Enter the new age of facial aesthetics with MESOSCULPT C71®, encompassing LIPOBLOCK XP2®, a powerful sculpting technology primed for facial remodeling. The revolutionary treatment revitalizes the contours of your face for a fresh and youthful appearance, concurrently enhancing skin smoothness and tone. It pioneers the resurgence of the “triangle of beauty” in mature skin.
SCULPTING A NEW YOU
MESOSCULPT C71® is an all-encompassing aesthetic treatment with the power to reduce lipids. It remodels the mid and lower facial regions, offering a rejuvenated, youthful contour. A fast-acting, long-term, and safe 3-in-1 technology for inhibiting adipogenesis, blocking lipogenesis, and stimulating targeted lipolysis.
The ultimate solution for lipid reduction, it effectively conserves viable fat cells, highlights the jawline, erases nasolabial folds, and minimizes double chins.
BENEFITS
MESOSCULPT C71® specializes in lipid reduction, reshaping the mid & lower face by curbing the creation of new fat cells, stimulating lipolysis and microcirculation, and activating lymphatic drainage. It offers a host of advantages, including:
- Restricting the absorption of dietary lipids by existing fat cells;
- Suppressing lipogenesis (formation of fatty acids in fat cells);
- Fueling lipolysis and fat burning;
- Converting white “fat-storing” adipocytes into beige “fat-burning” adipocytes;
- Inhibiting adipogenesis (creation of new fat cells).
OUTLINE A BEAUTIFUL FACE
Pioneered by ABG Lab and our esteemed research partners, including Dr. Michael Kane, M.D., a celebrated Manhattan board-certified plastic surgeon, MESOSCULPT C71® eliminates unwanted facial fat deposits that diminish the well-defined look and youthful contours of your face.
MESOSCULPT C71® curbs white fat tissue growth at the genetic level by inhibiting key factors of adipogenesis, thus halting adipocyte enlargement. It also inhibits crucial lipogenesis enzymes, blocking fat accumulation in existing cells.
HOW IT WORKS
REVIVING FACIAL CONTOURS
MESOSCULPT C71® takes on even the most stubborn facial fat deposits, bringing back the youthful facial triangle and refining the jawline. It has also shown impressive effectiveness in reducing and firming "turkey neck." Reclaim your youth with the power of LIPOBLOCK XP2®.
SKETCH YOUR STUNNING LOOK
It operates on the principle that fat cells possess a high degree of plasticity and are easily altered with the right molecular signals. MESOSCULPT C71® offers a fast-acting, durable, and efficient 3-in-1 technology for inhibiting adipogenesis, blocking lipogenesis, and stimulating targeted lipolysis.
REVIVE & RESHAPE
TAILOR-MADE FOR INTENSE SUBCUTANEOUS FACIAL FAT REDUCTION, FIRMING, LIFTING, AND CONTOURING
The cornerstone of our treatment is our proprietary, bioactive formulation of LIPOBLOCK XP2® and Hexapeptide-17. The formulation incorporates non-crosslinked, fermentative hyaluronic acid, vitamin C, retinol, microelements, an abundant array of amino acids, and nucleic acid precursors.
MESOSCULPT C71® injectable gel, supplied in a 1 mL single-use glass syringe, is a sterile, biodegradable, non-pyrogenic, viscoelastic, cloudy gel intended for hypodermal facial injections. This swift and effective solution employs a safe and effective mechanism to decrease subcutaneous fat tissue, helping to reshape and revive the facial contours and submental regions.
REMODELING & SCULPTING
MESOSCULPT C71® is an exceptionally efficient treatment that reduces subcutaneous fat mass. Through various mechanisms, it actively promotes the reduction of white fat tissue at the gene expression level. It inhibits factors vital for fat cell development and prevents fat tissue growth by increasing adipocytes. In simpler terms, it effectively blocks the creation of new fat cells.
The treatment lessens unwanted facial fat deposits by curbing the expression of some key factors of adipogenesis and preventing an increase in fat cells in subcutaneous tissue. These fat tissue deposits start with progressive lipid accumulation in mature adipocytes, occurring as a result of dietary fatty acid uptake from blood circulation, where most will be converted into triglycerides.
BATTLING LIPIDS ON THREE FRONTS
MESOSCULPT C71® inhibits the synthesis of enzymes in lipogenesis (fat accumulation in preexisting adipocytes), thus preventing fat tissue growth by enlarging individual fat cells. Stimulation leads to synthesizing enzymes that cleave accumulated lipids, thus promoting an active decrease of fat tissue mass.
KEY COMPONENTS
HYALURONIC ACID
Hyaluronic acid is a key component in our formulations, offering remarkable benefits for the skin. It acts as a potent moisture infuser, locking in hydration and providing essential nourishment. This hydrating action helps to keep the skin supple, plump, and youthful in appearance.
At ABG Lab, we prioritize the quality of our ingredients. We source hyaluronic acid exclusively from reputable manufacturers who adhere to stringent good manufacturing practices. This ensures that the hyaluronic acid used in our products meets the highest standards of purity, efficacy, and safety.
In addition to its exceptional moisturizing abilities, hyaluronic acid also offers antioxidant protection. It acts as a shield, safeguarding the skin against environmental factors such as pollution, UV radiation, and oxidative stress. This protection helps to prevent damage caused by free radicals and supports the skin's natural defense mechanisms.
LIPOBLOCK XP2®
With a fast-acting, long-lasting, and efficient triple-action technology, LIPOBLOCK XP2® revolutionizes facial contours, simultaneously smoothing and toning the skin for an ageless look. LIPOBLOCK XP2® takes facial sculpting to the next level, optimizing fat burning, inhibiting adipocyte lipid uptake, and blocking the formation of new fat cells. It's more than just a product – it's a comprehensive solution that ensures a non-traumatic lipo-modifying effect and serves as a revolutionary adipogenesis, lipogenesis, and lipolysis regulator.
SAFE, FAST, AND EFFECTIVE INHIBITORY MECHANISMS
Our formulation incorporates our quick-acting LIPOBLOCK XP2®, designed to shape and define facial features by decreasing subcutaneous fat mass through various action pathways. This speedy and effective technology significantly enhances facial contours, promotes skin smoothness, and adds a glow to your complexion by curbing the gene expression responsible for generating new fat cells.
HEXAPEPTIDE-17
Experience the invigorating power of Hexapeptide-17, a peptide renowned for its capacity to invigorate microvascular function, paving the way for enhanced circulation. But that's not all, it also acts as a soothing agent, curbing inflammation for added comfort and relief. With a specialized activation mechanism for δ-opioid receptors in lymphatic vessels, it empowers lymphatic drainage, flushing out toxins and rejuvenating your skin.
Embrace the potential of this opioid peptide that not only stimulates microcirculation but also activates lymphatic drainage through the δ-opioid receptors in lymphatic vessels. By doing so, it elevates the blood flow volume while firming the walls of blood and lymphatic vessels. The result? A surge in cellular nourishment and effective toxin removal, ushering in a new era of skin vitality.
VITAMINS & MICRONUTRIENTS
Micronutrients, specifically antioxidants, play a vital role in skincare by protecting the skin from harmful free radicals and strengthening the skin barrier. These essential components work diligently to maintain the overall health and well-being of the skin.
Antioxidants act as powerful defenders against free radicals, which are unstable molecules that can cause oxidative stress and damage to the skin. Environmental factors such as pollution, UV radiation, and stress can generate free radicals, leading to premature aging, inflammation, and skin damage. Micronutrients with antioxidant properties neutralize these harmful free radicals, preventing their detrimental effects on the skin.
DEVICE INFORMATION
DIRECTIONS FOR USE (DFU)
PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY BEFORE USE.
MESOSCULPT C71® gel is a heterogenous, cloudy gel. The contents may exhibit signs of separation or cloudiness; please shake the device well before use.
MESOSCULPT C71® injectable gel is a sterile, biodegradable, non-pyrogenic, viscoelastic, cloudy gel intended for hypodermal facial injection. MESOSCULPT C71® is a solution designed for intensive subcutaneous facial fat loss, firming, uplifting, and contouring.
The formulation contains a proprietary, bioactive formulation of LIPOBLOCK XP2®, Hexapeptide-17, and fermentative hyaluronic acid in a non-crosslinked form, vitamin C, retinol, microelements, a rich array of amino acids, and nucleic acid precursors.
MESOSCULPT C71® is a non-surgical cosmetic treatment indicated for microvessel perfusion rehabilitation in skin tissue and the correction of age-related facial contour changes associated with subcutaneous facial fat buildup, loss of definition, and sagging skin in adults over the age of 21.
MESOSCULPT C71® is a single-use device administered by a physician via multiple hypodermal 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 MESOSCULPT C71® 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;
- MESOSCULPT C71® 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 MESOSCULPT C71®, 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.
Five hundred and eighty (580) subjects were enrolled in a randomized, double-blinded (subject and evaluator) clinical trial to evaluate the safety of MesoSculpt C71 vs. a control saline solution containing hyaluronic acid of the same molecular weight and concentration. Preprinted forms were used by the subject for assessment of specific signs/symptoms at the sites of injections: Erythema, Swelling, Itching, Pain/Tenderness. Subjects rated each specific sign/symptom as mild, moderate, or severe for three weeks following the injections. All the specific signs/symptoms were present in the mild or moderate forms for the first three days in most subjects, up to 7 days in some of them, and very rarely in the severe form for more than seven days. No statistically significant differences in the specific signs /symptoms severity or duration were observed between MESOSCULPT C71® and the control solution.
MESOSCULPT C71 | (N=290) | n (%) | ||
Mild | Moderate | Severe | TOTAL | |
Erythema | 142 (49.0) | 55 (19.0) | 18 (6.2) | 215 (74.1) |
Swelling | 62 (21.4) | 14 (4.8) | 1 (0.3) | 77 (26.6) |
Itching | 24 (8.3) | 7 (2.4) | 2 (0.7) | 33 (11.4) |
Pain/Tenderness | 36 (12.4) | 8 (2.8) | 4 (1.4) | 48 (16.6) |
CONTROL | (N=290) | n (%) | ||
Mild | Moderate | Severe | TOTAL | |
Erythema | 131 (45.2) | 63 (21.7) | 18 (6.2) | 212 (73.1) |
Swelling | 60 (20.7) | 12 (4.1) | 3 (1.0) | 75 (25.9) |
Itching | 21 (7.2) | 9 (3.1) | 1 (0.3) | 31 (10.7) |
Pain/Tenderness | 33 (11.4) | 9 (3.1) | 2 (0.7) | 44 (15.2) |
Table 1. Treatment site responses in subjects after initial treatment.
MESOSCULPT C71 | (N=290) | n (%) | ||
1-3 Days | 4-7 Days | 8-14 Days | > 14 Days | |
Erythema | 203 (70.0) | 11 (3.8) | 1 (0.3) | 0 (0) |
Swelling | 68 (23.4) | 6 (2.1) | 3 (1.0) | 0 (0) |
Itching | 27 (9.3) | 5 (1.7) | 1 (0.3) | 0 (0) |
Pain/Tenderness | 37 (12.8) | 9 (3.1) | 2 (0.7) | 0 (0) |
CONTROL | (N=340) | n (%) | ||
1-3 Days | 4-7 Days | 8-14 Days | > 14 Days | |
Erythema | 199 (68.6) | 11 (3.8) | 2 (0.7) | 0 (0) |
Swelling | 61 (21.0) | 12 (4.1) | 2 (0.7) | 0 (0) |
Itching | 23 (7.9) | 5 (1.7) | 3 (1.0) | 0 (0) |
Pain/Tenderness | 33 (11.4) | 9 (3.1) | 2 (0.7) | 0 (0) |
Table 2. Duration of the treatment site responses in subjects after initial treatment.
MESOSCULPT C71® 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 mL of MESOSCULPT C71®, 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 MESOSCULPT C71® —
- 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 MESOSCULPT C71®.
- 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.
- MesoSculpt C71® is administered using a thin gauge needle (32G). The needle is introduced at an approximate angle of 90° to the facial skin’s surface - 6-13 mm deep. The injected amount per injection shall range from 0.05 - 0.1 mL per injection; the injection volume can be increased to 0.15 mL per injection, if necessary, based on clinical evaluation.
- Proper administration of MesoSculpt C71 consists of hypodermal injections into the subcutaneous adipose tissue; care should be taken to avoid mid-dermal injection.
- Needle length (6/8/13 mm) determined based on the degree of subcutaneous localized fat deposits.
- 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 1.0 mL per person.
🔻 DO NOT OVERCORRECT 🔻
Multiple Hypodermal Injections
- The needle is introduced at 90° to the skin surface — 6-13 mm deep, 0.8-1 cm apart;
- The injected amount per injection shall range from 0.05 - 0.1 mL per injection; the injection volume can be increased to 0.15 mL per injection, if necessary, based on clinical evaluation;
- Proper administration of MESOSCULPT C71® consists of hypodermal injections into the subcutaneous adipose tissue, and care should be taken to avoid mid-dermal injection.
Recommended Needle: 32G (0.23 x 6/8/13mm)
Needle length (6/8/13 mm) determined based on the degree of localized subcutaneous deposits
CAUTION: Use of a needle larger than 32G may cause incorrect distribution. Deviation from these methods can lead to pronounced swelling of the treated area.
ONE (1) 1.0 mL SYRINGE IS INTENDED TO TREAT BOTH AREAS: THE FACE & NECK
- 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].
- MESOSCULPT C71® 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 using and disposing 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.MS V2 [EN] © 2016 ABG LAB, LLC. All trademarks are the property of their respective owners.