BECAUSE OF HEALTH CONCERNS. HERE IN THE U.S., THEY ARE STILL
AVAILABLE.
AVAILABLE. >> I GET MESSAGES ALL THE TIME.
>> Reporter: RAYLINE STARTED A
FACEBOOK GROUP TO WARN WOMEN OF
TEXTURED BREAST IMPLANTS.
>> I SAWY I LOST MY CHEST BUT NO
MY VOICE.
MY VOICE. >> Reporter: THE 46-YEAR-OLD
MOTHER OF TWO FROM MISSOURI
WANTS TO SAVE OTHER WOMEN FROM
WHAT SHE ENDURED.
FIVE MONTHS OF TREATMENT TO RID
HER BODY OF CANCER.
IT IS A CANCER OF THE IMMUNE
SYSTEM.
SYSTEM. SO FAR, THERE HAVE BEEN 457
CASES IN THE U.S.
NINE WOMEN HAVE DIED FROM THE
DISEASE, WHICH WAS FIRST
IDENTIFIED IN 2011.
>> IT IS A MANMADE CANCER.
>> Reporter: THIS SPRING, THE
FDA SAID THIS CANCER IS MOST
LIKELY CAUSED BY TEXTURED BREAST
IMPLANTS, WHICH HAVE A
SUEDE-LIKE COATING.
SUEDE-LIKE COATING. THE AGENCY STOPPED SHORT OF
TAKING THE IMPLANTS OFF THE
MARKET, SAYING THEY WANTED TO
CONTINUE STUDYING THE DISEASE
AND TRACKING CASES.
IT IS ESTIMATED THAT OF THE
400,000 WOMEN WHO GET IMPLANTS
EACH YEAR, ONE IN TEN HAVE
TEXTURED IMPLANTS.
TEXTURED IMPLANTS. WOULD YOU TELL WOMEN NOT TO GET
THIS IMPLANT?
THIS IMPLANT? >> ABSOLUTELY.
>> ABSOLUTELY. >> Reporter: SHE GOT TEXTURED
BREAST IMPLANTS AFTER SURGERY
FOR BREAST CANCER WHEN SHE WAS
33 YEARS OLD.
WHAT MADE YOU CHOOSE THESE
IMPLANTS OVER ANY OTHERS?
>> I WAS SOLD ON THE FACT THAT
THIS WAS NEWEST TO THE MARKET
BUT, YET, APPROVED BY THE FDA.
THE SAFEST TEXTURED IMPLANT TO
THE MARKET.
THE MARKET. >> Reporter: NEARLY SEVEN YEARS
LATER, HER RIGHT BREAST FILLED
WITH FLUID AND SWELLED TO THREE
TIMES ITS NORMAL SIZE.
>> I SAW MY DOCTOR, AND HE
INFORMED ME THAT I HAD CANCER
AGAIN.
AGAIN. >> Reporter: AGAIN.
>> AGAIN.
>> AGAIN. HE SAID, IT IS NOT PREST CANSBRE
CANCER.
CANCER. IT IS ANTIPLASTIC LARGE CELL
LYMPHOMA
LYMPHOMA LYMPHOMA.
LYMPHOMA. THAT’S ALL I HEARD.
IMPLANTS ARE HEAVY MARKETED.
>> Reporter: DR. POTTER SAYS IN
THE PAST THREE MONTHS, SHE’S
HEARD FROM HUNDREDS OF WOMEN WHO
WANT THEIR TEXTURED IMPLANTS
REMOVED.
REMOVED. >> THE TEXTURED SURFACE IS
ALMOST LIKE A TINY VELCRO.
IT GROWS INTO THE WOMAN’S BODY.
I BELIEVE THAT IS THE SOURCE OF
THE LYMPHOMA.
THE LYMPHOMA. THERE IS AN INTERACTION BETWEEN
THE WOMAN’S BODY AND THE
IMPLANT.
IMPLANT. >> Reporter: SHE SAYS SOME
DOCTORS MAY BE UNAWARE OF THE
RISKS ASSOCIATED WITH THE
IMPLANTS.
IMPLANTS. SHE URGES WOMEN TO ASK QUESTIONS
AND CONSIDER OTHER OPTIONS.
LAST NOVEMBER, THE NBC NEWS ICIJ
INVESTIGATION REPORTED THE RISK
OF IMPLANT-ASSOCIATED CANCER
COULD BE AS HIGH AS 1 IN EVERY
1,000 WOMEN, ACCORDING TO
AUSTRALIAN HEALTH OFFICIALS.
SINCE OUR REPORT, 38 COUNTRIES
HAVE PULLED ONE BRAND OF
TEXTURED IMPLANTS OFF THE
MARKET.
MARKET. ALL BRANDS ARE STILL SOLD IN THE
U.S.
U.S. YOU WANT THEM OFF THE MARKET.
>> I THINK THE IMPLANT SHOULDN’T
BE ON THE MARKET UNLESS THE FDA
CAN SAY TO WOMEN, WE KNOW THAT
THERE’S NO INCREASED RISK OF
CANCER WITH THIS IMPLANT.
>> Reporter: THE FDA DECLINED TO
BE INTERVIEWED BY SAID, IN PART,
THE AGENCY IS INCREASINGLY
CONCERNED ABOUT THE POTENTIAL
BIA-A.L. CL RISK FOR WOMEN WITH
CERTAIN TEXTURED IMPLANTS.
EXPERTS ARE REVIEWING NEW
INFORMATION.
INFORMATION. WE INTEND TO UPDATE THE PUBLIC
SHORTLY ABOUT OUR FINDINGS.
>> Reporter: MEANWHILE, THE FDA
IS WORKING TO PROVIDE A BLACK
BOX WARNING, SIMILAR TO
CIGARETTES, TO FORCE MAKERS TO
SHARE THE CANCER RISK.
>> WE CAN CURE THE CANCER.
THEY NEED TO BE REMOVED FROM THE
MARKET.
MARKET. >> FIRST OF ALL, HOW IS RAYLINE
DOING?
DOING? >> MUCH BETTER.
SHE’S CANCER FREE AND IMPLANT
FREE.
FREE. HER BIG MESSAGE NOW, WHAT SHE’S
WORKING ON, IS MAKING SURE WOMEN
KNOW THEY HAVE TO BE THEIR OWN
ADVOCATES AND ASK THEIR DOCTORS
ABOUT THE RISKS WHEN IT COMES TO
IMPLANTS.
IMPLANTS. >> WHAT ARE SOME OF THE
SYMPTOMS, IF SOMEONE HAS THE
TEXTURED IMPLANT?
TEXTURED IMPLANT? WHAT ARE SYMPTOMS THEY SHOULD
LOOK OUT FOR?
>> FDA IS SAYING, LOOK, ASK YOUR
DOCTOR IF YOU DON’T KNOW WHAT
IMPLANT YOU HAVE.
SOME WOMEN DON’T REMEMBER.
DON’T RUN OUT AND GET THESE
REMOVED.
REMOVED. WORK WITH YOUR DOCTOR.
MONITOR TORTHE SYMPTOMS.
SWELLING, FLUID IN THE AREA, AND
PAIN.
PAIN. IF YOU HAVE PAIN, THAT IS
DEFINITELY A SIGN THAT YOU
SHOULD GET IN AND SEE YOUR
DOCTOR.
DOCTOR. >> WELL, IF THE FDA IS
CONCERNED, AND THEY’RE GOING TO
BE STUDYING, WHAT’S THE PROBLEM
WITH SAYING, LET’S PULL THIS OFF
THE MARKET UNTIL WE CAN
DETERMINE THAT THESE ARE 100%
SAFE?
SAFE? >> AL, THAT’S THE MILLION DOLLAR
QUESTION.
QUESTION. THAT’S WHAT THE WOMEN ARE
FIGHTING FOR.
FIGHTING FOR. EVEN TO HEAR A DOCTOR COME OUT
SO UNEQUIVOCALLY AND SAY SHE
BELIEVES THESE SHOULD BE OFF THE
MARKET, IT IS SOMETHING SO MANY
OTHER COUNTRIES HAVE DONE, AND
THAT’S WHAT IS FRUSTRATING FOR
WOMEN.
WOMEN. RAYLINE THINKS THIS IS A MANMADE
CANCER.
CANCER. >> WHAT OTHER COMPANIES MAKE
THESE TEXTURED IMPLANTS?
>> ALLERGAN, THE IMPLANT THAT
RAYLINE HAD, THE ONE WITH THE
MORE HIGH RISK OF CANCER, THEY
SAY PATIENT SAFETY REMAINS
ALLERGAN’S HIGHEST PRIORITY.
THEY STAND BEHIND THE
BENEFIT/RISK PROFILE OF THE
PRODUCTS.
PRODUCTS. THE SAFETY PROFILE IS SUPPORTED
BY PRE-CLINICAL DEVICE TESTING,
A DECADE OF WORLDWIDE CLINICAL
USE, AND A LARGE NUMBER OF
PEER-REVIEWED PUBLISHED STUDIES.
TWO OTHER FOLKS MAKE THIS.
WE REACHED OUT TO THE OTHERS,
AND THEY SAID, THE RISK OF
DEVELOPING THIS VARIES BETWEEN
TEXTURED DEVICES AND HAS BEEN
SHOWN TO BE RARE WITH MENTOR
BREAST IMPLANTS.
BREAST IMPLANTS. AND THE LONG-TERM SAFETY AND
EFFECTIVELY OF OUR IMPLANTS IS
SUPPORTED BY A DECADE OF
CLINICAL DATA AND STUDIES DUE TO
DISTINCT DIFFERENCES IN EACH
MANUFACTURER’S PROCESS AND
HEALING PROCESS, SAID SIENTRA.
IT IS CRATE CAL TO AVOID
CATEGORIZING ALL TEXTURED