FOR
FOR DECADES THE FDA HAS ALLOWED CERTAIN MEDICAL DEVICE MANUFACTURER S TO
REPORT PROBLEMS WITH
DEVICES THAT ONLY GOVERNMENT
WORKERS
COULD SEE.
AND AS THE KVUE DEFENDERS
UNCOVERED --
THESE HIDDEN REPORTS INCLUDED
SERIOUS
PROBLEMS LIKE CANCER.
LIFE FOR LACEY HEATHERLY HAS
NEVER BEEN CLEARER.
YOU SEE PEOPLE WALKING THEIR
DOGS, BIKING IT MAKES ME HAPPY,
IT'S SO CUTE."
IT'S BEEN FIVE MONTHS SINCE A
SURGEON REMOVED HER
BREAST IMPLANTS.
LACEY 11:27-:49 A WEEK AFTER I
LOST SO MUCH INFLAMMATION
WITHIN SEVEN DAYS I'D LOST SEVEN
POUNDS :32 MY EYES GOT
CLEARER MY SKIN GOT CLEARER :35
MY ACNE THAT I HAD HAD WENT
DOWN :39 MY BRAIN
HER SYMPTOMS WERE SIMILAR TO
THOUSANDS OF OTHER
WOMEN, BUT SHE HAD NO WAY OF
KNOWING.
THE FDA HAS MILLIONS AND
MILLIONS OF REPORTS THAT ARE
NOT PUBLICLY AVAILABLE
MADRIS TOMES IS A FORMER IT
MANAGER FOR THE FDA WHO
STARTED DEVICE EVENTS LLC.
SHE SAYS FOR DECADES THE FDA HAS
ALLOWED
CERTAIN MANUFACTURER S TO FILE
KNOWN SIDE
EFFECTS IN WHAT IS KNOWN AS
ALTERNATIVE SUMMARY
REPORTS.
23:28 THE FDA GIVES THEM AN
EXEMPTION AND SAYS YOU CAN
SUBMIT THESE IN SUMMATION :35 SO
WHAT THAT IS IS A SPREADSHEET
AND
IT'S NOT PUBLICLY AVAILABLE :42
IT IS SENT TO THE FDA AND THEY
FILE IT IN
STORAGE AND IF YOU ARE TRYING TO
FIND THE TRUE NUMBER OF
PROBLEMS WITH A DEVICE YOU CAN'T
SEE THOSE REPORTS :51 YOU
DON'T EVEN KNOW THEY EXIST :53
SO IF YOU DON'T EVEN KNOW WHAT
TO
ASK FOR :58
A
A SYSTEM
A SYSTEM SET UP IN THE 1970S AS A WAY TO MAKE REPORTING PROBLEMS EASIER FOR
MEDICAL DEVICE
MANUFACTURERS BUT MADRIS
DISCOVERED ONE REPORT COULD
CONTAIN THOUSANDS OF PROBLEMS.
THEY HAD BECOME A WAY TO HIDE
THE TRUE SCOPE OF
WHAT MAY BE HAPPENING WITH
CERTAIN DEVICES.
CASE IN POINT -- BREAST
IMPLANTS.
ABOUT TWO YEARS AGO I HAD
DISCOVERED SUMMARY
REPORTS WERE BEING USED FOR
BREAST IMPLANTS I DID NOT KNOW
THE
EXTENT OF IT :08 BUT WHAT I'D
FOUND WAS THAT DEVICE COMPANIES
THOUGHT A RUPTURE WASN'T A
SERIOUS INJURY :12 AND SO THEY
WERE
SAYING WE CAN PUT THIS IN A
SUMMARY REPORT
WHEN SHE ALSO FOUND CASES OF
LYMPHOMA BEING HIDDEN IN
THESE SUMMARY REPORTS - SHE
BROUGHT HER FINDINGS TO THE
FDA.
IT TOOK MY FINDING THIS PATTERN
FOR THE FDA TO SAY WAIT
MAYBE THESE SHOULDN'T BE COMING
IN AS SUMMARIES :34
TWO YEARS LATER THE FDA ORDERED
MANUFACTURER
S TO MAKE THOSE ISSUES PUBLIC.
PROBLEMS JUMPED FROM 51,000 TO
NEARLY 300-
THOUSAND OVERNIGHT.
31:45 SO 90% OF THE REPORTS
THAT EXISTED THE PUBLIC DIDN'T
KNOW ABOUT UNTIL THAT DAY :49
HEARING - JENNIFER ROB /
9:23-:30
HOW MANY LIVES HAVE TO BE LOST
BEFORE ACTION TAKES PLACE? ISN'T
ONE LIFE ENOUGH?
THE FDA THEN ORDERED HEARINGS.
DOZENS OF WOMEN AND DOCTORS
TESTIFIED.
AFTER DOING MY RESEARCH AND
FINDING OUT THAT THE FDA AND
PLASTIC SURGEONS KNEW PRIOR TO
2015 SURGERY THAT
TEXTURED IMPLANTS COULD CAUSE
THIS LYMPHOMA I FEEL
SAD AND ANGRY :37
IT'S NOT JUST BREAST IMPLANTS.
SEVERAL MANUFACTURER S INCLUDING
THOSE THAT
MAKE MESH, IMPLANTABLE CARDIAC
DEFIBRILLATORS
, PACEMAKERS AND TOOTH IMPLANTS
-- HAVE BEEN
ALLOWED TO FILE THESE SUMMARY
REPORTS FOR
DECADES.
A PRACTICE THE FDA ANNOUNCED
JUST LAST WEEK IT IS ENDING.
BUT NOT BEFORE COUNTLESS PEOPLE
LIKE
LACEY SUFFERED SILENTLY.
LACEY 41:49 I'M SO GLAD I GOT
THESE THINGS OUT OF MY BODY :51
HER EXPERIENCE HAS CHANGED THE
WAY SHE
VIEWS HER OWN HEALTH.
LACEY 24:25 IT MAKES ME JUST
WEARY OF THE FDA PERIOD :26
:40 ARE YOU COMPLETELY TRUSTING
THE DOCTOR SAYS AND
WHAT THE FDA SAYS :45
25:41 IF YOU THINK THIS JUST
EFFECTS BREAST IMPLANTS YOU ARE
SO
WRONG BECAUSE THIS CONCERNS
EVERYTHING WE ARE DOING FOR
OUR BODIES :47
WE'VE BEEN ASKING THE FDA ABOUT
THESE HIDDEN
REPORTS AND JUST LAST WEEK THE
AGENCY ANNOUNCED IT
IS ENDING THE PRACTICE OF
ALTERNATIVE SUMMARY REPORTING
AND PLANS TO RELEASE ALL OF THEM
IN THE
NEXT FEW WEEKS.
COUNT ON THE DEFENDERS TO LET
YOU KNOW WHAT HAPPENS.
IF YOU HAVE A QUESTION ABOUT A
MEDICAL DEVICE
OR WANT TO SHARE YOUR EXPERIENCE
WE HAVE CREATED A
FACEBOOK PAGE DEVOTED TO MEDICAL
DEVICE DANGERS. YOU CAN FIND A
LINK IN THIS STORY AT KVUE.COM.
FOR THE KVUE DEFENDERS I'M TERRI
GRUCA.
GRUCA.
IF
IF YOU
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.