Juvederm Ultra XC: Year-Long Lip Fillers

The US FDA has approved Allergan's JUVEDERM® ULTRA XC for the injection into the lips and perioral area for lip augmentation in adults over the age of 21.

Allergan's trials show that results last up to a year in the lips, but as always, there are two sides to the coin.

Since 2006, Juvederm formulations were already FDA approved for correction of moderation to severe facial wrinkles and folds such as parentheses lines around the nose and mouth. Then in 2013, the Juvederm XC for age-related mid-face volume loss was introduced.

Clinical trials for Juvederm revealed that 79% of subjects showed an improvement in lip fullness three months following the treatment. More than 78% of the subjects reported an improvement in their overall satisfaction with the smooth and natural look and feel of their lips at one year after treatment.

Executive Vice President & President, Allergan Medical Philippe Schaison said that:

As the leader in medical aesthetics, Allergan is committed to continued research and development in this area. Providing physicians and patients with premium products that allow them to achieve the aesthetic results they want is always our goal. Understanding that the desire with lip augmentation is to achieve a natural-looking and lasting result, we continued our research of JUVEDERM® ULTRA XC for the lips. With this approval, JUVEDERM®ULTRA XC is now the only filler that is approved to last up to one year in the lips while providing natural-looking results.

Juvederm Ultra XC contains a smooth gel formulation of modified form of hyaluronic acid (HA) and a small amount of lidocaine. The hyaluronic acid helps the skin to maintain its moisture and softness and the lidocaine acts as a local anesthetic to improve the comfort of the injection.

While the increase in the time between injections is going to be welcomed by patients, there are some physicians and clinics that might lose income since patients are not coming in as frequently. Additionally, these longer fillers might not be appropriate as a "first-time" filler for patients who are unsure if thy're going to love the effect. There's a big psychological difference between living with a change for a few months and an entire year. Still, the general increase in lenght is a good thing for clincs and patients who are familiar with the effects.

Radiesse: FDA Approved For Hand Rejuvenation

Radiesse is now FDA approved for "hand rejuvenation".

Radiesse is an FDA approved dermal filler for smoothening out facial wrinkles and facial contouring. Recently, Radiesse got its FDA approval, making it the only FDA-approved filler for the hands although hyaluronic acid has been used by physicans for years.

The product, according to its website, can hide visible bones and tendons, making the hands look more youthful and smooth. Radiesse utilizes a safe gel formula that contains calcium microspheres (CaHA). These can immediately create added volume and then stimulate the body to produce collagen which results in volume augmentation that can last for around a year.

According to board-certified plastic surgeon Dr. Brent Moelleken, MD FACS:

Radiesse is a great option as a filler for hands. It’s safe for all skin types, and leaves no obvious line between the hand and wrist. The hands are the last frontier, so-to-speak, and often give away the true age of a woman.

Depending on the severity of the volume loss, patients should expect to pay for about one to two syringes of Radiesse at an average cost of $800 - $1,200 per syringe for their hands.

Dr. Moelleken adds that because of the product's pliability and softness, it is a great filler which may also be used for deep filling in the face.

Patients are cautioned to seek out experienced and board-certified plastic surgeon in using the Radiesse hand filler because of the many veins, nerves, and arteries in the hand. During the clinical trials, patients showed swelling, redness, bruising and pain in injection sites.

Because of this recent development, cosmetic doctors may now offer enhancement and rejuvenation for both the hands and faces of their patients.

For more information, you may visit:

https://global.radiesse.com/treatment-options/hands#hands

FDA Approved Saline-filled Breast Implants

Ideal Implant Incorporated has recently announced the FDA approval of its Structured Breast Implant for use in the United States and Canada.

The breast implant was designed by a plastic surgeon and it is the first to provide women with the feel of silicone gel-filled implants combined with the safety of only saline inside. The natural feel of the breast implant is attributed to its patented unique design and internal structure which was a product of more than 10 years of research and clinical studies.

As to its design, the company's website provides the following:

Years of research and testing led to this innovative design, with a series of implant shells nested together and two separate chambers, which hold the saline filler. The internal structure controls movement of the saline, and is designed to reduce folding and wrinkling, thought to be the main cause of implant rupture and deflation. On the outside, the edges have been lowered for better contouring to the chest wall.

According to Robert Hamas, MD, a Dallas plastic surgeon:

Now, for the first time, women can have a breast implant that offers them a natural feel without silicone gel. It has only saline inside for their safety and peace of mind. Unlike silicone gel implants that have a high incidence of silent rupture that requires an MRI scan for detection, with the Ideal Implant, a women can look in the mirror each day and have the confidence of knowing her implants are intact.

In a study, patient satisfaction for those who received their first breast implants were at 94.3% while those who had replacements for their previous implants was at 90.6%. The high satisfaction rating among women were attributed to the natural feel of the implants coupled with ease of mind because of its saline-filled components. The surgeon satisfaction was also high at 95.9% for primary implants and 91.7% for replacements.

For more info,

you may visit www.idealimplant.com

or contact Adeena Fried, 917-633-4380, idealimplant@evolvemkd.com

First Implantation of FDA Approved Orbera Gastric Balloon

Following the FDA approval of Orbera's gastric balloon, the very first implantation after its approval has been made by Dr. Shawn Garber.

The gastric balloon has recently gained its FDA approval as an option for patients who are battling obesity but are not qualified to undergo invasive surgery.

According to Dr. Garber, a silicone intragastric balloon is inserted non-surgically in a deflated state into the stomach and then inflated with sterile saline solution through a self-sealing valve once it enters the stomach. The intragastric balloon will remain in place for a maximum of six months. During that six month period the patient will enjoy a feeling of fullness sooner and satiety will last longer after meals, which encourages portion control and helps manage hunger.

The procedure made by Dr. Garber lasted for around 15 minutes and the patient was under light sedation. After the gastric balloon was inserted, the patient stated that she felt full, and the patient was able to leave after 30 minutes. The procedure was performed in the office under light sedation and took approximately 15 minutes. The patient was able to leave the office 30 minutes later.

The patient stated "I feel full" after the procedure. Though this is one of the very first procedure done after its FDA approval, the procedure had already been used internationally for over 20 years.

For more information, you may contact:

Jon Libasci of New York Bariatric Group at 516-616-5500 or jon@nybg.com http://www.orberaweightlosssystem.com.au/

Finacea: US FDA Approved Topical Treatment for Rosacea

Rosacea is known to affect around 16 million Americans however, a survey by the National Rosacea Society found that 95 percent of rosacea patients had known little or nothing about its signs and symptoms prior to their diagnosis. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.

Recently, Bayer HealthCare Pharmaceuticals Inc. announced the US Food and Drug Administration approval of its product Finecea Foam (azelaic acid) 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

According to Bayer VP and General Manager, James Robins,

The FDA approval of Finacea® Foam is the result of several years of research and development. Not only does it add to our current product line, it also demonstrates Bayer's continued commitment to addressing the needs of patients with mild to moderate rosacea.

According to reports, the efficacy and safety of Finacea® Foam was evaluated in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials (Trials 1 and 2) in subjects with papulopustular rosacea, with a mean lesion count of 21.3 (range 12 to 50) inflammatory papules and pustules. A total of 1362 (active: 681; vehicle: 681) subjects aged 19 to 92 years (mean age = 50.6 years), 95.7% Caucasian, and 73.4% female participated in the trials. T

he severity of a subject's rosacea was based on scoring from an IGA scale as well as a count of the inflammatory lesions. The clinical trials revealed that the use of Finacea resulted in a higher success rate in the reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period.

Finacea gel is usually applied twice daily, in the morning and at bedtime. This treatment will soon be available by prescription only beginning in September 2015.

For more info:

https://www.finaceafoam.com/
http://labeling.bayerhealthcare.com/html/products/pi/Finacea_Foam_PI.pdf
http://www.rosacea.org/patients/causes/introduction

ReShape: US FDA Approved Non-Surgical Weight Loss Procedure

ReShape's approval by the US Food and Drug Administration comes as a good news for people who want to lose weight but have not achieved such by diet and exercise alone.

The ReShape Integrated Dual Balloon System, according to the company's website, is the first-of-its kind non-surgical weight loss procedure for those who do not want to undergo surgery or those who do not qualify for bariatric surgery.

It is best for obese patients with a Body Mass Index (BMI) of 30 – 40 kg/m2 and one or more obesity-related comorbid conditions. In the study that paved the way for the US FDA approval of ReShape, it was found that patients lost twice as much weight compared to those who only received diet and exercise coaching.In Europe, it was shown that patients lost around 47% of their excess weight and maintained 98% of their weight loss at one year.

A patient of ReShape will undergo and three-process journey in a span of one year. First, the patient will be educated regarding ReShape and a personalized evaluation will be done. In the second phase, two balloons will be inserted in a patient's stomach through an endoscopic procedure with sedation. The medical-grade and saline-filled balloons will take up room in the patient's stomach so there will be less space for food.

According to its website, these balloons will help curb appetite and will allow patients to enjoy food in healthy proportions. The balloons will be removed after six months, otherwise adverse effects such as intestinal obstruction may occur. Personalized coaching will still be undertaken so that a patient can focus on healthy eating and lifestyle habits to increase success.

The third phase will be the continued support and coaching after the balloons are removed to make sure that patients achieve and maintain their optimal weight and lifestyle.

In an interview, Carmella, a ReShape patient said that:

Anyone who struggled with diet and exercise to lose weight knows it can be a very frustrating cycle. Still the idea of undergoing surgery or being on medication for life is also unattractive. The ability to make long-term changes in my lifestyle with ReShape has not only changed how I see myself in the mirror, but how I see my future.

There are still several risks associated with the use of ReShape Integrated Dual Balloon which include ulceration, perforation, abdominal pain, nausea, vomiting, bloating, belching, heartburn, dehydration, sore throat, device migration, and intestinal obstruction. These may cause the early removal of the balloons before the 6 month period.

Read more at:

http://reshapeready.com/now-fda-approved-in-the-united-states/#sthash.eq4VUdYE.dpuf

PicoWay: FDA Approved Laser for Removal of Tattos and Benign Pigmented Lesions

Here's some good news for patients who want to remove their tattoos and cosmetic surgeons alike: the Food and Drug Administration's has approved of Syneron Candela's PicoWay, a dual-wavelength picosecond laser.

It is estimated that about 25% of the population in the United States have tattoos and about 50% of them want to have their tattoos removed.

The newly FDA approved PicoWay enables the removal of recalcitrant and multi-colored tattoos, as well as benign pigmented lesions on any skin.

According to the Syneron Candela's site, the PicoWay works by delivering ultra-short picosecond pulses of energy to the tissues. The burst of energy create a photo-chemical impact which breaks up the tattoo ink or pigmentation into smaller and more easily eliminated particles. 

Some of the advantages of using PicoWay include its use of dual wavelengths and its ability to treat wide range of tattoos. It claims also to have the shortest picosecond pulses, that is 40% shorter, making it more effective while lowering risks or other side effects.

As early as 1965, Q-switched lasers were already used. These types of lasers produce a very short laser pulse in nanosecond range. This is the most commonly used laser in clinical practice. As Q-switched lasers come in three types, there is a tendency that there will be a need to use another type of laser, rather than owning just one of them to completely remove a patient's tattoo.

To remedy this, physicians shrink the spot size and increase energy deposits which significantly lead to the probability of producing a scar.

Compared to Q-switched lasers, Dr.Shimon Eckhouse of PicoWay says that:

Scientists acknowledge that shorter pulse duration lead to higher efficiency for converting laser energy needed to fracture particles into fragments. Smaller fragments mean that it is easier for the body to effectively remove it. Q-switch technology requires numerous treatment sessions, causes significant discomfort during treatment and incompletely removes tattoos and pigmented lesions.

Picosecond technology has ultra-short pulse durations that are 100 times shorter than Q-switch lasers, and in trillionths of a second. 

Read more on:

http://syneron-candela.com/na/product/picoway

Stay Away From Medical Lasers That Are Not FDA Approved

There are several manufacturers from China who are now promoting their aesthetic devices on the internet and Ebay.  While it is tempting to try these devices out and buy them due to their inexpensive price tag, the vast majority of this equipment is not FDA approved.   Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires that all medical device manufacturers must register to notify FDA, at least 90 days in advance, of their intent to market a medical device.  Most foreign manufacturers have not done this.  Is is therefore illegal to use these devices in the United States.

It is extremely risky to be using any equipment that is not FDA approved.  It is very important to use only FDA approved devices and substances.  If anything were to go wrong during the treatment, the fact that a patient was given an FDA approved treatment limits your clinic’s liability dramatically.  In addition, you could be prosecuted by the FDA which is something don’t want to have happen.

As long as you follow the guidelines for use with those FDA approved aesthetic devices, you are on very safe ground.  A large portion of the liability is shared by the manufacturer, and most plaintiff’s go after the entities with the deepest pockets, which are typically the manufacturers.  If you are using a medical device that does not have FDA approval, you are on very shaky ground and if trouble arises, you could be the one left “holding the bag.”