FDA approves Teflaro - a new antibiotic for MRSA

The FDA has approved ceftaroline fosamil (Teflaro), an injectable cephalosporin antibiotic, to treat adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

"These are serious and potentially life-threatening infections for which new treatment options are needed," said Edward Cox, MD, of the FDA's Center for Drug Evaluation and Research.

Ceftaroline (Teflaro) was evaluated in 4 separate clinical trials, in patients ages 18 years and older (two each in CABP and in ABSSSI).

In the CABP trials, the effectiveness of ceftaroline was comparable to ceftriaxone, a proven antibiotic.
In the ABSSSI trials, Ceftaroline demonstrated efficacy and safety comparable to the control arm of vancomycin plus aztreonam.

The drug should not be used in patients with sensitivities to cephalosporin antibiotics. The most commonly reported side effects were diarrhea, nausea, and rash.

Source: MedPage Today

The "Boob Jab" - Macrolane for breast augmentation?

Macrolane is an injectable hyaluronic gel product from Q-Med, the makers of Restylane, which is available in Europe, but not in North America yet. Over there, Macrolane has been tried for body contouring applications, including breast augmentation - hence the catch-phrase "boob jab" for an injection of Macrolane to the breast.

In this month's Plastic and Reconstructive Surgery online is a preliminary publication (ahead of print) of a study from Sweden, looking at a 12 month study of 24 women who had Macrolane VRF30 injected into their breasts for cosmetic augmentation purposes. (Click here for abstract)

Twenty-four women (average age = 37 years) were treated. The Macrolane VRF30 gel, up to 100 cc per side, was injected in the subglandular position with the aid of local anesthesia. Since Macrolane is slowly absorbed by the body, it was fully expected that the results would change over time: at six months post-injection, 83% were pleased with the improvement, and at 12 months, 69% were still considered improved.

While there were no major complications or systemic issues, capsular contracture around the injected material was still the most commonly reported adverse effect, with 25% of patients reporting undesirable breast firmness due to this problem.

The authors concluded that this gel is worthy of further study, and may be an option for patients that want non-surgical improvement of breast volume. Personally, I find the reported 25% incidence of capsular contracture to be a lot higher than I would like to see.

Speaking of HA gels, I've often wondered: why not make a breast implant that is filled with a hyaluronic gel, instead of saline or silicone? Might give the feel of a silicone gel implant, but be easy to clean up in case of deflation. Hmmm.....You read it here first, at PSB!

Happy Halloween!!

Could Latisse be used for baldness?

Latisse, the blockbuster product for eyelash growth from Allergan, is now being tested to see if it has any effect on hair growth on the scalp. A clinical study (info here) is about to get underway, for both male-pattern and female-pattern hairloss.

The Phase 1 trial, scheduled to start this month, will focus on the safety of two formulations of bimatoprost, which is the active ingredient in Latisse.

We actually tried out this idea at our office for a patient with alopecia who had tried everything else - well over a year ago. And it did seem to work - the patient could see a visible difference in her hair growth in the problem areas. Although I contacted Allergan's Office of Clinical Affairs about our result, and suggested doing a study just like this, they claimed they weren't interested at the time. Now they've come around!

The key to success will probably be to adjust and optimize the dosing and formulation. Hey Allergan: try making it stronger, and put it in a gel or mousse!

Cool stuff. Hopefully, a future variant of the Latisse formula will be another option for men and women with hair loss. If successful, it would certainly be another home-run product for Allergan!

New: Cytori PureGraft 250 arrives in Altamonte

I am pleased to report that we are trialling Cytori's PureGraft 250 device. Our goal is to enhance and improve the results of fat transfer procedures with this clever system (seen here).

The FDA-approved device uses a filtering process, called "lipodialysis" (by Cytori), to help clean and filter liposuctioned fat, in order to make it suitable for grafting to other areas of the body. The purified fat is then ready for placement, using a special micro-droplet syringe called the Cytori CelBrush. The PureGraft system is designed to purify the fatty mixture without the need for transferring the fat into a high-speed centrifuge, which is a very time consuming process.

We're excited about this new gadget. If it lives up to the manufacturer's claims, it will be a great little tool in the OR!

Coming soon: Dr. Fiala's new e-book for prospective patients

I'm pleased to announce that we're in the final stages of getting a new booklet ready for our prospective patients. Tentatively titled "Plastic Surgery 101: what you need to know before your consultation", the e-book will be provided online free of charge to patients that schedule a consultation with us.

It will cover important topics, like:
- how to select a plastic surgeon
- how to evaluate before & after photos
- the importance of Board Certification
- what to look for in a surgery center
- who should not have plastic surgery
- preparing for surgery
- tips for a smooth recovery
- helpful trustworthy online resources

...and more.

Hopefully, our patients will find it a useful primer, answering many questions, and helping to put their mind at ease before they see us for a consultation.

Just another example of "value-added service"!

Thread lifts don't work - part 2

In journalism, reporters are always excited when they "scoop" the competition - and report on a story before the other guys. So, I'm pleased to report a bit of a "scoop" here. Last May, we discussed the thread lift technique (link here) and commented on how it didn't work for very long, and how the results were subtle and short-term at best.

Just this week, in the highly respected Yearbook of Plastic and Aesthetic Surgery, I see two reports on threadlifts. The authors note that the results are dismal:

"rates of revision surgery...are high after threadlift"

"time to revisional surgery is short"

"results achieved by threadlift are subtle and short-lived"

"threadlift is not a minimally invasive replacement for rhytidectomy (facelift)"

"the threadlift provides only limited short-term improvement"

Summary: There are surgeons locally that recommend and use threadlifts. Just say no - don't have threadlift procedures done. The experts feel they are a waste of time and money, as they are quite ineffective and don't last.

OT: Congratulations, Rachel

Congratulations to our friend, supermodel Rachel Lynn. This past weekend, the lovely Rachel won Miss Biketoberfest 2010 at Daytona. That makes three years in a row that she's won this competition.

Far more than just a pretty face, Rachel has serious plans for a future career in anesthesiology, and is working hard on her med school pre-requisites.

Her modelling site is here. But you really see her sense of humor with photos like this one. (link)

Congratulations, Rachel!

Botox approved for migraine headaches

According to multiple reports, the FDA today approved the use of Botox, the wrinkle fighter from Allergan, for chronic migraine headaches. (link)

"Chronic migraines" are those that occur more than 14 days out of each month. Botox has not been shown to work for the treatment of episodic migraine headaches, or for other forms of headache. The Botox treatments are given every 12 weeks, which could get quite costly. I'm sure though, that the people that suffer through the pain, nausea and vomiting and light sensitivity of repeated migraines will be happy to have another treatment option.

And they'll have fewer wrinkles, too!

Seromas and plastic surgery

It's medical terminology time. Today's word is "seroma". Read this, and impress your friends with your knowledge!

A seroma is a fluid collection which may show up after surgery. Different than a hematoma, (which is a collection of blood within the tissues) a seroma is typically a watery, yellow-colored fluid pocket that has accumulated in one main area beneath the skin. Seroma fluid looks a lot like the fluid you would see inside a large blister. Seromas are considered a minor complication - more of an annoyance, really - after surgery.

Surgeries in which large dissection pockets are created, such as a tummy tuck, a body lift operation, a mastectomy, or certain types of breast reconstructions have a higher rate of developing these fluid accumulations. It can happen after liposuction, too. Some times the patient just notices the area getting larger without any particular symptoms, sometimes seromas cause a low-grade burning sensation in the area.

We try to prevent these annoying seromas by several methods: compression, use of surgical drainage tubes, or internal "quilting" sutures. Each surgeon has their favorite method, and there is still debate at plastic surgery meetings about which technique is best. For example, the drain tubes used after a tummy tuck help to prevent a seroma from accumulating, allowing the tissue layers to heal back together correctly.

How do you know if you have a seroma? In the classic case, we look for a "fluid wave" during the post-operative check-up. This is where we lightly tap on the skin in one area, and see or feel the skin moving back and forth (like an ocean wave) somewhere nearby. Big seromas can look like a water balloon jiggling beneath the skin. Ultrasound scans can also be used to detect seromas.

The treatment is to aspirate the fluid. Usually this can be easily done with a needle and syringe, and a little local anesthesia. Once the fluid is out, it looks and feels better.

Seromas seem to occur more frequently in our body lift / gastric bypass patients, but can happen to anyone. Fortunately, for most people, after an aspiration or two, they go away and don't typically cause any long term issues.

Think Pink! Tomorrow is Pinktober 15th

Attention Orlando! Tomorrow is Pinktober 15th. Show your support for breast cancer patients and survivors by wearing a pink article of clothing. We'll all be wearing something pink here at our office, even me! Tammy, a breast cancer survivor who works with me at the office, has got us all geared up for the day. Maybe we'll even get some photos to post here...

Locally, we have some tremendous groups that do a lot for breast cancer advocacy. I'd particularly like to draw your attention to "Women playing for T.I.M.E.", which stands for Technology, Immediate diagnosis, Mammography and Education. Their website is here (link). These active women have raised over $8 million for breast cancer related resources at M.D. Anderson Cancer Center/ORMC here in Orlando. One of their many events, the 3rd annual Walk for TIME, is happening this Sunday, at Millenia Mall.

It's important to know the basic signs and symptoms of breast cancer, as it is the #1 most common cancer in women, affecting approximately one in eight women over their lifetime. Click here to read about signs of breast cancer.

Certain women are at higher risk for this disease. (Click here to read about risk factors)

Mammography, whether digital or analog styles, remains an important screening tool. Get a mammogram if you are a woman over 40, and it's been more than a year since your last one.

Do you own monthly breast self-exams. Learn what is normal and what is not. If you do find something new, get it checked out without delay.

Early diagnosis leads to early treatment. And that's a good thing.

A new skin closure system - "Prineo"

Everyone is familiar with "Crazy Glue". Strong enough to hold a man suspended in mid-air, right? Well, since the 1970's, people have been tinkering with the formula for medical purposes. These days, we've got some decent second generation tissue adhesives, but they're not perfect. Typically, the glued closure isn't nearly as strong as a sutured skin closure, so it's more prone to pop open. And that's not a good thing.

Enter "Prineo", from Ethicon. Introduced in Europe a few years ago, it combines a high-tech tape dispenser and a cousin of Crazy-Glue. I saw it demonstrated at the ASPS meeting, and compared to current tissue glues, the new combination system is three times stronger than glue alone. With Prineo, the wound strength is about the same as a standard suture closure.

Here's how it works: the surgeon sutures the deep layers of the incision, as usual. Next, the tape-like mesh strip is applied over the incision. The mesh contains activating agents for the glue. Once everything is nicely lined up, the glue is painted over the mesh tape, and it sets (polymerizes) within about 30 seconds. This is a bit like a high-tech version of wall patching, with mesh covered by plaster!

Prineo makes a water-tight and reasonably strong closure. Patients can shower immediately postoperatively. The glue peels off easily in about 3 weeks. Reportedly, the cosmetic result is just as good as a subcuticular sutured closure - the plastic surgeon's usual closure - but we'll have to see about that! More patient information can be found here.

FDA approval is expected shortly.

Impression: I think this new product could be quite useful for our body-lift patients, especially those with thin skin following massive weight loss. Having additional wound closure strength together with a waterproof closure could be quite helpful for brachioplasties, thighlifts, lower body lifts and such.

One drawback: maybe not so good for hairy areas when it comes time for tape removal. Ouch!

Latex allergies and plastic surgery

Allergic reactions to latex are becoming more common. Today, about 3 to 6% of people are found to be allergic to latex...and in the worst case, the reactions can get pretty serious. Prevention, rather than treatment after the fact, is really the key to success.

Latex is the milky fluid from the rubber tree, Hevea brasiliensis, found in Malaysia, Indonesia, Thailand, and South America. In addition to the organic polymer that gives it the characteristic stretchy properties, latex sap also contains more than 200 allergenic proteins.

In terms of surgical history, William Halstead was the first to use latex surgical gloves, back in 1890. Recently, as we've become increasingly aware of the need for protection against blood-borne pathogens, the use of latex gloves has skyrocketed. Simultaneously, the incidence of allergic reactions to latex began to rise in both patients and especially in health care workers.

Latex exposure is associated with 3 distinct clinical syndromes.

1) irritant dermatitis. This is the most common cause of latex-induced skin rashes. It is not associated with allergic complications.

2) contact dermatitis. Symptoms usually develop in a delayed fashion, within 24-48 hours of cutaneous or mucous membrane exposure to latex in a sensitized person.

3) immediate hypersensitivity. This is the least common, but most serious type, and is a classic allergic reaction against latex proteins. Symptoms generally begin within minutes of exposure. Symptoms range from rash and itching, runny nose and watery eyes all the way to bronchospasm, hypotension and full blown anaphylaxis.

Interestingly, certain other tropical fruits can have an allergic cross-reactivity with latex allergy: avocado, banana, chestnut, kiwi, papaya, peach, or nectarine. People who are allergic to one are more likely to allergic to the other.

So, what do we do if someone says they have a latex allergy? First, as best as possible, we try to learn the story, and get the details of what happened. What kind of reaction did they have? Was it immediate or delayed? If there are further unanswered questions, evaluation by an Allergy specialist is helpful.

Fortunately, with the increased awareness of this problem, most operating rooms (including our own) have the ability to use a latex-free set-up. There is no latex whatsoever in the anesthesia equipment set-up, the rubber syringes, IV tubing, the surgical gloves and gowns, surgical tapes and dressings. By avoiding any exposure to even the smallest bit of latex, the patients can do very well, and have a safe operation. Also, breast implants do not contain any latex - so they don't have the potential for a latex reaction.

If you think you might be allergic to latex, please mention it to your surgeon. With proper preparation, latex allergy issues can be avoided.

The "Stem Cell" facelift

Every so often, a catchy concept comes along, and suddenly, that buzzword is everywhere. The buzz used to be about "laser-this" and "laser-assisted that". Now the popular phrase for plastic surgery is ""stem cells" and in particular, "stem cell facelifts". There was heated discussion about this procedure at the "Hot Topics" portion of the recent Toronto ASPS meeting.

Stem cells, for those who are unfamiliar with the term, are a special type of human cell found in bone marrow, fat and other locations, that have the unique ability to develop into pretty much any other more specialized type of cell, given the right circumstances. As such, their potential uses for repair, regeneration and restoration are potentially huge. Scientifically speaking, our understanding of how to best harvest and properly use these adult stem cells is extremely preliminary. But as the saying goes, "never let the facts get in the way of a good story", and that phrase certainly applies here, with the "stem cell facelift".

The LA Times did a properly skeptical review of stem cell facelifts here. Essentially, this procedure has an old name: fat grafting to the face. Of course, that doesn't sound as sexy as "stem-cell facelift", does it? Especially when traditional fat grafting has been a bit disappointing for many surgeons - with short duration, lumpiness, and unpredictability.

Some (but not all) physicians who promote the stem cell facelift are working on enhancing and "turbo-charging" the fat to be grafted by adding additional stem cells to the fat. These cells can be obtained through one of two main sources: liberating them from liposuction-ed tissue with collagenase, as is done with Cytori Therapeutics' $100K+ machine, or separating them from blood, using a process known as apheresis. Adding the stem cells to the fat does seem to make the fat transfer process work more reliably. There's decent science on that part.

But so far, we have no evidence - zip, zilch, nada - that there is any actual regenerative effect on skin when the turbo-charged fat is added to the face. We know you get more volume in the treated areas, so the treatment could be useful for those with a volume-depleted area, or those who want fuller cheeks - but that's about it.

Furthermore, under FDA rules, when stem cells get involved with fat transfers, the procedure falls under a whole new set of regulations. The fat and stem cell combo is now seen as a "biologic agent" by the FDA, and regulated as a drug. In the eyes of the FDA, stem cells and fat represent a non-approved drug. Investigational, yes - approved, no.

Interestingly, one of the spin-offs of this change to drug status is a change in whether physicians can advertise this process. They are no longer just advertising a procedure (the stem cell facelift), but they are doing direct-to-consumer marketing for a drug (the fat and stem-cell mixture) which has not yet been cleared by the FDA. And it's illegal to promote non-approved drugs.

So, those websites you are seeing for stem-cell facelifts are advertising a procedure which is:
1) scientifically not yet proven to have any efficacy,
2) morally questionable, (since they are charging big bucks for an as-yet unproven procedure),
3) illegal under Federal statute.

So there are a few problems to be worked out, eh? That being said, this is an area of great research interest, which one day might really be something good. Stem cell facelifts, for now though, should be part of research studies, not commercial promotion.

Suggest a topic for PSB - reader's choice

OK, readers - here's your chance! Suggest a meritorious plastic surgery topic that interests you - and I will write about it.

Submit your suggestions and comments here, please - I'm looking forward to reading them!

Allergan's new Latisse promotion

Here's a way to receive up to $100 back from Allergan...but only in selected practices, like ours. It's called the Latisse Real $100 Reward Program.

This is for our patients that would like to try Latisse (the popular eyelash treatment), and also use either Botox or Juvederm XC (with lidocaine).

Here's how it works:
- have a Botox or a Juvederm XC treatment between now and December 31, 2010,
- purchase some Latisse as well, prior to December 31, 2010
- fill out a short form, and mail it in with your receipts and a proof-of-purchase.

There are some minimum dollar purchase requirements for each of the Botox, Juvederm XC and Latisse...but still, it's a nice incentive for patients who use these popular products by Allergan in combination. Take note: regular Juvederm is not part of this deal, only Juvederm XC.

Start your Latisse now, and have stunningly gorgeous lashes by Christmas!!

New, possibly improved fillers?

At the Toronto meeting, we heard about two new hyaluronic gel fillers that are edging ever closer to FDA approval. These are called "Belotero" and "Prevelle Lift".

Like Juvederm and Restylane, they are made from the same basic molecule, the ever-popular hyaluronic acid gel. These new formulations, however, are manufactured differently, with the result being that the properties of the final injectable gel are significantly different.

If you were to look at filler gels under a microscope, most HA's to date have a fluid portion and a separate, more granular component. They are called "bi-phasic" because of this. Belotero, on the other hand, has a smoother, more even consistency, and is called "monophasic". Clinically speaking, which is what matters, people who have used Belotero feel that it also looks and feels smoother when injected, and is allegedly less prone to lumpiness. Belotero has been available in the UK since 2007, and has a good track record there. Reportedly, it lasts between 6 to 9 months, but, as always, take these claims with a grain of salt.

Prevelle Lift, also known as Prevelle DGE, is designed to fill out and physically lift the skin more than its thinner cousins. It's targeted at the treatment of deep lines and wrinkles, and at applications that require more 3-D shaping. The Prevelle product also contains lidocaine, making injections less painful.

Hopefully, these two products will receive their FDA clearance within the year, and be available for use in the United States. Both look quite promising and useful for our patients...but time will tell.

And of course, we'll really need to see some head-to-head comparisons with the established fillers to know where the newcomers will end up. To paraphrase the Iron Chef TV show, "Which filler will reign supreme?" - too early to say.

Get more out of Sculptra...

Here's a neat little trick, courtesy of Dr. Laurie Casas, which was presented at the "hot topics" part of the ASPS meeting in Toronto: Sculptra users can get a better result if they combine the injectable treatment with the use of Retin-A cream.

Dr. Casas explained that, since both products work by stimulating collagen, it made sense to try them together to see if a synergistic (additive) effect would happen. Her study found that the combination worked especially well for patients younger than age 55, and particularly well for those patients getting Sculptra in the cheeks and mid-facial areas.

Often the patients found that they required less Sculptra product to achieve the desired result, when they used the Retin-A cream. Another money saving tip for you from PSB- the Plastic Surgery Blog!