SkinMedica® Acne System, Acne Treatment Lotion, Purifying Foaming Wash, and Purifying Toner, are over-the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 C.F.R. LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness. Allergan is a great company to work for, however at some point in time it becomes a work and go home type of situation. Filling the device with adipose tissue over the maximum fill volume line can lead to occlusion of the mesh resulting in mesh tear. For JUVÉDERM® VOLUMA. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method. Key adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV. Earn points on Allergan Aesthetics products and a variety of other in-office treatments—from facial injectables to microdermabrasion facials. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. Human Albumin and Transmission of Viral Diseases. Allergan is now part of AbbVie. Please refer to Boxed Warning for Distant Spread of Toxin Effect. Increased iris pigmentation has occurred when bimatoprost solution was administered. JUVÉDERM® VOLLURE™ XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21. Risk of Injecting Into or in Proximity to Vulnerable Anatomic Structures Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. The mission of Allergan Aesthetics, an AbbVie Company, is to provide our healthcare provider partners with exceptional resources and service so they, in turn, can best serve their patients. For JUVÉDERM® VOLBELLA™ XC, dryness was also reported. CoolTone® is also contraindicated in placing the active applicator over menstruating uterus, over areas of the skin that lack normal sensation, and in patients with fever, malignant tumor, hemorrhagic conditions, epilepsy, recent surgical procedure, pulmonary insufficiency, or pregnancy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined. BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of: - Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity, - Moderate to severe lateral canthal lines associated with orbicularis oculi activity, - Moderate to severe forehead lines associated with frontalis activity. Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). • Planned chemotherapy following breast implant placement. This website uses cookies and other technologies to personalize content and to show you more personalized ads (for example, Google Ads and Facebook) on this and other websites, as well as provide you with social media features on this website (such as, Facebook, Twitter, LinkedIn). Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Some of these patients had risk factors including pre-existing cardiovascular disease. Allergan plc was created from the 2015 merger and Irish corporate tax inversion of two companies, Irish-based Actavis plc and U.S.-based Allergan, Inc. Allergan is now part of AbbVie. See Approved Uses, Important Safety Information, and Prescribing Information, APPROVED USES, IMPORTANT SAFETY INFORMATION AND PRESCRIBING INFORMATION. Consult the CoolSculpting® System User Manual for a complete list of Contraindications, Warnings, Precautions, and potential side effects. Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. • Autoimmune diseases (eg, lupus and scleroderma). KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur. FOR IMMEDIATE RELEASE- GREENSPRING MEDICAL AESTHETICS IN TUCSON, ARIZONA NAMED AS PREMIER TOP 50 ALLERGAN PRACTICE FOR US. These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX. Our colleagues operate across six continents. The REVOLVE™ Advanced Adipose System (REVOLVE™ System) is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. JUVÉDERM® VOLBELLA™ XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21. At Allergan Aesthetics™ we create the products and technologies that drive the advancement of aesthetics medicine. CoolTone® is also indicated for strengthening, toning, and firming of buttocks and thighs. Part 352. Serious and/or immediate hypersensitivity reactions have been reported. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production. • Planned radiation therapy to the breast following breast implant placement. The safety and effectiveness of BOTOX® for unapproved uses have not been established. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment. § 333.301 et seq. For more information on LATISSE®, please see the full Prescribing Information. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic. Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method. Our patients are family, and every day we work to build their trust. There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. D - 60327 Frankfurt am Main. Allergan Aesthetics is entering into option to acquire Cypris Medical, a privately held, medical device company based in Chicago, following clinical trials in 2021. In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. Reuse of this device in the same patient in a subsequent surgical procedure, or for more than one patient, may result in infection and/or transmission of communicable diseases. for unapproved uses have not been established. Access information about Allergan’s portfolio of best-in-class medical aesthetics products. Allergan is now part of AbbVie. There have been reports of dry eye associated with BOTOX, The most frequently reported adverse reactions following injection of BOTOX, The most frequently reported adverse reaction following injection of BOTOX, The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Allergan Aesthetics TM U.S. April 1, 2019. Please discuss any history of mental health disorders prior to surgery. … They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX. Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. Most of the SkinMedica® products described on this website are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. Allergan | 604,390 followers on LinkedIn. CoolTone® should be used with caution in patients with Graves’ disease, active bleeding disorders, or seizure disorders. CONTRAINDICATIONS It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. Paradoxical hyperplasia (visibly enlarged tissue volume in the treated area) may develop 2-5 months after treatment and requires surgical intervention for correction. All trademarks are the property of their respective owners. AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. Dysphagia Stichlingstraße 1. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). ADVERSE EVENTS Serious and/or immediate hypersensitivity reactions have been reported. Senior Vice President, AbbVie, and President, Global Allergan Aesthetics. of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. There have been reports following administration of BOTOX. The majority were mild or moderate in severity. The capability of providing adequate, timely replacement is essential for patient safety. Cosmetic should be discontinued and appropriate medical therapy immediately instituted. Treatment applications that deviate from the guidelines are not recommended. Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment may exacerbate the condition. Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. CoolSculpting® is contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria. BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. 64.5k Followers, 30 Following, 78 Posts - See Instagram photos and videos from Allergan Aesthetics (@allerganaesthetics) All rights reserved. Pre-existing Conditions at the Injection Site. Allergan® has named Greenspring Medical Aesthetics as one of their “Top 50” aesthetic practices in the United States for 2019. Common adverse effects may include, but may not be limited to muscular pain, temporary muscle spasm, temporary joint or tendon pain, and local erythema or skin redness. The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. The potency units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. PRECAUTIONS Allergan’s websites may ask your browser to store cookies, a small piece of data, on your computer or mobile device. Natrelle® Breast Implants are available by prescription only. • A compromised immune system (eg, currently receiving immunosuppressive therapy). Women with active infection anywhere in their body. Please see LATISSE® full Prescribing Information. 17 talking about this. Consult the CoolTone® User Manual for a complete list of Contraindications, Warnings, Precautions, and potential side effects. For JUVÉDERM® VOLBELLA, XC, dryness was also reported. CoolTone® should not be used in the heart or head areas, areas of growth plate, over the carotid sinus nerves, or over the neck or mouth. Use caution when administering to patients with pre-existing cardiovascular disease. WARNINGS AND PRECAUTIONS There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. This product contains albumin, a derivative of human blood. WARNINGS REVOLVE™ System is available by prescription only. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see. It also helps deliver content-specific information to you and tracks how sections of websites are used. It also helps deliver content-specific information to you and tracks how sections of websites are used. Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. These symptoms have been reported hours to weeks after injection. Results of this procedure will vary depending upon patient age, surgical site, and experience of the physician. The CoolSculpting® procedure is FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of ≤ 30 and in submental and submandibular areas in patients with a BMI of ≤ 46.2. Postmarketing reports indicate that the effects of BOTOX, Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. Redeem & Save. ADVERSE EFFECTS Our people are our greatest strength– we value and listen to their ideas and perspectives. Results of this procedure may or may not be permanent. KYBELLA® is contraindicated in the presence of infection at the injection sites. As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. Our pursuit of new possibilities in medical aesthetics will never stop. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. Women who are close to menstruation may find that it comes sooner, or cramping is increased or intensified with CoolTone® treatments, therefore, it is recommended to not undergo treatment during this time of the month. If such reactions occur, further injection of BOTOX. Your points, your way. Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or under-correction of the treatment site, tissue lumps, bleeding, and scarring. To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles. Caution should be used for patients with suspected or diagnosed heart problems. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist. Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent. This system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. Ensure that persons with pacemakers are not present in vicinity of the device during treatment. For JUVÉDERM® VOLLURE™ XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM® Ultra XC, Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled, To minimize the risk of potential complications, these products should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy and product use in indicated areas, The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications, The safety and effectiveness for the treatment of anatomic regions other than the mid-face, chin, and prejowl sulcus regions with JUVÉDERM® VOLUMA, The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied, The safety for use of JUVÉDERM® VOLUMA™ XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation, The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLLURE, As with all transcutaneous procedures, dermal filler implantation carries a risk of infection, Use dermal fillers with caution in patients on immunosuppressive therapy, Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites, Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events, The safety for use of JUVÉDERM® VOLUMA™ XC injectable gel in patients with very thin skin in the mid-face has not been established, The safety of JUVÉDERM® VOLUMA™ XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI, JUVÉDERM® VOLUMA™ XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study, The effect of JUVÉDERM® VOLUMA™ XC injection into the chin on facial hair growth has not been studied, Patients may experience late onset nodules with use of dermal fillers including JUVÉDERM® VOLUMA, Patients may experience late onset adverse events with use of dermal fillers. We believe that Your Practice is Our Purpose (YPOP), and we modeled our business around that belief. April 05, 2019. These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products. No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Care should be taken to avoid inadvertent injection directly into an artery or a vein as it can result in vascular injury. Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions. No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX, Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX, injections for unapproved uses. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products. KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Injection-Site Hematoma/Bruising These sensations subside as the area becomes numb. To report an adverse reaction, please call Allergan at 1.800.367.5737. The aesthetics market is changing fast. JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21. Increased Risk of Clinically Significant Effects With Pre-existing Neuromuscular Disorders. REVOLVE™ System is designed to remove localized deposits of excess fat through small incision and subsequently transfer the tissue back to the patient. Do not administer KYBELLA® into affected area until complete resolution. Putting science at the core of everything we do. Use caution when administering to patients with pre-existing cardiovascular disease. There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%). Consumer Product Questions. Injection Site Ulceration and Necrosis The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration. Dry Eye in Patients Treated With BOTOX® Cosmetic. These products have not been approved by the FDA, and the statements on these pages have not been evaluated by the FDA. Do not use the product if sterile packaging is damaged. 1.3K likes. © 2021 AbbVie. Other potential adverse events that may occur with breast implant surgery include: asymmetry, breast pain, breast/skin sensation changes, capsular calcification, delayed wound healing, hematoma, hypertrophic scarring/scarring, implant extrusion, implant malposition, implant palpability/visibility, infection, nipple complications, redness, seroma, swelling, tissue/skin necrosis, wrinkling/rippling. • Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. REVOLVE™ System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. The majority were mild or moderate in severity. We have many years of experience developing tools and resources to help you grow your practice. Call 1 (800) 678-1605. Natrelle® Breast Implants are indicated for women for the following: Breast implant surgery should not be performed in: Safety and effectiveness have not been established in patients with the following: • Conditions or medications that interfere with wound healing and blood clotting. Injections that are too superficial into the dermis may result in skin ulceration and necrosis. You become burned out due to a lack of headcount in certain departments. For JUVÉDERM® VOLLURE™ XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA™ XC, most resolved within 30 days. Excessive neuromuscular weakness may be exacerbated by, Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after, There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX, Cosmetic in pregnant women. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see, and other botulinum toxin products can result in swallowing or breathing difficulties. Greenspring Medical Aesthetics with two locations in Tucson, Arizona has … Women who are currently pregnant or nursing. This simple phrase translates into the personal touch that we deliver to customers every day to help them achieve their desired aesthetic outcome for their patients. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. Potential adverse effects associated with REVOLVE™ System include fat necrosis, cyst formation, infection, chronic foreign body response, allergic reaction, and inflammation. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Injection Site Alopecia Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner. Ask your patient about any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies. To report an adverse reaction, please call Allergan at 1.800.367.5737. Customer Relations and Medical Affairs 1 (800) 678-1605. Allergan's websites may ask your browser to store cookies, a small piece of data, on your computer or mobile device. XC, most resolved within 2 to 4 weeks. This device should be used with extreme caution in patients with chronic medical conditions such as diabetes, heart, lung, or circulatory system disease or obesity. To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan at 1-800-433-8871. Allergan Aesthetics, an AbbVie company, will continue to lead the global medical aesthetics industry by offering the broadest portfolio of treatments, devices, and medical aesthetics products—all supported by our leading-edge programs and education. Use care when using surgical instruments in proximity with the breast implant. Report a Side Effect or Adverse Event. At Allergan Aesthetics™ we create the products and technologies that drive the advancement of aesthetics medicine. At Allergan Aesthetics™ we create the products and technologies that drive the advancement of aesthetics medicine. This device will not, in and of itself, produce significant weight reduction. JUVÉDERM® VOLUMA™ XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21. Passionate for progress, our products are backed by science — to prove safety, quality, and efficacy. Please see KYBELLA® full Prescribing Information. SkinMedica® Most of the SkinMedica® products described on this website are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, … The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%). Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). REVOLVE™ System must be used within the same surgical procedure. If you are experiencing a medical emergency, please consult your healthcare provider. Call 1 (800) 678-1605 The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%). In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning). As one company, we have brought together over 30 brands and leadership positions, expanding and diversifying our product portfolio. CoolTone® should not be applied over swollen, infected, inflamed areas or skin eruptions. Breast implants are not lifetime devices and not necessarily a one-time surgery. Some of these patients had risk factors including pre-existing cardiovascular disease. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. Use of this device is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty and tissue transfer. Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin.
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