FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3833849 · Received May 27, 2014

Report

Report Number
MW5036227
Event Type
Injury
Date Received
May 27, 2014
Date of Event
March 19, 2012
Report Date
May 2, 2014
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I DID A LOT OF RESEARCH PRIOR TO THIS PROCEDURE AND COULD NOT FIND ANYTHING NEGATIVE REGARDING THE ESSURE DEVICE NOR DID I FIND ANYTHING ABOUT ANY NICKEL ALLERGY WARNING. I RECEIVED THE ESSURE IN (B)(6) 2012 AS A MEANS OF PERMANENT STERILIZATION. THE PROCEDURE ITSELF WENT RELATIVELY WELL. THE IMPLANTING DOCTOR HAD A LITTLE TROUBLE GETTING THE DEVICE INTO THE LEFT FALLOPIAN TUBE. TOOK ABOUT 20-30 MINUTES. I STARTED TO FEEL LIGHTHEADED AND DIAPHORETIC TOWARD THE END OF THE PROCEDURE AND THOUGHT I MIGHT PASS OUT. THE NURSE HAD ME LAY THERE FOR A FEW MINUTES AND BROUGHT ME A (B)(6) TO DRINK. I WENT HOME AND SLEPT FOR A FEW HOURS AND FELT PRETTY GOOD AFTERWARD. I HAD SOME VAGINAL SPOTTING OFF AND ON FOR THE NEXT 3 MONTHS WHEN I WENT IN FOR MY CONFIRMATION HSG. MY LEFT TUBE WAS NOT CLOSED AT THAT TIME, THE RIGHT SIDE WAS OCCLUDED. THIS TEST WAS FAR MORE PAINFUL THAN THE IMPLANTATION OF THE ESSURE AND AGAIN I ALMOST PASSED OUT. I WENT HOME TO THINK ABOUT WHAT I WANTED TO DO IN THE MEANTIME REGARDING BIRTH CONTROL SINCE THE LEFT TUBE WAS STILL OPEN. I CONTINUED TO HAVE VAGINAL BLEEDING AND SPOTTING OFF AND ON UNTIL (B)(6) 2012 (7 MONTHS AFTER I WAS IMPLANTED WITH ESSURE). I NEVER HAD ANY TYPE OF GYN PROBLEMS PRIOR TO ESSURE. I WAS NOT ON ANY TYPE OF BIRTH CONTROL FOR AT LEAST 3-4 YEARS PRIOR TO BEING IMPLANTED WITH ESSURE. I FINALLY WENT BACK TO THE DOCTOR TO INQUIRE ABOUT THE BLEEDING AND SPOTTING. IT WAS AN OLD BROWN BLOODY DISCHARGE THAT I WAS EXPERIENCING. MY DOCTOR THOUGHT THAT THE ESSURE MAY HAVE PERFORATED THE FALLOPIAN TUBE SO HE WANTED TO DO SURGERY TO FIND OUT WHAT WAS GOING ON. ON (B)(6) 2012 I HAD A DIAGNOSTIC LAPAROSCOPY, BILATERAL TUBAL LIGATION (SINCE MY LEFT TUBE WASN'T BLOCKED HE WENT AHEAD AND DID BOTH SIDES WHILE HE WAS THERE), D AND C; AND A ROLLERBALL ABLATION. MY PATHOLOGY CAME BACK AS PROBABLE ADENOMYOSIS. I RECOVERED FROM THAT PROCEDURE AND THOUGHT ALL WAS WELL. OVER THE NEXT YEAR AND A HALF I NOTICED THAT I WAS BLOATED A LOT, HAD A LOT OF JOINT PAIN AND PELVIC PAIN. I ALSO NOTICED BEING VERY TIRED, DIZZY AND HAD VISUAL CHANGES AS WELL. IN ADDITION, I GAINED ABOUT 25 POUNDS WITHOUT HAVING ANY CHANGES TO MY ACTIVITY OR DIET. ONCE AGAIN, I NEVER HAD ANY OF THIS PRIOR TO HAVING ESSURE. I TRIED DIET CHANGES, INCREASING MY EXERCISE, STRETCHING FOR THE JOINT PAIN AND LOTS OF IBUPROFEN. TOWARD (B)(6) 2013 I NOTICED AN INCREDIBLE INCREASE IN THE PELVIC PAIN AND BLOATING THAT I WAS HAVING. IT WOULD LAST ABOUT 3 WEEKS OUT OF THE MONTH. THE JOINT PAIN WAS INCREASING AS WELL. I ALSO HAD MY PHYSICAL EXAM AT THE END OF (B)(6) 2013 AND MY VITAMIN D WAS LOW FOR THE FIRST TIME IN MY LIFE. THIS WAS AT THE END OF SUMMER AFTER HAVING SPENT A MAJORITY OF MY TIME IN THE SUN AT THE NEIGHBORHOOD POOL. I WENT TO MY DOCTOR IN (B)(6) 2014 DUE TO THE WEIGHT GAIN, PELVIC PAIN AND BLOATING. HE PERFORMED A VAGINAL ULTRASOUND AND EVERYTHING APPEARED TO BE NORMAL. HE WAS ABLE TO VISUALIZE THE LEFT ESSURE COIL BUT NOT THE RIGHT. HE SAID THE ONLY THING LEFT TO DO AT THIS POINT WAS TO REMOVE THINGS. I CHOSE TO HAVE A COMPLETE HYSTERECTOMY WITH BILATERAL REMOVAL OF FALLOPIAN TUBES AND ESSURE COILS. HE ALSO REMOVED MY RIGHT OVARY DUE TO A VERY LARGE CYST. THIS WAS PERFORMED ON (B)(6) 2014. I WAS IN THE HOSPITAL OVERNIGHT AND HAD TO MISS 4 WEEKS OF WORK, WHICH I DID NOT HAVE ENOUGH PTO TO COVER THE TIME OFF. DURING MY SURGERY, MY DOCTOR NOTED THAT MY FALLOPIAN TUBES HAD ALMOST DISINTEGRATED BEYOND WHERE THE ESSURE WAS PLACED. MY DOCTOR BELIEVES THAT I WAS ALLERGIC TO THE NICKEL IN THE ESSURE. I AM UNABLE TO WEAR ANY TYPE OF JEWELRY WITH NICKEL, ESPECIALLY EARRINGS. I WAS UNAWARE OF THE NICKEL IN THE PRODUCT PRIOR TO PLACEMENT. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
310654 ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 41.000 YR Hospitalization| O I WAS NOT USING ANY OTHER MEDICATIONS