Some literature denies that symptoms women get
post-implant are psychosomatic, but I have found more evidence to
prove the opposite. There are chemicals in the implant shell, they can
become infected with bacteria and/or mold/fungi. Numerous women have
suffered similar symptoms, and gone on to recover after explantation.
From the FDA:
“Widespread reports of adverse reactions to silicone gel-filled
implants and a lack of evidence supporting their safety led the Food
and Drug Administration to order the devices off the market in April
1992. They remained available only to women in clinical studies,
mostly women seeking breast reconstruction after breast cancer
surgery. Saline-filled implants were allowed to remain on the market
for all uses.”
“Although many of the local complications of gel-filled implants are
also associated with saline implants, the latter were permitted to
remain on the market unrestricted for both reconstruction and
augmentation. FDA considers saline-filled implants less risky, because
although they have the same silicone rubber envelope as gel-filled
implants, leakage or rupture would release only salt water, not
silicone gel, into the body.
Nevertheless, FDA is requiring manufacturers to collect data on the
saline implants as well, because the incidence of known risks (for
example, deflation and capsular contracture) is not well defined. When
the Medical Device Amendments were passed, it was determined that
these devices would also eventually require premarket approval. In
January 1993, FDA notified saline implant manufacturers that they
would have to submit safety and effectiveness data for their products.
In December 1994, the agency told them what type of safety and
effectiveness data were needed, and delineated objectives and time
frames for the trials. Saline implants will stay on the market while
the studies are conducted, but the companies must report the
laboratory, animal and clinical data in stages, and must provide
written information on the known and possible risks of their
products.”
“Women considering saline implants should ask their doctor for a copy
of the manufacturer’s information sheet, a copy of the product insert
sheet for the specific implant to be used, and a copy of the hospital
informed consent form,” says Barbara Stellar, FDA’s breast implant
information and outreach coordinator.”
Let’s hope your implants were made after 1991: “About 110,000 women
have silicone gel-filled implants with a polyurethane coating,
intended to reduce the risk of capsular contracture. In April 1991, an
FDA analysis showed that polyurethane foam could break down under
human body conditions to form a chemical called TDA, which can cause
cancer in animals. As a result, the manufacturer immediately stopped
selling the product.
Recently, however, a study to measure TDA in women with polyurethane
implants found that a woman’s risk of cancer from exposure to TDA
released by the implant is negligible–about one in a million over a
lifetime. FDA considers it unlikely that even one woman would develop
cancer from these implants. The study supports the agency’s original
recommendation that women who are not having problems should not have
the implants removed solely because of concern about cancer from TDA
exposure.”
Risks of implants:
• “Autoimmune-like disorders–signs include joint pain and swelling;
skin tightness, redness or swelling; swelling of hands and feet; rash;
swollen glands or lymph nodes; unusual fatigue; general aching;
greater chance of getting colds, viruses and flu; unusual hair loss;
memory problems; headaches; muscle weakness or burning; nausea or
vomiting; and irritable bowel syndrome.
Recent studies have shown, however, that there is not a large
increased risk of traditional autoimmune, or connective tissue
disease, from silicone gel implants.
• Fibrositis/fibromyalgia-like disorders (pain, tenderness and
stiffness of muscles, tendons and ligaments).
http://www.fda.gov/fdac/features/995_implants.html
“Over time, the outer silicone elastomer shell is attacked and
literally devoured by the immune system’s macrophages. In this way,
the shell, which is made of highly toxic fumed silica, is distributed
throughout the body and stored in major organs.”
“It is very clear to us that Health Canada has no alternative but to
place a moratorium on saline breast implants, especially those
manufactured by Mentor, or risk being sued by women who have already
suffered or will suffer damages from this medical device. Health
Canada is derelict in its duty to enforce the Food and Drug Act
regarding saline breast implants. It is also failing to report the
damages of saline breast implants to the Provincial Ministries of
Health, and thence to GPs and plastic surgeons.”
http://www.info-implants.com/BC/0030.html
“Once a saline breast implant has deflated, it can not be refilled. If
yor implants have not caused any health problems before they deflate,
ruptured saline implants are relatively safe if there is no mold,
bacteria, or fungus. If any of these are present, you will probably
notice symptoms of infection or allergic-type symptoms.”
http://www.breastimplantinfo.org/augment_4faq4.html
“Capsular Contracture: Almost every woman with breast implants has
scar tissue surrounding her implants. This scar capsule doesn’t show
– it’s inside her breast, and is her body’s natural way of protecting
her from a foreign object. Sometimes, however, that capsule is too
tight for the implant. Capsular contracture is when the capsule is too
tight and feels like it is squeezing the implant.
• It can happen with either saline or silicone gel breast implants
• It can be slightly uncomfortable or very painful
• It can change the shape of your breast, or make it look round and unnatural
• You may need surgery to fix it
• Once it is surgically fixed, it is likely to happen again
“Everyone agrees that implants can cause local complications, such as
those listed above. There is much more controversy about whether it
can cause diseases or disorders. Some women can have implants for many
years and never have any problems, but as the years go by, many women
with implants become seriously ill. Common symptoms include joint pain
or stiffness, memory problems, trouble concentrating, fatigue,
flu-like symptoms that don’t go away, or pain throughout the body
(fibromyalgia). Auto-immune diseases such as rheumatoid arthritis,
lupus, and scleroderma are also problems among women with implants.
Are these symptoms caused by implants, are women who are susceptible
to these illnesses more likely to get them if they have breast
implants, or would these women have become ill even if they didn’t
have implants?
Research has not yet answered those questions. Women with implants are
more likely to have these diseases and symptoms in some studies, but
not others. The Institute of Medicine (IOM) summarized 17
epidemiological studies that attempted to answer this question, but
unfortunately, most of the studies included relatively small numbers
of women who had implants for very short periods of time. Longer-term
studies conducted after the IOM report have found some risk of
diseases among women with implants. That is why the IOM study is not
proof of implant safety. For more information on the IOM study, please
see http://www.breastimplantinfo.org/what_know/iom_crit.html.
Only one study has been performed on women with rheumatoid symptoms:
“In the only study of women with rheumatology symptoms who had their
implants removed, doctors found that 97% of women with pain and other
rheumatology symptoms felt better after their breast implants were
removed and not replaced. Many symptoms lessened or disappeared over
the next few months. In contrast, 96% of the women who did not have
their implants removed became even more ill. This study was conducted
by a physician (Dr. Noreen Aziz) at the University of South Florida
Colleges of Medicine and Public Health, who now works for the National
Cancer Institute.
Studies published in 2001 by other scientists at the National Cancer
Institute raised questions about the long-term safety of breast
implants. Unfortunately, many doctors are not aware of these recent
studies. One study found that women who had breast implants for at
least eight years were twice as likely to die from brain cancer, three
times as likely to die from lung cancer or other respiratory diseases,
and four times as likely to commit suicide, compared to other plastic
surgery patients. A second study found that women with breast implants
for at least eight years were 21% more likely to be diagnosed with
cancer compared to other women their age.”
http://www.breastimplantinfo.org/what_know/having_problems.html
Before and after breast augmentation
Saline-filled breast implant
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