Sientra Doubles Down on Commitment to Breast Implant Safety

The FDA recently asked all breast implant manufacturers to provide prospective patients with adequate risk information and a decision checklist to guide the decision-making process.

The agency didn’t stop there, either. They also called on breast implant manufacturers to add a boxed warning to implants, update silicone gel-filled breast implant rupture screening recommendations, and include a device description with a list of specific materials used in the device and a patient device card in their packaging.

Breast implant manufacturer Sientra recently brought thought leaders and journalists together to discuss the company’s long-term commitment to safety, including their 20-year warranty, which is longest in the industry. The company also highlighted their thorough patient-decision checklist and ongoing commitment to only sell implants to board-certified plastic surgeons.

“As a plastic surgeon, my goal is to provide the most beautiful, natural, and long-lasting results, and I feel great choosing a breast implant company that prioritizes patient safety and product quality,” says B. Aviva Preminger, MD, a New York City plastic surgeon, who spoke at the event. “Sientra stands behind its product, even offering a longer warranty than any other breast implant company. Furthermore, Sientra only sells to board-certified and board-eligible plastic surgeons, which is a real commitment to ensuring patient safety.”

Aquavit’s Neurotoxin Submitted to FDA

Aquavit Pharmaceuticals, Inc. has submitted its IND for a new botulinum toxin (DTX-021) to FDA for approval. The company also unveiled its development programs at the annual meeting of the American Academy of Dermatology in Boston.

DTX-021, a botulinum toxin type A drug intended for the treatment of moderate to severe glabellar lines, is a highly purified and clinically tested injectable neuromodulator with a 900kDa protein complex derived from neurotoxins produced by Clostridium botulinum.

Aquavit says it will be initiating a long-term Phase 2 clinical trial shortly after approval of the IND. With FDA approval, DTX-021 will be marketed as Dermatox.

Aquavit is accelerating its clinical development program by introducing DTX-022 shortly after DTX-021. With final approval of DTX-022, it will be the world’s first FDA approved pan-facial microinjection of neurotoxins. DTX-022 features a novel route of administration (RoA) of DTX-021 utilizing Aquavit’s innovative microchannel delivery system, a patented “repeated motion” technology.

For several years, Aquavit has been investing in its proprietary delivery technologies and related intellectual property for botulinum toxin. Aquavit is currently evaluating all other potential therapeutic indications of botulinum toxins.

“We are thrilled to present DTX-021 and DTX-022 programs at this year’s AAD. With Aquavit’s proven track record of developing and launching a global brand such as Aquagold, combined with our network of physicians and knowledge of botulinum toxins, we are poised to make a significant impact in the fast-growing multi-billion dollar neurotoxin market,” says Sobin Chang, CEO of Aquavit.

Study: YouTube Videos May Provide Misleading Info on Injectables

YouTube videos on Botox and soft-tissue fillers don’t always provide accurate information, according to an article in the March 2022 issue of Plastic and Reconstructive Surgery.

“Our study shows the need for improvement in the quality of YouTube videos related to cosmetic injectables, and plastic surgeons—already the most frequent contributors to online videos—are the most qualified to meet that need,” says study author Robert D. Galiano, MD, of Northwestern University Feinberg School of Medicine in Chicago.

The popularity of injectables may be driven largely by social media and other platforms. In particular, YouTube has become an increasingly important source of online health information. YouTube videos provide “a unique opportunity for plastic surgeons to educate thousands of patients in a thorough and vastly accessible manner,” Dr. Galiano and colleagues write.

For the study, researchers searched Google and YouTube to identify the highest-ranking websites and videos providing information about botulinum toxin type A and soft-tissue fillers. The analysis included 95 YouTube videos: 50 on soft-tissue fillers and 45 on botulinum toxin type. Forty-seven percent of videos were contributed by plastic surgeons and other physicians, 6 percent by other health professionals, 24 percent by patients, and 22 percent by other sources, such as news media, online magazines, and social media influencers.

For each video and website, the quality of the information was graded using three standard tools plus a newly developed content score. Consistent with previous studies of online health information, the quality of the videos showed room for improvement. By all four measures, the videos met no more than half of quality criteria.

Quality also varied based on the source of the videos. Videos created by physicians, non-physician health professionals, and other sources such as news media had significantly higher quality scores than patient-based videos. On the content score, patient-based videos met only about 40 percent of quality criteria, compared to 55 percent for physician-based videos.

Although direct comparisons were difficult, websites identified on Google search offered higher quality of information than YouTube videos. Content scores were about 60 percent for injectable websites versus less than 40 percent for videos. Yet the YouTube videos were more popular, averaging about 16,000 views per month, compared to fewer than 4,000 views per month for websites.

The findings show that physician-created videos provide more reliable information—similar to those created by other health professionals as well as by influencers, news and magazine channels. “By comparison, videos created by patients are of lower quality,” Dr. Galiano adds. “These patient-based videos, on YouTube or elsewhere, should not be recommended as sources of information on Botox or soft-tissue fillers.”

The popularity of YouTube helps plastic surgeons to understand where to focus their online presence—practice websites may not be as influential as videos. Dr. Galiano and colleagues conclude: “YouTube can serve as an incredible asset to plastic surgeons to reach patients in a way that has never existed before, which comes with the responsibility of providing accurate, comprehensive, and understandable information.”

New From Alma: Alma TED, CBD+ Professional Line

Alma TED, an ultrasound-based system with a propriety tip engineered with impact delivery, offers a non-invasive, non-traumatic option to address the market’s growing hair loss concerns. Alma launched the device, along with the CBD+ Professional Skincare Solution, at the the American Academy of Dermatology Annual Meeting in Boston.

“Hair loss is a debilitating concern that can impact the quality of life for both men and women, especially for my younger patients,” says Shraddha Desai, MD, a dermatologist at Duly Health and Care in Naperville, IL. “While we have effective prescription medications, over-the-counter supplements, and at-home topical applications, our in-office treatment solutions have been limited and more invasive, such as PRP.”

Lady Dy, MD, a dermatologist at the Dy Dermatology Center in Glenview, IL, who treats over three hundred hair loss patients a month, comments, “Hair loss is a traumatic experience for patients. These patients are hypersensitive to retaining their existing hair and anxious to regain their fuller head of hair back.” Dr. Dy has incorporated Alma TED into many of her treatment plans because her Alma TED patients are showing higher compliance and satisfaction. “Alma TED is not only a comfortable treatment, but my patients are noticing results as early as three weeks. Patients find the treatment soothing and enjoyable, which is a huge breakthrough for this treatment category.”

CBD+ Professional Skincare Solution, consisting of 10 unique skincare products, represents the first commercial brand and expansion into the US market for Alma under its parent Company, Sisram Medical.

Take Five Wendy Lewis Founder and President, Wendy Lewis & Co, Ltd.

It’s been 25 years since Wendy Lewis launched her global consulting firm, and in that time, she’s kept the pulse of the evolving medical aesthetics industry. In addition to running her company, she is a speaker, marketing educator, and writer—including in the pages of Modern Aesthetics® magazine. As she marks two-and-a-half decades in aesthetics, she reflects on where the industry has been and where it’s headed.

Aesthetics Has Aged Well

“My entrance to aesthetics was purely by accident. I graduated from Barnard cum laude at age 20 with a degree in English. My first real job was in Manhattan for a large recruiting firm. I stumbled upon a position that caught my interest for a prominent Fifth Avenue surgeon and decided to take a chance. The recruiter was looking for someone who was educated, dressed well, with managerial skills, and I fit the part. Thus, purely by accident and good fortune, I entered the field of aesthetic surgery to manage a very high-end practice where glam patients and celebs came from all over the world. I enjoyed the challenge, and you could say I was hooked from the start.

In the early days, the focus was plastic surgery. At that time, most dermatologists were focused on medical treatments and skin cancer. However, the advent of bovine collagen fillers changed the face of aesthetics. Then in 2002, FDA approved Botox Cosmetic and not long after, CO2 lasers were widely cleared to be used in dermatology. Many prominent dermatologists embraced aesthetics early on and the rest is history.

The field of plastic surgery was indeed led by men during that period. It took quite a long time before women were embraced as leaders in the field, and I think they had to work twice as hard as the men to prove themselves, not unlike many other professions. I can recall when there were only about seven percent of plastic surgeons who were female, and most of them were relegated to breast surgery. Fast forward to 2022, and the first female plastic surgeon will be sworn into the role of President of The Aesthetic Society. I call that progress!”

Digital Marketing Has Evolved, Too

“I took the plunge into social media in the early days—2008—when it was basically free and thoroughly enjoyable! Twitter and Facebook were the key channels. I taught a lot of people how to use Twitter. It was fun and exciting, and I made long-lasting friends and met colleagues on that platform. Slowly but surely, social kept expanding and became big business as new channels arose. It was very frustrating for physicians, who are often natural control freaks, to navigate how to use these challenges in the beginning. After all, it was counterintuitive to most of us. As time went on, it became crystal clear that digital was taking over everything. We moved away from all printed materials for our marketing clients and embraced social media and digital marketing. Yet what started out as a fun hobby has quickly become overwhelming and extremely challenging for small businesses. Digital marketing certainly keeps us on our toes.”

There is Always Something New

“The accomplishments I am most proud of are the many books I have written in my own byline, as well as the books I have ghost-written for prominent physicians over the years. I penned a dozen books on aesthetics for consumers, and my first marketing textbook was published by CRC Press. I have a second edition of that textbook coming out later this year as well, and another textbook under contract with Thieme. The number of articles I write every month, plus webinars and speaking engagements I am honored to do, keep me interested and curious about all things aesthetics. I still get excited when I come across a new technology or product that gets my juices flowing. In our industry, there are always new surprises coming.”

Still Need for Caution

“The aesthetic industry is in a constant state of flux, which makes it exciting. Practitioners and consumers alike are always looking for new, new, new, yet ‘new’ is not necessarily synonymous with ‘better.’ Though the shiny bells and whistles that arise may be tempting, the science, outcomes, safety, and studies need to be solid to take the plunge. As a practitioner, you are only as good as your results and satisfied patients. Sadly, the aesthetic graveyard is littered with products, treatments, and technology that didn’t make the cut. Do your homework and your research to be sure a new technology is safe, effective, and worthwhile for your patients and for your brand.”

Still A long Way to Go

“I am obsessed with the whole field of exosomes that has quickly become a hot topic in aesthetics worldwide. In my view, aesthetics still has a long way to go, and the field continues to exceed all of my expectations.”