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

FDA-cleared Ultherapy

Ultherapy uses time-tested ultrasound energy to lift and tighten the skin naturally—without surgery or downtime.


The Non-invasive Lift

Ultherapy is the only non-invasive procedure FDA-cleared to lift skin on the neck, under the chin and on the eyebrow. Now also FDA-cleared to improve the appearance of lines and wrinkles on the décolletage, Ultherapy can help you achieve a fresher look from your brow to your chest!


Focused Ultrasound. No Surgery.

Ultherapy harnesses the power of ultrasound to transform the brow, chin, neck and chest. Ultrasound, of course, has been used throughout the medical field for more than 50 years—and Ultherapy has been established as effective in clinical studies* and in over a million treatments worldwide. Ultherapy relies on ultrasound therapy to deliver its collagen-boosting treatment. It also incorporates traditional ultrasound imaging, which allows practitioners to see the layers of tissue they are treating, ensuring the treatment energy is delivered to where it will be most beneficial.


Builds New Collagen

The Ultherapy® procedure stimulates collagen production by delivering focused ultrasound energy to the skin’s foundational layer typically addressed in cosmetic surgery—without cutting or disrupting the surface of the skin.


No Toxins or Needles

Unlike lasers, radio frequency, surgery and other technologies, non-surgical Ultherapy bypasses the surface of the skin to deliver the right amount of ultrasound energy at the right depths and the right temperature. This energy triggers a natural response under the skin, jumpstarting the regenerative process that produces fresh, new collagen.

No Downtime. Natural Results.

Some patients see an initial effect right after their treatment, but the real results appear over 2−3 months* as new collagen works to lift and tighten skin on the neck, chin and brow as well as smooth skin on the chest. While Ultherapy won’t duplicate the results of a facelift, it’s a clinically proven non-invasive alternative for those not ready for surgery—and can even be an option for patients who wish to extend the effects of cosmetic surgery.

 
 

How Does Ultherapy Work?

Ultherapy harnesses the power of ultrasound to non-invasively lift and tighten skin. Ultrasound is a form of mechanical energy that is significantly diffferent than Light (Lasers) and Electrical (Radio-Frequency) energy. During Ultherapy, ultrasound it is micro-focused below the skin’s surface to cause cellular friction and precise, pin-point heating. Similar to a magnifying glass focusing sunlight, heat is only generated at the focal point, leaving the skin’s surface and intervening tissue unaffected. Tissue at the focal point is heated to ~65°C, causing immediate collagen contraction and denaturation, and initiating aggressive collagen synthesis. Over 90-180 days, the wound-healing response stimulates long-term tissue remodeling and leads to further lifting and tightening, with results that can last a year or more.

 

The Ultherapy System

The Ultherapy® System is a true platform technology that allows clinicians to simultaneously visualize deep tissue planes while precisely delivering micro-focused ultrasound to these tissues. The system has 4 main components:

Control Unit: The control unit has a 27” graphical touchscreen display that provides patented, real-time tissue visualization down to 8mm and easy selection of treatment regions and tracking of treatment progress. It comes complete with the new Amplify™ software, which is clinically proven to increase patient comfort without affecting efficacy. About the size of a personal computer, the control unit is compact, portable and requires minimal room for use and storage. 

Handpiece: The ergonomic design of the Ulthera® handpiece optimizes control and reduces grip fatigue during treatment. The handpiece interfaces with 6 different transducers.

Transducers: Ulthera® DeepSEE® transducers provide simultaneous visualization and treatment. Three different treatment depths are currently available - the SMAS/Platysma (4.5mm), Deep Dermis (3mm) and Superficial Dermis (1.5mm). Each transducers is multi-patient use.

Cart: The Ulthera® Cart simplifies use and storage of system components, and its contemporary design makes it look at home in any aesthetic treatment room.

 

FREQUENTLY ASKED QUESTIONS

+ What is Ultherapy?

Ultherapy is a non-surgical ultrasound treatment that counteracts the effects of gravity on your skin. Ultherapy uses the body's own regenerative response to gently and gradually lift skin on the eyebrow, under the chin and on the neck, and smooth lines and wrinkles on the décolletage.

+ What is unique about Ultherapy?

Ultherapy is the only non-invasive treatment cleared by the FDA to actually lift skin. Ultherapy is also the only cosmetic procedure to use ultrasound imaging, which allows practitioners to see the layers of tissue targeted during the treatment to ensure the energy is deposited to where it will be most beneficial.

With the addition of the new Ultherapy® Décolletage Treatment, Ultherapy is also now the only non-invasive procedure specifically indicated by the FDA to improve lines and wrinkles on the chest.

+ Can Ultherapy replace a face lift?

Ultherapy treats the deep foundational layer addressed in cosmetic surgery, but won't duplicate the results of a facelift. Ultherapy is a great alternative, however, especially for those not ready for surgery or for patients looking to extend the effects of cosmetic surgery.

+ How does Ultherapy differ from laser treatments?

Ultherapy uses sound energy - tried-and-true ultrasound - which has unique properties that allow it to bypass the surface of the skin to treat depths not matched by any other non-invasive cosmetic device. Ultherapy ultrasound stimulates collagen production in the skin's foundation, resulting in a clinically significant lift of tissue over 2-3 months.

Lasers rely on light energy, which cannot reach deeper skin layers at an optimal temperature, so laser treatments typically only treat superficial skin and are not FDA-cleared to lift skin.

Since the two technologies often treat different types of skin issues, they're actually very compatible.

+ How does Ultherapy stimulate the creation of collagen?

Ultherapy deposits focused ultrasound energy deep beneath the skin at the optimal temperature for collagen regeneration. The treatment jumpstarts a natural process, known as neocollagenesis, to produce fresh, new collagen. Ultherapy doesn't involve any creams, fillers or toxins; it just relies on your body's own collagen-building process for natural, noticeable results.

+ How long does an Ultherapy® treatment take?

The length of the treatment will depend on the area being treated and your individual treatment plan. A face and neck procedure typically takes 60-90 minutes, while a chest treatment takes approximately 30 minutes.

+ Will I need to take time off?

With Ultherapy, there is no downtime. After your procedure, you can resume your normal activities immediately, without having to follow any special post-treatment measures.

+ What does the Ultherapy® treatment feel like?

As the ultrasound energy is delivered, you will feel tiny amounts of energy being deposited to precise depths, indicating that the collagen-building process has been initiated. Comfort levels vary from person to person, but the sensation only lasts while the ultrasound energy is being delivered.

+ When will I see results? How long do they last?

After your Ultherapy® Treatment, you may see some initial effect, but the ultimate results will take place over 2-3 months, as your body naturally regenerates collagen. Since the procedure stimulates your own collagen production, how long the results last really depends on you. The treatment produces new collagen on the inside, but your natural aging process will dictate how long that translates into visible results on the outside.

+ How many Ultherapy® treatments will I need?

Most patients only need one treatment. However, based on the degree of skin laxity, the biological response to ultrasound energy and the individual's collagen-building process, some patients benefit from additional treatments. Because skin continues to age, future touch-up treatments can help patients keep pace with the body's natural aging process.

+ Are there any side effects?

The skin might appear flushed at first, but the redness should disappear within a few hours. Some patients experience slight swelling, tingling or tenderness to the touch, but these are temporary in nature. Other, less common post-procedural effects may include temporary bruising or numbness on small areas of skin. As with any medical procedure, there is the possibility for other rare effects, which your practitioner will review with you.

+ How much does an Ultherapy® procedure cost?

The cost of an Ultherapy® treatment can range depending upon the area being treated and factors such as geographic location and individual physician practices. Since the treatment is so personalized, to get the most accurate price quote, it is best to speak with a nearby provider. To find and connect with a nearby practitioner, please use the Ultherapy Doctor Locator tool.

+ Who is a good candidate for Ultherapy?

A good Ultherapy candidate has mild to moderate skin laxity where the skin begins to feel and look less firm. Examples include a lowered eyebrow line, loose skin on the neck, sagging under the chin, and lines or wrinkles on the chest. Of course, the best way to find out if you're an Ultherapy candidate is to consult with a practitioner. You can easily connect with a nearby provider using our Doctor Locator tool.

+ Where can I get an Ultherapy® treatment?

Ultherapy is offered by thousands of cosmetic medical practices around the world. Visit our Doctor Locator to find and connect with a practice near you.

 
 

Indications for Use

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

  • Lift the eyebrow

  • Lift lax submental (beneath the chin) and neck tissue

  • Improve lines and wrinkles of the décolleté

The Ulthera System, in conjunction with the Ulthera DeepSEE transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to:

  • Ensure proper coupling of the transducer to the skin

  • Confirm appropriate depth of treatment such as to avoid bone

Contraindications

The Ulthera System is contraindicated for use in patients with:

  • Open wounds or lesions in the treatment area

  • Severe or cystic acne in the treatment area

  • Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment area

Precautions

When not in use by trained personnel, the Ulthera System Access Key should be removed from the system to help prevent unauthorized use. Keep the Ulthera System Access Key in a designated place accessible only to authorized and trained personnel. The Ulthera System has not been evaluated for use over various materials. Therefore, treatment is not recommended directly over those areas with any of the following:

  • Mechanical implants

  • Dermal fillers

  • Breast implants

Treatment energy is not recommended for use directly on an existing keloid. The Ulthera System has not been evaluated for use in patients on an anticoagulant treatment plan.

It is recommended that the following areas should be avoided during treatment:

  • Thyroid gland, thyroid cartilage and trachea

  • Major vessels

  • Breast tissue or breast implants

The Ulthera System has not been evaluated for use in the following patient populations:

  • Pregnant or breast feeding women

  • Children

  • Those with the following disease states

    • A hemorrhagic disorder or hemostatic dysfunction

    • An active systemic or local skin disease that may alter wound healing

    • Herpes Simplex

    • Autoimmune Disease

    • Diabetes

    • Epilepsy

    • Bell’s Palsy

Patient Safety

  • Warning: Ulthera should not be used on a patient’s eyes or in a location or technique where ultrasound energy can reach the eye.

  • Warning: Use this system only if you are trained and qualified to do so.

  • Warning: If any problems occur during system operation, take immediate action(s): lift the transducer off the patient’s skin, press the See pushbutton on handle to discontinue treatment in progress, and/or press the red emergency Stop button to completely halt system operation.

Potential Side Effects

Side effects reported in the clinical evaluation of the Ulthera System for the brow, submental (under the chin) area and neck treatment(s) were mild and transient in nature. These were limited to:

  • Erythema (redness): The treated area may exhibit erythema immediately following treatment. This typically resolves within a few hours of treatment.

  • Edema (swelling): The treated area may exhibit mild edema following treatment. This typically resolves within 3 to 72 hours of treatment.

  • Pain: Momentary discomfort may be experienced during the procedure while energy is being deposited. Post procedure discomfort typically resolves within 2 hours and 2 day. Tenderness to the touch is also possible and typically resolves within 2 days to 2 weeks of treatment.

  • Bruising: Mild bruising, which is caused by damage to soft tissue blood vessels, may occur occasionally and typically resolves within 2 days to two weeks of treatment.

  • Nerve Effects:

    • Transient local muscle weakness may result after treatment due to inflammation of a motor nerve. This typically resolves in 2 to 6 weeks of treatment.

    • Transient numbness may result after treatment due to inflammation of a sensory nerve. This typically resolves in 2 to 6 weeks of treatment.

    • Transient pain, paresthesia and/or tingling may be experienced. This typically resolves in 2 to 6 weeks of treatment.

    No permanent injuries to facial nerves have been reported.

  • Scarring: The possibility for scar formation (which may respond to medical care) may exist if incorrect treatment technique is used.

Side effects reported in the clinical evaluation of the Ulthera System for the décolleté treatment were mild and transient in nature. These were limited to:

  • Erythema (redness): The treated area may exhibit erythema immediately following treatment. This typically resolves within a few hours of treatment.

  • Edema (swelling): The treated area may exhibit mild edema following treatment. This typically resolves within 3 to 48 hours of treatment.

  • Pain: Momentary discomfort may be experienced during the procedure while energy is being deposited. Post procedure discomfort typically resolves within 2 hours and 2 day. Tenderness to the touch is also possible and typically resolves within 2 days to 2 weeks of treatment.

  • Raised area of edema: The treated area may exhibit a localized area of linear visible edema following treatment. This typically resolves within 1 day to 3 weeks of treatment.

  • Bruising: Mild bruising, which is caused by damage to soft tissue blood vessels, may occur occasionally and typically resolves within 3 days and 3 weeks of treatment.

  • Transient Sensory Nerve Effects (as a result of inflammation of the nerve):

    • Paresthesia and/or numbness may be experienced and typically resolves within 4 days to 5 weeks of treatment.

    • Tingling may result after treatment and typically resolves within 3 to 5 days of treatment.

    • Itching may result after treatment and typically resolves within 1 to 3 weeks of treatment.

    No permanent nerve injuries have been reported.

  • Scarring: The possibility for scar formation (which may respond to medical care) may exist if incorrect treatment technique is used.

Complaints and Adverse Events

No serious adverse events were observed during the clinical study evaluation of the Ulthera 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 480-619- 4069; for those outside the U.S., contact your local Ulthera representative.

Post Market Surveillance

The following adverse events have been identified during routine clinical use following FDA clearance (post market) of the Ulthera system. Because they are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to the Ulthera system. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to the Ulthera system: pain, burns, or burning sensation, edema / swelling, nodules, bruising, fat / volume loss, neuropathy, numbness, paresthesia, palsy, paresis, speech difficulty, muscle weakness, headache, migraine, visual change, skin sagging / drooping, asymmetry, erythema, welts, hives, rash, urticaria, pruritus, blistering, scarring, discoloration and hyperpigmentation.

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

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