via Rhinoplasty Northern Va – Aesthetica Cosmetic Surgery

As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

With today’s approval, there are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.

“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health.

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.” said Maisel.

The FDA based its Sientra approval on three years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

In June 2011, the FDA released a report that included preliminary safety data from post-approval studies from earlier breast implant approvals. The experience collecting and analyzing data from these studies informed the design and structure of post-approval studies for Sientra breast implants.

In addition to other post-approval conditions, Sientra will:

• continue to follow the 1,788 clinical trial participants in their pre-market study for an additional 7 years;
• conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer; and
• conduct five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

“The design of these post-approval studies will require Sientra to collect valuable safety information with adequate enrollment and follow-up,” said Maisel. “The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness.”

Sientra Inc. is based in Santa Barbara, Calif.

The graphic’s information is based on research made available by the National Institute of Health (NIH), American Society of Plastic Surgeons (ASPS), RealSelf.com, and the United States Census. It charts the sharp increase in breast implants between 2000 and 2010, delineates the amount of money spent on breast implants in 2010—more than $2 billion—and demonstrates what a large portion of breast augmentations are performed in the Western states of the U.S.

“Any plastic surgeon can tell you that breast augmentation has only become more popular with the years,” said Dr. Brown, “and most who live here on the left coast won’t be surprised to see that more than one third of them are performed in the West. Patients come to California from every corner of the U.S. to get their breast implants—we have a reputation for excellence here.”

In addition to presenting the basic numbers involved with breast augmentation in the United States, “Swimming in Breast Implants” explores the demographics of the women who are seeking out breast augmentation—including age, reasons for pursuing the procedure, and satisfaction with the results. The infographic shows that the highest percentage of women, 36 percent, get implants between the age of 30 and 39, and that the overwhelming majority—90 percent—get them after having children. Satisfaction with the procedure is also high: 79 percent of patients say they’re happy with their results.

“There’s a reason that breast augmentation has been the number one cosmetic surgery—not just here in the U.S., but worldwide—for so long now,” said Dr. Brown. “As the high rate of patient satisfaction shows, this is a procedure that works. I hope this infographic serves as a helpful reference going forward, not only for other plastic surgeons, but for patients as well.”

“This year’s symposium will feature groundbreaking technologies from Europe, Latin America and the U.S. in the emerging fields of regenerative medicine, stem cell research, dermal fillers and volumizing agents, neuromodulators, lasers, light, ultrasound and radiofrequency based technologies and aesthetic plastic surgery. The faculty we have assembled represents top experts from plastic surgery, dermatology, facial plastic and oculoplastic surgery, as well as anti-aging medicine,” said Course Chairman Z. Paul Lorenc, M.D., F.A.C.S. “We are entirely focused on what is happening now, what is coming next and what the future will bring.”

The prestigious international faculty includes: William Adams, M.D., Robert Bard, M.D., Cheryl Burgess, M.D., James Carraway, M.D., Steven Cohen, M.D., Sydney Coleman, M.D., Joseph Eviatar, M.D., Steven Fagien, M.D., Rebecca Fitzgerald, M.D., Roy Geronemus, M.D., Christopher Godek, M.D., Miles Graivier, M.D., Joseph Gryskiewicz, M.D., Geoffrey Gurtner, M.D., Christine Hamori, M.D., David Hidalgo, M.D., Haideh Hirmand, M.D., Joseph Hunstad, M.D., Nolan Karp, M.D., Jeffrey M. Kenkel, M.D.,Brian Kinney, M.D., Wendy Lewis, Z. Paul Lorenc, M.D., Alan Matarasso, M.D., Foad Nahai, M.D., Ivona Percec, M.D., Joel Pessa, M.D., Jason Pozner, M.D., Andrea Pusic, M.D., Sam Rizk, M.D., J. Peter Rubin, M.D., Neil Sadick, M.D., Anthony Sclafani, M.D., Robert Silich, M.D., Henry M. Spinelli, M.D., Arthur Swift, M.D., Heidi Waldorf, M.D., V. Leroy Young, M.D., and Sabine Zenker, M.D.

The 2012 program has been expanded to include innovative workshops led by leading experts on social media and marketing, laser lipolysis and body shaping, facial rejuvenation with novel agents, advanced imaging systems, and new techniques for fat grafting and platelet rich fibrin matrix (PRFM). Live demonstrations of dermal fillers, volumizing agents and neuromodulators injection techniques will be featured.

Before getting a New York City tummy tuck, you must meet your surgeon in a consultation. Ask plenty of questions to be sure you will get the best possible care and see the results you expect. Here are some questions to get you started:

Are you board certified?

Plastic surgeons who have been board certified by the American Board of Plastic Surgery are qualified to safely perform a tummy tuck.

How much experience do you have?

Find a doctor who has plenty of experience performing tummy tucks. Ask not only how long he’s been doing the procedure, but how many he’s done. Look through the before-and-after photos to see results.

Is the facility accredited?

An abdominoplasty should only be performed in an accredited facility, whether it is a hospital or surgery center.

What about anesthesia?

Who will provide anesthesia? What type of anesthesia will be used? Is the anesthesiologist board certified? Will any medications or supplements I’m taking interfere with the anesthesia?

How do I prepare for surgery?

How do I physically prepare for my tummy tuck? What paperwork do I need to bring? How early should I arrive on the day of surgery?

What happens during the tummy tuck?

How long will the surgery take? What complications can arise during surgery?

What about my appearance?

Where will my scar be? How do you avoid or treat “dog ears” at the ends of the scars?

Would combining procedures be advisable?

Would liposuction along with the tummy tuck help optimize my results?

What happens after the tummy tuck?

When will I go home? When can I go back to work? How much discomfort should I expect, and what can I take to relieve the pain?

When can I resume regular activity such as exercise and sex?

The popularity of neurotoxin and soft tissue filler injection procedures rose nearly 400% during the past decade, according to the American Society of Plastic Surgeons. The Ouchless® Needle eliminates waiting time, works to instantly reduce the pain associated with an injection, minimizes post-injection numbness, swelling and bruising, and provides patients a far superior injectable treatment experience. While numbing creams can take up to 40 minutes to work and may cause face discoloration, the Ouchless® Needle delivers a short spray of FDA-compliant blend of vapocoolant onto the skin before the skin is pierced. The vapocoolant spray immediately refrigerates the skin, reducing the feeling of needle penetration and making the injection more comfortable. The Ouchless® Needle Collection is available in models to work with most commonly used cosmetic injection syringes.

The American Society of Plastic Surgeons reports that, in 2010 alone, U.S. consumers spent more than $216 Million pursuing Intense Pulsed Light therapy. IPL therapy is a minimally-invasive procedure that literally lifts brown spots, age spots, acne scars and redness (or Rosacea) from across the face, neck and chest.

“The buzz around IPL has definitely increased,” says Shawn Miele for FaceForum.com. “People with skin imperfections get great results with IPL photofacial treatment. This isn’t a vanity issue, either. Some have felt stigmatized or self-conscious for years.”

In honor of the New Year and consumers’ interest in the latest “new you” techniques, FaceForum.com has added an IPL overview to its website.

“IPL therapy is so popular because its results are immediate,” adds Miele. “That’s pretty impressive for a relatively painless, 30-minute, lunch-break procedure.”

“They’re also long-lasting and multi-dimensional. Patients routinely get 2-for-1 benefits, since both light and heat are used in the IPL process. That doesn’t only lift pigment from the skin. It also jump starts collagen production and boosts new cell growth to deliver a better complexion overall.”

“There’s not even any down time involved. Each click with an IPL wand lifts a little more pigment. Most patients we’ve talked with liken it to being lightly snapped with a rubber band and love being able to jump back into their normal routines right away.”

IPL therapy treats skin imperfections which include:

・    Sun Damage

・    Hyperpigmentation

・    Redness or Rosacea

・    Unwanted Hair Growth

・    Age Spots or Brown Spots

・    Under-Eye Bags & Premature Wrinkles

・    Enlarged Pores, Acne Scarring or Other Scarring

At FaceForum.com, consumers have free 24/7 access to articles about facial cosmetic plastic surgery procedures, a board-certified surgeon database and an active user discussion board. For more information about IPL therapy and other procedures, such as face lift, visit FaceForum.com.

“Liposonix is a significant scientific advance for people who want a safe, effective and convenient way to get rid of that last unwanted inch around the waist,” said Anne Chapas, M.D., Assistant Clinical Professor at New York University School of Medicine and Founder and Medical Director of Union Square Laser Dermatology. “When diet and exercise just aren’t enough to lose that last inch, the Liposonix custom contouring treatment is a terrific option for patients to achieve the shape they want without the expense, discomfort and recovery time of invasive procedures, such as liposuction.” (See Dr. Chapas demonstrate Liposonix treatment on the Dr. Oz show.)

Unlike other non-invasive fat reduction treatments, Liposonix permanently destroys the fat cells found beneath the skin, without harming the skin, with just one treatment in a procedure that takes about one hour. The body naturally processes and removes the fat tissue over a period of 8 to 12 weeks, leaving behind the desired slimmer, more contoured waistline. Clinical studies have demonstrated an average waist circumference reduction of approximately 2.6 cm (1 inch) after a single Liposonix treatment.

“Liposonix technology was developed over a period of 10 years by leading scientists and ultrasound experts with more than 200 years of combined experience in the development of therapeutic and diagnostic ultrasound devices,” said Grant Stevens, M.D., F.A.C.S, Associate Clinical Professor of Plastic Surgery USC Division of Plastic Surgery, Director of the USC-Marina del Rey Aesthetic Surgery Fellowship and Marina Plastic Surgery Associates. “I feel confident that I can now offer my patients an effective non-invasive treatment that specifically targets the stubborn fat in the abdomen and love handles that so many of my patients want to lose.”

To quantify the extent of the desire to lose fat in the waist area, Solta Medical sponsored “The State of Love Handles in America” nationwide survey of more than 1,000 women. The just released survey findings reveal that:

62% of women say the part of their body they are most uncomfortable with is their tummy/love handles.

45% claim they would give up sex for one year to lose an inch.

66% would give up chocolate for one year to lose an inch.

75% would give up clothes shopping for one year to lose an inch.

The survey findings support a growing demand for fat reduction treatments. In fact, more than a half million fat reduction procedures were performed in the U.S. in 2011, and it is estimated that the non-invasive fat reduction market will grow by 42% annually through 2016 – nine times faster than its surgical counterparts.¹

“The addition of Liposonix to our brand portfolio allows us to expand into the fast-growing, non-invasive fat reduction market and to offer a new and exciting approach to custom body contouring,” said Stephen J. Fanning, Chairman of the Board, President and Chief Executive Officer of Solta. “We now have one of the strongest portfolios in the aesthetic space, with non-invasive, cutting-edge technologies in large and growing market segments – body contouring, skin tightening, skin resurfacing and rejuvenation, as well as acne treatment.”

The most common cosmetic surgery procedure of 2010 was breast augmentation, and the most popular non-surgical procedure was Botulinum Toxin Type A (also known as Botox) injections, with almost 2.5 million procedures reported last year, far surpassing other common non-surgical procedures including: hyaluronic acid, laser hair removal, laser skin resurfacing and chemical peels.

Americans spent an estimated $10.7 billion on cosmetic procedures last year; $1.9 billion was spent on injectable procedures alone.

Several states, including New Jersey, currently charge what has been dubbed a “Botax”—a 6 percent tax on elective cosmetic surgery procedures, including Botox injections.  But the New Jersey legislature has just voted to phase out the tax; the bill is currently waiting for approval from Governor Chris Christie.

Proponents of the tax say the state needs the tax-revenue generated from elective surgeries. But opponents fear that people will simply choose to take their business to other states that don’t tax cosmetic surgery procedures.

Interested in having some cosmic surgery work done? Want to find the best plastic surgeons or best dermatologists in your area? FindTheBest’s Best Plastic Surgeons comparison can help users find and compare their options.  For those in the New Jersey area, FindTheBest’s New Jersey Plastic Surgeons comparison and New Jersey Dermatologists can help residents compare their options.

FindTheBest is an unbiased, data-driven comparison engine that allows you to find and compare your options.  We organize and present data in a consumer-friendly format so that you can make quick and informed decisions based on what’s important to you.

While less expensive than standard plastic surgery, cosmetic procedures like chemical peels, Botox and others can be costly as well. To help offset that cost, nearly one-in-ten (9 percent) women ages 18-44 said they have used a coupon or a daily deal to help pay for a cosmetic procedure. In addition, 22 percent of U.S. adults who haven’t used a coupon or daily deal to pay for a cosmetic procedure said they would consider it. Nearly one-third (31 percent) of women ages 18-44 indicated this, compared to 23 percent of men in the same age bracket.

Coupons and daily deals are not only being used for cosmetic enhancements, but for routine medical procedures as well. Five percent of U.S. adults said they have used a coupon or a daily deal for a medical procedure like a teeth cleaning or doctor’s visit. Of those who have used a coupon for a medical procedure, 34 percent said it was to help fill in gaps in medical insurance coverage.

“The popularity of coupon and daily deal use has spread from products and basic services to a variety of medical procedures,” said Jackie Warrick, President and Chief Savings Officer at CouponCabin.com. “Many people are taking advantage of the discounts offered by coupons and daily deals to enhance their appearances and maintain their overall health. Others may be more cautious about using such offers. No matter what side of the fence you’re on, it’s important to read all the fine print before using a coupon or daily deal for a procedure on your body.”

Of those U.S. adults who have used a coupon or daily deal for a cosmetic procedure, many were able to achieve significant savings. When asked approximately how much money they saved, respondents said the following:

Under $100 – 48 percent

$100 – $149 – 12 percent

$150 – $499 – 17 percent

$500 – $1,499 – 10 percent

$1500 or more – 13 percent