FDA Approves Sientra Silicone Breast Implants in the United States

The Food and Drug Administration today cleared Sientra Inc.'s silicone breast implants for use in the U.S., adding another competitor to versions of the product already offered by Allergan Inc. (AGN) and Johnson & Johnson (JNJ) unit Mentor Worldwide LLC. Sientra will be the third manufacturer of silicone breast implants in America given the current US FDA regulations.

The latest approval comes after the FDA in August said it will allow silicone implants to remain on the U.S. market while manufacturers work to boost enrollment rates in required long-term studies.

The agency has said women receiving silicone-gel breast implants experience frequent complications and sometimes need additional surgery to fix or replace them, but recent studies haven't shown any unexpected or new safety concerns for the existing implants on the market.

The FDA based its Sientra approval on three years of clinical data from 1,788 participants. The latest approval permits breast-augmentation surgery in women at least 22 years old as well as reconstructive procedures for women of any age.

"Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness," said William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health.

The agency will also require that Sientra run post-approval studies judging the long-term safety and effectiveness of the implants as well as the risk of rare diseases among women using them.

Sientra founder and Chief Executive Hani Zeini helped launch the privately held company after an earlier stint at Inamed Corp., the breast-implant maker later acquired by Allergan.

As a plastic surgeon who performs many breast augmentation surgeries, it is exciting to have another brand available on the market to choose from! Competition is a good thing in the world of medical devices and I am glad that women will have a third option when it comes to silicone gel breast implants.

You Are What You Eat!

Everyone has heard the phrase “You are what you eat”. The phrase applies not only to internal health but to our appearance as well. Dr. Walden recently appeared on KEYE Austin to talk about our food choices and how it affects our looks. Overall, her recommendations are to drink 8 glasses of water a day, eat 2-3 servings of fruit per day, and eat fatty or sugar-filled foods in moderation. To learn more about how to firm up the collagen in your skin, prevent and/or reduce sun damage of the skin, prevent acne and oily skin, and get an all over youthful look, check out what she said.  

MedSpa Safety

Have you looked in the mirror recently and wondered who was looking back at you? With an 88% increase of men undergoing plastic surgery in the last 15 years, it seems that in fact, men do not age more gracefully. An increasing number of individuals, men and women alike, are looking to fight aging and to see that young, vibrant person they feel inside. Many are turning to plastic surgery procedures to achieve their goals but for those who are looking for a more affordable treatment with little to no down time, minimally invasive procedures are available and are quickly gaining popularity. With the rapid growth of products like Botox, Juvederm, and Restylane, consumers must be aware of Do-It-Yourself kits, Botox parties, and even day spas that offer these treatments. Dr. Jennifer Walden was recently on Fox 7 News discussing what we should be aware of, what to look for, and what questions to ask to ensure we are receiving FDA approved products by a licensed provider. See what she had to say.   

You Don't Look Like a Grandmother!

With the pressure to look young even as we age, soft tissue fillers and plastic surgery have become more common and acceptable to maintain that youthful look. According to the American Society for Aesthetic Plastic Surgery, even with a 17% overall decrease in plastic surgery procedures performed between 2005 and 2010, during that time, there was a 29% increase in patients 65 years or older electing for some form of rejuvenation. Among the most popular procedures for those 65 years or older are Botox, Juvederm, Facelifts, Brow Lifts, Liposuction, and even Breast Augmentation. In the past, it was believed that senior citizens were at a higher risk for anesthesia complications during or after a surgical procedure, however a clinical study conducted by Cleveland Clinic says otherwise. See what Dr. Walden says on KVUE News about the study and suggests for older patients considering plastic surgery. 

Roundup of the Best Cosmetic Surgeons in NYC

Dr. Jennifer Walden was honored to be featured as a top cosmetic surgeon in NYC prior to her move to Austin, Texas. Pierce Mattie, an esteemed beauty and fashion public relations firm, wrote the article below, entitled,"Roundup of the Best Cosmetic Surgeons in NYC" on November 14, 2011. Thanks, Pierce Mattie!

If you’re looking to undergo cosmetic surgery, here are three cosmetic surgeons located in New York City, known for their skill and expertise.

Dr. Phillip Miller: Dr. Philip Miller is a cosmetic surgeon that has remained on the list of Best Doctors in America since 2007. He specializes in facial surgeries, including plastic, cosmetic, and rejuvenation procedures. Due to his extensive training, studying and applied experience of over twenty years, he attracts many patients, including an extensive-secret celebrity list.

Dr. Phillip Miller has also been featured in many magazines like W Magazine, Marie Claire and The Wall Street Journal, in addition to newspaper articles, each displaying his knowledge and success. He was recently featured in Elle Magazine - who reports that Dr. Phillip Miller is NYC’s best facial plastic surgeon. Dr. Phillip Miller has been the recipient of many doctorial awards including Top Doctor of New York.

If you want to engage in more information and stay connected regarding Dr. Phillip Miller, be sure to follow him on Twitter, and YouTube to catch his latest interviews and answers. He also has an app! If you have an iPhone or Android you can download his App to stay up to date on his practices and procedures.

Dr. Kolker: Dr. Adam R. Kolker focuses his practice on facial cosmetic surgery as well as breast and body augmentations. Not only does Dr. Kolker serve in his practice, but also finds the time to exert the position of a surgical volunteer for Operation Smile. Operation Smile is a non-profit organization that Dr. Kolker is a proud representative of. The organization helps children all around the world by performing free surgery to those in need.

In addition to Dr. Kolker’s success, he has produced his own line of skin care products entitled, AKMD. For every AKMD product sold, a portion is generously donated to Operation Smile.

To request an appointment with Dr. Kolker, you can do so online or visit their contact page. 

Dr. Jennifer Walden: Dr. Jennifer Walden is frequently seen on Fox News where she shares her expertise on cosmetic surgery. She's also routinely sourced in magazines such as Vogue, Shape, The New York Sun and more, on surgical related topics. She is very well known for her extensive list on procedure selection from injections, breast implants, tummy tucks, makeovers and more.

Dr. Walden has a growing list of jaw dropping “before and afters” that really display her talent. She succeeds in every aspect of emotionally and physically transforming patient’s lives, so they can achieve and live their dream. Dr. Walden is also the co-author of Aesthetic Plastic Surgery which covers unique topics and provides guidance and expertise on cosmetic surgery and the outcomes. The hardcover inspirational book also comes with a DVD, both are available for purchase through Amazon for $315.

If you are eager to learn more about Dr. Walden you ‘Like’ her Facebook page and follow her on Twitter. She also posts videos on YouTube to share, her recent post reflecting Breast Cancer Awareness, which is a great video to educate yourself with.

Have you had the experience of working with any of these extremely talented doctors? Tweet us @PierceMattiePR