On Friday, Sientra announced a new warranty program, which they are calling “C3”.  The program, which begins Novemeber 1, 2013, will apply to first-time breast augmentation patients who choose Sientra-brand textured implants.
In addition to the current implant deflation warranty, the C3 program provides a free replacement implant if the patient requires revisional breast surgery for a Baker Grade III or IV capsular contracture, within the first two years after the original implantation surgery.
No additional registration forms or fees will be required.
Capsular contracture is one of the most frustrating and unpredictable complications after breast implant surgery.  Previous studies have found that it happens more often in the subglandular implant, if a periareolar or trans-axillary approach is used, or if there is bleeding or infection in the breast.  In some studies, smokers have an increased risk.
In the upcoming November issue of Plastic & Reconstructive Surgery, a new study looking at Sientra implants also found a protective effect for their textured breast implants, when compared to the smooth Sientra implants.
Bottom line:  I’m sure that patients who choose Sientra’s gummy bear implants will be pleased to hear about this program, going forward.  It will be interesting to see how the other established manufacturers – Allergan & Mentor – react to this new program.

At least 24 people in Hawaii have developed acute non-viral hepatitis after using the dietary supplement OxyElite Pro, marketed for use in weight loss and muscle building. Additionally, two patients have received liver transplants, and one patient died, but it is not clear whether they took OxyElite Pro or a different dietary supplement.

The cases (median age, 33) all lived in Hawaii, but the CDC is investigating whether there are cases of liver injury elsewhere, since the supplement is sold nationwide. The FDA advises consumers to stop using OxyElite Pro during the investigation.
Bottom line:  Dr. Fiala does not recommend OxyElite Pro or similar non-FDA approved dietary supplements to his patients. 
portions reprinted from New England Journal of Medicine online Journal Watch; Kelly Young – author.
Benelli Breast Lifts Orlando, Advances in Breast Lift SurgeryMany patients who would like a more uplifted and perky breast shape tell me that they are very worried about a breast lift, due to the surgical scars.  Most women worry that they will need the traditional anchor lift – and that’s not always the case.  Today, I’d like to talk about one type of breast lift, which has a very minimal amount of scars:  the donut lift.  It goes by several names.  You might also hear the terms “Benelli lift” or “circumareolar lift” mentioned by surgeons.
The concept is simple:  limit the scars to just the outside of the areola.  There’s no scar down the front or underneath the breast.  This technique can work nicely for women that have reasonably elastic skin, and only need a small lift, where the nipple position just needs to lift up 1-1.5 inches to look centered properly.  The nipple stays attached, and sensation is preserved.  Only an off-center donut-shaped zone of extra skin is removed. A careful skin closure, with multiple layers of sutures, is then performed.
The Benelli lift works particularly well for women with tuberous breasts or prominent, dome-shaped areolas. (“puffy nipples”)  It is also very effective when combined with a breast implant or with fat grafting to the breast to restore missing breast volume.  There are many examples of this technique in our photo gallery.
Most times, the incision blends in nicely at the edge of the areola, and a nice improvement is obtained.  An internal “purse-string” suture, made of a long-lasting Gortex thread, helps to prevent the new areolar shape from stretching back out, maintaining the lift effect over many years.
If you are thinking about a breast lift, but are worried about the scars, ask Dr. Fiala if this method might work for you.

In a pilot study of 10 patients just published in The Lancet, Danish researchers showed that the addition of stem cells to a fat graft improved the survival of the fat graft at 4 months, compared to a plain unenhanced fat cell graft.   This study is significant, as it represents the first randomized study of its kind for fat grafting.

Here’s what the researchers did: participants had liposuction twice – once to harvest stem cells, and once to harvest fat cells. The stem cells were then grown in the lab, using specialized cell culture methods, and mixed back into one of the two fat cell preparations in large numbers, equal to 12% of the volume grafted.  The two fat cell grafts of about 1 ounce each – one with stem cells, one without – were then placed on the back of the patient’s arm. MRI was used to measure the fat cell volume at the time of injection, and 4 months later.

They found that the stem cell enhanced grafts did much better, with 80% retention, versus the plain fat grafts, which only had 16% retention.

Pretty cool – but what does this mean? Despite the encouraging result, this preliminary study needs to be repeated with many more patients, using much larger volumes of fat, before we can decide whether it’s clinically useful. And we need an FDA-approved method to get the huge numbers of stem cells that we would need to make this work in the volumes that we use in daily practice.

For example, if we were going to perform a Brazilian buttock lift, we might typically use 400 cc of fat on each side, or more. The Danish study would suggest we would need 50 cc of concentrated stem cells per side – and without cell culture techniques, this would take the isolation of every single stem cell in 3.5 liters of fat to get this amount. – for each buttock!! That’s neither practical nor safe.  So clearly, without some new FDA-approved method, we can’t duplicate the recipe of the Danish study in our daily practice.

I found it interesting that the retention rate was only 16% for the non stem cell group. That’s really low. By contrast, other studies that studied fat grafting to the breast found a 65% retention rate in the breast, as long as the breast was prepared with pre-operative BRAVA expansion – without needing stem cells.

Just this month, the FDA decided to officially grant Allergan another approved indication for the use of Botox: the treatment of Crows’ Feet. The approval was granted after the FDA reviewed data for effectiveness and safety of Botox in the crows’ feet area in a placebo-controlled study of over 800 patients.
Of course, physicians have been using Botox for this purpose “off-label” for years – pretty much ever since Botox was approved for cosmetic use for glabellar wrinkles, back in 2002!  It’s a very effective treatment – depending on the dose used, it can soften and reduce the crow’s feet wrinkling at the corner of the eyes for up to 6 months. So, this approval is not going to change our day-to-day practice patterns, but I do think it is useful for patients, as it will give them a greater feeling of safety and confidence in the treatment.
Allergan’s competitors, namely Xeomin and Dysport, do not yet have this approval, as it’s something the manufacturers have to apply for with lots of study data. With an official FDA indication behind them, Allergan can now advertise this particular use. So expect to see lots of direct-to-consumer advertising from Allergan starting immediately.
Earlier this year, the FDA approved a new type of silicone gel breast implants, with a thicker type of silicone gel on the inside. Although they’re not at all related to the popular squishy colored candy, one surgeon from L.A. nicknamed them “gummy bear implants”, and the name has stuck.  Technically, gummy bear implants are more properly known as “generation 5 implants”, or “form-stable gel implants”.
The firmer gel permits the creation of a teardrop shaped implant, as well as the usual round shaped implant. The teardrop implant is particularly helpful for breast reconstruction after mastectomy. The round implant, made by Sientra, is slowly becoming more popular with our patients who want breast enhancement.
Studies from Europe and the U.S. show that the new implants work well, with a high rate of patient satisfaction. One study suggests that the rate of capsule formation may be slightly less than historical controls – but that finding will need to be checked in a direct comparison study. The main feature that interests patients is the leak-resistance of the firmer gel. Should the implant shell crack or break, the thicker gel is unlikely to leak out and spread into the tissues, according to the manufacturer.
Some worry that the thicker gel may create an overly firm breast. Our experience with these implants is that this concern is not the case – the patients are pleased with their results.
The implants do require a slightly larger incision – but only about another ¼” in length. And the cost of the gummy bear implants is the same as the standard gel implants….unlike some, we don’t up-charge for these new implants.
On the minus side, these implants are relatively new to the U.S. Not all surgeons are convinced of their superiority. In particular, the teardrop implants can rotate within the pocket in 3-5% of patients, leading to re-operation. And some question whether the gel that is firm and cohesive now will maintain those properties as the decades go by. And of course, no implant lasts forever. Follow-up imaging studies are still required for the women that select these implants, just like with standard silicone gel implants.
One of the requirements of the FDA approval of these implants was mandatory follow-up studies for all the manufacturers. So, we’ll get more information as time goes on. But based on European experience and scientific studies, the “gummy bear” implants are a good alternative for both cosmetic and reconstructive breast patients.
If you are interested in breast augmentation with a “gummy bear” implants, please give us a call at the office (407-339-3222) for a consultation with Dr. Fiala.

New data suggests that one year after quitting smoking, your risks of a smoking-related surgical complication are the same as a non-smoker.  The study, published in JAMA Surgery, looked at over 600,000 adult patients between 2008 and 2009, and assessed the effects of current and past smoking (>1 year prior) on postoperative outcomes.

The authors tracked 30-day postoperative mortality, heart attack & stroke, DVT and pulmonary embolism, and respiratory events (pneumonia, unplanned intubation, or ventilator requirement >48 hours).Results:   If you were a “current smoker”, your odds of postoperative death were significantly increased, beginning at 10 pack-years of smoking exposure (= 1 pack a day x 10 years), and increasing from there, based on your total exposure.

Smoking cessation at least 1 year before major surgery was found to eliminate the increased risk of postoperative mortality, and also reduced the risks of perioperative heart attack, stroke, DVT and respiratory events.
Editor’s comment:  In plastic surgery, we know that smokers have a much higher risk of complication for the surgeries where large flaps of tissue are moved – like facelifts, tummy tucks and breast lifts.  The tissues can literally turn black and die…which is a bad thing.  While this study didn’t track flap necrosis as a complication, we usually recommend quitting smoking completely for at least 2 months before these kinds of surgeries.  But maybe, as this study shows, that time frame isn’t long enough – further research will have to be done to settle that question.

Today, the FDA announced the approval of the “MemoryShape” breast implant, made by Mentor.  This is the teardrop-shaped implant, filled with the latest generation of form-stable silicone gel.  It’s certainly a home-run for breast reconstruction patients, and may be useful for some breast augmentation patients as well.  Mentor now joins Allergan and Sientra with implants of this type.

Today’s approval was based on six years of safety data. The silicone gel in the MemoryShape Breast Implant contains more cross-linking compared to the silicone gel used in Mentor’s regular silicone gel implant. This gives it a firmer feel, compared to our usual silicone implants, and makes it more leak-resistant.
As usual, the FDA approval came with conditions.  This time, Mentor must continue to monitor the patients from their 2 pre-market studies, conduct a new 10 year study of 2500 women to collect more information on long-term complication rates, and start another 10,000 patient study, looking for rare diseases in women that have implants.The Mentor MemoryShape implant, previously known as the “CPG implant”, will now compete with Allergan’s Style 410 implant, and Sientra’s implants.  All three implants feature a firmer gel, the teardrop shape, and some type of textured “fuzzy” coating, which varies by manufacturer.We’ll see whether these catch on with American consumers.  There are pros and cons to the new designs.  They require a much larger incision, are significantly firmer to the touch, and still require follow-up imaging studies.  They have a drawback that round implants don’t have – which is rotation of the implant, which occurs in about 5% of patients.  Their shape is very conservative – it doesn’t really give any significant fullness in the upper part of the breast, which, in my practice, is one of the most commonly-asked for features women request during their breast surgery consultation.  On the other hand, it does look very natural, and is more leak-resistant in case of a break in the implant’s shell.

Daily use of sunscreen can prevent wrinkles and slow the aging of the skin, according to a new study published in Annals of Internal Medicine.

The researchers looked at 900 Australian adults younger than 55 (mean age, 39), and randomized them to four treatments:

– daily broad-spectrum sunscreen (SPF 15+) plus beta carotene supplementation,
– daily sunscreen plus placebo,
– discretionary sunscreen plus beta carotene, or
– discretionary sunscreen plus placebo.
In this case, “discretionary” meant “just do what you always do”.After 4.5 years’ follow-up, only the group that used sunscreen daily showed no increase in photoaging. Compared with discretionary sunscreen users, daily users were 24% less likely to have increased photoaging. Beta carotene use did not appear to make a difference.

In addition, the authors note that small increases in photoaging also correlate with increased risk for skin cancer.  They note: “A reduction in the highly prevalent aging changes among middle-aged adults by regular application of sunscreen will therefore be associated with cosmetic benefit … and reduced risk for skin cancer.”

Since our weather patterns here are similar, Floridians would be wise to take note!

BELOTERO BALANCE Dermal Filler before after picturersWhile most people are familiar with Restylane and Juvederm, you might want to get to know the new kid on the block, Belotero Balance.

Just like Juvederm and Restylame, Belotero is an FDA-approved filler that is also made from hyaluronic acid gel.  But it’s manufactured a little differently, and has a smooth and soft consistency.  It’s quite useful for superficial wrinkles, and gives a nice, natural-looking correction.

Other HA fillers, when they are placed too close to the surface of the skin, can have an issue called the “Tyndall effect” – which basically looks like a blue-grey colored bleb caused by the superficial placement of the filler.  This doesn’t happen with Belotero.  So it’s really quite useful in areas where the skin is thin, like near the eyes.  Belotero, however, does not come with added lidocaine, which may be a disadvantage for some patients, making the injections a little less comfortable.

The manufacturer, Merz Pharmaceuticals, claims that Belotero lasts longer than the other fillers, up to 12 months, rather than the usual 6 to 8 month duration for Juvederm.  I haven’t seen a head-to-head comparison study yet, so will have to wait and see on that claim.

For more information of the treatments and procedures offered at this Orlando Plastic Surgery Center & Medical Spa by Plastic Surgeon, Dr. Thomas Fiala, please contact us at (407) 339-3222(407) 339-3222 or visit:
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