By:Toxic Discovery Network, Inc
The National Organization of "People Helping People"
Discovery Network, Inc.
Suggested points to cover when writing to Congress were provided
by the Natl. NOW Legislative Liaison in Washington, DC. Should
you care to do so, language from the Natl. NOW resolution that
just passed may be quoted WITH THE UNDERSTANDING that the
resolution is still officially in draft form, has not been
finalized & released, &, has yet to be posted on the Natl. NOW
website. (Copy of resolution follows.) Brief letters are more
likely to be read.
I want to assure you that the resolution DID pass by a unanimous
vote of "the body" (all members eligible to vote) at the 1999
Natl. NOW Conference. However, all resolutions must be reviewed
by the Natl. NOW Board, &, checked for "policy content,"
spelling, grammar, etc., before they are formally released.
You may notice the absence of the words "informed consent" in
the resolution, although language having the same meaning was
included. The phrase "informed consent" was not used due to
it's strong association with another political group.
Partial text of informal letter from the Natl. NOW Legislative
The women in California should be emphasizing
in their letters three points (which are essentially the same as
the recommendations of the IOM and the resolveds in the NOW
resolution): that Congress should mandate of the Food and Drug
Administration a thorough informed consent process which tells
every women considering breast implants what the known risks are,
including the rupture rates found in the Goldberg study. The
informed consent [phrase used here because it was used by the
IOM] process must be required, not optional and it must be both
oral and in writing. Congress needs to mandate time certain when
the full text of the informed consent is prepared within three
months of the date of effectiveness of the law (which is yet to
be written, by the way). Without a deadline, the FDA will take
YEARS to develop the text of the informed consent. (And, again by
the way, we may want to consider writing the points to be
stressed in the informed consent right into the law rather than
leaving it to the FDA to water down.)
Secondly, we need to be urging that a breast implant registry be
established for all current breast implant wearers as well as
future. The IOM said that there needs to be thorough
surveillance, so this falls right in line. Dr. Goldberg even
suggested that we require that all future breast implants each
contain a manufactures label, with lot number, date of
manufacture, etc. I think that this is a good idea.
Thirdly, and most importantly, we want Congress to assure that
the funding for ongoing and planned research on breast implants
by the federal government be continued. We absolutely have to
have this independent clinical research on women with implants:
with and without symptoms, and on women who've had ruptured
implants and on those who haven't, plus with the necessary
We could even specify that any advertisements for breast implants
in magazines or newspapers or other media contain a warning label.
Diane [Griffith] has the information on this. When we sit down
with [Rep.] Trafficant to write a new bill [in addition to, not to
replace the SBIR&I Act] we can contemplate other possibilities,
such as requiring the FDA to set a standard for safety and by a
time certain (when these other studies are done) to declare that
they're safe or not safe.
The California women ought to write to Sens. Barbara Boxer,
Dianne Feinstein, and all of the California Representatives. They
[everyone] should also write to Senate Majority Leader Trent Lott
and to Speaker J. Dennis Hastert.
OTHERS TO CONTACT: (cc to Sens. Landrieu & Hutchison)
Address: U.S. House of Representatives, Washington, D.C. 20515
Rep. Thomas J. Bliley, Jr. - Chair, House Commerce Committee
(which handles health legislation)
Rep. John Dingle - Ranking Democrat, House Commerce Committee
Rep. Michael Bilirakis - Chair, House Subcommittee of the House
Committee on Health & Environment
Address: U.S. Senate, Washington D.C. 20510
Sen. James Jeffords - Chair, Health, Education, Labor, & Pensions
Sen. Edward M. Kennedy - Ranking Democrat, H.E.L.P. Committee
ALL members of the H.E.L.P. Committee should be written concerning
this matter. A list of the members can be found on the "Thomas"
website at http://thomas.loc.gov/
Very brief recap of the points to make when writing:
1. Very thorough "informed consent": All letters should focus on
this because it is exactly what the IOM report recommended.
2. Very thorough ongoing surveillance of all implant wearers: We
must call for a registry of current AND future implant wearers.
3. Continued funding for well-founded, independent clinical
research by the federal government: Stress "independent" - NO
4. Don't forget to ask everyone you write to co-sign the SBIR&I
Act, if they haven't already! (A partial list of the co-signers is on the "Thomas" website.)
Note: The "Thomas" website also lists email addresses of the
Congresspersons that have them."FURTHER CLINICAL RESEARCH ON BREAST IMPLANTS WITH SUPPORTING LEGISLATION IN CONGRESS"
WHEREAS, in 1996, the National Organization for Women (NOW) passed a resolution that stated, "Therefore Be It Resolved, that NOW work to educate women and men about the details of the breast implant issue and the product," and, "Be It Further Resolved, that NOW support individuals affected by the breast implant issue by supporting legislative intervention and avenues of relief"; and
WHEREAS, in 1997, NOW passed a resolution that stated, "Therefore Be It Resolved, that NOW supports legislation funding research on
possible side effects of implantation with silicone shell breast
WHEREAS, in December of 1991, the House of Representatives of the
102nd Congress issued a committee report, "The FDA's Regulation of
Silicone Breast Implants", which found that the Food and Drug
Administration (FDA) had not fulfilled its responsibility of
protecting and adequately informing consumers regarding these
products and that this responsibility remains unfulfilled to this
WHEREAS, the current published failure rates of these devices are
much higher than estimated in 1993, when FDA Commissioner Dr. David Kessler stated that a failure rate of even 5% was "not a safety
standard that the FDA can accept" in an article of the Journal of
the American Medical Association, and that a recently published
study by scientists at the University of Florida, Gainesville,
Department of Materials Science and Engineering, examining 8,000
explant cases, found that rupture rates occur at 30% over 5 years
and up to 70% over 17 years; and
WHEREAS, the Institute of Medicine (IOM), noting the deficiencies
of current research findings, recently recommended that all breast
implant patients be extensively surveilled, that all prospective
breast implant patients be provided with enough information to make
an informed decision, and that more definitive research be
WHEREAS, much of the data concerning breast implants is seriously
flawed, and since new and important findings possibly indicating
serious health consequences for breast implant wearers are about to
be released, and additional clinical studies are being planned by
the National Institutes of Health (NIH); and
WHEREAS, silicone activists have worked with U.S. Sens. Barbara
Boxer, Mary Landrieu, and Kay Bailey Hutchison, as well as U.S. Rep.
Gene Green and other members of Congress in order to have
legislation introduced known as "The Silicone Breast Implant
Research and Information Act(s)"; these bills ask NIH to conduct
independent and unbiased research, and "require more accurate and
timely dissemination of information to women who consider silicone
breast implants," and conduct other activities;
THEREFORE BE IT RESOLVED, that NOW calls upon Congress to pass such legislation, to make funding by NIH and other government agencies a priority, to disclose the findings of such studies to the public promptly, and to strengthen such legislation in light of the IOM
recommendations and other considerations; and
BE IT FURTHER RESOLVED, that NOW encourages all chapters to make available comprehensive, unbiased information regarding the effects of breast implants; and
BE IT FINALLY RESOLVED, that NOW support in spirit the efforts of
activists to encourage the creation of a carefully monitored system
of tracking all implant patients on a long-term basis with reports
of rupture, illness or disease being presented in a timely fashion
to the FDA.
Submitted by Issues Hearing: Disability Rights
Passed by unanimous vote 7/4/1999