAS THEN NEEDED AND CONSUMER HAD HER FALLOPIAN TUBES REMOVED DUE TO THE DEVICE. GENITAL BLEEDING IS LISTED WHILE DISABILITY IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE MAY CAUSE BLEEDINGS AND THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. IN CONTRAST, THE REASON FOR THE INCAPACITATING CONDITION WAS NOT PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO ASSESS THE DISABILITY AT THIS TIME. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677936 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization| O| R| S |