Botox TM Also called: Botulinum toxin type
Botox is a drug made from a toxin
produced by the bacterium Clostridium botulinum. It's
the same toxin that causes a life-threatening type of food
botulism. Doctors use it in small doses to treat
health problems, including
- Temporary removal of facial wrinkles
- Severe underarm sweating
- Cervical dystonia - a neurological disorder that causes
severe neck and shoulder muscle contractions
- Blepharospasm - uncontrollable blinking
- Strabismus - misaligned eyes
Botox injections work by weakening or paralyzing certain
muscles or by blocking certain nerves. The effects last about
three to four months. Side effects can include pain at the
injection site, flu-like symptoms, headache and upset stomach.
Injections in the face may also cause temporary drooping
eyelids. You should not use Botox if you are pregnant or breast
Botox Restylane and Injectables - Before and After
Facial Refinement / Restylane
Restylane (Hyaluronic Acid)
injection gave this middle aged woman the desired
wrinkle reducer around the mouth and
Add to 'My Interests'
Science Meets Beauty: Using Medicine to Improve
By Carol Rados
A smaller nose. Bigger breasts. Slimmer thighs. Plumper
lips. Less hair on the body. More hair on the head. Whether
we're looking to tighten our tummies or lighten our laugh
lines, America's fascination with youth and beauty has long
fueled the development of medical products for cosmetic
purposes. And if such "vanity drugs" can be shown to be safe
and effective, the Food and Drug Administration just may
The ongoing fight to delay or reverse the aging process has
dermatologists and cosmetic plastic surgeons responding with
products like Restylane (hyaluronic acid), one of a handful of
soft tissue fillers recently approved by the FDA to treat
facial wrinkles. Restylane is an injectable gel that acts as a
filler to remove the wrinkle, producing instantaneous results.
Such products are not as invasive as facelifts, eyelid surgery,
and other reconstructive procedures. And they are more
effective and last longer than creams, lotions and other
topical products, whether over-the-counter or prescription. In
addition, the fact that the treatments result in little or no
downtime makes them more attractive to those seeking a quick
fix. Without making a single incision, doctors can erase
wrinkles, acne scars and sun damage in a matter of minutes.
"This is a huge industry," says Jonathan K. Wilkin, M.D., a
medical officer in the FDA's Division of Dermatologic and
Dental Drug Products. "The way people try to move the clock
back is through the skin." Basically, he says, through various
products and procedures, "they are addressing the effects of
gravity on the skin over time."
Aging Skin 101
An increased understanding of the structure and function of
the skin is helping to drive the development of products that
reduce the visible signs of facial aging, according to the
American Academy of Dermatology (AAD).
With aging, all skin cells begin to produce excess amounts
of free radicals--unstable oxygen molecules that, under ideal
circumstances, are removed by naturally occurring antioxidants
within the skin's cells. In aging skin cells, antioxidants are
in short supply. The free radicals generated are left unchecked
and cause damage to cell membranes, proteins, and DNA. These
free radicals eventually break down a protein substance in
connective tissue (collagen) and release chemicals that cause
inflammation in the skin. It is a combination of these cellular
and molecular events that leads to skin aging and the formation
of wrinkles, the AAD says.
As we get older, two components of our skin--collagen
and elastin--degenerate, setting the stage for the
appearance of wrinkles, creases, folds, and furrows. The
breakdown of these components, accelerated by sun exposure
and gravity, results in the sagging skin of old age.
Illustration by Renée Gordon.
Source: National Institute on Aging.
Considerable research has been done to understand the aging
process, and studies now show that products containing
bioactive ingredients (those that interact with living tissues
or systems) can benefit sun-damaged, discolored, and aging
skin, giving consumers new choices for restoring their overall
appearance. But why is the FDA reviewing products that simply
make people look and feel good when typically the agency
evaluates disease-fighting treatments?
"If something that is being implanted into the body could
have health consequences, we're concerned about it," says
Stephen P. Rhodes, M.S., chief of the FDA's Plastic and
Reconstructive Surgery Devices Branch. "Wrinkle fillers affect
the structure of the face and could have such health
Under the Federal Food, Drug and Cosmetic Act, the FDA
legally defines products by their intended uses. Drugs are
defined as products intended for treating or preventing disease
and affecting the structure or any function of the body. A
medical device is a product that also is intended to affect the
structure or function of the body, but which does not achieve
its primary intended purposes through the chemical action of a
drug--nor is it dependent on being metabolized.
The hyaluronic acid in Restylane, although biosynthetically
produced (formed of chemical compounds by the enzyme action of
living organisms), is almost identical to that in all living
organisms. Hyaluronic acid is a structural component of skin
that creates volume and shape. Concentrations of hyaluronic
acid throughout the body decline with age, causing undesirable
changes in the skin. Restylane binds to water and provides
volume to easily fill in larger folds of skin left by tissue
loss around the mouth and cheeks. "This makes it a structural
action," says Rhodes, "much like a chin implant."
In contrast, cosmetics are defined as substances that
cleanse, beautify, promote attractiveness, or alter the
appearance, without affecting the body's structure or function.
This definition includes skin-care products such as creams,
lotions, powders and sprays; perfume; lipstick; fingernail
polish; and more.
Different laws and regulations apply to each type of
product. Some products must comply with the requirements for
both cosmetics and drugs. This happens when a product has two
intended uses, such as an antidandruff shampoo. A shampoo is a
cosmetic because it is intended to clean hair. An antidandruff
shampoo is a cosmetic and a drug because it is intended to
treat dandruff (which affects the follicles where the hair is
formed) and clean hair.
Warning letters issued by the FDA recently to firms that
marketed hair care products with claims such as restoration of
hair growth and hair loss prevention illustrate an important
distinction between the legal definitions of cosmetics and
drugs. Warning letters officially inform companies that they
may be engaged in illegal activities, and instruct
manufacturers on how to bring their products into compliance
with the law. Hair growers and hair loss prevention products,
because of their mechanism of action, are considered drugs, not
cosmetics, and these firms were not meeting the legal
requirements for marketing a drug.
Unlike drugs and medical devices, neither cosmetic products
nor cosmetic ingredients are reviewed or approved by the FDA
before they are sold to the public. The agency only acts
against cosmetic products found to cause harm after they are on
Cosmetics or Drugs?
Much confusion exists about the status of cosmetic products
having medicinal or drug-like benefits, says Linda Katz, M.D.,
M.P.H., director of the FDA's Office of Cosmetics and Colors.
Although the FDA does not consider the term "cosmeceutical" to
be a valid product class, Katz says it is used throughout the
cosmetic industry to describe products that are marketed as
cosmetics but that have drug-like effects. Tretinoin (retinoic
acid), the biologically active form of vitamin A, for example,
is not prohibited from use in cosmetics. However, when it is
used topically for treating mild to moderate acne, sun-damaged
skin, and other skin conditions, it is recognized by the FDA as
a drug. This is because it acts deep at the skin's cellular
level by increasing collagen.
According to the AAD, the answer to whether or not
cosmeceuticals really work lies in the ingredients and how they
interact with the biological mechanisms that occur in aging
skin. The regulatory question the FDA faces when considering
such products, Katz says, "is whether or not a manufacturer is
making a structure or function claim."
The FDA uses different standards when evaluating the risks
and benefits of products used for cosmetic treatments than for
therapeutic uses of products. Steven K. Galson, M.D., M.P.H.,
acting director for the FDA's Center for Drug Evaluation and
Research, adds that products like tretinoin and Restylane that
are not indicated for serious or life-threatening conditions
are subject to close examination by the agency because of the
"Because these products are for cosmetic purposes, they must
be extraordinarily safe," Galson says. This means that the FDA
may allow someone to incur a greater risk from products that
treat medical conditions, rather than from those that are
intended for cosmetic purposes. "We generally won't tolerate
much risk for a drug whose primary use is cosmetic," he
Welcome Side Effects
Many cosmetic treatments are the result of common disease
therapies whose unexpected side effects were pleasant
surprises. Vaniqa (eflornithine hydrochloride), the first
prescription drug for removing unwanted hair, is a topically
applied version of a drug that was originally developed to
treat African sleeping sickness. Similarly, minoxidil
originally had been prescribed as an oral tablet to treat high
blood pressure. As a result of side effects that included hair
growth and reversal of male baldness, Rogaine (2 percent
minoxidil) was the first drug approved by the FDA for the
treatment of hair loss (androgenetic alopecia).
"There's a lot of serendipity in drug development," says the
FDA's Wilkin. A pill to help smokers quit, for example, evolved
out of the unexpected observation that a drug intended to treat
depression also seemed to take away the desire to smoke.
Bupropion was first marketed in 1989 by GlaxoSmithKline as an
antidepressant under the name Wellbutrin. After doctors noticed
that patients being treated with Wellbutrin gave up smoking
spontaneously, studies were done to show that the product could
help smokers quit, as well. As a result, the slow-release form
of bupropion, marketed as Zyban, was approved by the FDA in
1997 as an aid to smoking cessation treatment.
Some pharmaceutical companies, however, apparently aren't
ready to enter the vanity drugs arena. Patrick Davish, the
global product communications spokesman for Merck & Co.
Inc., says that the drug company has no "cosmetic" drugs in its
product pipeline at this time.
"The fact that we don't participate in that market right
now-I'm not sure that's reflective of any particular
deliberation or decision," he says. "That's just not where the
science has taken us."
Before electing to have a cosmetic procedure
- Discuss it with a physician who can refer you to a
specialist in the fields of dermatology and aesthetic
- Begin with a consultation to find the right doctor,
and select one who is qualified to do the procedure you
- Make sure the doctor you choose is certified by an
appropriate medical board.
- Have realistic expectations about the benefits you
want to achieve.
- Compare fees--insurance does not usually cover
According to the American Society for Aesthetic Plastic
Surgery (ASAPS), nearly 7 million Americans underwent surgical
and nonsurgical cosmetic procedures in 2002. Laura Bradbard was
one of them.
Despite the sudden explosion of such "lunchtime" techniques
as Restylane for erasing wrinkles, and Botox (botulinum toxin
type A) for smoothing out frown lines, Bradbard, of
Gaithersburg, Md., opted for a longer-lasting reconstructive
facelift that included a chin implant, eyelid surgery, and
surprisingly, only a few days of pain-free recovery.
"None of this was medically necessary," admits Bradbard, a
48-year-old FDA press officer, "but I had been feeling worn out
and tired. What I saw in the mirror was sad." Bradbard says she
didn't get a facelift to look younger; she only wanted her face
to look more balanced. In the end, she says, "My doctor gave me
a chin that geometrically fit my face," and a look that she
says makes her feel better about herself.
Like Bradbard, others are spending a lot of money to look
good. "With patients living 90-plus years, today's anti-aging
modalities offer people noninvasive procedures that mimic true
facelifts," says Craig R. Dufresne, M.D., a plastic and
reconstructive surgeon in Chevy Chase, Md., who performed
Bradbard's surgery. However, Dufresne says he suggested
reconstructive surgery for Bradbard because "she wanted to deal
with structural changes to restore facial balance," which was
more than the chemical action of a drug could produce. "And
skin product application (such as wrinkle fillers) following a
facelift," adds Dufresne, "will actually allow the facelift or
any other reconstructive procedure to last longer and make a
great result even better."
Top 5 Cosmetic Nonsurgical
botulinum toxin injection (Botox®, Myobloc®)
laser hair removal
Source: American Society for
Aesthetic Plastic Surgery
Top 5 Cosmetic Surgical
Source: American Society for
Aesthetic Plastic Surgery
Seeking Professional Advice
Since it is often difficult for people to determine the
validity of claims made about topical products and to decide
among the overwhelming number of anti-aging procedures, how do
people know what's right for them?
"A good place to start is with a dermatologist," says
Arielle N.B. Kauvar, M.D., clinical associate professor of
dermatology at the New York University School of Medicine.
"Dermatologists are trained in the health, function and disease
state of the skin, and people could save time, money and
confusion by seeking the advice of a dermatologist rather than
guessing what might work for them."
Kauvar says a dermatologist's recommendations can help
consumers make informed decisions. "People shouldn't hunt and
peck for products," she adds. "Not knowing what type of skin
you have is why so many people try unnecessary products that
can often do more harm than good."
An expert in laser procedures, Kauvar says that, in the
past, techniques for improving aging skin required invasive
laser or surgical procedures, which produced open wounds and
required long recovery times. Today, she says, people can
choose from a variety of non-ablative (non-wounding) laser
treatments that are designed to reverse, improve or erase the
early signs of aging, take very little time to perform, and
have a minimal, if any, recovery time.
While Bradbard wasn't interested in removing wrinkles at the
time of her facelift, given what she knows about new
technologies and drug delivery systems today, she says, "I
would consider both non-invasive procedures and another
facelift down the road, depending on how much my skin changes.
I would ask my doctor what would give me the best results with
the longest-lasting effects."
Anti-aging products that promise to diminish wrinkles and
fine lines are found on many store shelves. However,
dermatologists recommend that people consider only those
procedures and products that have proven, over time, to be most
effective at reversing the aging process. Most doctors agree
that the leading product to prevent premature wrinkles and sun
damage is sunscreen. A broad-spectrum sunscreen that protects
the skin from both UVA and UVB rays, with a sun protection
factor (SPF) of 15 or higher, can prevent the skin from looking
older than it is.
According to the ASAPS, it's important to realize that
although certain products and procedures are effective, they
are also limited by the skin's normal aging process. A product
that has been deemed effective for erasing wrinkles doesn't
necessarily erase wrinkles--there are lots of variables that
determine its effectiveness.
For example, the active ingredient in a drug must be
delivered to the skin at a therapeutic concentration and remain
in the skin long enough to have an effect. Also, because the
composition of a man's body differs from a woman's, products or
procedures can have different effects. The facial area in men
contains hair, for example, and their skin is thicker. This
means the blood supply is greater--and so is the risk of
bleeding--but it also could mean better healing.
And cosmetic procedures come with risks. If a procedure is
performed poorly, the physical and emotional scars could be
carried for life. Understand the risks and side effects that
may be involved.
"My wanting to improve my appearance is like my husband's
desire to restore a vintage automobile," says Bradbard. "We
both want something to look good for as long as it can."
For More Information
American Academy of
PO Box 4014, Schaumburg, IL 60168-4014
for Dermatologic Surgery
5550 Meadowbrook Drive, Suite 120, Rolling Meadows, IL
for Aesthetic Plastic Surgery
11081 Winners Circle, Los Alamitos, CA 90720