Perlane

Perlane

Generic Name: dermal filler

Company: Medicis

Treatment for: Facial Wrinkles

FDA Approves Perlane

The U.S. Food and Drug Administration ("FDA") has approved the dermal filler Perlane for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds.

Perlane is comprised of biotechnologically engineered, non-immunogenic, stabilized hyaluronic acid gel particles. Perlane is intended to be implanted into the deep dermis to superficial layer of the subcutis to add volume to restore surface contour in facial wrinkles and folds. The three-dimensional gel particles in Perlane are hydrophilic molecules, attracting and binding to water molecules as they degrade, helping to maintain volume augmentation for about six months.

Perlane is a class III restricted medical device indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. Perlane should only be administered under the supervision of a licensed practitioner.

Patient Information

What is Perlane used for?

Perlane is used to smooth moderate to severe facial folds and wrinkles such as the lines from the nose to the corners of the mouth (nasolabial folds). Perlane generally lasts for about 6 months. It has been found to be a safe dermal filler that restores volume and fullness to the skin.

How does Perlane work?

Perlane is injected into the skin with an ultrafine needle. It plumps the skin to smooth away wrinkles and folds. Perlane’s water-loving nature attracts and binds water molecules to help maintain volume. Perlane is composed of hyaluronic acid, a natural substance that already exists in the body. The hyaluronic acid in Perlane is a crystal clear gel that is chemically cross-linked (the long chemical strands are tied together) to delay breakdown by skin enzymes. Perlane is non-animal-based and free from animal protein. This quality prevents disease transmission. Allergy pre-testing is not necessary.

How long does Perlane last?

Perlane is proven to deliver long-lasting results. Studies have shown that Perlane effects generally last about six months. Perlane gradually disappears from the body without a trace.

Who should not use Perlane (Contraindications)?

Perlane should not be used by people with previous bad allergies (particularly to certain microorganisms known as gram positive bacteria), to drugs that have required in-hospital treatment, or in people with bleeding disorders. Perlane should not be injected anywhere except the skin or just under the skin.

What are some warnings to consider?

The use of Perlane at sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of Perlane in these instances could delay healing or make your skin problems worse.

You may experience skin discoloration (bruising), swelling, redness, tenderness, pain, itching, or small lumps in the area where you are injected. If any of these events occur, the majority usually last less than seven days. If any symptom lasts longer than two weeks, call the doctor who administered the Perlane injection.

Inflammatory papules (red or swollen small bumps) may rarely occur. You may need antibiotics to treat them.

What are some risks that may be experienced?

As with all procedures like this, the injection of Perlane carries a theoretical risk of infection and formation of scar tissue. The safety and effectiveness of Perlane have not been established in the treatment of lips, in nursing mothers, and in patients under 18 or over 65 years of age. Perlane use in nursing could harm you or the nursing child.

The use of Perlane in African-American patients can result in hyperpigmentation (darkening of skin color), which may take several weeks to correct.

If you have had herpes before, an injection can cause the herpes to come back. The safety of Perlane used with other skin therapies such as laser, mechanical or chemical peeling, and hair removal has not been established. The use of Perlane in these skin therapies may not work or they may damage your skin.

You should avoid exposing the area(s) treated with Perlane to excessive sun or UV lamps, and extreme heat and cold until any redness or swelling has disappeared.

What are the major side effects?

Rarely, the doctor may inadvertently inject the product into a blood vessel, which can cause injury to the blood supply and damage to the skin.

Rarely, a few people have developed infections of the gel that must be treated with antibiotics or other treatment. Infection of the gel may be hard to treat, but will always go away when the gel is absorbed.

What should patients do prior to treatment?

Perlane requires no pretesting, but you should take a few precautions before being treated. Avoid using St. John’s Wort, high doses of Vitamin E supplements, aspirin, and other non-steroidal anti-inflammatory medications, such as ibuprofen prior to treatment, because these may increase bruising or bleeding at the injection site. Also, if you have previously suffered from facial cold sores, discuss this with your physician. He or she may consider prescribing a medication to minimize recurrence.

Do the injections hurt?

Perlane is injected directly into the skin in tiny amounts by an ultrafine needle. To help maximize your comfort, you should discuss the use of numbing medicines with your doctor before treatment.

How much do Perlane treatments cost?

Perlane is a customized procedure based on your specific needs, so the cost will vary from patient to patient. In general, the cost of Perlane is comparable to the cost of similar procedures. Because Perlane is long lasting, it may prove to be very economical over the long term. Please ask your doctor to give you an estimate of the cost.

What should I call my doctor about after the treatment?

Most side effects like bruising, swelling, pain, tenderness, redness, and itching will usually go away within a week. Call your doctor if you have persistent problems beyond 14 days.

Blisters or skin sores may signal that you are having a recurrent herpes infection that should be treated.

You can develop an infection that should be treated with antibiotics. If you experience redness, tenderness, and pain that does not go away you should call your doctor.

What is the dose of Perlane?

The amount used depends on your face and what you would like to have treated. The average patient who has all of the severe wrinkles around the mouth corrected will use less than half of a tablespoon.

Post-Treatment Checklist

Please observe the following after treatment with Perlane:

Cold compresses (a cloth dipped in cold water, wrung out, and applied to the injected area) may be used immediately after treatment to reduce swelling.

Avoid touching the treated area within six hours following treatment so you do not accidentally injure your skin while the area is numb. After that, the area can be gently washed with soap and water.

Until there is no redness or swelling, avoid exposure of the treated area to intense heat (sun lamp or sun bathing).

If you have previously suffered from facial cold sores, there is a risk that the needle punctures could contribute to another occurrence. Speak to your physician about medications that may minimize a recurrence.

Avoid taking aspirin, non-steroidal anti-inflammatory medications, St. John’s Wort, and high doses of vitamin E supplements for one week after treatment. These agents may increase bruising and bleeding at the injection site.