Meso-Wharton P199®

MESO-WHARTON P199® injectable gel is a sterile, biodegradable, non-pyrogenic, viscoelastic, transparent, colorless gel intended for facial intradermal injection. MESO-WHARTON P199® is a solution designed for intensive dermal revitalization & facial contouring.

The formulation contains fermentative hyaluronic acid in a non-crosslinked form and regulatory peptides, oligopeptides, vitamins, microelements, amino acids, and nucleic acids.

MESO-WHARTON P199® is a non-surgical cosmetic treatment indicated for the correction of age-related skin changes (lines and wrinkles, loss of tone and elasticity, and lax facial contour); in preparation for plastic surgery or during the postoperative period; in preparation for superficial and deep peeling or recovery, laser resurfacing, or various burns; hyperpigmentation; and surface or dermal dehydration in adults over the age of 21.

MESO-WHARTON P199® is a single-use device administered by a physician via multiple intradermal microinjections.

• Patients with severe allergies set on by a history of anaphylaxis or history/presence of severe allergies;
• Patients with previous hypersensitivity to hyaluronic acid or intolerance to one or more of the device’s constituents;
• Patients with bleeding disorders;
• Implantation in anatomical spaces other than the dermis.

• Postpone treatment at a site(s) in which an active inflammatory response (skin eruptions such as pimples, rashes, cysts, or hives) or infection is present until the response or infection has been treated.
• Do not implant MESO-WHARTON P199® injectable gel into blood vessels. Take extra care when injecting soft tissue — checking to ensure proper insertion.
• Typical treatment response primarily centers around short-term inflammatory symptoms at the injection site, starting post-treatment and lasting up to three (3) days. Other potential adverse effects reported during post-market surveillance include short-term erythema, edema, pruritus, or moderate soreness in the injection sites. Reference the ADVERSE EVENTS section for more details.

• This device is meant to be used on a single patient in one treatment session. Do not resterilize. Observe sanitary and epidemiological requirements during any invasive procedures. Verify the integrity of the packaging before use. Do not use the device past the indicated shelf life or if the packaging has been damaged;
• The safety and effectiveness of this device for the treatment of the regions below have not been established in controlled clinical studies. During any transcutaneous procedure, there is a risk of infection - standard precautions associated with injectable materials should be adhered to;
• Any and all uses of this device outside of the intended uses or any modification/use outside of the stated Directions For Use may impact the quality, homogeneity, sterility, or performance of the device and its constituents;
• Do not use this device in conjunction with devices of similar nature and/or purpose. Avoid the treatment of similar sites within fourteen (14) days before or after treatment with Botulinum Toxin agent, use of chemical peeling, or laser treatment;
• The safety of this treatment for use in patients during pregnancy, breastfeeding, or in patients under 18 years has not been established. Use with caution in patients on immunosuppressive therapy or patients with bleeding disorders. Avoid site(s) with a permanent implant;
• Patients should avoid taking high doses of Vitamin A or E supplements, aspirin, or nonsteroidal anti-inflammatory medications prior to treatment as these products may increase bleeding or bruising at the injection site(s);
• Previous acute inflammatory elements (acne, herpes) or chronic skin diseases (cysts, pimples, rashes, or hives) in the area of the potential injection site(s) may experience an inflammatory response or reactivation of herpes;
• Refrain from using saunas or tanning salons while also avoiding direct sunlight between treatment sessions;
• Syringe contents, syringes, and needles must be safely discarded immediately after use to prevent potential biohazards. Dispose of these items in accordance with accepted medical guidelines and applicable local or federal requirements;
• MESO-WHARTON P199® should only be used by licensed medical professionals with appropriate training, experience, and knowledge in the fields of anatomy at/around the injection site to maintain a safe, sterile, and effective treatment procedure. By encouraging discussion of the potential risks of soft tissue injection with patients prior to the procedure, clinicians can be sure that patients are aware of the symptoms and signs of potential complications;
• Failing to follow needle attachment instructions may result in needle disengagement or leakage at the LUER-LOK adaptor or connection, failure to adhere to recommended needle size or use of a needle larger than 32G can lead to improper distribution of the device, and the formation of large papules.

• After treatment with MESO-WHARTON P199®, reactions related to invasive procedures may occur and continue for 1-3 days. These reactions include redness, swelling, itching, tenderness, and change in skin color at the injection site(s). Other known potential adverse effects reported during post-market surveillance include short-term erythema, edema, pruritus, or moderate soreness in the injection site(s) for 1-3 days.

MESO-WHARTON P199® is supplied in a disposable glass syringe with LUER-LOK™ fitting (needle provided separately), packaged in a vac-formed tray with a Tyvek-film seal. Each packaged preparation contains a disposable one-time-use syringe filled with 1.5 mL of MESO-WHARTON P199®, directions for use, and a label containing the following information: Device name, syringe volume, lot number, and expiration date.

The provided label is affixed to the patient’s medical record and provides the physician with a medical history.

• Store away from sunlight at a temperature of 2 - 25°C.
• Do not freeze, reuse, or resterilize.
• The device must be used prior to the printed expiration date.

Proper assembly ensures the safe and accurate use of MESO-WHARTON P199® —

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Assembly of 30-33 Gauge Needle

• Hold firm around both the glass syringe barrel and at the cusp of the LUER-LOK adaptor using the thumb and forefinger.
• Proceed to grasp the needle shield with the other hand while pushing and rotating to ensure proper assembly.

• Examination of the patient’s medical history is advised to identify indications and contraindications for the use of soft tissue injection solutions. Potential allergies can be identified by interviewing the patient and, if necessary, performing allergic and tissue sensitivity testing. Treatment shall be prescribed on the basis of indications and the patient’s age.
• Patients should avoid taking high doses of Vitamin A or E supplements, aspirin, or nonsteroidal anti-inflammatory medications prior to treatment, as these products may increase bleeding or bruising at the injection site(s).
• Do not expose the injection sites to severe cooling (wind, frost) shortly before treatment.
• Refrain from using any indoor tanning or sauna/steam baths shortly before treatment.
• Remove any makeup before the procedure.
• Treat the skin three times with a 0.05% chlorhexidine solution before administering MESO-WHARTON P199®.
• The application of local anesthetic cream is permitted if required.

• Ensure that patients are properly counseled and that all potential risks, benefits, and expected outcomes are discussed.
• Assess the patient’s needs for pain management by utilizing the appropriate anesthetic treatment for managing comfort.
• The patient’s face should be washed and treated with alcohol or another suitable antiseptic solution.
• It is recommended to use sterile gloves during invasive procedures to ensure sterility.
• Upon injection, press the syringe rod until any pockets of air escape and a small droplet of the solution is visible at the tip.
• MESO-WHARTON P199® is administered using a thin gauge needle (32G). The needle is introduced at an approximate angle of 45° parallel to the facial skin’s surface - 2-4 mm deep, 0.8-1 cm apart, and at 30° to the neck skin’s surface — 1-2 mm deep. Proper administration of Meso-Wharton P199 consists of mid-dermis injections; care should be taken to avoid deep-dermis injections.
• Inject by applying equal pressure along the plunger rod; close attention must be paid to ensure the injection is halted just before the needle is removed from the skin to prevent material from protruding or being injected too superficially.
• Average use per treatment session is dependent on the injection site(s) as well as the amount of correction desired. Based on clinical observations, the maximum recommended dose per session is 1.5 mL per person.

🔻 DO NOT OVERCORRECT 🔻

• Do not apply or use decorative cosmetics for 24 hours.
• Do not expose the injection sites to severe cooling, i.e., wind or frost.
• Refrain from using any indoor tanning or sauna/steam baths throughout the treatment procedures.
• Refraining from active sports or physical exercise for 48 hours, these stressors can cause temporary redness, swelling, or itching at the injection site(s).
• To report potential adverse effects, please promptly notify ABG LAB at 1-800-682-5741 or [email protected].

• MESO-WHARTON P199® does not include a needle, use extreme caution to avoid sharps exposure. Ensure appropriate usage of referenced needle size.
• To help avoid needle breakage, do not attempt to straighten a bent needle. Discard it and complete the procedure with a replacement needle.
• Do not shield used needles. This practice should be avoided; discard unshielded needles in approved collectors.
• Follow all national, state, local, or institutional guidelines for the use and disposal of sharp medical devices. Obtain prompt medical attention if an injury occurs.

Manufactured For

To place an order, please call 1-800-682-5741 or email [email protected].

12/2016 DFU.MW V2 [EN] © 2016 ABG LAB, LLC. All trademarks are the property of their respective owners.