ESSURE
Report
- Report Number
- MW5058034
- Event Type
- Injury
- Date Received
- November 23, 2015
- Date of Event
- November 6, 2014
- Report Date
- March 13, 2016
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
(B)(4). I GOT ESSURE PLACED IN (B)(6) OF 2012. MY DR SAID EVERYTHING WENT SMOOTHLY AND THERE WERE NO COMPLICATIONS. THERE WAS APPARENTLY PROBLEMS WITH MY INSURANCE AND THE PROCEDURE WAS NOT PAID FOR MY INSURANCE TILL MONTHS LATER, MY DR AT THE TIME SAID THAT THEY COULD NOT TO THE CONFIRMATION TEST UNTIL THE PROCEDURE WAS PAID FOR. ONCE I GOT THE OKAY FROM MY INSURANCE THAT THE PROCEDURE WAS PAID FOR I TRIED TO SCHEDULE THE CONFIRMATION TEST BUT MY DR NEVER GOT BACK WITH ME TO DO IT. I HAVE NEVER HAD ANY PROBLEMS UNTIL ABOUT A YEAR AGO. MY HAIR BEGAN TO FALL OUT, I FEEL TIRED ALL THE TIME EVEN WITH ADEQUATE SLEEP, IRRITABILITY, MAJOR DENTAL ISSUES ( I HAVE NEVER EVEN HAD SO MUCH AS A CAVITY UNTIL RECENTLY) A CONSTANT DULL STABBING PAIN ON MY RIGHT PELVIC AREA THAT RADIATES INTO MY LOWER BACK, JOINT PAIN ESPECIALLY IN MY HIPS AND LEGS, LEG SPASMS, IRREGULAR AND VERY HEAVY PERIODS ARE JUST TO NAME A FEW OF THE SYMPTOMS I AM HAVING. I HAVE RECENTLY BEGAN TO SEE A NEW DR TO TRY TO PIN POINT IF ESSURE IS TRULY THE PROBLEM.
(B)(4). SURGERY WAS CANCELED BECAUSE THE DR WANTED TO PULL COILS OUT. I WENT TO A 3RD DR WHO IS WORKING ON GETTING A HYSTERECTOMY APPROVED THROUGH MY INSURANCE. MY PAIN HAS NOT GOTTEN ANY BETTER AND IT HAS NOW BEEN A MONTH SINCE I HAD A PERIOD. THE DR SUSPECTS ENDOMETRIOSIS, WHICH I NEVER HAD BEFORE ESSURE.
(B)(4). WENT AND SAY MY PCP, SHE DID SEVERAL BLOOD TESTS INCLUDING A CBC, ARTHRITIS AND DIABETES ALONG WITH AN X-RAY. DIABETES TEST DETERMINED THAT MY A1C IS ELEVATED, I WAS TOLD TO WATCH MY CARBS AND EXERCISE (WHICH I CANT DO YET BECAUSE I AM STILL ON RESTRICTIONS FROM SURGERY) SHE IS GOING TO RETEST IN 3 MONTHS, IF IT HASN'T COME DOWN WE WILL ACT ACCORDINGLY. X-RAY ALSO SHOWED THAT NOW HAVE ARTHRITIS IN MY HIPS AND BACK. I NEVER HAD THESE ISSUES BEFORE ESSURE WAS PLACED.
(B)(4). AS OF (B)(6) 2016 I NO LONGER HAVE ESSURE. I HAD A TOTAL HYSTERECTOMY BILATERAL SALPINGECTOMY AT THE AGE OF (B)(6). I AM ONLY 5 DAYS POST OP BUT I CAN ALREADY FEEL A DIFFERENCE. THE BRAIN FOG IS GONE, I CAN REMEMBER THINGS BETTER. I DO NOT FEEL TIRED AND NO LONGER NEED A NAP DURING THE DAY. MY HIP AND FOOT PAIN IS GONE. PELVIC PAIN IS GONE AS WELL. HAVEN'T HAD A HEADACHE SINCE REMOVAL. MY STOMACH HAS A DRASTIC NOTICEABLE DIFFERENCE. I WILL CONTINUE TO COMPILE A LIST OF SIDE EFFECTS THAT I NO LONGER HAVE, VS THE ORIGINAL SIDE EFFECTS I HAD WHILE IMPLANTED.
(B)(4). I AM SCHEDULED TO HAVE TUBES AND COILS, AND POSSIBLY UTERUS REMOVED IF THERE IS MORE DAMAGE SEEN ONCE INSIDE. I HAVE ALSO BEEN DIAGNOSED WITH PLANTAR FASCIITIS WHICH IS AN INFLAMMATION OF THE MUSCLE ON THE UNDERNEATH OF THE FOOT, MY HIPS HAVE GOTTEN WORSE AND I AM SCHEDULED TO SEE A SPECIALIST TO RULE OUT ARTHRITIS
(B)(4). I SHOULD ALSO ADD THAT I HAD NON OF THESE SYMPTOMS PRIOR TO HAVING ESSURE, AND THEY HAVE ALL DEVELOPED WITH IN THE LAST YEAR TO YEAR AND A HALF. BLOOD TESTS, X-RAYS OF MY BACK AND JOINTS HAVE ALL COME BACK NEGATIVE.
(B)(4). HAD A SECOND OPINION APPOINTMENT AND DOCTOR SAID SHE RECOMMENDS I HAVE MY TUBES AND COILS REMOVED (POSSIBLY MORE IF THERE IS DAMAGE ELSEWHERE) BECAUSE THERE HAVE BEEN LOTS OF REPEATS ON ESSURE REPORTED LATELY, AND IT COINCIDES WITH THE PELVIC PAIN, BLEEDING AND OTHER SYMPTOMS I AM HAVING. DO NOT HAVE A DATE SET YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774273 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27.000 YR |