From Lana - FDA Announces New Program to Transform and Strengthen Medical Device Safety

[Guest guest]

Lana has been working very hard to educate the public,

politicians, AND THE FDA about silicone

hypersensitivity . . . I'm sure she was influential in

the FDA's changing policy on MedWatch. Let's pray that

she is successful in getting the FDA to require

silicone hypersensitivty testing of all placentas of

children born after breast implants.

Lana is an example of what one woman can do if she

sets her mind to it and persists! . . . We need an

army of women like her!

Thanks so much Lana! . . . Please enjoy your break!

You will be missed! - Love, Rogene

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From Lana:

THE FDA RELEASED DOCUMENT YOU SEE BELOW is a chance

FOR all of YOU to really make a change!

I am not saying that it is not important, but it

really concerns me that everyone is so focused on the

platinum studies.

As of January 2006 The FDA has admitted that AFTER AN

EXTENSIVE REVIEW, their med watch reporting policies

accuracy and effectiveness is in question. AT THIS

TIME, the FDA is in the process of changing their

adverse reactions reporting policies, this includes

but is not limited to elective surgery devices, and no

one is saying a word about it.

By the time everyone is done focusing on the platinum

issue, that will lead to NO CHANGES, their chance to

have an input into the reporting of adverse reactions

from the implants will be GONE. If you want to have

your children's implant related medical problems

reported NOW IS THE TIME TO SPEAK UP!! If you want

" MANDATORY REPORTING " of implant rupture AND MANDATORY

REPORTING OF POSSIBLE ADVERSE REACTIONS FROM THE

IMPLANTS to include ALL DOCTORS, NOW IS THE TIME TO

SPEAK UP!!

Women who had silicone implants could have migrated

silicone gel all through out their bodies and with the

FDA'S admission that the MRI studies do not have the

ability to show the migrated gel, NOW IS THE TIME TO

WRITE TO THE FDA AND SEND THEM ANY REPORTS YOU HAVE TO

EVERIFY THAT YOU HAVE MIGRATED GEL AND THAT IT DID NOT

SHOW ON YOUR MRI!!

AFTER LIVING WITH THIS SILICONE NIGHT MARE FOR 21

YEARS, CONTINUIOUSLY WORKING ON GATHERING INFORMATION

AND INFORMING PEOPLE OF THE DANGERS OF THE IMPLANTS,

HAVING TWO SICK CHILDREN, GOING THROUGH 3 COURT

BATTLES, MEETING AND TALKING WITH THOUSANDS OF INJURED

WOMEN AND CHILDREN, READING EVERY STUDY EVER RELEASED

ON BREAST IMPLANTS, MEETING MANY DISHONSET AND A FEW

VERY HONEST DOCTORS, I CAN TELL YOU THAT THE SILICONE

HYPERSENSITIVITY TESTS ARE THE MOST IMPORTANT KEY TO

THIS ISSUE. THE FDA MUST BE PRESSURED INTO ADDING AN

ANAYLIS OF THE SILICONE HYPERSENSITIVITY PROBLEM TO

THE IMPLANTS SAFETY STUDY.

AFTER HAVING TWO SICK CHILDREN, WHOSE SILICONE

EXPOSURE COULD HAVE EASILY BEEN PROVED IF THEIR

PLACENTAS HAD BEEN TESTED, I ALSO FIRMLY BELIEVE THAT

A STUDY OF THE PLACENTAS OF IMPLANT WOMEN SHOULD BE

INCLUDED IN THE SAFETY STUDIES. THESE STUDIES ARE

NO-INSTRUCTIVE AND INEXPENSIVE AND COULD INCLUDE A

HYPERSENSITIVITY TEST.

IF MY SONS HAD NEVER BEEN GIVEN MEDICATION WITH

SILICONE IN IT, THEY WOULD HAVE NEVER GOTTEN SICK AT

ALL!!

THE MANUFACTURES MADE MONEY OFF MY IMPLANTS THEN THEY

MADE MONEY OFF THE MEDICATIONS MY KIDS AND I TOOK

AFTER WE GOT SICK FROM THE IMPLANTS. THE BIGGEST

" " TRICK " " OF ALL IS THAT THE MEDIATIONS THAT WERE

DESIGNED TO GET US WELL KEPT ME SICK, MADE THEM SICK,

AND KEPT US NEEDING MORE MEDICATIONS. FOLLOW THE

MONEY!!

IF YOU HAD YOUR IMPLANTS REMOVED AND YOU ARE STILL

SICK, THEN YOU SHOULD BE VERY INTERESTED IN THIS.

" GOD " MADE OUR BODIES IMMUNE SYSTEM TO FIGHT OFF

FOREGIEN INVADERS!!

THE IMMUNE SYTEM AND THE ALLERGY REACTIONS ARE VERY

REALLY AND CAN NOT BE DISMISSED! MANY OF YOUR IMPLANT

RELATED SYMTOMS CAN BE FOUND IN THE LISTS OF ALLERGY

SYMTOMS! THE WAY AN ALLERGY WORKS IS EVEN IF YOU

REMOVE THE IMPLANT, THE MARKER STAYS IN YOUR BLOOD.

THE HYPERSENSITIVITY PROBLEMS THAT MANIFESTED YOUR

UNUSUAL CHRONIC SILICONE INDUCED ILLNESS, IF YOU TAKE

MEDICATION WITH ANY TYPE OF SILICON, WILL REMAIN AND

YOU WILL CONTINUE TO GET SICK EVEN AFTER THE ORIGANAL

OFFENDING ALLERGIN, THE IMPLANT, IS REMOVED!

I HAVE TO MOVE ON WITH MY LIFE NOW. ON THURSDAY I WILL

BE PLACING MY LAST E-BAY AD. AFTER PLACING IT A YEAR

AGO, I AM NO LONGER GOING TO BE RUNNING MY AD. I HAVE

WORKED VERY HARD TO INFORM EVERYONE POSSIBLE OF WHAT I

HAVE LEARNED THAT COULD HELP. AFTER SHARING WHAT I'VE

LEARNED, CHANGING THE LAW IN OUR STATE, HOLDING THE

MANUFACTURE OF MY IMPLANTS ACCOUNTABLE, GETTING MY

BOYS WELL AND LESSENING MY MEDICAL PROBLEMS AS WELL, I

AM TIRED AND I NEED TO MOVE ON.

I WILL CONTINUE TO WRITE TO THE FDA AND I WILL

CONTINUE TO FORWARD THEIR REPOSNSES TO ROGENE. IF

THERE IS A PROTEST ORGANIZED AT THE FDA'S OFFICE I

WOULD LOVE TO BE APART OF IT AS WELL BUT OTHER THAN

THAT I AM GOING ON A LONG OVER DO VACATION FOR A LONG

TIME.

I AM VERY HAPPY TO HAVE MET YOU ALL AND I WISH EVERY

ONE OF YOU THE VERY BEST ON YOUR EFFORTS TO MAKE

CHANGES IN ALL OF THE DIFFERANT AREAS THAT NEED TO BE

ADDRESSED. THANK YOU FOR YOUR FRIENDSHIP, LANA

FDA News

FOR IMMEDIATE RELEASE

P06-10

January 20, 2006

Media Inquiries:

King, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

FDA Announces New Program to Transform and Strengthen

Medical Device Safety

The U.S. Food and Drug Administration (FDA) is

launching a new program to transform and strengthen

the way it currently monitors the safety of medical

devices after they reach the market — both new

technology and existing products.

The FDA Center for Devices and Radiological Health's

(CDRH) Postmarket Transformation Initiative will

better protect the public health by allowing the FDA

to identify, analyze and act on problems more quickly,

including alerting the public sooner of potential

medical device issues.

" Over the next decade, medical technology innovations

will fundamentally transform the health care and

delivery system, providing new solutions with medical

devices that will challenge existing paradigms and

revolutionize the way treatments are administered, "

said Dr. Gottlieb, FDA's Deputy Commissioner for

Medical and Scientific Affairs. " Under the leadership

of our device center's expert staff, we are working to

develop even better ways to evaluate new technologies

to maximize benefits and minimize risk, including more

efficient ways to develop more effective post-market

systems that can support safer medical practices as

well as continued innovation. "

Areas in which this initiative will focus include:

Working toward an electronic reporting system for

adverse medical device events; Unique ways to identify

medical devices including standardized and globally

accepted names; Ways to improve device information in

patient records; Improved internal collaboration on

post market safety issues; andIdentifying

opportunities to improve the safety of medical devices

through collaborative efforts with professional

organizations and the medical device industry.

The FDA undertook this initiative after a

comprehensive, year-long internal inventory of the

tools used to monitor the safety of medical devices

after they are approved. This inventory identified

many areas that are working well; however, it also

identified challenges associated with medical devices

after they reach the market.

" With this initiative, FDA intends to improve the way

it monitors the safety of medical devices and provide

a strong safety net to protect public health, " said

Schultz, M.D., Director, Center for Devices and

Radiological Health.

To guide this process, the CDRH Postmarket

Transformation Leadership Team has been established

consisting of senior level FDA management as well as

outside consultants who are experienced in device

safety and product regulation. As the first step, the

team will review CDRH's Medical Device Postmarket

Safety Program report and accompanying recommendations

for possible ways to address areas that need

improvement.

The CDRH Postmarket Transformation Leadership Team is

expected to have recommendations back to CDRH within

approximately four months.

To obtain a copy of CDRH's Medical Device Postmarket

Safety Program or Medical Device Postmarket Safety

Program – Synopsis and Recommendations,

see: www.fda.gov/cdrh/postmarket/mdpi.html