HAPPENING
HAPPENING TO US. NOBODY IS SPEAKING ABOUT IT, NOBODY." HAVE YOU OR A LOVED ONE HAD A
HERNIA?
HERNIA? OR PELVIC PROLAPSE? CHANCES ARE IT WAS FIXED WITH A SURGICAL
MESH.
SURGICAL MESH. MILLIONS OF PEOPLE HAVE IT
IMPLANTED IN THEIR BODIES.
THE KVUE DEFENDERS HAVE
UNCOVERED THOUSANDS OF PATIENTS REPORTING
PROBLEMS --
SEVERAL RIGHT HERE IN CENTRAL
TEXAS.
TONIGHT-- TERRI GRUCA CONTINUES
HER ONGOING
INVESTIGATION INTO MEDICAL
DEVICE DANGERS.
DEVICE DANGERS. MORE THAN A MILLION HERNIA
SURGERIES ARE PERFORMED IN THE U.S. EVERY YEAR. THE
MAJORITY OF THEM USE A
PLASTIC MESH -- SIMILAR TO THIS.
DESPITE THOUSANDS OF
ISSUES REPORTED TO THE FDA --
THIS MESH
CONTINUES TO BE THE STANDARD
TREATMENT.
TONIGHT NEW PROOF THAT THE
DANGERS OF MESH MAY BE
GROWING.
STUCK AT HOME IS NOT HOW CARMEN
PACHECO
PACHECO
EXPECTED
EXPECTED TO LIVE OUT LIFE IN HER 50S. THE HOSPITAL TWICE THIS MONTH
:29 IT'S TERRIBLE > CONT
VO
HER PAIN AND WORRY MATCHED BY
HER MOUNTAIN OF MEDICAL BILLS.
A SPIRAL THAT BEGAN 6 YEARS AGO
WHEN DOCTORS
PERFORMED WHAT MOST CONSIDER
ROUTINE SURGERIES FOR
PELVIC PROLAPSE AND A HERNIA
IMPLANTING PLASTIC MESH.
SOT
<10:00 THEY NEVER TOLD ME WHAT
COULD HAPPEN AND A YEAR TO THE
DAY I HAD A STRANGULATED HERNIA
:05 THE AMBULANCE HAD
TO COME PICK ME UP :07>
CONT VO
A SECOND SURGERY RESULTED IN A
MASSIVE INFECTION
-- FOLLOWED BY A THIRD SURGERY
AND MORE PAIN.
SOT
<12:55 I CAN'T DO NOTHING NOW I
CAN'T EVEN EAT :57>
SOT
SOT
SOT 4:58-:06
4:58-:06
4:58-:06 I'VE SEEN A LOT OF PLAINTIFFS HAVE A LIFETIME OF INJURIES AS
A RESULT :00 A LIFETIME OF
ADDITIONAL SURGERIES IN
PURSUIT OF REPAIRING WHAT'S BEEN
DONE >
MELISSA NAFASH DOES NOT
REPRESENT CARMEN, BUT IS
A NEW YORK ATTORNEY WHOSE FIRM
HAS MORE THAN
10-THOUSAND HERNIA MESH CASES.
DUE TO DESIGN DEFECTS IN THE
MESHES OFTEN THERE IS A
SURGERY TO REMOVE THAT MESH. :23
POLYPROPYLENE WHICH A LOT OF THESE PRODUCTS ARE MADE OF CAN BE THOUGHT OF LIKE A WINDOW
SCREEN AND TISSUE IS
INTENDED TO GROW INTO THAT
SCREEN
SCREEN 18:07 IT'S AS IF YOU POUR CEMENT THROUGH A SCREEN AND LET IT DRY AND TRY TO PULL THAT
SCREEN
OUT :18 IT HAS BECOME A PART OF
THE BODY
SOUND FAMILIAR?
SOUND FAMILIAR?
:55
:55 THE
:55 THE DOCTOR REPORTED MESH HAD ERODED INTO MY BLADDER,
ATTACHED TO MY BOWELS, MY NERVES
AND MY MUSCLES
THIS IS AFFECTING LIVES AND IT'S
MAJOR AND NO ONE IS REALLY
LISTENING TO US
FOLDER
IN FEBRUARY DOZENS OF WOMEN
SHARED THEIR STORIES
AT AN FDA HEARING ABOUT THE
PROBLEMS ASSOCIATED
WITH PELVIC MESH.
FORMER IT MANAGER FOR THE FDA
MADRIS TOMES WAS
THERE.
THERE. PRESENT DATA ON ALL TYPES OF MESH, BUT THEY ONLY WANTED TO
SEE IT FOR STRESS URINARY
INCONTINENCE OR PELVIC ORGAN
PROLAPSE :29>
CONT VO
WWW.DEVICEEVENTS.COM
TOMES' STARTED DEVICE EVENTS LLC
WHICH CREATED A
WEBSITE THAT MAKES ADVERSE
EVENTS INFO EASY TO FIND
AND UNDERSTAND.
21:23-:33
I DID A SEARCH ON HERNIA MESH
AND I FOUND 25-THOUSAND
ADVERSE EVENT REPORTS TO THE FDA
AND OVER 200 OF THOSE
REPORTS WERE DEATHS
HTTPS:
LAST MONTH THE FDA
ORDERED MANUFACTURER S TO STOP
SELLING PELVIC
MESH.
YET MADE NO MENTION OF HERNIA
MESH.
16:03- :10
THEY REALLY NEED TO BE LOOKING
AT WHAT ARE ALL THE OTHER
DEVICES
JUST LIKE THIS :10
SO HOW DID WE GET HERE?
NONE OF THESE PRODUCTS HAVE GONE
THROUGH THE RIGOROUS
PROCESS OF BEING FDA APPROVED
DR. VINEET CHOUDHRY IS A GENERAL
SURGEON
SPECIALIZING IN HERNIA REPAIR.
I'VE DONE CLOSE TO 1-THOUSAND
HERNIA REPAIRS AND PUT IN MESH
IN
IN
ALMOST
ALMOST EVERY SINGLE ONE OF THEM DR. CHOUDHRY SAYS YEARS AGO HERNIAS WERE REPAIRED USING
SUTURES OR BIOLOGIC MESH -- MADE
FROM ANIMAL TISSUE
OR HUMAN CELLS.
THAT MESH TENDS TO ABSORB AWAY
OVER TIME GETS REAL SOFT AND
PLIABLE AND DOESN'T LAST VERY
LONG :30 SO IT'S NOT REALLY A
PERMANENT SOLUTION BUT IT HELPS
TEMPORARILY
PLASTIC MESH SEEMED TO LAST
LONGER.
SO IT'S BEEN USED MORE
FREQUENTLY SINCE THE
1980S.
THE GREAT MAJORITY OF PATIENTS
TOLERATE THE
MESH EXTREMELY WELL AND DON'T
EVEN KNOW THAT IT'S IN THERE :18
WHEN MESH GOES WELL IT GOES
REALLY WELL, BUT WHEN IT
DOESN'T,
IT'S NOT JUST A LITTLE BIT OF
PAIN, IT'S DISABLING -- WHERE
PEOPLE
PEOPLE
NEED
NEED MULTIPLE SURGERIES :04 AS MANY AS SIX SURGERIES TEN SURGERIES
THE PROBLEMS TEND TO BE REPORTED
TEN YEARS OR
LONGER AFTER THE INITIAL
SURGERY.
DEVICE EVENTS -- SHOWS THE
PROBLEMS INCREASING
EVENTS
ESPECIALLY IN THE LAST TWO
YEARS.
THE MOST COMMON ONES INCLUDE
"INFECTION"...
..MESH THAT ADHERES TO INTERNAL
ORGANS LIKE
THE COLON OR BOWEL...
...EVEN SEPSIS AND DEATH. >
THE MESH DOESN'T STAY WHERE IT'S
PUT BY ITSELF OVER A PERIOD OF
TIME IT WILL INCORPORATE INTO
THE SURROUNDING STRUCTURE :54
BUT
AS IT'S HEALING IT CAN
DEFINITELY SHIFT OR MOVE I HAVE BOWEL OBSTRUCTIONS, THROWING UP BILE EVERY MORNING
CARMEN
CARMEN IS
CARMEN IS NOT ALONE. DEVICE EVENTS FOUND MORE THAN 5000 BOWEL
OBSTRUCTIONS -- MORE THAN
56-HUNDRED INFECTIONS --
ALL PEOPLE WITH HERNIA MESH --
MOST HAPPENING
SINCE 2007.
I HAD A HERNIA THE SIZE OF A
CHERRY :33 NOW THEY TELL ME IT'S
THE SIZE OF
A TORTILLA :37 IT'S HUGE
A
A ONCE
A ONCE 225 POUND CARMEN IS NOW BARELY 125 POUNDS.
FACING
FACING ANOTHER SURGERY BY AN OUT OF STATE DOCTOR WHO SAYS HER ONLY HOPE IS
TO ADD MORE MESH.
STARTS TO CRY 22:53 THEY
DESTROYED
DESTROYED MY LIFE -- THE MESH :55 TAG:
:55 TAG:
TAG:
SO
SO WHAT
SO WHAT DO YOU DO IF YOU HAVE MESH? PAY ATTENTION TO SYMPTOMS -- IF
YOU EXPERIENCE
ANY PAIN YOU SHOULD GET CHECKED
BY YOUR DOCTOR.
IN MOST CASES PEOPLE EXPERIENCE
SYMPTOMS
YEARS AFTER THE SURGERY.
AND IF YOU DO HAVE AN ISSUE
REPORT IT TO THE FDA.
MAKERS OF MESH ARE AMONG A
NUMBER OF
MEDICAL DEVICE MANUFACTURER S
THAT HAVE BEEN GIVEN
PERMISSION TO POOL SOME OF THE
SIDE EFFECTS INTO
REPORTS THAT CAN ONLY BE SEEN BY
THE FDA. MORE ON THOSE HIDDEN
REPORTS NEXT WEEK. FOR THE
DEFENDERS I'M TERRI GRUCA.
IF YOU HAVE SOMETHING YOU'D LIKE
THE KVUE DEFENDERS TO INVESTIGATE --
EMAIL US AT DEFENDERS AT
KVUE DOT COM OR CALL US AT THE
NUMBER ON YOUR SCREEN.