You’d like a way to smooth wrinkles, but you want a gentle, discreet way to do it. That’s why there’s PREVELLE Silk, a dermal filler that contains lidocaine, a common local anesthetic that can increase your comfort during treatment. And with PREVELLE Silk, you’ll see visible results right away—with little or no downtime following the procedure.

It takes only about 30 minutes, and most patients experience little or no downtime following the procedure. Smoother skin with minimal disruption. Now that’s time management!

• Increased comfort with the addition of lidocaine
• Effective treatment for lines and folds
• Soft, natural results
• Convenient, same-day procedure
• Immediate results
• Minimal irritation post-procedure
• Little or no downtime

What are the risks of using PREVELLE® SILK?

As with all procedures that involve an injection through the skin, there is a risk of infection occurring following treatment.

The most common symptoms with PREVELLE SILK include temporary injection site reactions such as swelling, pain/tenderness, redness, and lumps/bumps which are normal after hyaluronic acid injections (see Table 1). These reactions are typically mild and go away within 3 days. Some patients may experience one or more of these symptoms for a longer period of time than expected; however, these symptoms typically go away without treatment.

Is the product safe?

The product is safe for most patients. However, patients with certain conditions or allergies should not use this product (see the section “What should Dr. Keshwani WARN me about?”). Dr. Keshwani will ask you about your medical history to determine whether PREVELLE SILK is right for you.

Do the injections hurt?

In general, patients may experience varying levels of discomfort. However, PREVELLE SILK contains Lidocaine that helps reduce injection site pain. In a clinical study, 87% of patients experienced significant pain relief at the time of injection with PREVELLE SILK. Dr. Keshwani may choose additional anesthetic to further minimize discomfort.

What did the clinical studies show?

PREVELLE SILK was studied in 45 patients who were injected with PREVELLE SILK on one side of the face and Captique, another hyaluronic dermal filler, on the other side of the face. Local symptoms were reported in diaries for 14 days by the study patients. Most symptoms were mild and went away within 3 days. These results are shown in Table 1 below.

In the clinical study, 69% (29) of the 42 patients who responded to the questionnaire preferred treatment with PREVELLE SILK over Captique. Of these 29 patients, 97% (28) preferred PREVELLE SILK because it was less painful (see Figure 1).

What should I ask Dr. Keshwani about after my treatment?

Ask when you may resume normal activities such as strenuous exercise, sun exposure or tanning booths, and alcoholic beverages. You may also want to know when it is safe to have laser treatments or chemical peels.

When can I apply make up after the procedure?

You should ask Dr. Keshwani as to when make up can be applied.

How often will I require treatment?

After the initial injection an additional treatment, or touch up, may be needed 1 to 2 weeks later to achieve the desired level of correction. Over time PREVELLE SILK will be broken down naturally by your body, which is why you may want repeat treatments. In general, repeat treatments are needed within 3 to 6 months to maintain the desired result, but the timing of additional treatment varies from person to person.

What other treatments are available?

There are a variety of treatments available for correcting wrinkles and folds, which include other dermal fillers, facial creams, chemical peels, and laser skin surface treatments. Consult with Dr. Keshwani to determine which one is right for you.

When should I notify my health care professional?

Be sure to report to your health care professional any redness and/or visible swelling that lasts for more than a few days or any other symptoms that cause you concern. In addition, you may contact Mentor (1-888-704-9193).

Table1 – Symptoms Reported in Patient Diaries After Treatment

How is PREVELLE SILK used?

PREVELLE SILK is injected into facial skin, using a very fine needle, for correction of moderate to severe wrinkles and folds (e.g. areas around the nose and the mouth). The gel plumps the skin to smooth away wrinkles and folds. Dr. Keshwani will work with you to develop a treatment program to meet your individual needs.

Are there any reasons why I should not receive PREVELLE SILK (Contraindications)?

Dr. Keshwani will determine if there is any reason why you are not an appropriate candidate for PREVELLE SILK.

You should be aware that PREVELLE SILK:

• Should not be used in patients with a history of allergies to lidocaine or gram positive bacterial proteins.
• Should not be used in patients with a history of rare, potentially life-threatening allergic reactions or multiple severe allergies.

What should Dr. Keshwani warn me about?

The following are important treatment considerations for you to discuss with Dr. Keshwani and understand in order to help avoid unsatisfactory results and complications:

• Patients using aspirin, ibuprofen, and other nonsteroidal antiinflammatory drugs (NSAIDs), or warfarin (a blood thinner) prior to treatment with PREVELLE SILK may notice increased bruising or bleeding at or near the injection sites. Inform Dr. Keshwani if you are using these medications to determine when or if you should avoid taking them.
• PREVELLE SILK should be used with cautionin patients who are receiving treatment to lower the body’s normal immune response (immunosuppressive therapy).
• The safety and effectiveness of PREVELLE SILK for treatment of areas other than facial wrinkles and folds (such as lips) has not been studied in clinical trials.
• The safety of PREVELLE SILK has not been studied in patients with a known potential for excessive scarring (for example, keloid formation and hypertrophic scarring) or disorders involving changes in the color of the skin (pigmentation disorders).
• The safety of PREVELLE SILK has not been studied in patients who are pregnant or breastfeeding or are under 18 years of age.