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2005-11-08T21:48:00.000-08:00

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The FDA's draft guidance document says that two to three years of
follow-up data may not be enough to allow the agency to evaluate the
safety and effectiveness of breast implants. The agency recommends
the use of tests that can predict clinical outcomes, such as how long
breast implants will last before rupturing in the body, as well as tests
that explain how and why the breast implants rupture. In addition, the
agency recommends that more data be gathered regarding the rate of
rupture over time, as well as the health consequences of rupture.

2005-11-07T13:48:00.000-08:00

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In January 2004--contrary to the recommendation of the agency's
advisory panel--the FDA determined that the new silicone gel-filled
breast implant PMA was "not approvable" at that time. This meant
that the implants were not approved for marketing pending additional
information, but that women would continue to have limited access to
them by enrolling in clinical studies.

2005-11-06T05:48:00.000-08:00

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A Turn of Events
In October 2003, the FDA held a two-day advisory panel meeting to
discuss a manufacturer's PMA for a silicone gel-filled breast implant.
Some people complained that the meeting was premature in light of
the fact that long-term studies had not been completed, but the FDA
proceeded because the agency was required by law to consider the
pending PMA within a specified time frame. The meeting also
provided patients and others with timely access to information and
expert analyses on the issue. The issues before the panel reflected
much of the decades-long debate over the implants. Moreover, the
meeting provided a valuable public forum for discussing the issue from
many diverse perspectives and for raising important additional
questions.

2005-11-05T21:48:00.000-08:00

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In the years that followed that decision, thousands of women filed
lawsuits against the manufacturers of silicone gel-filled implants,
claiming the devices had caused serious ailments, such as connective
tissue diseases, neurological diseases, and cancer. Consumer groups
repeatedly filed petitions urging more studies on the implants. But
many women said they were pleased with their implants, including
cancer patients who had pleaded for the opportunity to choose
silicone gel-filled implants for reconstruction.

2005-11-05T13:48:00.000-08:00

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In April 1992, the agency decided that no PMA yet submitted
contained sufficient safety and effectiveness data to support approval.
However, access to these silicone gel-filled breast implants would
continue for women enrolled in certain clinical studies.

2005-11-05T05:48:00.000-08:00

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In January 1992, the FDA called for a voluntary moratorium--a delay
on the use of these implants--until new safety information could be
thoroughly reviewed. The moratorium was not intended to "ban" the
implants, but instead to allow time to review the new safety
information.

2005-11-04T21:48:00.000-08:00

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But over the years, questions did arise about the effects of silicone on
the body. In 1991, the FDA published a regulation that required
manufacturers of silicone gel-filled breast implants to submit
premarket approval applications (PMAs). This requirement meant
that the FDA needed to agree that the manufacturer has presented
data showing a reasonable assurance of safety and effectiveness in
order for the devices to remain on the market.

2005-11-04T13:48:00.000-08:00

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The Silicone Controversy
Breast implants were first marketed in the early 1960s, before the
1976 Medical Device Amendments to the Federal Food, Drug, and
Cosmetic Act required a reasonable assurance of safety and
effectiveness to be shown for certain medical devices. The 1976 law
gave the FDA authority over such devices, but breast implants were
"grandfathered" into the regulatory scheme, meaning that
manufacturers were not required to provide the agency with scientific
evidence of product safety unless questions arose about the safety
and effectiveness of these already-marketed devices. Silicone was
initially assumed by manufacturers to be biologically inactive and,
therefore, to have no harmful effects.

2005-11-02T21:48:00.000-08:00

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While every surgical procedure has potential risks, such as infection,
bleeding, and scarring, there are risks that are specific to breast
implants. Learning about them is key to being properly informed
about the procedure.

2005-11-02T13:48:00.000-08:00

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Some people see an enormous benefit to getting implants and are
willing to accept associated risks. They say that using breast implants
to rebuild the breast (reconstruction), or change its size and shape
(augmentation), significantly improves the quality of life for many
women. Advocates of breast implants also say that a woman's
consent to the surgery should be considered valid as long as she
weighs the risks and benefits of the procedure.

2005-11-01T21:48:00.000-08:00

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Making an Informed Decision About Breast Implants
By Carol Rados

2005-10-27T21:48:00.000-07:00

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A lawsuit against Omni Bio Tech and the simultaneous settlement
were filed today by the Attorney General�s Consumer Protection
Division in Snohomish County Superior Court.

2005-10-27T13:48:00.000-07:00

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�Products that claim to improve physical appearance will always be
an easy sell,� Gregoire said. �Unfortunately, the evidence to back up
the claims is often less than skin deep.�

2005-10-27T05:48:00.000-07:00

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Omni BioTech International, Inc., which also did business as Small
Breast Solutions (SBS), targeted consumers who desired breast
enlargement, weight loss, and sexual dysfunction cures. The products
ranged from $14.95 for a supply of breast-enhancement soap to
$349.90 for a six-month supply of the �Complete System.�

2005-10-26T21:48:00.000-07:00

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AG Settles with Second Firm over Unproven Body-Enhancement
Claims
SEATTLE �A Marysville company that made unsubstantiated claims
about the effectiveness of body-enhancement products it sold over
the Internet has agreed to stop offering the products in Washington,
Attorney General Christine Gregoire announced today.

2005-10-26T05:48:00.000-07:00

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How many steps are there in each procedure? What are they?
How much experience do you have with each procedure?
What is the estimated total cost of each procedure?
How long will it take to complete my reconstruction?
Do you have before-and-after photos I can look at for each
procedure and what results are reasonable for me?
What will my scars look like?
What kind of changes in my reconstructed breast can I expect over
time?

2005-10-25T13:48:00.000-07:00

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What are my options if I am dissatisfied with the cosmetic outcome of
my implanted breasts?
What alternate procedures or products are available if I choose not to
have breast implants?
Do you have before-and-after photos I can look at for each
procedure and what results are reasonable for me?
Source: FDA

2005-10-24T21:48:00.000-07:00

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Institute of Medicine
National Cancer Institute
(800) 422-6237
Office of Research on Women's Health
American Society of Plastic Surgeons
(888) 475-2784
American Society for Aesthetic Plastic Surgery
(888) 272-7711
Questions to Ask a Surgeon About Breast Augmentation
What are the risks and complications associated with having breast
implants?

2005-10-23T21:48:00.000-07:00

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Three years later, Long's breasts measure 36C--one size larger than
before she was implanted--suggesting that her own breasts continued
to develop even after the implants were removed. "When you're
making a decision that can impact your life at 19," Long advises other
young women, "you need to research the subject like you're 50 years
old."

2005-10-23T13:48:00.000-07:00

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Many of the changes to the breast that occur with an implant cannot
be undone. If a teen chooses to have her implants removed, she may
experience dimpling, puckering, wrinkling, or other cosmetic changes.

2005-10-23T05:48:00.000-07:00

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Following implantation, Long went to a 34D. But complications
convinced her to have the implants removed a short time later. "I had
shooting pains in my arms, excruciating pain in every joint, bone, and
muscle of my body, I was exhausted all the time, had no energy, lost
my hair, and had pains in my chest, heart, and ribs. I had trouble
remembering things and thinking clearly, and the list goes on," she
says. "Before the implants, all I had was allergies."

2005-10-22T21:48:00.000-07:00

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Teen-agers who are dissatisfied with their bodies see breast implants
as a harmless--and, according to Long, "fun"--thing to do to improve
their self-image. Long says she felt that her body was too "bottom
heavy" for her breasts and wanted to "even out" her figure. "But I
never thought about my implants being dangerous," she says. A
friend's mother worked for a plastic surgeon for 12 years and told
Long she knew of no problems with patients who had gotten the
implants. "I really thought that I had inside information, and that these
devices were completely safe and maintenance-free."

2005-10-21T21:48:00.000-07:00

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Experts also advise women to have realistic expectations about breast
implants. There is no guarantee that the results will match those of
other women. Overall health, age, chest structure, the shape and
position of the breast and nipple, skin texture, the tendency to bleed,
prior breast surgeries, and the surgical team's skill and experience all
figure into the outcome of breast implant surgeries.

2005-10-21T13:48:00.000-07:00

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"I love my breast implants, but I also spent six months researching the
devices, which included picking the best doctor for me," says Bracy,
a 38-year-old self-employed bookkeeper from Tampa, Fla. "It's not
necessarily the product, but who is doing the surgery." The key to
breast implant satisfaction, she says, is to "find a doctor who is willing
to answer all your questions and take all your concerns seriously. And
the relationship with your doctor doesn't end after the surgery."

2005-10-21T05:48:00.000-07:00

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After switching to a new, firmer silicone gel-filled implant through a
clinical study only a year after experiencing rippling with her saline
implants, Kathy Bracy says it's important that women who are
considering breast implants do their homework.

2005-10-20T21:48:00.000-07:00

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Another consideration is the choice of a surgeon. Patient advocates,
professional groups, and others agree that it's important to choose a
plastic surgeon who has been trained in breast implant surgery and
who has performed it successfully on many women.

2005-10-20T13:48:00.000-07:00

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In addition, women should be aware that hard pressure on the breast
(compression) during mammography may cause implant rupture.
Breast implants also can interfere with finding breast cancer during
mammography. Doctors say the implant can hide breast tissue and, as
a result, hide lesions as well. Extensive scarring and calcium deposits
in tissue surrounding an implant can mimic the appearance of cancer,
making the deposits difficult to distinguish from tumors on a
mammogram.

2005-10-20T05:48:00.000-07:00

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Experts caution that breast implants do not last a lifetime. Women
should be prepared for long-term follow-up and additional surgeries
to treat complications. They also should be prepared for the
accompanying additional costs. One of the biggest problems Faussett
says she hears from women in her breast implant support group is that
"most don't plan for the money it takes to fix what goes wrong."

2005-10-19T21:48:00.000-07:00

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Faussett had her implants removed a year after implantation because
she believes they caused a mixed bag of health problems, including
disturbed vision, heart palpitations, muscle twitching, and an
autoimmune thyroid disease. She says, "The risks were much greater
than my surgeon led me to believe."

2005-10-19T13:48:00.000-07:00

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Other Considerations
"My doctor told me that these implants would go with me to my
grave," says 44-year-old Patty Faussett of Henderson, Nev., who
chose to augment her breasts with saline breast implants in 1997, after
years of breast-feeding distorted their shape.

2005-10-18T21:48:00.000-07:00

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Roth did survive--both breast cancer and two silicone breast implants
gone bad. But the ruptured devices, she believes, caused her to lose
her good health, her job, and eventually her health insurance over the
next 11 years. "I found out the hard way," she says. "There were
many risks with the implants that I didn't know about."

2005-10-18T13:48:00.000-07:00

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"I trusted what my highly respected doctors were telling me was true,"
says the 63-year-old social worker in central Colorado. "You're in
shock, you think you're going to die, so what kind of informed
decision can you possibly make about what you want your breasts to
look like if you're lucky enough to survive?"

2005-10-18T05:48:00.000-07:00

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Lynda Roth, who was diagnosed with breast cancer in 1990, says she
was forced to make a quick decision, based on very little information,
about getting breast implants following a mastectomy.

2005-10-17T21:48:00.000-07:00

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But many women disagree. They have reported health problems
related to their immune systems or neurological symptoms that they
believe are caused by ruptured or intact breast implants. And some
women who have received breast implants claim they weren't fully
informed of the risks.

2005-10-17T13:48:00.000-07:00

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The IOM committee also found that women with silicone breast
implants are no more likely than women without implants to develop
the life-threatening systemic illnesses that some people have claimed
might be related to the implants.

2005-10-17T05:48:00.000-07:00

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Women should know that, regardless of the type of implant, it is likely
they will need to have one or more additional surgeries (reoperations)
over the course of their lives, because of complications from breast
implants. Reasons for reoperations include any of the potential
complications, such as capsular contracture, wrinkling, asymmetry,
rupture, or implant malposition.

2005-10-16T21:48:00.000-07:00

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Another potential complication of implant surgery is nerve damage,
which can cause some women to experience a loss or increase in
sensation in their nipples and breast tissue. These symptoms may
disappear eventually, but can be permanent in some cases. It is
unclear at this time whether insufficient milk production to breast-
feed--another reported problem--is due to damaged nerves or to
other reasons.

2005-10-16T13:48:00.000-07:00

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Called "silent ruptures," these breaks involving silicone gel implants
may occur without a visible change. And a woman may not feel any
sensation, says Sahar M. Dawisha, M.D., a medical officer in CDRH
who has reviewed data submitted by implant manufacturers. Magnetic
resonance imaging (MRI) with equipment specifically designed for
imaging the breast may be used for evaluating women with suspected
rupture of their silicone gel-filled implant. The FDA considers MRI to
be the best method at this time. There are no standards on how often
to screen for silent rupture with MRI, and the costs of this procedure
must be considered when choosing a silicone gel-filled breast implant.
Physicians usually recommend removal of the implant if it has
ruptured, regardless of whether it is saline-filled or silicone gel-filled.

2005-10-16T05:48:00.000-07:00

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In addition, a rupture can occur at any time. While saline-filled breast
implants leak only salt water when they rupture, the health effects of
leaking silicone gel-filled implants remain controversial. Women sense
a change more easily when saline-filled breast implants rupture. But
the silicone gel-filled implants are more likely to maintain their shape
after they rupture, which can make it more difficult to detect a break.

2005-10-15T21:48:00.000-07:00

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One risk is capsular contracture, which is a tightening and squeezing
of the scar tissue that naturally forms around the implant. This
contracture may result in hardening of the breast tissue, rippling of the
skin, and changes in breast shape. It also may cause pain, which, if
severe, can require surgery to remove the scar tissue or replace the
implant.

2005-10-15T13:48:00.000-07:00

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Breast Implant Risks
In 1999, the Institute of Medicine (IOM) issued a report on a review
of information related to health effects associated with silicone breast
implants, both gel-filled and saline-filled, in humans. An important goal
of the IOM was to provide women with detailed information about
the potential risks of silicone breast implants.

2005-10-15T05:48:00.000-07:00

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"Current testing doesn't reflect reality," says Michael A. Choti, M.D.,
an associate professor of surgery and oncology at the Johns Hopkins
University School of Medicine in Baltimore, and also an FDA
advisory panel member. The implants, he says, are extremely durable
when tested outside the body. "You can virtually run a truck over
them and they'll hold up. But the question is, what happens when
implanted long-term in a woman's body?"

2005-10-14T13:48:00.000-07:00

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Also in January 2004, the agency released a draft of its new
guidelines for companies submitting breast implant PMAs, explaining
the scientific issues that the FDA recommends be addressed as part
of their applications. The guidance document reflects the FDA's
current thinking about new scientific information that the agency,
manufacturers, and the clinical community have gained over the last
10 years, including information learned at the October 2003 advisory
panel meeting. Consistent with the FDA's good guidance practices,
the agency has asked for public comments on the breast implant
guidance. The guidance is not intended for implementation until it is
finalized.

2005-10-14T05:48:00.000-07:00

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"The public scientific process that has been used to consider these
devices is fully consistent with the FDA's mission--to use the best
available science to protect and promote the public health interests of
the American people," says Linda Kahan, deputy director of the
FDA's Center for Devices and Radiological Health (CDRH).

2005-10-13T21:48:00.000-07:00

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2005-10-13T13:48:00.000-07:00

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That, according to Anderson, "is reasonable informed consent."

2005-10-13T05:48:00.000-07:00

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"The use of implants and augmentation conjures up some social
judgments that may well be unfair," says Anderson, a professor of
surgery and director of the University of Washington's Breast Health
Center. Rather than deciding that no woman can have access to
silicone gel-filled implants because a small number may be at risk for
certain illnesses, he says, "I believe the better approach is to make the
devices available and inform all women of the degree of risk
involved."

2005-10-12T21:48:00.000-07:00

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As a panel member, Benjamin O. Anderson, M.D., voted with the
majority to recommend that the FDA approve the new PMA, but
only with specific conditions. Anderson says he wants to avoid getting
into the business of determining how a woman defines the value of
breast reconstruction or augmentation.

2005-10-12T13:48:00.000-07:00

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At this time, there are two manufacturers with approved saline-filled
breast implants. No manufacturer has yet received FDA approval to
market a silicone gel-filled breast implant.

2005-10-10T05:48:00.000-07:00

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Breast implants are designed for augmentation, a cosmetic procedure;
reconstruction; and replacement of existing implants, called revision.
There are two primary types: saline-filled and silicone gel-filled.
Depending on the type of implant, the shell is either pre-filled with a
fixed volume of solution or filled through a valve during the surgery to
the desired size. Some allow for adjustments of the filler volume after
surgery. Breast implants vary in shape, size, and shell texture.

2005-10-09T21:48:00.000-07:00

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But also in 2003, 45,000 augmentation patients and 17,000
reconstruction patients had their breast implants removed. The
medical community and others, including the Food and Drug
Administration, would like to better understand why.

2005-10-09T13:49:00.000-07:00

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A Primer on Breast Implants
According to the American Society of Plastic Surgeons (ASPS),
there were nearly 255,000 breast enhancement implant surgeries in
2003, nearly twice the number done in 1998. Another 68,000 women
received breast implants for reconstruction following mastectomy due
to cancer or other disease.

2005-10-09T05:48:00.000-07:00

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2005-10-08T13:48:00.000-07:00

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Despite more than a decade of controversy over their safety, breast
implants are more popular than ever among women who want to build
upon what nature gave them or who want to restore what disease has
taken away. Whatever the reason, opting for breast implants is a
personal decision that should be made only after a woman fully
understands and accepts the potential risks of the devices and the
importance of follow-up evaluations with her physician.

2005-10-08T05:48:00.000-07:00

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Making an Informed Decision About Breast Implants
By Carol Rados

2005-10-07T21:48:00.000-07:00

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The policy outlines various abnormalities that may require breast
augmentation such as trauma, disease and inherited problems. The
policy requires plastic surgeons to determine if potential patients are
emotionally and physically mature enough to have the surgery.

2005-10-07T13:48:00.000-07:00

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"Nevertheless, the ASPS leadership felt a responsibility to more than
just quietly comply with the FDA. We want our members and the
public to see how strongly we feel about teenage cosmetic breast
augmentation," Spear said.

2005-10-07T05:48:00.000-07:00

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"Contrary to popular belief, people 18 and younger make up only 4
percent of all cosmetic plastic surgery procedures. Although the
numbers have increased over the years, teens continue to be a small
percentage of the plastic surgery population," ASPS President Dr.
Scott Spear said in a prepared statement.

2005-10-06T21:48:00.000-07:00

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The new policy is in response to recent media reports about teenage
girls seeking purely cosmetic breast enlargement. The policy is
consistent with the U.S. Food and Drug Administration's rules
regarding saline-filled breast implants for women at least 18 years old.

2005-10-06T13:48:00.000-07:00

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Breast Implants Should Be Adult Matter
New industry policy says teens have to be 18 to have cosmetic breast
surgery
E-mail this article
Subscribe to news
WEDNESDAY, Dec. 29 (HealthDayNews) -- Cosmetic breast
augmentation should be restricted to women aged 18 and older, says
a new policy adopted by the American Society of Plastic Surgeons
(ASPS).

2005-10-06T05:48:00.000-07:00

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Omni BioTech is the second Internet-based, body-enhancement
business to face action by the Attorney General�s Consumer
Protection Division this year. The office earlier settled with a
Snohomish County business that marketed a product called Nature�s
Advantage, which claimed to increase breast size without surgery.

2005-10-05T05:48:00.000-07:00

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Refunds will be offered to hundreds of customers who have already
filed complaints with the company, the Attorney General�s Office or
the Better Business Bureau, or who file complaints with the business
or the AG�s Office within the next three months.

2005-10-04T21:48:00.000-07:00

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Under the settlement, Omni BioTech agreed to pay $34,000 in civil
penalties and legal costs, to pay refunds to dissatisfied consumers,
and to stop selling its products in Washington.

2005-10-04T13:48:00.000-07:00

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Also named in the lawsuit and settlement are Bailey Rosson-Gray,
President of Omni BioTech and her husband Robert Rosson,
secretary of the corporation.

2005-10-04T05:48:00.000-07:00

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The company sold products on a variety of websites, including
http://www.sbsproducts.com, http://www.weightloss-formulas.com,
http://www.dreamalean.com, http://www.mdjournals.com,
http://www.breastenhancement-solutions.com, and
http://www.velotrim.com.

2005-10-03T21:48:00.000-07:00

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SBS products included breast enhancement capsules, liquid, Fenu-
Fennel Spray Lotion, tea and soap, and Sher Breast Cream. In
addition to breast enhancement products, SBS also sold
DreamaLEAN, Simply Slender Body Wraps, and sexual
performance products called Veletrin, Velotrex and Stimulaire.
DreamaLEAN promised to break up fatty pockets and cellulite in
specific areas of the body such as the hips, thighs, stomach, buttocks,
back of the arms, and any other areas with excessive fatty deposits.�

2005-10-03T13:48:00.000-07:00

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The lawsuit alleges that the defendants marketed their products with
unsubstantiated claims of effectiveness. For example, the defendants
claimed that the SBS Breast Enhancement Capsules were �packed
with the only four herbs that actually build healthy new cells and
tissues in the breasts, making them larger and firmer.� The defendants
also claimed that the changes in breast size were permanent and
completely safe.

2005-10-03T05:48:00.000-07:00

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A lawsuit against Omni Bio Tech and the simultaneous settlement
were filed today by the Attorney General�s Consumer Protection
Division in Snohomish County Superior Court.

2005-10-02T21:48:00.000-07:00

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�Products that claim to improve physical appearance will always be
an easy sell,� Gregoire said. �Unfortunately, the evidence to back up
the claims is often less than skin deep.�

2005-10-02T13:48:00.000-07:00

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2005-10-01T21:48:00.000-07:00

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What kind of changes in my implanted breast can I expect with
pregnancy?
What are my options if I am dissatisfied with the cosmetic outcome of
my implanted breast?
How much pain or discomfort will I feel and for how long?
How long will I be in the hospital? Will I need blood transfusions, and
can I donate my own blood?
When will I be able to resume my normal activities?
Source: FDA

2005-10-01T13:48:00.000-07:00

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2005-10-01T05:48:00.000-07:00

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Questions to Ask a Surgeon About Breast Reconstruction
What are all my options for breast reconstruction?
What are the risks and complications of each type of breast
reconstruction surgery and how common are they?
What if my cancer recurs or occurs in the other breast?
Will reconstruction interfere with my cancer treatment?

2005-09-30T21:48:00.000-07:00

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2005-09-30T13:48:00.000-07:00

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How many additional implant-related operations can I expect over my
lifetime?
How will my breasts look if I choose to have the implants removed
without replacement?
What shape, size, surface texturing, incision site, and placement site is
recommended for me?
How will my ability to breast-feed be affected?
How can I expect my implanted breasts to look over time?
How can I expect my implanted breasts to look after pregnancy?
After breast-feeding?

2005-09-30T05:48:00.000-07:00

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Consumers can get a copy of the "FDA Breast Implant Consumer
Handbook 2004," which provides in-depth information on both saline
and silicone breast implants, by visiting
www.fda.gov/cdrh/breastimplants/, or by writing to: FDA, Office of
Device Evaluation, Division of General, Restorative, and Neurological
Devices, 9200 Corporate Blvd., HFZ-410, Rockville, MD 20850.
For More Information
Food and Drug Administration
www.fda.gov/cdrh/breastimplants/
FDA Center for Devices and Radiological Health
Consumer Affairs Staff
(800) 638-2041
National Women's Health Information Center
(800) 994-9662

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Ongoing clinical studies for unapproved saline-filled and silicone gel-
filled breast implants do not allow for those younger than 18 to
receive the implants for augmentation purposes. Some of these clinical
studies even limit reconstruction and revision uses to women 18 and
over.

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"I didn't know my breasts were still growing when I signed up for the
surgery," admits Kacey Long, who got saline-filled breast implants in
July 2001, when she was 19. Prior to her surgery, the college student
from Ennis, Texas, was a 34B--a breast size she thought would be
with her for life.

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The Teen Scene
In addition to safety issues, there is concern about the growing use of
breast implants among teen-agers. Health officials worry that teen-
agers and their parents may not realize the relative permanence of the
changes caused by the devices. They also want to be sure that teens
are physically ready--that is, they're finished developing--and that
they are psychologically mature enough to handle the outcome of
surgery.

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