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Posts Tagged ‘product reviews’

Product Review – Radiesse for Hand Rejuvenation

Saturday, June 6th, 2015

 

One important aspect of hand rejuvenation is volume restoration of the back (dorsum) of the hand. Skeletonization of the hand occurs through loss of subcutaneous fat allowing the tendons and bones to be easily seen which is associated with aging.  (bony hands) This has been shown to be effectively treated using a variety of filler materials. The most commonly used are many of the off-the-shelf synthetic fillers since they can be done in the office under local anesthesia for a quick plumping of the back of the hands.

Radiesse Plus Injections Dr Barry Eppley IndianapolisRadiesse Injectable Filler Dr Barry Eppley IndianapolisOne of the potential synthetic injectabl efillers to use in the hand is Radiesse. This is an opaque injectable filler that contains calcium hydroxyapatite microspheres in a water-based gel carrier. It has been used for facial augmentation since it was introduced in 2001 and has a longevity of around one year after injection.

The US Food and Drug Administration (FDA) just announced that they have approved Radiesse for hand augmentation to correct volume loss in the dorsum of the hands. FDA approval essentially means that it is both safe and effective for this use and that its benefits outweigh the potential risks. The clinical study data to support its use was done in the hands of over 100 middle-aged women using grading scales of aesthetic improvement. Compared to a placebo (control) filler, Radiesse treated hands had at least a one-point improvement at three months after treatment compared to just 3% for the controls and 98% of the patient reported visible improvement by their assessment. Any adverse effects that occurred from the treatments were common to what is known for any injectable filler such as temporary redness, swelling and bruising which all resolved within one week after injection.

Fat Injections to Hands Dr Barry Eppley IndianapolisRadiesse provides an effective method of hand rejuvenation that has some of teh better persistence of any filler on the market today. Despite its white opaque color it is not seen through the skin as such and is not visible through the skin.

Dr. Barry Eppley

Indianapolis, Indiana

Product Review – XAF5 Ointment for Eye Fat Reduction

Friday, May 29th, 2015

 

XAF5 Ointment for Eye Fat Reduction Dr Barry Eppley IndianapolisAn ointment that would help melt fat? Sounds to good to be true? Well it might be but preliminary clinical studies suggest that such an ointment exists and will be a clinical fat treatment in the not so far future. An active ingredient used in the treatment of glaucoma is showing promise as a nonsurgical option in the reduction of periorbital fat. (fat around the eyes)

Like many coincidental cosmetic medical discoveries (minoxidil was originally a high blood pressure medication, finasteride was a prostate shrinking drug), prostaglandin eye drops for glaucoma have a common side effect of reducing fat around the human eye. They have also been shown to do in fat cells in tissue cultures.

Topokine ointmentAs reported in the Dermatology Times, the company Topokine has been studying compound XAF5 in phase 1 FDA clinical trials with it being well tolerated and showing fat reduction at the treatment site.  XAF5 ointment has just completed Phase 2 FDA clinical trials to reduce excess eyelid fat. (steatoblepharon) Their researchers report that almost half of patients in the XAF5 ointment group showed visible improvement in both eyes of at least one level on their rating scale as well as a patient satisfaction scale which was superior to that of a placebo. The majority of patients saw improvement in facial appearance and were satisfied with the treatment. XAF5 ointment had few adverse side effects of which temporary redness around the eyes was the most common.

Once approved, XAF5 ointment would be the first topical drug scientifically studied and proven to reduce excess fat under the skin.

Dr. Barry Eppley

Indianapolis, Indiana

Product Review – Radiesse Plus Injectable Filler

Monday, March 23rd, 2015

 

Radiesse Injectable Filler Dr Barry Eppley IndianapolisRadiesse is a semi-permanent injectable filler that has been in clinical use for over a decade since its initial FDA approval inj 2004.. It is unique amongst injectable fillers because of its composition and mechanism of action. It is composed of approximately 30% calcium hydroxyapatite spheres contained in a 70% aqueous gel carrier. The aqueous gel carrier is comprised of sodium carboxymethycellulose, glycerin and water. There are no human or animal derived components in it. While the aqueous gel carrier gets absorbed, the calcium hydroxypatite spheres remain much longer leading to a collagen reaction that creates a sustained volume retention result.

Radiesse Plus Injections Dr Barry Eppley IndianapolisRadiesse Plus contains 0.3% lidocaine and has recently received FDA approval. Its approval was based on a clinical study with over 100 patients who had ‘regular’ Radiesse injected on one side of their face and Radiesse plus on the other side. Based on pain ratings patients rated their pain about 6.7 on a scale of 0 to 10 for the side of the face injected with ‘regular’ Radiesse  compared to about 2.3 on the same scale for the side of the face treated with Radiesse Plus. One hour after treatment, patients rated their pain about 1.1 on a scale of 0 to 10 for the side of the face injected with Radiesse compared to about 0.3 on the same scale for the side of the face treated with Radiesse Plus.

Not surprisingly, Radiesse that contains a local anesthetic is less painful to inject. This is compatible with what all of the hyaluronic acid-based fillers that have previously incorporated a similar approach have shown. This is particularly useful in an injectable filler like Radiesse which by its composition is thicker to inject and takes a bigger needle to do so.

Dr. Barry Eppley

Indianapolis, Indiana

Plastic Surgery Product Review: Keller Funnel for Silicone Breast Augmentation

Friday, April 19th, 2013

 

Despite the different types and sizes of breast implants and the different incisions used to place them, all these breast augmentation issues share one factor…implant insertion. With a prefilled and fully inflated silicone breast implant, there is increased difficulty in getting the implant into place because of the mismatch between the diameter of the implant and the length of the incision. Historically silicone gel implant insertion has been done by the manual method. The plastic surgeon must physically handle the implant and push it through the incision into the created submuscular or subglandular pocket. The actual handling of the implant by the surgeon adds another source of potential infection as well as stresses the shell of the implant as it usually needs to be ‘forced’ through the incision.

A novel breast implant insertion device is available that overcomes all of the concerns about manually handling and manipulating the implant. Known as the Keller Funnel, it is a cone-shaped device with an internal silicone lining. This allows the breast implant to be opened and placed directly into the funnel right out of the sterile box. Then by twisting the backside or larger end of the funnel, the silicone implant can be squeezed out of the end of the smaller end of the implant and through the incision right into the created breast pocket. The implant shell is less stressed as the forces of distortion or pressure on it are more evenly distributed throughout the entire implant shell. The silicone lining allows the implant to be lubricated so it can flow smoothly out of the funnel when under manual compression.

The Keller funnel is a significant advance for silicone breast augmentation. While it does add a very small cost to the procedure, it reduces the risk of infection and potentially even adds to the longevity of the implant’s durability.

Dr. Barry Eppley

Plastic Surgery Product Review: Sculptra Injectable Facial Filler

Monday, August 24th, 2009

Sculptra is one of the numerous injectable facial fillers that has an established history of treating the condition known as facial lipoatrophy, most commonly seen in patients with HIV disease as a result of their antiviral therapy. By working as a facial volume restoration method rather than as a wrinkle or lip filler, Sculptra’s mechanism of action is different than all other injectable fillers. Because of its FDA approval and differing injection method, Sculptra has been the most obscure of the injectable fillers.

On July 29, 2009, the U.S. Food and Drug Administration (FDA) approved Sculptra from its original medical indication of facial lipoatrophy to a broader cosmetic one. Specifically, Sculptra Aesthetic (injectable poly-L-lactic acid) is intended for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial contour and wrinkle areas. The duration of action for Sculptra is around two years and now separates itself as the long-lasting injectable filler currently available.

The FDA approval of Sculptra was based on a study of 233 patients who received either Sculptra or human-derived collagen for the treatment of their deep nasolabial folds. Unlike the collagen injections, Sculptra injections are different in that they are given in a series of three treatments, spaced three weeks apart, rather than all at once.  The Sculptra patients maintained their treatment effects for up to twenty-five months after the last treatment session, while the human injections lasted only three months. The improvement in nasolabial folds is significant in aesthetic treatments as this is one of the classic hallmarks of facial aging and is a gold standard test site.

Of equal relevance is that no serious adverse events were reported in this study, regardless of the treatment used. The injected areas did have some typical short-term reactions such as bleeding, tenderness and swelling. Sculptra did have a few delayed small bumps and lumps that occurred over the twenty-five month period but these resolved on their own. The mechanism of action of Sculptra and its unique injection technique does pose the risk of developing localized bumps under the skin but their occurrence was quite low.

Sculptra offers another but different injectable filler to options in non-surgical facial rejuvenation. In my Indianapolis plastic surgery practice, facial volume restoration with Sculptra can easily be combined with Botox or Dysport as well as numerous methods of light facial skin resurfacing to create significant improvements that require little recovery.

Dr. Barry Eppley
Indianapolis, Indiana

 

Product Reviews: Dysport – A New Facial Wrinkle Reducer

Saturday, May 2nd, 2009

It has finally happened….a competitive alternative to Botox for cosmetic facial wrinkle reduction has been approved by the FDA. Last week, The FDA put its stamp of approval on the boulinum toxin A drug Dysport. (had been known as Reloxin) This was anticipated since January when an FDA panel gave it a preliminary nod. Dysport has been used for some time in Europe and other countries so its formulation is not new. Actual distribution will begin in 30 days or so. Because of training requirements and a pent up demand, Dysport vials probably won’t start to flow and become widely available until mid-summer.

As the first (and surely not the last) major competitor to Botox, how does Dysport compare in clinical performance? The information from pre-approval clinical trials indicates that it is just as effective as Botox in facial muscle reduction and lasts the same month of time, around 4 months. Its one advantage is that its onset is quicker, occurring within a day or two rather than a week. This buys the patient an extra week of results for the same price so to speak. Unit dosages are different between the two so they cannot be compared by what we know now as a ‘Botox unit’.

In a 2006 Dermatology journal report, a clinical study compared Botox and Dysport. At a 2.5:1.0 unit Dysport:Botox ratio, Botox was more effective for wrinkle treatment. In a previous study cited by the same authors, a 4:1 ratio produced similar results, but the patients receiving Dysport had more adverse effects. To me this means that the proper use of Dysport will involve a learning curve even for experienced Botox injectors, which will slow its wide acceptance unless the cost difference significantly favors Dysport.

Dysport’s biggest advantage, therefore, will likely be its price. I am assuming that the quickest way to take a significant share of Botox’s market is to undercut it in price. Botox, because of its long-term monopoly on the market, has had ongoing price increases over the years and is not known for its service in many geographic regions. There are definitely significant numbers of physicians as a result that can’t wait to jump ship and use a competitor. Botox will undoubtably respond quickly by lowering its price. Where the price points and treatment costs will settle out for both is unknown at this point. But the patient is likely to be a winner in this scenario because of the stiff competition that will ensue.

Dr. Barry Eppley

Indianapolis, Indiana

Product Reviews – Evolence Injectable Filler

Thursday, July 3rd, 2008

As of June 30 2008, a new soft tissue filler has been approved by the FDA for cosmetic facial application. With the name, EVOLENCE, it is an advanced collagen-based dermal filler that provides long-lasting treatment of moderate to deep facial wrinkles and folds, such as nasolabial folds. The results of treatment with EVOLENCE are immediate and its duration of action (persistence) is proven to last through six months. One year persistence data is still being gathered from the clinical trials so a longer than 6 month duration can not be confirmed at this time.

 

Unlike other dermal fillers that use hyaluronic acid (HA), which absorb water to create their effect, EVOLENCE is a true rebuilding agent due to its three-dimensional collagen structure. This collagen structure benefits patients as it is directly linked to the minimal bruising and swelling that might result. EVOLENCE does not use chemicals for cross-linking like many other products do, but instead uses natural sugar to improve durability. EVOLENCE® collagen is cross-linked through its patented GLYMATRIX™ Technology using the natural sugar, D-Ribose. The GLYMATRIX™ process is designed to mimic naturally occurring collagen in the skin by creating a true structural framework with natural, durable cross-links to ensure filler longevity, provide consistent and predictable results, and use natural ingredients for natural-looking results.
The naturally sourced porcine collagen used in EVOLENCE is the most genetically similar to human collagen and has been used safely and effectively for decades in various medical applications, including heart valve replacement.

 

This new generation collagen filler is intended for injection into the mid-to-deep dermis for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. The most common side effects of EVOLENCE injections are usually injection-site related and include mild swelling, redness, and pain. Other rare side effects include the development of small areas of firmness under the skin at the treated sites that may be noticed when the areas are pressed upon. When these do occur, they eventually resolve by resorbing away on their own.
With eight injectable filler products now available, the question becomes where does EVOLENCE fit? For those patients and physicians who would prefer a collagen-based filler, EVOLENCE lasts longer than those that have been historically on the market including Zyderm, Zyplast, Cosmoderm, and Cosmoplast.

Dr. Barry Eppley

Indianapolis, Indiana

Product Review – Prevelle Silk Injectable Filler

Monday, June 9th, 2008

The number of commercially-available injectable fillers continues to expand. Most injectable fillers that are available today, and into the near future, are hyaluron or hyaluronic acid-based (HA) due to its human compatability and lack of any significant complications. HA is a sugar molecule well known to the human body being present in much of the body as an intercellular matrix material and in such as areas as the fluid in the eyeball. As a result, no skin test is needed prior to its injection and it goes away much slower than traditional collagen.
The Mentor Corporation has just released PREVELLE SILK for commerical use. This is a new line of hyaluronic acid dermal fillers and it contains 0.3% Lidocaine. It is very soft gel that flows in easily and is more comfortable due to its addition of the local anesthetic lidocaine. Due to its soft gel density, there is less likelihood that there will be ridging or lumping. Between its easy flow into the skin and the comfort factor of the lidocaine, there should be less of a chance of any bruising or swelling. Hence the marketing slogan….Today For Tonight….get injected in the afternoon and look completely normal for that evening.
When there are so many injectable fillers now available, the bottom line question for patients is……how long does it last and at what cost? There is where Prevelle Silk has a patient niche in my opinion. Based on the clinical studies and FDA submission data, Prevelle Silk will last about 3 to 4 months, probably comparable to Restylane but certainly less than JuvaDerm, Perlane, Radiesse or ArteFill. But the cost to the patient (in my practice) for a .75ml syringe is also less than all other injectable fillers at $425. (Juvaderm $550, Radiesse $850, ArteFill $1,250) This creates an injectable filler option at a very affordable price. So a woman can have her lips done with a smooth, minimally uncomfortable injectable filler at a very reasonable price. Like coffee, you can have Starbucks or Dunkin Donuts….or…..you get (in terms of longevity) what you pay for.
Dr. Barry Eppley

Indianapolis, Indiana


Dr. Barry EppleyDr. Barry Eppley

Dr. Barry Eppley is an extensively trained plastic and cosmetic surgeon with more than 20 years of surgical experience. He is both a licensed physician and dentist as well as double board-certified in both Plastic and Reconstructive Surgery and Oral and Maxillofacial Surgery. This training allows him to perform the most complex surgical procedures from cosmetic changes to the face and body to craniofacial surgery. Dr. Eppley has made extensive contributions to plastic surgery starting with the development of several advanced surgical techniques. He is a revered author, lecturer and educator in the field of plastic and cosmetic surgery.

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