XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION

Read the Medication Guide before you start receiving XEOMIN (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:

Talk to your health care provider or pharmacist Visit www.xeominaesthetic.com to obtain the FDA-approved product labeling Call 1-866-862-1211 Uses XEOMIN is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary).

It is not known if XEOMIN is safe and effective in children under 18 years of age.

Warnings

XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:

Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN. People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN. Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing. These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

Do not use XEOMIN if you are allergic to XEOMIN or any of the ingredients in XEOMIN (see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DYSPORT®) or have a skin infection at the planned injection site.

Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:

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HOW IT WORKS

Long-Lasting Results

The Cellfina® System is the only FDA-cleared minimally invasive procedure clinically proven to improve the appearance of cellulite for at least three years—the longest FDA-cleared duration for a cellulite treatment. Performed in a doctor’s office by a qualified physician, Cellfina® treats the primary structural cause of cellulite for a smooth and healthy look that gives patients the confidence to wear a bathing suit and higher hemlines.

How Cellfina® Works to Improve the Appearance of Cellulite

The Cellfina® System treats the primary structural cause of cellulite—the connective bands woven throughout fat in the thighs and buttocks. These tight bands pull down the skin, creating the puckering you see on the surface of the skin. Similar to a rubber band under tension, once released, the treated skin bounces back to smooth itself out in as little as three days. This one-time cellulite treatment is performed at a doctor’s office in less than an hour.

Limited Downtime

After the Cellfina® cellulite treatment, patients can go about their day, but may want to take it easy for up to 24 hours. There have been no serious adverse events associated with Cellfina®. The most common side effects reported by patients in the FDA-cleared pivotal study were soreness and bruising. Over 90% of patients had no bruising at four weeks after the cellulite procedure. For full product and safety information, including possible mild side effects, visit cellfina.com/IFU.

Proven Efficacy and Safety

The FDA-cleared Cellfina® cellulite treatment typically takes less than an hour. Performed by a qualified physician in an office setting, Cellfina® combines a proven approach with innovative, proprietary technology to treat the primary structural cause of cellulite. First, cellulite dimples are marked. Then, the provider delivers a local numbing agent followed by the treatment itself. Afterward, patients are able to go about their day, but may want to take it easy for up to 24 hours. Results are visible in as little as three days and those results are still evident three years after treatment.

 
 

Tissue Stabilized-Guided 
Subcision® (TS-GS)

Cellfina® combines highly advanced, proprietary technology with a well-established procedure called Subcision® to provide precise and reproducible results.

  • The in-office procedure takes approximately 45 minutes, depending on the patient and number of areas being treated

  • External system allows procedure to be used in a physician setting (no operating room needed)

  • Significant, rapid, reproducible results

  • Limited downtime with quick recovery

*Subcision® is a registered trademark of David S. Orentreich

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Controlled Anesthetic Infiltration

  • Infiltrates at depth of release with multi-hole, 22G needle

  • Simplifies procedure and increases effectiveness

 

Rapid Tissue Release

  • Uses a reciprocating, precision, micro-blade that snaps on to an ergonomic hand piece

  • Stabilizes tissue for exact and controlled release, leading to precise and reproducible results

 

FREQUENTLY ASKED QUESTIONS

+ What is the Cellfina® System?

Cellfina® is the only FDA-cleared, minimally invasive, one-time procedure clinically proven to improve the appearance of cellulite for at least three years—the longest FDA-cleared duration for a cellulite treatment. A straightforward solution to cellulite, Cellfina® combines a proven approach with innovative, proprietary technology, to produce precise, long-lasting results.

+ How does the Cellfina® System work?

The Cellfina® System treats the primary structural cause of cellulite—the connective bands woven throughout fat in the thighs and buttocks. These tight bands pull down the skin, creating the puckering you see on the surface of the skin. Similar to a rubber band under tension, once released, the treated skin bounces back to smooth itself out.

+ How soon will I see improvements?

Results can be seen in as little as three days. In the pivotal study, patient satisfaction was 85 percent at three months, 94 percent at one year, 96 percent at two years and 93 percent at 3 years, surpassing the patient satisfaction rates of other leading cellulite treatments.*

+ Does Cellfina® involve cutting?

Cellfina® does not involve an operating room or general anesthesia. It relies on a minimally invasive, small needle-sized device to treat the cellulite-causing bands just beneath the surface of the skin.

+ How long do results last?

Patients in the pivotal study showed significant improvement shortly after the treatment, with results lasting at least three years—the longest FDA clearance for a cellulite treatment.

+ Are there any side effects?

No serious adverse events were associated with Cellfina® in the pivotal study. The most common side effects reported by patients in the FDA‑cleared pivotal study were soreness, tenderness and bruising. Just three days after treatment, patients rated their pain as minimal (2.7 on a scale of 0 to 10; 0=no pain, 10=extreme pain) and most (82 percent) felt pain only with touch or pressure to the area treated. This minimal pain improved quickly with time. More than 90 percent of patients had no bruising at four weeks.

+ How long does the procedure take?

In just one 45-minute treatment, Cellfina® significantly improves the appearance of cellulite on the buttocks and thighs.

+ Will I need to take time off?

There is limited downtime associated with Cellfina®. Some patients experience initial soreness and tenderness, but these side effects resolve quickly with time.

+ How much does the Cellfina® Treatment cost?

Since the treatment is so personalized, the best way to secure an accurate quote is to consult with a physician. Visit Cellfina.com to find a provider.

+ How can I learn more about Cellfina®?

To learn more about the Cellfina® Treatment, visit find a provider to schedule an initial consult with a doctor in your area, see Cellfina® results to view before and after photos and listen to patient testimonials, and sign up for automatic email updates and notifications.

 
 

Indications for Use

The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 3 years of observation.

CAUTION: Federal law restricts this device to use by or on the order of a physician.

CONTRAINDICATIONS

The System should not be used on patients who have (or who are):

  • Coagulant disorders

  • On anticoagulant medications

  • Uncontrolled hypertension

  • Diabetic

  • Phlebitis and vasculitis

  • Tumors

  • Excessive obesity

  • Pregnant

  • Vascular fragility

  • Had recent surgery (6 weeks)

  • Skin infections/ open lesions

  • Varicose veins (in the area of treatment)

WARNINGS

  • Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on procedural outcomes.

  • The safety and effectiveness of the Cellfina System has been evaluated in the buttocks and thighs of adult females between the ages of 25 and 55, with a body mass index (BMI) between 18 and 35, and with moderate to severe cellulite. Safety and effectiveness in other anatomical areas or in patients outside of these criteria has not been established.

  • The safety and effectiveness of more than one treatment with the Cellfina System has not been established.

  • The sterile products provided as part of the Cellfina System are for single use only. Do not re-use or re- sterilize. Re-sterilization of the device or components may result in a risk of device malfunction and/or contamination due to residual fluids/tissue in the device.

  • Do not operate the Cellfina System Motor Module and Power Supply where aerosol (spray) products, flammable anesthetics, or oxygen administering equipment is used.

  • The Cellfina System Motor Module and Power Supply are intended for indoor, dry area use only. Do not allow to be exposed to liquids. Never immerse any of the components in any liquid, or place the product where it can fall or be pulled into liquid.

  • Make sure the Cellfina System Motor Module and Power Supply and your hands are completely dry before plugging in the AC Power Cable.

  • Avoid using around alcohol or other flammable solutions. If alcohol is used to clean any component, assure that the product is dry and the area ventilated of fumes before plugging in.

  • To avoid electrical shock, never clean the Cellfina System Motor Module and Power Supply with the power supply plugged in or the Motor Module powered on.

  • The Anesthesia Delivery Needle and Micro-Blade Assembly contain sharp areas – handle with extreme caution and dispose of in appropriate sharps containers per standard practice.

  • Do not sterilize any of the Cellfina System Motor Module and Power Supply.

  • Prior to use, inspect packaging for damage or breach of sterile packaging seals. Do not use product if there is any evidence of damage or breach.

  • There are no user serviceable or replaceable parts inside the Cellfina System Motor Module or Power Supply. Do not open housings under any circumstances.

ADDITIONAL WARNINGS

Additional boxed warnings are provided within the Directions for Use Section of the IFU for specific procedural steps.

PRECAUTIONS

  • The Cellfina System should only be used by physicians who have read and understood the User Manual.

  • To protect sterility after opening, the blade and needle should remain covered prior to use.

RISKS

Potential adverse events are those typically associated with anesthesia infiltration, liposuction, Subcision® and other methods of body sculpting including:

  • Abscess

  • Anetoderma

  • Anxiety (nervousness, apprehension)

  • Blanching (generalized whiteness)

  • Blurred or double vision

  • Bleeding

  • Dizziness, drowsiness, confusion

  • Ecchymosis/bruising

  • Fluid accumulation (swelling, edema)

  • Fluid extravasation reaction from the injected anesthetic

  • Hematoma

  • Hemosiderosis

  • Hyperpigmentation

  • Hypopigmentation

  • Induration, fibrosis

  • Infection

  • Inflammation / generalized redness

  • Nausea/vomiting

  • Numbness, tingling, or sensitivity change

  • Petechiae or purpura (vacuum acquisition marks)

  • Red Spots (from needle punctures)

  • Redness, erythema, or rash

  • Scarring or keloid formation

  • Sensations of heat or cold

  • Seroma

  • Skin necrosis

  • Skin surface convexity, depression or other irregularity

  • Soreness or discomfort - pain

  • Tinnitus

  • Toxic, allergic, or other

COMPLAINTS AND ADVERSE EVENTS

No serious adverse events were observed during the clinical study evaluation of the Cellfina™ System.

Ulthera follows MDR (Medical Device Reporting) rules for handling complaints and adverse events. Should an adverse event be suspected or reported, contact Ulthera, Inc. at 1.877.ULTHERA.

NOTE:

This document is for web purposes only. It has been condensed from its original version. For additional information, contact 1.877.ULTHERA.