Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the United States launch of BELOTERO BALANCE (+), the lidocaine formulation of BELOTERO BALANCE. First approved in 2011, BELOTERO BALANCE is a hyaluronic acid (HA) filler for etched-in lines that provides a flawless finish for filler patients. BELOTERO BALANCE (+) offers the same benefits plus the advantages of a lidocaine formulation.
“Healthcare providers can now rely on the well-known rheological properties and performance of BELOTERO BALANCE with the time savings and consistency of a pre-mixed lidocaine formulation,” said Patrick Urban, North America President, Merz Aesthetics. “The new offering plays an important role in the Merz Aesthetics portfolio, taking us a step further in our commitment to providing our customers with a cultivated range of quality products to deliver outstanding outcomes for their patients.”
BELOTERO BALANCE (+) is an injectable filler used to smooth moderate-to-severe etched-in facial lines and wrinkles in the lower face that is known for blending evenly with natural skin tissue for a seamless feel with minimal tissue disruption. The HA in BELOTERO BALANCE (+) is specially formulated in a proprietary process to create a uniquely smooth and cohesive gel that blends into the natural structure of the skin, to fill etched-in lines and wrinkles while creating a smooth, natural look and feel.
“BELOTERO BALANCE has been a go-to filler for superficial lines for nearly 10 years, as its special HA formulation evenly blends with natural skin tissues, providing a flawless finish,” said board-certified dermatologist, Dr. Michelle Henry. “Healthcare providers and patients now have the added value of a lidocaine formulation, with BELOTERO BALANCE (+).”
About Merz Aesthetics
Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven and category-leading, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 110 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 52 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.
Corporate Contact:
Brittany Kotary
Senior Communications Manager
Merz Aesthetics
6501 Six Forks Road, Raleigh, NC 27615
(919) 985-7939
AxCorpCommNA@Merz.com
Copyright © 2021 Merz North America, Inc. All rights reserved. MERZ AESTHETICS is a registered trademark of Merz Pharma GmbH & Co. KGaA. BELOTERO BALANCE and BELOTERO BALANCE (+) are registered trademarks of Merz Pharma GmbH & Co. KGaA.
IMPORTANT SAFETY INFORMATION FOR BELOTERO BALANCE (+):
INTENDED USE/INDICATIONS:
BELOTERO BALANCE® (+) is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.
Warnings:
Use of BELOTERO BALANCE® (+) in any person with active skin inflammation (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
Precautions:
In order to minimize the risks of potential complications, BELOTERO BALANCE® (+) should only be used by health care professionals who have appropriate training experience, and who are knowledgeable about the anatomy at and around the site of injection.
Health care professionals are encouraged to discuss all potential risks of soft tissue infection with their patients prior to treatment and ensure that patients are aware of the signs and symptoms of potential complications.
As with all skin-injection procedures, there is a risk of infection with BELOTERO BALANCE® (+).
BELOTERO BALANCE® (+) should be used with caution in patients on immunosuppressive therapy.
The use of BELOTERO BALANCE® (+) in patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
Based on clinical trials, patients should be limited to a 6.0 mL of BELOTERO BALANCE® (+) per year. The safety of injecting greater amounts has not been established.
The long-term safety and effectiveness of BELOTERO BALANCE® (+) beyond 96 weeks have not been investigated.
The safety and effectiveness of BELOTERO BALANCE® (+) during pregnancy or breastfeeding, for the treatment of dermal contour defects other than nasolabial folds, such as use in the lips, or in patients under 21 years have not been established.
The safety of BELOTERO BALANCE® (+) in patients with known susceptibility to recurrent sore throat or Osler Rendu endocarditis has not been studied.
No studies of BELOTERO BALANCE® (+) Injectable Implant with drugs or other substances or implants have been conducted.
Patients using medications that prolong bleeding, such as aspirin, non-steroidal anti-inflammatory drugs, or warfarin, may experience increased bruising and bleeding at the injection site.
Exposure of the treated area to excessive sun, UV lamp exposure, Turkish baths, and extreme cold weather should be minimized until any initial swelling and redness have resolved and puncture sites have healed.
Laser treatment, chemical peeling, or any other procedure based on active dermal response performed after treatment with BELOTERO BALANCE® (+) may increase the risk of an inflammatory reaction at the injection site.
Adverse Events:
The most common adverse events seen in clinical studies with BELOTERO BALANCE® (+) were swelling, bruising, redness, hardening of the skin, pain, altered color or itching. Other adverse events that have occurred with BELOTERO BALANCE® (+) include headache, swelling of the side of the nose, moderate cold sore, lip numbness, and lip dryness. Side effects were often mild to moderate and often resolved within 7 days.
Information on adverse events from post-market surveillance of BELOTERO BALANCE® (+) are included in the Instructions for Use (IFU) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to the products. Please see the IFU and PIG available on www.belotero.com for a complete list of these events.
To report a problem with BELOTERO BALANCE® (+), please call MyMerz Solutions at 1-844-469-6379.
For complete Safety Information, please visit www.belotero.com
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