FROM A STATE BAN ALL NEW AT
6:00.
ON ORLANDO WOMAN REACHED
OUT
TO 9 INVESTIGATES WITH CLAIMS
HER SILICON GEL-FILLED BREAST
IMPLANTS MADE HER SICK.
SHE COMPLAINED OF CONSTANT
FLU-LIKE SYMPTOMS THAT WENT
AWAY
ONCE THE IMPLANTS WERE REMOVED.
DARLENE JONES AS SINCE LEARNED
AN ATTORNEY IS DRAFTING A
LAWSUIT AGAINST THE LEADING
MANUFACTURER OF IMPLANTS.
DARLENE, IT COULD BE THE FIRST
IN THE STATE.
IT COULD BE AND IT WILL
LIKELY FOCUS ON WHETHER THE
COMPANY MENTOR WAS NEGLIGENT IN
WARNING PATIENTS ABOUT THE
POTENTIAL RISK OF IMPLANTS, BUT
ALSO WHETHER THE FDA ALLOWED
THE
COMPANY AND OTHERS TO CONTINUE
MARKETING DESPITE WHAT SOME
CALL
WEAK STUDIES.
TERRY DIAZ WAS
WORRIED ABOUT HER APPEARANCE
AFTER TWO SCOPE THE ORLANDO
MOTHER PAID $6,000 FOR -- AFTER
TWO CHILDREN, SO THE ORLANDO
MOTHER PAID $6,000 FOR BREAST
IMPLANTS.
I WAS DONE BREASTFEEDING.
IT WAS TIME FOR A MOMMY
MAKEOVER.
Reporter: SIX YEARS LATER,
DETAILS ARE IN THESE LAB
REPORTS.
THE FIRST WAS FLU-LIKE
SYMPTOMS OF I WAS DIAGNOSED
WITH
LEAKY GUT COLITIS.
THE BRAIN FOG WAS.
NO DOCTOR COULD FIGURE OUT
WHAT WAS WRONG.
NOT 100%.
THEY HAD
DIAGNOSIS BUT I NEVER GOT
BETTER.
Reporter: UNTIL ABOUT 8
MONTHS AGO THE DAY SHE PAID TO
GET THE IMPLANTS REMOVED.
MORE
WOMEN, NEARLY 20,000 IN THIS
FACEBOOK GROUP ARE TALKING
ABOUT
HEALTH ISSUES THEY BELIEVE WERE
ONLY CAUSED BY IMPLANTS.
THEY
FINALLY HAD REMOVED THE
IMPLANTS.
LIKE THESE IMPLANTS A
PLASTIC SURGEON SHOWED US THIS
WEEK, THE WOMEN DESCRIBE
IMPLANTS THAT APPEAR TO BE
PERFECTLY IN TACT.
WITH A SUFFICIENT NUMBER OF
LAWSUITS AND WE BELIEVE THERE
WILL BE AND WE'RE INVOLVED IN
PREPARING THEM AT THE MOMENT WE
THINK THAT ATTENTION WILL BE
GIVEN.
Reporter: THIS ATTORNEY TOLD
US HE IS PREPARING A LAWSUIT
AGAINST MENTOR WORLDWIDE, ONE
OF
THREE FDA-APPROVED IMPLANT
MANUFACTURERS, BUT WE BELIEVE
THE FDA DROPPED THE BALL.
IN --
BUT HE BELIEVES THE FDA DROPPED
THE BALL.
THE COMPANIES WERE
REQUIRED TO PERFORM POST MARKET
STUDIES OVER 10 YEARS TO
MONITOR
SAFETY AND EFFECTIVENESS.
A
LAWSUIT ALREADY PENDING IN
CALIFORNIA ALLEGES BY YEAR 7
THE
OVERALL FOLLOW-UP RATE WAS ONLY
20%.
IN ITS RESPONSE MENTOR
SAID A MAJORITY OF WOMEN DIED
OR
DISCONTINUED PARTICIPATION AND
NOTES THE NDA IS EMPOWERED TO
WITHDRAW PREMARKET APPROVAL AND
THE APPROVALS RENAME EFFECT AND
HAVE NEVER BEEN -- REMAIN IN
EFFECT.
POOR FOLLOW-UPS AND YET
THEY STILL HAD THIS PUSH.
Reporter: IN A STATEMENT THE
COMPANY TOLD US PATIENTS CAN BE
ASSURED THAT THE SCIENCE AND
LONG-TERM DATA FROM MULTIPLE
CLINICAL STUDIES SUPPORT THE
SAFETY OF OUR BREAST IMPLANTS.
THE SCIENTIFIC LITERATURE DOES
NOT SHOW AN ASSOCIATION BETWEEN
IMPLANTS AND ILLNESS AND WE ARE
DEFENDING AGAINST THE
ALLEGATIONS IN THE LAWSUITS.
I GOT THEM BECAUSE THEY
WERE FDA APPROVED.
NOW THAT
APPROVAL MEANS NOTHING TO ME.
SO, DARLENE R THERE ANY
OTHER COMPANIES FACING THE SAME
LEGAL BUSINESS.
WE FOUND THERE ARE TWO
LAWSUITS PENDING AGAINST
ALLERGAN.
BOTH COMPANIES SAID
IN STATEMENTS THEY BELIEVE THEY
SHOULD BE PROTECTED FROM THESE
LAWSUITS BECAUSE THE LAW
SHIELDS
MEDICAL DEVICES RECEIVING THAT
PREMARKET APPROVAL WE TALKED
ABOUT IN OUR REPORT.
THE OTHER
COMPANY HERE, SIENTRA IS
FIGHTING A LAWSUIT FROM
INVESTORS CLAIMING IT FAILED TO
DISCLOSE ITS IMPLANTS COULD
HAVE
BEEN CONTAMINATED WITH FOREIGN
PARTICLES.
10 YEARS IS THE REPLACEMENT
PLAN ON MOST OF THESE.
THAT'S WHAT DOCTORS SAY AND
THEY SAY PLASTIC SURGEONS DON'T
ALWAYS RELAY THAT INFORMATION,
SO IT'S IMPORTANT TO ASK A LOT
OF QUESTIONS.
WE KNOW THAT A
LOT OF YOU STILL HAVE
QUESTIONS,
SO JOIN ME IN ABOUT FIVE
MINUTES