Toxin Type A (Botox Cosmetic) is a protein complex produced by the bacterium Clostridium
botulinum, which contains the same toxin that causes food poisoning. When used
in a medical setting as an injectable form of sterile, purified botulinum toxin,
small doses block the release of a chemical called acetylcholine by nerve cells
that signal muscle contraction. By selectively interfering with the underlying
muscles' ability to contract, existing frown lines are smoothed out and, in most
cases, are nearly invisible in a week.
are the fastest-growing cosmetic procedure in the industry, according to the American
Society for Aesthetic Plastic Surgery (ASAPS). In 2001, more than 1.6 million
people received injections, an increase of 46 percent over the previous year.
More popular than breast enhancement surgery and a potential blockbuster, Botox
is regarded by some as the ultimate fountain of youth.
was first approved in 1989 to treat two eye muscle disorders--uncontrollable blinking
(blepharospasm) and misaligned eyes (strabismus). In 2000, the toxin was approved
to treat a neurological movement disorder that causes severe neck and shoulder
contractions, known as cervical dystonia. As an unusual side effect of the eye
disorder treatment, doctors observed that Botox softened the vertical frown (glabellar)
lines between the eyebrows that tend to make people look tired, angry or displeased.
But until this improvement was actually demonstrated in clinical studies, Allergan
Inc., of Irvine, Calif., was prohibited from making this claim for the product.
April 2002, the FDA was satisfied by its review of studies indicating that Botox
reduced the severity of frown lines for up to 120 days. The agency then granted
approval to use the drug for this condition.
regulates products, but not how they are used. Approved products are sometimes
used by a licensed practitioner for uses other than those stated in the product
label. Botox Cosmetic, for example, is currently being used by physicians to treat
facial wrinkles other than those specified by the FDA. Consumers should be aware,
however, that this "off-label" use has not been independently reviewed
by the agency, and the safety and effectiveness of Botox injections into other
regions of the face and neck, alone or in combination with the frown-lines region,
have not been clinically evaluated.
Ella L. Toombs,
M.D., a dermatologic medical officer in the FDA's Office of Cosmetics and Colors,
says, "Careful deliberation, investigation and evaluation is undertaken by
the agency before any prescription product is approved." Drugs such as Botox,
which are not indicated for serious or life-threatening conditions, "are
subject to a greater level of scrutiny because of the benefit-to-risk ratio."
Toombs 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 approved
for cosmetic purposes.
Considering Botox Cosmetic?
sure that a qualified doctor performs the procedure.
Make sure that the doctor
is trained and qualified in cosmetic skin surgery of the face.
and be informed about the benefits and risks involved in the procedure.
alcohol and remain upright for several hours following the procedure.
a medical setting using sterile techniques. Necessary equipment should be available
to respond to any potential problems.
Source: The American Society for Dermatologic
The recent rise in the popularity of Botox
has much to do with the manner in which it is frequently marketed. Some practitioners
buy the toxin in bulk and arrange get-togethers for people receiving their treatments.
As in business, volume discounts can be found in medicine.
surgery events known as Botox parties--also seminars, evenings and socials--are
a key element of Botox marketing in much of the United States. The gatherings
are thought to be a convenient means of providing Botox treatments more economically,
and may help reduce the anxiety that normally goes along with getting an injection.
Doctors are finding that treating people in groups allows them to make the procedure
more affordable to their patients.
Here's how a "party"
typically works: A group of often nervous, but excited, middle-aged men and women
mingle in a common area. Sometimes refreshments are served. One by one, as their
name is called, each slips away for about 15 minutes to a private exam room. He
or she pays a fee and signs an informed consent agreement. Anesthesia is rarely
needed, but sedatives and numbing agents may be available. The practitioner injects
about one-tenth of a teaspoon of toxin into specific muscles of the forehead most
often targeted for the effect. The person then rejoins the group.
A. Greenberg, M.D., a board-certified plastic surgeon in Winter Park, Fla., has
been hosting monthly "Botox Happy Hours" in his medical office since
the drug's approval in April. Greenberg feels that these by-invitation-only events
to previous patients "are an opportunity to treat a lot of people at one
time in a relaxed but professional atmosphere." Greenberg says there is no
difference between treating 10 people during individual office visits throughout
the day and treating 10 people individually, but in a more socialized setting.
"The important thing is that the identical standards of medical care are
maintained at these gatherings as in a routine daytime office consultation."
Clifford, Ph.D., of the FDA's Division of Vaccines and Related Products Applications,
explains that "Botox is licensed for marketing and distribution as single-use
vials." This means that as packaged, "each vial is intended to be used
for a single patient in a single treatment session." Botox does not contain
a preservative against potential contamination of the product through repeated
use of a single vial. Once opened and diluted, Botox must be used within four
hours. Treating multiple people with one vial violates product labeling, which
is stated on the package insert, the vial and the carton.
lose something when we mass treat," says Franklin L. DiSpaltro, M.D., president
of the ASAPS. "One of my concerns is that these parties are a marketing tool--gathering
as many patients as possible trivializes a medical treatment, which could deteriorate
over time into a nonprofessional environment." DiSpaltro says there's more
to medicine "than just dispensing drugs."
FDA is concerned that Botox has the potential for being abused. The ASAPS recently
reported that unqualified people are dispensing Botox in salons, gyms, hotel rooms,
home-based offices, and other retail venues. In such cases, people run the risks
of improper technique, inappropriate dosages, and unsanitary conditions. "Botox
is a prescription drug that should be administered by a qualified physician in
an appropriate medical setting," says Toombs.
there is no chance of contracting botulism from Botox injections, there are some
risks associated with the procedure. If too much toxin is injected, for example,
or if it is injected into the wrong facial area, a person can end up with droopy
eyelid muscles (ptosis) that could last for weeks. This particular complication
was observed in clinical trials.
Other common side
effects following injection were headache, respiratory infection, flu syndrome,
and nausea. Less frequent adverse reactions included pain in the face, redness
at the injection site, and muscle weakness. These reactions were generally temporary,
but could last several months.
While the effects of
Botox Cosmetic don't last, still, people don't seem to mind repeating the procedure
every four to six months in order to maintain a wrinkle-free look. Battling the
signs of aging in a non-invasive way, after all, is part of the allure of the
product--that and the fact that there are no unsightly scars, and that there is
very little recovery time with the procedure.
FDA recommends that Botox Cosmetic be injected no more frequently than once every
three months, and that the lowest effective dose should be used.