Posts Tagged ‘Fda Approval’

What is Botox®, and How Does it Work?

Saturday, November 21st, 2009
Patricia Woloch recently asked:


Since its introduction and approval in 2002, Botox® has become the number one cosmetic surgery procedure in the United States, according to the statistics of the American Society of Plastic Surgeons. This seemingly magic cure for deep-set frown lines and rugged furrowed brows is very popular among politicians and Hollywood actors. With its relatively low cost and long lasting effects, over 4 million people in the U.S chose Botox treatments in 2006 alone.

Botox is made of a sterile form of botulinum toxin, which is injected under the skin to deaden the nerve endings that cause wrinkles. When injected, the toxin inhibits the release of the chemical acetylcholine, which signals the muscles in your face to contract. Since those muscles are chemically paralyzed, they do not pinch the skin and cause wrinkles to form.

Even though Botox is made from a deadly toxin produced by Clostridium botulinum, it is relatively safe. The toxin itself is extracted from the live bacteria, and no live bacteria are injected into the skin. There is no chance of contracting botulism. Only small, localized doses of the toxin are administered during treatments, and the risks are relatively small.

The toxin treatment was first approved to treat blepharospasm (twitching eye muscles) in 1989. Cosmetically desirable effects of Botox were noticed when the frown lines between the eyebrows were observed to soften following treatment applied for eye muscle disorders. Subjects no longer had deep creases or folds of tissue near the areas where the injections were given.

These observations lead to clinical trials and subsequent FDA approval as a cosmetic application in April 2002. As of 2006, Botox injection are the most common cosmetic procedure in the United States.

Since Botox is not an injectable filler, but a chemical blocker, many wrinkle lines are not treated with Botox. Sun damaged skin and other wrinkles that are not caused by neuromuscular action are better treated with injectable fillers like collagen or Restylane.

The number of injections needed is based on the area being treated. Crow’s feet might only take from two to five injections where as glabellar lines (furrowed brow) might take eight to ten injections. The injection sessions usually only take from ten to fifteen minutes of your time, and you can resume normal activities right away.

Like all medical treatment, Botox does have potential side effects.

Some of the side effects may include:

• Pain

• Bruising

• Redness

• Nausea

• Headache

• Ptosis (drooping of upper eyelid)

There is virtually no down time after a Botox injection treatment, you can resume a normal day as soon as you leave the physician’s office. Be careful not to rub or massage the treated area as this could cause the injected material to migrate to other areas. Full results are seen after a few days, and last up to six months. Re-injections are needed to maintain your new fresh appearance. Cosmetic Botox® injections should be given no more than once every three months.

It is important to find a doctor who has experience with Botox injections to minimize risks, and ensure proper dosing. Botox is delivered to the physician in dry form and must be reconstituted with the right amount of saline. Each vial of Botox is intended for onetime use on a single patient.

A growing phenomenon around the country is the so-called “Botox parties” where a clinician will open up his clinic and basically throw a party. As the participants wait their turn for injection, they socialize and have fun. The FDA has issued warnings about these types of events as they can diminish the serious nature of the injections and their use. However, when compared to other cosmetic treatments, the complication rate of Botox is remarkably low. A recent campaign to put more severe warnings on Botox by the group Public Citizen, listed only one death from cosmetic treatment with the drug. Considering the millions of treatments performed annually, this represents a fraction of a tenth of a percent of a percent of risk.





“Incredible Injectables” - A Great Cosmetic Choice

Thursday, October 8th, 2009
Michele Ellingsen recently asked:


Most injectables fall into the category of “fillers” and are designed to fill in wrinkles and depressions in the face. You’re probably familiar with the filler product, Collagen, and there are dozens more available on the market today. Botox is slightly different from fillers in that it works by weakening ****** muscles in order to lessen the appearance of wrinkles and frown lines. With the exception of one product, the recently FDA-approved Artefill, these injectables disappear after a period of time; Artefill is different in that it is considered “permanent”.

Patients often have ****** filler and Botox injections done at the same time. When you meet with a board-certified dermatologist or a board-certified plastic surgeon, he or she will able to advise you as to which product or products will best help you achieve your desired result.

ARTEFILL: This is a non-resorbable filler that recently received FDA approval. We expect to see it available to patients early in 2007. Anyone who has used other fillers in the past may find Artefill to be a great choice. Artefill is made up of particles of polymehtymethacrylate (PMMA) that are carried in purified collagen gel, so a skin test prior to treatment is required. Artefill is injected in stages over a period of several weeks to months. It’s indicated use is for folds around the nose and upper lip (nasolabial folds).

BOTOX: A neurotoxin drug (Botulinum toxin) that acts by temporarily blocking nerve pulses in ****** muscles. It tends to be most effective in muscles related to expression lines around the eyes, forehead and mouth. It is often effective in areas where fillers may not be. Botox is a very safe and effective injectable and therefore very popular among patients.

CAPTIQUE: A hyaluronic acid filler with a finer consistency than some and often is selected for areas closer to the surface of the skin to erase fine lines and wrinkles.

COLLAGEN: The new generation of Collagen, CosmoDerm and CosmoPlast, are based on human collagen so no pre-testing is required. Zyderm and Zyplast are Collagen products derived from cows and do require a pre-test. Collagen is a dermal filler and it is good for ****** fine lines and furrows, especially for fine lines around the eyes.

JUVEDERM: This is a filler that works together with the body’s own hyaluronic acid to create volume. Just released to market in 2007, Juvederm is effective for the nasolabial folds, under the eyes, between eyebrows and for lip-plumping.

RADIESSE: Another “filler,” made of calcium hydroxiapatite (CaHA), which is a primary component of teeth and bones. No skin testing is required. This product has a thicker consistency and is best for deeper nasolabial folds and rebuilding hollow areas. The consistency of this product allows it to last longer than most fillers, up to a year or longer.

RESTYLANE: Next to Botox, Restylane is the second most common injectable. It is a hyaluronic acid filler that plumps up creases under the skin. This filler is also used for nasolabial folds, under the eyes and between eyebrows, with results that can last up to six months. Restylane is the most popular product for creating fuller looking lips.

SCULPTRA: Another filler, Sculptra is composed of poly-L-lactic acid, a synthetic material and does not require a skin test. This product fills in wrinkles and depressions in ****** areas such as the nasolabial folds. Sculptra is injected in small amounts so for certain areas multiple treatments are necessary but results can last a year or more.

Deciding which “incredible injectable” is right for you, considering all the variable of your own body as well as your goals and expectations, is something to discuss with a qualified, experienced, board-certified dermatologist or board-certified plastic surgeon. Only a trained, experienced physician can safely determine which, if any, injectable is suited to you, individually. While other “licensed health professionals” may legally inject dermal fillers, we recommend that you adhere to the standard of having a physician give you advice and do your treatment.

Note: The specific risks and the suitability of any injectable product for a given individual can be determined only at the time of consultation with a physician. All procedures have some degree of risk. The information provided here is not a substitute for a consultation.





Botox Sydney Botox is Probably the Most Talked About and Popular Cosmetic Procedure of Today

Wednesday, July 8th, 2009
Freelance Writer recently asked:


Botox

Botox is probably the most talked about and popular cosmetic procedure of today. Since its release millions of women, and men have been rushing into the offices of the nearest practitioners to have the procedure done. With the FDA approval for cosmetic procedure came the emergence of the trendy “Botox parties.” Practitioners began sending out invitations to potential candidates for food, drinks, conversation and a Botox injection. While the procedure itself is quick, and virtually painless you would be well advised to discuss the procedure with your doctor beforehand and schedule an appointment to have the treatment administered in a clinical setting, rather than at a social affair.

Botox is a trade name for the neurotoxin botulinum type A; a complex protein produced by the bacterium Clostridium botulinum. The botulinum toxin acts as a nerve blocker and binds itself to the nerves leading to the muscle preventing the release of acetylcholine, a neurotransmitter that stimulates the muscle to contract. Botulism is a paralyzing form of food poisoning that occurs when the neurotoxin is ingested, the reason that it can be fatal is usually due to the paralysis of the respiratory muscles making it impossible to breath. So in this way, Botox is related to the food borne illness, but that is where the similarities end. With controlled application the botulinum type A can be injected into specific muscles and alleviate many problems associated with muscle spasms, or involuntary contraction of the muscle. Botox Cosmetic, when injected into the corrugator and procerus muscles, temporarily prevents them from contracting and this is what reduces the appearance of glabellar, or frown lines. Basically if the muscles cannot contract, or scrunch up, the wrinkles go away.

Botox has been indicated in treatment of several medical conditions, and has been proven to successfully treat blepharospasm, a condition which causes the involuntary spasmodic contraction of certain eye muscles, strabismus, a manifest lack of parallelism of the visual axes of the eyes, or crossed eyes and cervical dystonia, a state of abnormal tension in any of the tissues resulting in the impairment of a person’s voluntary movement in the neck area. It has also been used to treat other dystonias, such as writer’s cramp, as well as ****** spasms, head and neck tremors and hyperhidrosis, or excessive sweating. Other applications for which Botox may be useful are currently being investigated. By injecting the toxin into the affected muscles the spasms or contractions that normally occur are greatly reduced or eliminated. The effects of the treatment for these conditions can be seen and felt anywhere from a couple of hours to a couple of days after treatment, they are temporary and will last anywhere from three to eight months.

Botox Cosmetic is a simple non-surgical treatment that has been proven to treat moderate to severe glabellar, or frown lines and eliminates wrinkles temporarily. It is the only treatment of its kind approved by the FDA for use in adult patients aged 18-65. The FDA approved the use of Botox for cosmetic use in April of 2002 and before that it was approved for use to treat certain medical conditions since 1989. In the year 2005 there were over 3 million procedures performed.

The procedure itself takes about ten minutes and involves a few tiny injections. The injections go directly into the muscle and then it enters into the nerve endings to block the chemical that causes the muscle to contract. Once the muscles are at rest and can no longer contract the appearance of the skin becomes firmer and smoother and the lines or wrinkles that would normally be see are greatly diminished or eliminated altogether. The results of the treatment can usually be seen within hours and will last for about four months. Because the treatment targets only certain areas and only the muscles that are affected the risk of the toxin spreading is severely reduced.

A topical anesthetic is usually applied to the area that will be treated to numb the injection site. There is usually only minimal pain or discomfort associated with the actual injection but it does not persist past the process of injection. There is usually no downtime resulting from the procedure so return to work and normal activity can usually resume immediately. There is usually little to no bruising, bleeding, swelling, pain or other discomfort involved with the procedure.

It would seem only natural to think that there would be a lot of risk involved with injecting toxins into the body but in fact Botox injections are believed to be safe and result in few side effects. Any side effects that may arise from the treatments typically last no more than six months since the treatment itself is temporary. The most common, but rare side effects associated with treatment include bruising at the site of the injection, headache, respiratory infection, nausea, and flu like symptoms. In rare occurrences the Botox cosmetic may spread to adjoining muscles and cause temporary paralysis. In less than 1% of patients this can cause drooping of the eyelid. Less frequently occurring side effects include pain in the face, erythema, or abnormal redness at the injection site, and muscle weakness. These adverse reactions occurred in less than 3% of patients and occurred within the first week of treatment. They are thought to be associated with the injection itself.

There are only few restrictions to who is eligible to receive treatment. Those who are pregnant or nursing are definitely ineligible. Those who suffer from neuromuscular disease have allergies to certain medications or who are taking certain medications should discuss this in depth with their physician, as they may not be eligible for treatment. Any medications that are being taken should always be disclosed as certain medications; mostly antibiotics can alter the effects of Botox. Many people return for new treatments as soon as the effects start to wear off. The cost of the procedure varies depending on how many areas are being treated and who is performing the procedure. The price typically ranges from $175 for one area of treatment to $800 for three or more areas of treatment.