BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3929741 · Received July 11, 2014

    Report

    Report Number
    MW5037221
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    September 2, 2013
    Report Date
    July 31, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH A MEDICAL DEVICE IMPLANT CALLED ESSURE ON (B)(6) 2013. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMALLY BY CONCEPTUS INC. MY LOT NUMBER IS A96184. LEFT SIDE WAS SAID TO BE DIFFICULT TO PUT IN. HAD A HSG ON (B)(6) 2013 TO CONFIRM TUBES WERE BLOCKED. LEFT TUBE WAS NOT BLOCKED AND COIL I WAS TOLD WAS NOT ANYWHERE TO BE SEEN FROM MY LEFT TUBE. I HAD A SECOND ATTEMPT TO PUT IN LEFT COIL ON (B)(6) 2012 THAT WAS UNSUCCESSFUL. LOT NUMBER WAS NEVER GIVE TO ME NOR PUT IN MY RECORDS. THIS DEVICE HAS A THREE YEAR SHELF LIFE. I HAVE THE EXPIRATION DATE OF FIRST COILS STATING 2/2016. I HOWEVER DO NOT HAVE INFORMATION ON THE SECOND SET OF COIL(S) FROM THE SECOND ATTEMPT. THE ONSET OF MY SIDE EFFECTS AND SYMPTOMS STARTED AROUND (B)(6) 2013. FIRST ATTEMPT AT COIL INSERTION LASTED AROUND 30MINUTES. NO PAIN DURING THAT EXAM. MY HSG CONFIRMATION TEST WAS A BIT MORE PAINFUL THAN A NORMAL PERIOD CRAMPING. MY SECOND ATTEMPT AT PUTTING THE COIL IN MY LEFT TUBE LASTED LONGER THAN 20 MINUTES. I WAS IN EXTREME PAIN. NO PAIN MEDS, LOCAL ECT WERE OFFERED EXCEPT FOR 800MG OF IBUPROFEN AND THAT WAS ONLY HALF WAY THROUGH THE PROCEDURE. PAIN WAS SO BAD I WAS IN TEARS. HAD ESSURE SALES PEOPLE IN ROOM WITH ME. PAIN WAS SO BAD THAT AFTERWARDS I COULD HARDLY WALK OUT OF THE CLINIC. PAIN CONTINUED TO WORSEN AFTER THAT ATTEMPT. I WAS BED BOUND DUE TO THE EXTREME PAIN. THIS IS A LIST OF SIDE EFFECTS AND SYMPTOMS I HAVE EXPERIENCED DUE TO ESSURE: BLEEDING/SPOTTING DURING AND AFTER INTERCOURSE; PAINFUL PERIODS; SEVERE BLOATING; ANXIETY/PANIC ATTACK INCREASE; SHARP AND STABBING PELVIC PAIN; DIZZINESS; ABDOMINAL SPASMS, TWITCHING AND FLUTTERING; BACK PAIN HAS WORSENED; INABILITY TO MAINTAIN BLOOD SUGARS HAS WORSENED; MIGRATED AND MISSING COILS; PID (PELVIC INFLAMMATORY DISEASE); WEIGHT GAIN; DEPRESSION/SUICIDAL THOUGHTS HAVE WORSENED; BLACK OUT AND FAINTING SPELLS; LONG MENSTRUAL CYCLES; SEXUAL DYSFUNCTION; BLEEDING BETWEEN PERIODS; DISCHARGE; YEAST INFECTIONS; CHRONIC PELVIC PAIN; FATIGUE AND LOSS OF ENERGY; FREQUENT URINATION; SKIN ACNE (CYSTS); EXCESSIVE SWEATING; UNEXPLAINED AND EASILY BRUISING; MOOD DISORDERS; INSOMNIA WORSENED; LOSS OF LIBIDO; PAINFUL INTERCOURSE; GASTROINTESTINAL ISSUES; NAUSEA; PELVIC PAIN AFTER INTERCOURSE. I HAVE BEEN SEEN BY THREE DIFFERENT DOCTORS TO SEE WHAT WAS CAUSING MY SYMPTOMS. MY REGULAR PHYSICIAN, MY OB AND A GASTROENTEROLOGIST. I WAS DIAGNOSED WITH PID ON (B)(6) 2014. STARTING IN (B)(6) 2013 MY DEPRESSION GOT EXTREMELY BAD TO THE POINT WHERE I WAS SUICIDAL. ANXIETY ATTACKS INCREASED TO WHERE I WAS PUT ON 10MG XANAX TWICE DAILY. IN (B)(6) 2013 I ALSO STARTED GAINING WEIGHT AT A FASTER RATE THAN NORMAL. I'VE HAD THE FOLLOWING SURGERIES DUE TO ESSURE: ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY ON (B)(6) 2014. THE DEVICE HAS BEEN REMOVED ON (B)(6) 2014. THE DEVICE AS FAR AS I KNOW WAS NOT RETURNED TO MANUFACTURER. (B)(4).

    Description of Event or Problem · 1

    (B)(4). ON MONDAY (B)(6) 2014 I HAD MY "6" WEEK (IT WAS ACTUALLY 7 WEEKS BY THEN) CHECK UP FOLLOWING MY HYSTERECTOMY. MY OB DID A VAGINAL EXAM AND SAID I WAS EXTRA TENDER BUT THAT EVERYTHING SEEMED TO BE HEALING FINE. I WAS HAVING SOME EXTRA PAIN IN MY VAGINAL CUFF REGION AND TOOK (B)(6) AND IBUPROFEN FOR THE PAIN AND THAT ONLY MASKED IT A BIT. THE NEXT DAY I WOKE UP IN MORE PAIN. BY MID DAY I HAD A LOW GRADE FEVER OF 99. BUT STARTED HAVING THE SHAKES AND CHILLS AND STILL MORE PAIN. I CONTINUED MY OTC PAIN MEDICINE. BY TUESDAY NIGHT MY FEVER HAD SPIKE TO 104 WITH OTC PAIN/FEVER REDUCERS. TEMPERATURE DID NOT GO UNDER 102 AND WOULD QUICKLY SPIKE BACK TO 104. BY WEDNESDAY AFTERNOON I HAD A STEADY FEVER OF 104 WITH OTC FEVER/PAIN MEDICINES IN ME. I WAS NAUSEOUS AND WOULD NOT EAT. I COULD NOT EVEN TAKE CARE OF MY CHILDREN. AT 4PM I CALLED MY OB AND TALKED TO HER ASSISTANT. I TOLD ANN, THE ASSISTANT MY SYMPTOMS AND ASKED IF I NEEDED TO BE SEEN BY MY OB DR. (B)(6) OR EVEN IF I SHOULD HEAD INTO THE ER. WHEN SHE FOUND OUT MY TEMPERATURE ((B)(6)) WAS 104 SHE QUESTIONED ME THERMOMETER BEING BROKEN AND SAID I WOULD FEEL LIKE DEATH. I LET HER KNOW I HAD TESTED MY CHILDREN'S (4) TEMPERATURES AND THEY WERE ALL NORMAL AND THAT I COULDN'T DO ANYTHING AND FELT LIKE DEATH. I THEN GOT OFF OF THE PHONE WITH HER AS I AWAITED FOR HER TO TALK WITH DR. (B)(6) AND TO GET BACK TO ME. 45 MINUTES LATER ANN RETURNED MY PHONE CALL. SHE SAID THAT MY THERMOMETER WAS MOST LIKELY BROKEN AND THAT I'D BE SORE AND NEEDED TO CONTINUE RESTING AND THAT THEY HAD CALLED IN VICODIN FOR ME. NOTE I CANNOT HAVE VICODIN DUE TO BEING ADDICTED TO IT 9 YEARS PREVIOUSLY AND THIS IS STATED IN MY MEDICAL RECORDS WITH THEM. I ALSO GET MIGRAINES AND NAUSEATED WHEN I TAKE IT. MY FEVER STAYED AROUND 104 THROUGH WEDNESDAY NIGHT. THURSDAY MORNING ((B)(6) 2014) I WOKE UP FEELING MY ARMS, HANDS, FEET AND LEGS WERE TINGLING AND GOING NUMB. I CHALKED IT UP TO SLEEPING ON THEM TOO LONG SO I GOT UP. I TOOK MY TEMPERATURE AND IT WAS 104.5 AT THAT TIME, AGAIN WITH OTC PAIN/FEVER REDUCING MEDICINES IN MY SYSTEM. I TOOK MORE MEDICINE AND SAT DOWN ON THE COUCH. THIS WHOLE TIME I STILL HAD THE SHAKES AND CHILLS AND COULD NOT GET WARM. MY ARMS, HANDS, LEGS AND FEET CONTINUED TO FEEL NUMB AND TINGLING. AROUND 12PM I REMOVED THE COVERS AND NOTICED THAT MY ARMS, HANDS, LEGS AND FEET WERE ALL PURPLE AND BLUE AND I FELT ALL OF A SUDDEN VERY WEAK. AT 1PM MY HUSBAND AND I WITH OUR FOUR KIDS ARRIVED AT (B)(6) HOSPITAL ER IN (B)(6). SOMEHOW I WAS ABLE TO WALK IN EVEN THOUGH I FELT LIKE I COULD PASS OUT AT ANY MOMENT. I CHECKED IN AND THEY TOOK MY VITALS. IMMEDIATELY THE NURSE SAID "I'M GETTING YOU A WHEEL CHAIR, PLEASE DO NOT STAND UP." SHE GOT ME A WHEEL CHAIR AND WHEELED ME TO A BED AND ASKED ME TO LAY DOWN. WITHIN TWO MINUTES I WAS BEING WHEELED BACK TO A ROOM. I WAS ASKED TO PUT A GOWN ON AND WENT THROUGH MY HISTORY AND RECENT MEDICAL SURGERY (A HYSTERECTOMY). I HAD A NURSE ON EACH SIDE OF ME PUTTING AN IV IN EACH ARM. AND PROCEEDED TO TAKE BLOOD. A DOCTOR WALKED IN (DR. (B)(6)) AND SAID THAT THEY SUSPECT SEPSIS AND THAT THEY NEEDED TO FIND WHERE THE INFECTION WAS, IN THE MEAN TIME THEY WERE PUTTING FLUIDS AND THREE DIFFERENT ANTIBIOTICS IN ME BY IV. THEY ORDERED A CT SCAN FOR MY PELVIC REGION. I WAS TAKEN TO DO THE CT SCAN. ON THE WAY BACK I GAVE THEM A URINE SAMPLE. WHEN I ARRIVED BACK FROM MY CT SCAN THE DOCTOR PERFORMED A PELVIC EXAM. SPENT LESS THAN 30 SECONDS IN THERE WHEN HE SAID "YEP THERE'S THE INFECTION, THERE'S PUSS COMING FROM YOUR VAGINAL CUFF." THEY THEN CALLED MY HUSBAND AND FOUR KIDS BACK SO I COULD TELL THEM I WOULD BE ADMITTED. ONCE MY HUSBAND WAS BACK THERE IS WHEN I FOUND OUT I'D BE ADMITTED TO THE ICU. I FOUND OUT MY BLOOD PRESSURE HAD BEEN 74/53 AT CHECK IN AND MY TEMPERATURE WAS AT 106. HUSBAND LEFT AND WAS TRYING TO FIND SOMEONE TO TAKE OUR KIDS SO HE COULD RETURN TO ME. MY CT SCAN DID NOT SHOW AN ABSCESS BUT DID SHOW THE AREA OF INFECTION. I WAS THEN WHEELED UP TO A ROOM IN ICU. ONCE STABILIZED THERE I WAS TOLD I WOULD HAVE AN IV PLACED IN MY NECK TO GET THE BLOOD PRESSURE MEDICINE TO MY HEART FASTER AND THEY WOULD HAVE A BETTER WAY TO GET MEDICINES, BLOOD ECT TO ME SHOULD SOMETHING HAPPEN. AT THIS POINT IT IS THE NIGHT OF (B)(6). MY BLOOD PRESSURE STILL WASN'T STABILIZED. ONCE THE NECK IV WAS IN I HAD TO HAVE AN X-RAY TO MAKE SURE IT WAS PLACED CORRECTLY. MORE BLOOD WAS TAKEN AND MEDICINE WAS PUT THROUGH THAT WAY. MY RIGHT ARM IV WAS TAKEN OUT. MY OB DR. (B)(6) HAD BEEN NOTIFIED THAT I WAS IN THE ICU. SHE CAME THAT NIGHT TO CHECK ON ME AND DID THE SWAB OF MY VAGINAL CUFF FOR TESTING. MID DAY THE NEXT DAY MY BLOOD PRESSURE HAD FINALLY STABILIZED AND MY FEVER WAS DOWN TO 100. MY OB CALLED TO MAKE SURE I WAS DOING ALRIGHT. THEY HOPED TO GET ME OUT OF THE ICU BY THAT NIGHT OR THE NEXT DAY. AROUND 2AM SATURDAY MORNING ((B)(6) 2014) I WAS MOVED TO A REGULAR HOSPITAL ROOM AS THEY NEEDED MY ROOM IN ICU. GOOD NEWS IS I WAS DOING BETTER. SAD NEWS IS SOMEONE ELSE WASN'T. SATURDAY MORNING DR. (B)(6) THE DOCTOR ON STAFF AND THE INFECTIOUS DISEASE SPECIALIST DR. (B)(6) CAME TO TALK WITH ME. THEY WANTED TO MAKE SURE I WAS HAVING NO PAIN, MY FEVER WAS GONE AND TO EXPLAIN WHAT HAPPENED. DR. (B)(6) EXPLAINED I HAD GOTTEN A STREP A INFECTION IN MY VAGINAL CUFF AREA. AND THAT THEY WOULD BE PUTTING ON ONE ANTIBIOTIC VERSES THREE. HE EXPLAINED HOW PEOPLE CAN GET IT AND HOW IT CAN BE SERIOUS. IT IS RARE TO GET IT IN YOUR BLOODSTREAM AND IT IS EVEN MORE RARE TO GET IT IN THE AREA (VAGINAL CUFF) THAT I HAD GOT IT AT. I HAD TO MAKE SURE I WAS ABLE TO HOLD DOWN FOOD AND LIQUIDS, THAT MY FEVER WAS GONE AND I'D BE ABLE TO HOLD DOWN AN ORAL ANTIBIOTIC BEFORE I WAS BEING RELEASED HOME. AT THAT TIME THEY ESTIMATED I'D BE IN THE HOSPITAL ANOTHER 2-4 DAYS. YET ANOTHER WEEK AWAY FROM MY CHILDREN. BY THAT NIGHT THE PAIN WAS GONE, MY FEVER GONE AND I WAS ABLE TO HOLD DOWN SMALL AMOUNTS OF FOOD. SUNDAY MORNING ((B)(6) 2014) I WAS ABLE TO HOLD DOWN EGGS AND WHEN DR. (B)(6) SAW THAT HE WAS HAPPY TO SWITCH ME TO AN ORAL ANTIBIOTIC AND EVEN SEND ME HOME THAT AFTERNOON. AROUND 1PM DR. (B)(6) CAME IN AND EXPLAINED THAT I WAS ABLE TO GO HOME AND THAT SHE WOULD BE CALLING IN A PRESCRIPTION (AUGMENTIN) FOR ME TO TAKE TWICE A DAY FOR THE NEXT TEN DAYS. BUT AT THE FIRST SIGN OF TROUBLE TO COME STRAIGHT BACK IN. AFTER MY RELEASE I WAS VERY UNCOMFORTABLE AS I WAS FULL OF IV FLUIDS. I WAS ABLE TO FINISH MY TEN DAYS OF ANTIBIOTICS. HOWEVER THE PAIN (NOT AS BAD) CAME BACK THE NEXT DAY OUT OF THE HOSPITAL ALONG WITH SPOTTING. THE FOLLOWING TUESDAY, (B)(6) 2014, I SAW MY OB AGAIN FOR ANOTHER CHECK UP. SADLY HER ASSISTANT (B)(6) DID NOT ASK HOW I WAS, NOR APOLOGIZE FOR THE WAY I WAS TREATED IN THE PHONE BEFORE I HAD DECIDED TO GO TO THE ER. MY OB DR. (B)(6) WAS VERY APOLOGETIC AND REALLY CARED ABOUT HOW I WAS DOING AND FEELING. SHE SAID I HAD GOTTEN TOXIC SHOCK SYNDROME. RARE TO GET WITHOUT THE USE OF TAMPONS, ECT. MY BLOOD PRESSURE WAS FINE AS WAS MY TEMPERATURE. SHE ASKED A LOT OF QUESTIONS AND LET ME KNOW THAT THE PAIN AND SPOTTING I WAS NOW HAVING WAS MOST LIKELY JUST THE VAGINAL CUFF FINALLY HEALING AND JUST A BIT IRRITATED. SHE SAID AT THE FIRST SIGN OF TROUBLE TO CALL HER AND SHE WILL SEE ME OR GO IN TO THE ER ONCE AGAIN. I SEE HER IN TWO WEEKS FOR ANOTHER VAGINAL EXAM. SO FAR THE PAIN AND SPOTTING ARE STILL THERE TODAY. BUT NO FEVER AND BLOOD PRESSURE SEEMS TO BE NORMAL. I WILL UPDATE AFTER MY SECOND VAGINAL EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406062 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32.000 YR Other ESSURE