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liposuction | Facelift | Botox
Breast Augmentation Houston
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 approve.
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 consequences."
Facing Facts
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 the market.
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 benefit-to-risk
ratio.
"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 says.
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 plastic surgery.
Begin with a consultation to find the right doctor, and
select one who is qualified to do the procedure you want.
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 elective
procedures.
Saving Face
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 Procedures
(2002)
botulinum toxin injection (Botox®, Myobloc®)
microdermabrasion
collagen injection
laser hair removal
chemical peel
Source: American Society for Aesthetic
Plastic Surgery
Top 5 Cosmetic Surgical Procedures
(2002)
lipoplasty (liposuction)
breast augmentation
eyelid surgery
rhinoplasty (nose reshaping)
breast reduction
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."
Buyer Beware
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 Dermatology
PO Box 4014, Schaumburg, IL 60168-4014
(888) 462-3376
American Society for Dermatologic
Surgery
5550 Meadowbrook Drive, Suite 120, Rolling Meadows, IL
60008
(800) 441-2737
American Society for Aesthetic Plastic
Surgery
11081 Winners Circle, Los Alamitos, CA 90720
(888) 272-7711
General/Overviews
Botox Cosmetic: A Look at Looking Good (Food and Drug
Administration)
Botulinum Toxin (American Academy of Dermatology)
Tired of That Same "Old" Expression? Botulinum Toxin Erases
Signs of Aging and Common Facial Expressions (American
Academy of Dermatology)
Disease Management
Safe Administration of Botulinum Toxin is the Key Ingredient
to Younger, Smoother Skin (American Academy of Dermatology)
Specific Conditions/Aspects
Botox and Migraine (American Council for Headache Education)
Botox Treatment (Children's Hemiplegia and Stroke Association)
Botox: Can It Treat Fibromyalgia? (Mayo Foundation for
Medical Education and Research)
Botulinum Toxin Injections: A Treatment for Muscle Spasms
(American Academy of Family Physicians)
Botulinum Toxin Type A (BTX-A) for Dystonia (We Move)
Botulinum Toxin Type B (BTX-B) for Dystonia (We Move)
Organizations
American Academy of Dermatology
American Society of Plastic Surgeons
We Move
From the National Institutes of Health
Skin Care and Aging (National Institute on Aging)
General/Overviews
Mature Skin (American Academy of Dermatology)
What Is Aging Skin? (American Academy of Dermatology)
Pictures/Diagrams
Slide Show: How Aging Affects Your Skin (Mayo Foundation
for Medical Education and Research)
Research
FDA Approves New Product for Facial Wrinkles (Food and
Drug Administration)
More Ways to Rejuvenate Your Face (American Academy of
Dermatology)
Specific Conditions/Aspects
Aging Eyelids (American Society for Dermatologic Surgery)
Aging Skin FAQs (American Academy of Dermatology)
Collagen Creams: Do They Nourish the Skin? (Mayo Foundation
for Medical Education and Research)
Liver Spots and Aging Hands (American Society for Dermatologic
Surgery)
Smoking: How Does It Cause Wrinkles? (Mayo Foundation
for Medical Education and Research)
Treatment
Cosmetic Procedures (American Academy of Dermatology)
Laser Resurfacing: One Way to Treat Wrinkles (Mayo Foundation
for Medical Education and Research)
Saving Face: The Nips and Tucks of Face-Lifts (Mayo Foundation
for Medical Education and Research)
Treating Non-Facial Aging Skin (American Academy of Dermatology)
Wrinkle Treatment: When You Don't Want a Face-Lift (Mayo
Foundation for Medical Education and Research)
Dictionaries/Glossaries
AgingSkinNet: Glossary (American Academy of Dermatology)
Glossary of Terms (American Academy of Facial Plastic
and Reconstructive Surgery)
Directories
Find a Dermatologic Surgeon (American Society for Dermatologic
Surgery)
Find a Dermatologist (American Academy of Dermatology)
Organizations
American Academy of Dermatology
American Society for Dermatologic Surgery
National Institute of Arthritis and Musculoskeletal and
Skin Diseases
Also available in: Spanish
National Institute on Aging
Information from the Medical Encyclopedia
Skin Aging
Dermatologic Surgery
Dermatologic surgeons are board-certified specialists
in dermatology who are trained and experienced in procedures
to repair the function and improve the appearance of the
skin. Using a variety of sur details...
American Society For Dermatologic Surgery
Find a Dermatologic Surgeon
Search by name, state, or procedure to find a dermatologic
surgeon. details...
American Society For Dermatologic Surgery
Find a Dermatologist
The American Academy of Dermatology is the largest and
most influential of all dermatologic associations. With
a membership of 13,000 it represents virtually all practicing
dermatologists in the Unite details...
American Academy of Dermatology
Health Information from the National Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS)
Browse this site for online publications, consensus statements
and fact sheets on musculoskeletal and skin diseases.
Includes information about Fibromyalgia, hip and knee
joint problems, vitiligo, pso details...
National Institute of Arthritis and Musculoskeletal and
Skin Diseases, National Institutes of Health
Online Digital Dermatology Image Library
This site features over 3,000 dermatology images for use
by health care professionals, parents, and patients. details...
Educational Institution--Follow the Resource URL for More
Information
Retinoids
In recent years new synthetic derivatives of Vitamin A
(retinoids) have been developed for the treatment of various
skin conditions, such as severe acne, sun spots, wrinkles,
and psoriasis. Some retin details...
American Society For Dermatologic Surgery