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HUMAN ADJUVANT DISEASE CORP.
by "crusadercindy" <cindymarshall2005@[EMAIL PROTECTED]
> Nov 13, 2005 at 06:56 PM
HUMAN ADJUVANT DISEASE CORP.
We bring physicians and patients together
Silicone Implants
Silicone implants have been linked to various illnesses including fungal
infections, bacterial infections, fibromyalgia, chronic fatigue syndrome,
carcinomas, neurological disorders, multiple chemical sensitivity, and
diseases resembling Sjögren's disease, mixed connective tissue disease,
rheumatoid arthritis, lupus erythematosus, polymyositis, dermatomyositis,
and scleroderma. Silicone-related diseases (SRDs) affect patients
globally. Many patients travel great distances for treatment because they
are unable to find healthcare professionals in their local area who have
experience with SRDs.
Some physicians are still unaware that silicone or saline-filled breast
implants can cause systemic diseases.They believe that implants would not
be available on the market if they could potentially harm patients. This
issue continues to be a controversial topic in medicine.
Complicating this matter are the statistics disclosed by the
manufacturers
of silicone implants which state that the likelihood of an implant
recipient developing a systemic disease is the same as anyone in the
general population. Research regarding silicone implants is ongoing, but
as many as 25-30% of implanted patients may eventually be affected by
systemic complications.
The number of men and women having augmentation procedures with silicone
containing devices continues to rise in the U.S. Without understanding
all
of the local and systemic complications that can occur after any
augmentation procedure with silicone, these patients are unable to give
informed consent to plastic surgeons.
Saline-Filled Breast Implants
The envelope of a saline-filled breast implant is a silicone polymer that
may break down in the body into silica, thus eliciting an immune
response.
Silica has been re****ted in lymph nodes in saline breast implant
recipients
who have never had silicone gel implants. Both silicone and silica (up to
30% of the elastomer shell and the gel of a silicone breast implant) are
cytotoxic (Kessel et al., 1963; Allison et al., 1966; Kossovsky et al.,
1987) and immunostimulatory agents (Pernis and Paronetto, 1962; Heggers
et
al., 1983; Mancino et al., 1984; Kossovsky et al., 1987).
Implants and the F.D.A.
The Food and Drug Administration did not regulate medical devices until
1976. Under the 1976 law, devices already in use such as saline-filled
breast implants and silicone gel-filled breast implants were
"grandfathered".The manufacturers did not have to demonstrate to the
F.D.A. that the devices were safe at that time.
Saline-filled breast implants were on the market for nearly three decades
in the U.S. before the FDA approved them in May 2000.
Silicone gel-filled breast implants were removed from the U.S. market in
April 1992. Since then the FDA has permitted a small number of women, who
wanted silicone gel-filled breast implants for cosmetic purposes and
women
undergoing mastectomies, to receive the implants in a long-term study. On
October 14th and 15th in 2003, the F.D.A. sought input from an Advisory
Panel of experts on the data contained in the Inamed pre-market approval
(PMA) for silicone gel-filled breast implants during an open public
meeting. In a 9-6 vote, the Panel recommended approval of the Inamed PMA
with conditions. Ultimately in January 2004, the Food and Drug
Administration rejected Inamed Corp.'s bid to bring silicone gel-filled
breast implants back on to the market.
Mentor Cor****ation submitted their silicone gel-filled breast implant PMA
in December 2003. The General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee reviewed applications submitted by
Inamed Corp. and Mentor Corp. for marketing silicone gel-filled breast
implants in April 2005. The advisory panel rejected U.S. sales of Inamed
Corp.'s silicone gel-filled breast implants by a 5-4 vote. The following
day, the Panel voted 7-2 in favor of allowing Mentor's application to be
approved.
On Thursday, July 28,2005, the F.D.A. issued an approvable letter for
Mentor’s application for silicone gel-filled breast implants. Inamed
Cor****ation received an approvable letter from the Food and Drug
Administration (FDA) for its silicone gel-filled breast implants on Sept.
21, 2005. The letters contained information regarding conditions that the
companies must meet to obtain final FDA approval for marketing the
implants in the U.S.
The F.D.A.'s approvable letters do not mean the implants have been
approved for marketing in the United States at this time.
About The Human Adjuvant Disease Corp.
The HUMAN ADJUVANT DISEASE CORP. is a non-profit organization dedicated
to
improving the diagnosis of silicone-related diseases, helping patients
and
their families affected by these disorders, educating medical
professionals and the public about silicone-related diseases, and
promoting research on these illnesses.
H.A.D.C. and IMPLANT~INFO~NET provide a sup****t network for patients with
silicone-related diseases and for their families. We invite all patients
to participate in the IMPLANT~INFO~NET FORUM.
We encourage physicians, especially plastic surgeons, to learn about
illnesses associated with silicone and saline-filled implants. Patients
should be examined annually after implantation. Patients should be orally
advised of the symptoms associated with silicone-related diseases before
surgery and should contact their surgeon immediately if they begin to
experience problems so that they may receive treatment.
Join the Human Adjuvant Disease Corp
HADC member****p is free. If you are interested, please write to one of
the
following e-mail addresses provided below.
Patients
If you are a patient interested in joining our organization ,please write
to us and include the following information:
1). Name
2). Location
3). Have silicone or saline-filled breast implants negatively affected
your health, personal life, career, and/ or mental abilities?
OR
If you are a relative or friend of a patient, let us know how a
silicone-related disease has affected your life.
EMAIL: HumanAdjuvantDisease@[EMAIL PROTECTED]
Physicians
If you are a physician interested in joining our organization, please
write to us and include the following information:
1). Name
2). Location
3). Specialty
EMAIL: physicians4patients@[EMAIL PROTECTED]
Copyright 2004-2005, Human Adjuvant Disease Corp.
The information on this website is presented for educational purposes.
1 Posts in Topic: HUMAN ADJUVANT DISEASE CORP.
"crusadercindy" 2005-11-13 18:56:18
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tan10V112 Mon Nov 14 11:23:52 EST 2005.
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