Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("CRAMPS/ ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("SWOLLEN ABDOMEN"), WEIGHT INCREASED ("WEIGHT GAIN ((B)(6) KGS THEN (B)(6) KGS)"), BACK PAIN ("MUSCULAR PAIN IN THE BACK AND NECK") AND NECK PAIN ("MUSCULAR PAIN IN THE BACK AND NECK") IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("SWOLLEN ABDOMEN") AND WEIGHT INCREASED ("WEIGHT GAIN ((B)(6) KGS THEN (B)(6) KGS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN, NECK PAIN ("MUSCULAR PAIN IN THE BACK AND NECK"), ARTHRALGIA ("JOINT PAIN IN THE BACK AND NECK"), ACNE, FATIGUE, METRORRHAGIA, VISUAL IMPAIRMENT ("VISUAL DISORDERS") AND BALANCE DISORDER ("BALANCE DISORDER"). THE PATIENT WAS TREATED WITH SURGERY (DEVICE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN HAD RESOLVED, THE ABDOMINAL DISTENSION WAS RESOLVING AND THE WEIGHT INCREASED, BACK PAIN, NECK PAIN, ARTHRALGIA, ACNE, FATIGUE, METRORRHAGIA, VISUAL IMPAIRMENT AND BALANCE DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACNE, ARTHRALGIA, BACK PAIN, BALANCE DISORDER, FATIGUE, METRORRHAGIA, NECK PAIN, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (ARTICLE IN LAY PRESS (MIDI LIBRE) ON (B)(6) 2017:) IN THE DAYS FOLLOWING THE PLACEMENT OF ESSURE, THE PATIENT EXPERIENCED CRAMPS AND SWOLLEN ABDOMEN. WITHIN THE FIRST THREE MONTHS AFTER THE PLACEMENT OF ESSURE, THE PATIENT GAINED (B)(6) KGS OF WEIGHT . THE PATIENT EXPERIENCED HEMORRHAGE AND BLEEDING OUTSIDE MENSTRUATION PERIODS WITH CONSEQUENCES ON PRIVATE LIFE. HER BELLY KEPT GOING ON SWELLING. SIX MONTH LATER, SHE GAINED (B)(6) KGS WITH NO CONTROL. ESSURE WAS REMOVED. MORE THAN ONE MONTH AFTER THE REMOVAL OF ESSURE, THE PATIENT FELT AN IMPROVEMENT. HER BELLY WENT DOWN AND THE ABDOMINAL PAIN HAD RESOLVED. 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 DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: ABDOMINAL PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (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. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. 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.