ESSURE
Report
- Report Number
- 2951250-2018-01925
- Event Type
- Injury
- Date Received
- April 23, 2018
- Date of Event
- January 1, 2012
- Report Date
- August 29, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL)") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 761438) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SKIN RASH, THROMBOCYTOSIS, HEADACHE, URINARY URGENCY, OBESITY, SKIN RASH, MENSTRUAL DISORDER, C-SECTION AND BACK PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: YAZ. CONCURRENT CONDITIONS INCLUDED MIGRAINE, PSORIASIS, ESOPHAGEAL STRICTURE, OBESITY, HYPERTENSION, GERD, EPISTAXIS (RECURRENT), NASAL POLYPS, MALAISE, FATIGUE, ANEMIA, CRAMP IN LOWER ABDOMEN, ANEMIA, VAGINAL BLEEDING AND MENOMETRORRHAGIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), WEIGHT INCREASED ("WEIGHT GAIN") AND SWELLING ("SWELLING"). IN 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN 2014, THE PATIENT EXPERIENCED HYPOTHYROIDISM ("DEVELOPED HYPOTHYROIDISM"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND VERTIGO ("VERTIGO"). IN (B)(6) 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2015, 3 YEARS 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2016, THE PATIENT EXPERIENCED INFECTION ("INFECTION AFTER HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POSTOPERATIVE WOUND COMPLICATION ("POSTOP INCISION PROBLEM (AT SUTURE SITE)"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERTENSION ("HYPERTENSION"), EPISTAXIS ("NOSE BLEEDING"), ABDOMINAL PAIN LOWER ("ABDOMINAL LOWER PAIN BOTH SIDES"), BACK PAIN ("BACK LOWER PAIN BOTH SIDE") AND SUTURE RELATED COMPLICATION ("BODY REJECTING STITCHES FROM THE INSIDE"). THE PATIENT WAS TREATED WITH SURGERY (ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, POSTOPERATIVE WOUND COMPLICATION, HYPOTHYROIDISM, GENITAL HAEMORRHAGE, INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, WEIGHT INCREASED, HYPERTENSION, VERTIGO, SWELLING, EPISTAXIS, ABDOMINAL PAIN LOWER, BACK PAIN AND SUTURE RELATED COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, EPISTAXIS, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, HYPOTHYROIDISM, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POSTOPERATIVE WOUND COMPLICATION, SUTURE RELATED COMPLICATION, SWELLING, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VERTIGO AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PERFORMED PER PROTOCOL BILATERALLY. RIGHT SIDE: 2 COILS, LEFT SIDE: 1 COILS. CURRENT WEIGHT 196 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 83.91 KGS. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION CERVIX: BENIGN CERVICAL/ENDOCERVICAL MUCOSA WITH MILD CHRONIC INFLAMMATION. MYOMETRIUM: ADENOMYOSIS AND A SMALL BENIGN LEIOMYOMA OVARIES: BENIGN CYSTIC FOLLICLES AND CORPORA LUTEA. GROSS DESCRIPTION: THE RIGHT FALLOPIAN TUBE HAS A SILVER METALLIC COIL WITHIN THE LUMEN; PINPOINT LUMEN IS SEEN ON CROSS. UPT (URINE PREGNANCY TEST) WAS NEGATIVE: SECTIONS. THE LEFT OVARY HAS A BOSSELATED PINK-WHITE OUTER SURFACE; CROSS SECTION SHOWED NORMAL. OVARIAN PARENCHYMA. A SILVER METALLIC COIL IS IDENTIFIED WITHIN THE LUMEN OF THE FALLOPIAN TUBE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018 : EVENTS- "DEVELOPED HYPOTHYROIDISM, ABNORMAL BLEEDING(GENERAL), INFECTION AFTER HYSTERECTOMY, BLADDER PROBLEMS, URINARY PROBLEMS OR CHANGES, MIGRAINES, HEADACHES, NAUSEA, FATIGUE, WEIGHT GAIN, HYPERTENSION, VERTIGO, SWELLING, NOSE BLEEDING, ABDOMINAL LOWER PAIN BOTH SIDES, BACK LOWER PAIN BOTH SIDE, BODY REJECTING STITCHES FROM THE INSIDE" ADDED FROM PFS. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL)") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 761438) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SKIN RASH, THROMBOCYTOSIS, HEADACHE, URINARY URGENCY, OBESITY, SKIN RASH, MENSTRUAL DISORDER, C-SECTION AND BACK PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: YAZ. CONCURRENT CONDITIONS INCLUDED MIGRAINE, PSORIASIS, ESOPHAGEAL STRICTURE, OBESITY, HYPERTENSION, GERD, EPISTAXIS (RECURRENT), NASAL POLYPS, MALAISE, FATIGUE, ANEMIA, CRAMP IN LOWER ABDOMEN, ANEMIA, VAGINAL BLEEDING, MENOMETRORRHAGIA, VOMITING, GASTROESOPHAGEAL REFLUX DISEASE, ANEMIA, HIATAL HERNIA, DYSPLASIA AND ADENOMYOSIS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), WEIGHT INCREASED ("WEIGHT GAIN") AND SWELLING ("SWELLING"). IN 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN 2014, THE PATIENT EXPERIENCED HYPOTHYROIDISM ("DEVELOPED HYPOTHYROIDISM"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND VERTIGO ("VERTIGO"). IN (B)(6) 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2015, 3 YEARS 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2016, THE PATIENT EXPERIENCED POST PROCEDURAL INFECTION ("INFECTION AFTER HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POSTOPERATIVE WOUND COMPLICATION ("POSTOP INCISION PROBLEM (AT SUTURE SITE)"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERTENSION ("HYPERTENSION"), EPISTAXIS ("NOSE BLEEDING"), ABDOMINAL PAIN LOWER ("ABDOMINAL LOWER PAIN BOTH SIDES"), BACK PAIN ("BACK LOWER PAIN BOTH SIDE") AND SUTURE RELATED COMPLICATION ("BODY REJECTING STITCHES FROM THE INSIDE"). THE PATIENT WAS TREATED WITH SURGERY (ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, POSTOPERATIVE WOUND COMPLICATION, HYPOTHYROIDISM, GENITAL HAEMORRHAGE, POST PROCEDURAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, WEIGHT INCREASED, HYPERTENSION, VERTIGO, SWELLING, EPISTAXIS, ABDOMINAL PAIN LOWER, BACK PAIN AND SUTURE RELATED COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, EPISTAXIS, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, HYPOTHYROIDISM, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST PROCEDURAL INFECTION, POSTOPERATIVE WOUND COMPLICATION, SUTURE RELATED COMPLICATION, SWELLING, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VERTIGO AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PERFORMED PER PROTOCOL BILATERALLY. RIGHT SIDE: 2 COILS, LEFT SIDE: 1 COILS. CURRENT WEIGHT 196 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 83.91 KGS. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. CERVIX: BENIGN CERVICAL/ENDOCERVICAL MUCOSA WITH MILD CHRONIC INFLAMMATION. MYOMETRIUM: ADENOMYOSIS AND A SMALL BENIGN LEIOMYOMA. OVARIES: BENIGN CYSTIC FOLLICLES AND CORPORA LUTEA. GROSS DESCRIPTION: THE RIGHT FALLOPIAN TUBE HAS A SILVER METALLIC COIL WITHIN THE LUMEN; PINPOINT LUMEN IS SEEN ON CROSS. UPT (URINE PREGNANCY TEST) WAS NEGATIVE: SECTIONS. THE LEFT OVARY HAS A BOSSELATED PINK-WHITE OUTER SURFACE; CROSS SECTION SHOWED NORMAL OVARIAN PARENCHYMA. A SILVER METALLIC COIL IS IDENTIFIED WITHIN THE LUMEN OF THE FALLOPIAN TUBE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 761438) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SKIN RASH AND THROMBOCYTOSIS. CONCURRENT CONDITIONS INCLUDED MIGRAINE, PSORIASIS, ESOPHAGEAL STRICTURE, OBESITY, HYPERTENSION, GERD, EPISTAXIS (RECURRENT), NASAL POLYPS, MALAISE, FATIGUE AND ANEMIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND POST PROCEDURAL COMPLICATION ("POSTOP INCISION PROBLEM (AT SUTURE SITE)"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: THE CASE WAS UPGRADED TO INCIDENT CATEGORY. THE REPORTER INFORMATION WAS UPDATED. THIS CASE CONCERNS ADULT PATIENT. ESSURE INSERTION AND REMOVAL DATE WAS ADDED. ESSURE INDICATION WAS ADDED. LOT NUMBER WAS ADDED. EVENT: SEVERE PHYSICAL INJURIES WAS UPDATED TO ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), PAIN AND POSTOP INCISION PROBLEM (AT SUTURE SITE). ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294814 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 761438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other| R |