Coming & Going: March/April 2019

COMING

Zero Tolerance for Wrinkles

Sure every wrinkle tells a tale, but it may not be something our patients want to share with the world. And they no longer have to. It may be buh-bye, frown lines and other wrinkles for good now that Evolus' Jeuveau has received the coveted FDA nod and is expected to be available shortly.

Neuromodulators including Botox Cosmetic, Xeomin, and Dysport, are always among the most requested minimally invasive procedures, and there hasn't been a newcomer in this category since Dysport in 2009 and Xeomin in 2011. FDA studies yielded non-inferiority and “equivalent” results to Botox in treatment of the glabellar lines with 20 Units of Jeuveau. With a reported rapid onset, Jeuveau will continue to grow the toxin market and maybe bring in more patients who haven't taken the plunge yet.

New advertising campaigns are targeting millennials in search of prejuvenation (i.e., stopping wrinkles before they start), further expanding this already hot market. These are not the only reasons that facial wrinkles may no longer be a given. More and more people are using sunscreen today and grew up using sunscreen, compared with previous generations, and we know photodamage is one of the main causes of skin aging. We are getting better at preventing wrinkles and smoothing them if and when they do occur, and as a result the US may soon be a wrinkle-free zone.

GOING

Textured Breast Implants

It's déjà vu all over again as top plastic surgeons descend upon FDA headquarters to defend the safety of breast implants against women who feel duped. The main issue at hand is textured breast implants and a small associated risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Since the FDA first issued a warning about this risk in 2011, nearly 700 cases and 17 deaths (nine in the US) have been tallied worldwide. The risk has only been associated with textured breast implants to date. The presentation is usually swelling in a breast two to 28 years after a textured implant has been placed. If this occurs, a plastic surgeon should be consulted. Many textured implants are already gone in Europe where Allergan took its leading brands off the market after French regulators suspended their approval.

As I write this column, all eyes are on the FDA, and it's anyone's guess if they will proceed with warnings or restrictions on textured breast implants. Many plastic surgeons have already sent letters to patients who received textured breast implants alerting them to reports of BIA-ALCL and suggesting removal and replacement if they are at all concerned. With this as the backdrop, we will see fewer and fewer textured breast implants in the US, regardless of what the FDA decides.