Description of Event or Problem · 1
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER / ATTORNEY IN THE UNITED STATES, ON BEHALF OF A (B)(6) FEMALE PLAINTIFF IN UNITED STATES ON 23-OCT-2015 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2012 FOR STERILIZATION. PLAINTIFF DEVELOPED POST PROCEDURE PAIN AND BLEEDING BY (B)(6) 2012. THE PAIN WAS SEVERE AND SHE WAS VOMITING. SHE WAS ALSO STILL BLEEDING HEAVILY. THE PAIN WAS SO SEVERE THAT SHE SUFFERED SEVERAL EPILEPTIC SEIZURES. SHE WAS SO CONCERNED THAT SHE CONTACTED THE GYNAECOLOGY DEPARTMENT AND WAS ADVICE TO GO STRAIGHT TO A & E. THE EMERGENCY CARE ASSESSMENT DOCUMENTATION FOR THAT ATTENDANCE STATES: PAINFUL PROCEDURE FOLLOWING DAY 5 FITS DUE TO PAIN. SINCE THEN PV (INTERPRETED AS PER VAGINAL) BLEEDING. INITIAL PAIN RIF (INTERPRETED AS RIGHT ILIAC FOSSA) BUT THEN IT WAS THROUGHOUT LOWER ABDOMEN. HER SYMPTOMS FAILED TO IMPROVE AND SHE THEREFORE VISITED HER GP ON (B)(6) 2012. THE CLINICAL NOTES STATES: SHE HAD ESSURE STERILIZATION 1 WEEK AGO, HAD FOUND PROCEDURE VERY PAINFUL. LOTS OF POST-OPERATIVE BLEEDING AND RIF DISCOMFORT. PASSING CLOTS AND FEELING UNWELL. PAIN NOT WELL CONTROLLED ON DISCHARGE. HAS STRUGGLED TO CONTINUE NORMAL ACTIVITY. HAS BEEN SEEN BY GYNECOLOGIST 4 DAYS AGO - EXAM AND SWOBS, BLOODS NORMAL. AUGMENTIN AND NORETHISTERONE WERE STARTED FOR BLEEDING, REVIEWED AFTER TWO DAYS IF BLEEDING HAD NOT SETTLED. PLAINTIFF'S BLEEDING AND PAIN CONTINUED. SHE THEREFORE CONTACTED HER GP AGAIN ON (B)(6) 2012 AND THE DECISION WAS MADE TO REFER HER TO A & E FOR ASSESSMENT BY THE GYNAECOLOGY TEAM WHERE SHE WAS TREATED WITH DICLOFENAC AND ANTIBIOTICS. DESPITE THIS TREATMENT HER PAIN CONTINUED. BY (B)(6) 2011, SHE CONTACTED HER GP SURGERY AGAIN. THE CLINICAL NOTES FOR THIS ATTENDANCE STATES: PAIN AND BLEEDING PERSIST, NO IMPROVEMENT WITH MEDICATION. MAY DO USS, MAY DO DIAGNOSTIC LAP - WILL DECIDE MANE. THE LETTER WRITTEN TO THE HOSPITAL ON (B)(6) STATES AS FOLLOWS: WHEN INITIALLY REVIEWED HER ONE WEEK AFTER THE PROCEDURE SHE WAS PASSING A LOT OF CLOTS AND WAS TENDER IN THE RIGHT ILIAC FOSSA. SHE WAS PRESCRIBED WITH SOME TRAMADOL AND AUGMENTIN AND NORETHISTERONE. HER PAIN BECAME WORSE AND SHE WAS REFERRED TO GYNAECOLOGIST FOR REVIEW. EXAMINATION SWABS AT THAT POINT WERE NORMAL AND SHE WAS GIVEN AN INCREASED DOSE OF NORETHISTERONE; AS THE PAIN AND BLEEDING WERE NOT GETTING ANY EASIER. PLAINTIFF WAS THEREFORE ADMITTED TO THE WARD WHERE HER PAIN AND BLEEDING WERE NOTED. SHE UNDERWENT A CT SCAN THE FOLLOWING DAY AND WAS DISCHARGED HOME. SHE REMAINED IN TERRIBLE PAIN AND DISCOMFORT. ON (B)(6) 2012, SHE CONTACTED HER GP. THE RECORDS FROM THAT DATE STATES: PAIN IN RIF, MUCH MORE SEVERE AGAIN, NOT CONTROLLED WITH ORAL ANALGESIA AND BLEEDING STARTED AGAIN - HEAVIER THAN NORMAL PERIODS. SHE WAS URGENTLY REFERRED BACK TO HOSPITAL WHERE SHE UNDERWENT DIAGNOSTIC LAPAROSCOPY, DIAGNOSTIC HYSTEROSCOPY/LAPAROSCOPIC ADHESIOLYSIS. IN A LETTER FROM THE HOSPITAL DATED (B)(6) 2012 THE FOLLOWING WAS STATED: DURING THE LAPAROSCOPY THE LEFT TUBE WAS SCARRED AND ADHERED TO THE LEFT SIDE WALL AND THIS WAS DISSECTED SO THEREFORE THE PAIN WAS MOST PROBABLY DUE TO THIS, THE LEFT SIDED PAIN MIGHT BE DUE TO THAT. SHE WAS OBVIOUSLY VERY ANGRY REGARDING THE PAIN SHE WAS EXPERIENCING POST OPERATIVELY AND SHE WISHED THAT THIS HAD BEEN EXPLAINED TO HER AT THE TIME. ON (B)(6) 2012, PLAINTIFF WAS ADMITTED TO HOSPITAL BY AMBULANCE. THE AMBULANCE RECORDS FOR THAT DATE STATED AS FOLLOWS: O/E PT LYING ON THE FLOOR - DISTRESSED. THE HOSPITAL RECORDS FOR THAT DATE STATE PLAINTIFF PRESENTED WITH SUDDEN ONSET SEVERE PAIN, SUPRAPUBIC RADIATING TO RIF, LIKE BEING STABBED WITH A KNIFE AND HAVING IT DRAGGED ACROSS HER LOWER ABDOMEN. LASTED THIS SEVERELY FOR APPROXIMATELY 15 MINUTES, SHE THOUGHT SHE MIGHT HAVE BLACKED OUT WITH THE PAIN - PARTNER SAID HE FOUND HER SLUMPED ON THE SOFA, AWOKE WITHIN SECONDS. PAIN EASED A LITTLE BY CURLING LEGS UP AND HOLDING RIF. FOLLOWING THAT ATTENDANCE, SHE UNDERWENT HYSTERECTOMY TOGETHER WITH HYSTEROSCOPIC REMOVAL OF THE ESSURE. BY (B)(6) 2013 HOWEVER THE PAIN RETURNED. IT WAS DESCRIBED IN HER GP NOTES ON (B)(6) 2013 AS BEING, EXACTLY THE SAME PAIN AS POST STERILISATION. IT WAS NOTED AT THAT TIME THAT SHE HAD TAKEN TRAMADOL WITHOUT EFFECT AND SHE WAS GIVEN A NUMBER OF GNRH ANALOGUE INJECTIONS. THESE HOWEVER HAVE NOT BEEN WITHOUT DIFFICULTIES AND HAVE NOT RESULTED IN AN END TO HER PAIN. SHE WAS LEFT WITH THE POSSIBILITY THAT SHE WILL HAVE TO UNDERGO FURTHER SURGERY. PRODUCT TECHNICAL COMPLAINT (PTC) INVESTIGATION RESULT RECEIVED ON 07-NOV-2015: (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENTS IS EXCLUDED. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, POTENTIAL LEGAL AND SPONTANEOUS CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED LEFT SIDED PAIN (INTERPRETED AS ABDOMINAL PAIN), PV BLEEDING/ PASSING CLOTS ++ (INTERPRETED AS HEMORRHAGE VAGINAL), INITIAL PAIN RIF (RIGHT ILIAC FOSSA PAIN), SUPRAPUBIC PAIN, RESULTING IN HOSPITALIZATION. SHE REPORTED THAT THE PAIN WAS SO SEVERE THAT SHE SUFFERED SEVERAL EPILEPTIC SEIZURES. THE LEFT TUBE WAS SCARRED AND ADHERED TO THE LEFT SIDE WALL (PERITUBAL ADHESIONS) AND EXPERIENCED O/E PT LYING ON THE FLOOR - DISTRESSED/ BLACKED OUT. ALL THESE EVENTS ARE SERIOUS. LEFT SIDED PAIN, PV BLEEDING/ PASSING CLOTS, INITIAL PAIN RIF (RIGHT ILIAC FOSSA PAIN) AND SUPRAPUBIC PAIN ARE LISTED AND THE OTHER ARE UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, CONSUMER UNDERWENT HYSTERECTOMY TOGETHER WITH HYSTEROSCOPIC REMOVAL OF THE ESSURE. CONSIDERING THE NATURE OF THE EVENTS LEFT SIDED PAIN, PV BLEEDING/ PASSING CLOTS , INITIAL PAIN RIF (RIGHT ILIAC FOSSA PAIN) AND SUPRAPUBIC PAIN AND A LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH SUSPECT INSERT CANNOT BE EXCLUDED. WITH REGARDS TO THE OTHER EVENTS, CONSIDERING THEIR NATURE AND THAT ESSURE HAS A LOCAL ACTION IN FALLOPIAN TUBES, A CAUSAL RELATIONSHIP CAN BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE A SURGICAL INTERVENTION WAS PERFORMED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT.