Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane^® Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21. In 2020 alone, online searches for chin enhancement increased by 185 percent, reinforcing the emerging patient need for a product like Restylane Defyne. Restylane Defyne is the first and only chin filler to demonstrate results* across a wide range of participants, including participants with all skin types, male subjects and subjects† over the age of 52. Restylane Defyne is a hyaluronic acid (HA) dermal filler that was first approved in 2016 by the FDA for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in subjects over age 21.

“My patients often come to me asking about new treatment options to continue looking their best. Many are surprised when I explain the impact of chin augmentation and how balancing the lower face is key to helping achieve total facial attractiveness, said Anne Chapas, M.D., a board-certified dermatologist and dermatologic surgeon in New York and an investigator in clinical trials of Restylane Defyne for chin. “The lower part of the face is constantly in motion, so it is important for patients to have the option of a dynamic filler like Restylane Defyne that is scientifically developed to adapt to their facial expressions."

Restylane Defyne is the only FDA-approved filler designed for use in the chin that is produced using Galderma’s unique manufacturing process, XpresHAn Technology™, globally referred to as the OBT technology (Optimal Balance Technology), which creates a smooth, injectable gel that integrates into the skin for natural, dynamic movement. Treatment with Restylane Defyne in the lower face, using XpresHAn Technology™, has shown to produce highly satisfactory natural looking results.

“This marks Galderma’s 8th FDA aesthetics approval in 5 years, illustrating our long-term commitment to advancing aesthetics through new innovation,” said Alisa Lask, General Manager and Vice President of the U.S. Aesthetics Business at Galderma. “The chin is the foundational anchor of the face that brings the rest of your features into balance. Consumers can now address the chin with a non-surgical, safe option from a brand that uses cutting-edge XpresHAn Technology^TM to shape and produce long-lasting results.”

 

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Source:

Galderma

Allison Escolastico, a 30-year-old transgender woman, has wanted breast augmentation surgery for a decade. By 2019, she finally thought her insurance company, Aetna, would pay for it, only to find that it considered the procedure cosmetic, not medically necessary, and refused to cover it.

“I knew from my case, it wasn’t cosmetic,” said Ms. Escolastico, who contacted a lawyer after she lost her appeal last year. “I knew I had to fight for this,” she said.

Ms. Escolastico’s surgery is now scheduled for February. Working with the Transgender Legal Defense and Education Fund, a nonprofit that advocates transgender rights, and Cohen Milstein Sellers and Toll, a large law firm that represents plaintiffs, she and a small group of trans women persuaded Aetna to cover the procedure if they can show it to be medically necessary.

To qualify, the women would need to demonstrate that they had persistent gender dysphoria, undergo a year of feminizing hormone therapy and have a referral from a mental health professional.

The shift by Aetna represents an important evolution in how health insurers view the medical needs of transgender individuals. While some insurers offer a broad range of surgeries for trans women if they are deemed medically necessary, others exclude breast augmentation and other treatments as merely cosmetic.

“This has the potential to be a transformative moment,” said Kalpana Kotagal, a partner at Cohen Milstein.

Insurers have typically covered genital reassignment surgery as medically necessary. But transgender women and others say breast augmentation is also a necessary treatment for individuals who receive a diagnosis of gender dysphoria. “There is no question from a medical perspective,” said Noah E. Lewis, the director of the Trans Health Project at the fund.

 

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Source:

The New York Times