Although medicine is a global community, specific protocols tend to be local. Most countries boast their own regulatory agencies that, in turn, impose their own guidelines regarding safety, efficacy, evidence and approval of medical devices, drugs and applications.

Dr. Sattler

Protocols currently making a splash across the pond include two noninvasive body-contouring techniques — cryolipolysis (CoolSculpting, Zeltiq Aesthetics), which uses cold, and UltraShape (UltraShape), which employs focused ultrasound technology.

"Cryolipolysis is based on the principle that fat cells are more vulnerable to energy extraction than surrounding tissues. Cooled fat cells undergo apoptosis and are gradually eliminated, reducing the thickness of the fat layer," says Gerhard Sattler, M.D., a founder of Rosenpark Clinic, Darmstadt, Germany.

Dr. Steinert

"Procedure time can take up to two hours or more depending on the size of the area to be treated," Dr. Sattler says. During the final phase, the fat cells are removed in a natural process that continues for several months and results in gradual fat-layer reduction.

"Clinical studies demonstrate the CoolSculpting procedure provides noticeable, measurable fat reduction in properly selected patients over the course of two to four months following the procedure. Additional procedures may be administered [then] to achieve greater fat reduction," Dr. Sattler says.

Long-term studies have not been completed, but available data presented as a poster at the 2009 annual meeting of the American Society for Dermatologic Surgery indicates patients show persistent results at least six months after the procedure. Results are expected to last as long as those from more invasive protocols (such as liposuction), although the actual effect is often less dramatic in comparison.

Ideal candidates are relatively fit and want to target stubborn, modest-sized fat bulges noninvasively.

"The CoolSculpting procedure is not intended for weight loss or obesity, and it is not a substitute for invasive methods, such as liposuction," Dr. Sattler says. It is currently most commonly used to treat "muffin tops," love handles and back fat, though other areas may also be addressed.

Contraindications for cryolipolysis treatment include two rare conditions — cryoglobulinemia and paroxysmal cold hemoglobinuria. Otherwise, risks are low, side effects rare and recovery immediate.

The Zeltiq CoolSculpting cryolipolysis device.

Before use, physicians need to be trained on the device, committing to specific patient selection criteria, case management responsibilities and protocol requirements. Zeltiq CoolSculpting has been cleared for use in the United States for applications related to skin cooling during dermatologic treatments, and it holds a pending application with the FDA for use in noninvasive fat-layer reduction.

TUCSON, ARIZ. — Transaxillary mastopexy presents technical challenges, but it is a worthwhile technique for women seeking breast enhancement due to decreased morbidity and no unsightly breast scars, says Robert M. Dryden, M.D.

Dr. Dryden

"Many women are reluctant to have a mastopexy because of the extent of the surgery and the potential for having ugly scars," says Dr. Dryden, president, Arizona Centre Plastic Surgery, Tucson, Ariz., and clinical professor, department of ophthalmology, University of Arizona School of Medicine, Tucson. "The transaxillary approach is challenging, because the suturing needs to be done through a small entry site. However, the procedure is very effective in providing lift, can be enhanced with augmentation, and not only avoids a visible scar but also eliminates or reduces the chance of other complications — such as dehiscence and infection — that accompany a larger incision procedure."

"There is definitely a learning curve, so better results should be expected with increased experience, and perhaps (that) explains the results of the first procedure," Dr. Dryden says.

CANDIDATES, PROCEDURE Women with grade I or II ptosis are the best candidates for transaxillary mastopexy, he says. Grade III ptosis presents more of a challenge, but Dr. Dryden reports that he has also operated on these women with good results.

To perform the procedure, Dr. Dryden infuses 360 mL of tumescent solution prepared by mixing 1,000 mL normal saline, 150 mL 1 percent lidocaine, 12.5 mL 8.4 percent sodium bicarbonate, 1 mL 1:1,000 epinephrine and 0.25 mL triamcinolone acetonide 40 mg/mL. The axillary incision is hidden in a crease, but it is placed at a site a little farther anterior in the axilla compared to that used when performing a transaxillary augmentation alone.

"This incision location provides improved intraoperative visibility," Dr. Dryden says.

Next, a pocket is created in the subglandular plane, and then the superior breast tissue — which can be identified easily via endoscopy — is sutured to the pectoralis fascia and muscle superiorly overlying the second rib, at the level of the manubrium, or higher. Three to five sutures are placed using 2-0 PDS on a CT-1 taper point needle (both from Ethicon).

"It's important to use this heavy-duty needle, because trying to find a broken needle in the pectoralis major would be like searching for a needle in a haystack, something that we found out when we first started doing the transaxillary technique," Dr. Dryden says.

ADDING AUGMENTATION Since the lifted breast usually does not have the desired full, rounded appearance, the transaxillary mastopexy is generally performed in conjunction with augmentation. In the combined procedure, an expander, 1.5 times the size of the implant, may be used as well to create a generous pocket and for hemostasis.

"Placing an implant also helps with the outcome of the lift. The lift alone generally causes a drop in the inframammary crease, but the implant will help to support the breast," Dr. Dryden says.

Postsurgery, women are prescribed a six-day course of antibiotic treatment as infection prophylaxis. The most important element of their postoperative care is the need to wear a supportive bra (one with nonstretchable straps) around-the-clock (24 hours, seven days a week) — even when showering — for at least six months.

"The supportive bra will permit the occurrence of scar contraction and healing, which is what will be relied on to maintain the lift," Dr. Dryden says.

Autologous fat transplantation is an exciting treatment for facial rejuvenation, breast enhancement/reconstruction and general soft tissue augmentation, according to cosmetic surgeons who perform this treatment, because it accomplishes these deeds without incisional scars or the complications that are associated with injection of foreign materials.

The use of fat as a soft tissue filler has been a staple in the armamentarium of a handful of forward-thinking cosmetic surgeons for a couple of decades, but more recent refinements that concentrate on isolating and transplanting the powerful and abundant stem cells found in adipose tissue are adding depth and promise to the already versatile and burgeoning field of fillers.

CELL-ASSISTED LIPOTRANSFER While autologous fat transplantation and its use of stem cells are in various stages of clinical use and development around the world, Japanese cosmetic surgeons are making remarkable strides. Kotaro Yoshimura, M.D., associate professor, department of plastic surgery, University of Tokyo, is one of the leading investigators in stem cell research and usage for aesthetic applications. Along with his colleagues, Dr. Yoshimura has developed a novel strategy known as cell-assisted lipotransfer (CAL) to overcome problems that typically have been associated with lipoinjection, such as unpredictable results and a low rate of graft survival due to partial necrosis.

Dr. Yoshimura's experience and outcomes in more than 450 breast augmentation and reconstruction patients since 2003 suggest that CAL is safe and effective for soft tissue augmentation.

Before (left) and nine months after stem cell fat grafting breast augmentation. Breast volume increase nine months post-operatively was +4.5 cm.

According to Dr. Yoshimura, supplementation with ASC-containing SVF may boost the efficacy and safety of conventional autologous micro-fat grafting. "ASCs are a promising tool in the initial stages of regenerative medicine. A substantial (therapeutic) amount of cells can be obtained without cell culture, and the anticipated therapeutic potential is similar to that of bone marrow-derived mesenchymal stem cells.

"Our results are pretty encouraging. We can use it for breast implant replacement as well as breast reconstruction. Facial reconstruction for inborn or acquired diseases are also good indications," Dr. Yoshimura says. The basis for stem cell transplant utilization and efficacy, he says, is, "We need stem cells to repair, renew and reconstruct our tissue. What is important is how to activate stem cells and control their behavior so that they behave in the right way."

Dr. Yoshimura stresses that confirming long-term safety and efficacy is important, and that several challenges remain. "We still see some challenges for thin patients (as far as insufficient donor site fat), as well as breast reconstruction with adhesive scar tissues and previous irradiation," he says.

Cosmetic surgeons can be very skilled in their trade and achieve excellent aesthetic outcomes, but those who can minimize the discomfort and pain that a patient perceives during and after a cosmetic procedure are likely to be the most professionally — and financially — successful.

There are many variables that influence a patient's decision to have cosmetic surgery, and arguably the most important factor in the decision process is potential peri- and postoperative discomfort. According to one expert, there is a direct relationship to the business of a surgeon and his or her ability to make and keep patients comfortable, and this can be best witnessed in dentistry.

Dr. Niamtu

"Little things like an assistant holding the hand of a patient being injected with filler or Botox — 'handaesthesia' — or the surgeon speaking in a softer tone and communicating with the patient in a relaxing manner while injecting — 'talkaesthesia' — all make a little difference, and these little differences are cumulative to a more pleasant experience," Dr. Niamtu says.

The "miniblock" infiltration technique involves using a 32-gauge needle with a 1 mL syringe. After topical anesthesia, the entire length of the needle is threaded near the sulcus to minimize puncture sites, and 0.2 mL to 0.3 mL of local anesthesia is injected in the right, left and center regions between the canine teeth.

"A prospective facelift or laser patient can gain a lot of insight and confidence and be more relaxed after speaking with a patient who has already had the procedure," Dr. Niamtu says. "The continued reassurance from physicians that they and their staff will individually and specifically cater to the patient's post-operative discomfort will also put the patient at ease and diffuse periprocedural fear and apprehensions. In our office, we refrain from using the 'P' word when discussing post-operative pain and speak of discomfort instead."

Each patient should be approached individually in terms of apprehensiveness to pain and the subsequent control of it. Postoperative pain can be managed well with powerful analgesics, which can be used for several days where necessary and deemed appropriate. Significant advancements in postsurgical pain control with tumescent anesthesia can also be very effective; in some cases it can keep patients comfortable for 24 hours postoperatively.

Local anesthesia is used for all filler injections. In folds or wrinkles, the 32-gauge needle is inserted deep into the fold, as not to distort the fold anatomy. Two injections of 0.2 mL to 0.3 mL of local anesthesia solution is threaded from the corner of the mouth to the nostril from two puncture sites. This will render the actual filler injection painless. (Photos credit: Joseph Niamtu III, D.M.D.)

Pain management is not only an issue in more invasive surgical procedures; it's an issue in simple aesthetic injectable procedures, as well. Those physicians who can administer pain-free Botox (onabotulinumtoxinA, Allergan) and filler treatments will surely gain popularity among their aesthetic clientele. This is crucial to a physician's business, as word-of-mouth can be a powerful marketing tool as patients communicate freely about "who hurts" and "who does not." However, positive feedback is not free, and it requires a heightened commitment and dedication to patients and practice.

"Adequate pain control requires more time, and some doctors are too busy to take this time. If a practitioner is truly concerned about a painless procedure, it simply takes more time, but pays off dividends in increased business," Dr. Niamtu says.

A revolutionary new filler product known as Ellansé (AQTIS Medical, Netherlands) boasts a tunable longevity, total bioresorbability and a sustained performance, say two European doctors who use the product regularly. The filler, which is composed of polycaprolactone (PCL), is currently available only in Europe, but plans to enter the U.S. market are under way, with the hope of achieving Food and Drug Administration approval toward the end of 2011, according to Henk Super, AQTIS Medical's chief operating officer.

Current fillers are composed of hyaluronic acid (HA), calcium hydroxylapatite or collagen. Ellansé is composed of PCL, a well-known, completely bioresorbable soft medical polymer that has been used for decades in CE-marked and FDA-approved commercial bioresorbable product applications.

"The PCL contained in Ellansé is the same material that you find in some resorbable sutures and other devices in surgery. The experience with PCL spans over 40 years in medicine, and it has a solid proven safety record in terms of biocompatibility," says Kostas Gritzalas, M.D., a dermatologist in private practice in Chalkis, Greece. "In my opinion, the 100 percent biodegradability, decades-long excellent safety record and never-before-seen long-lasting cosmetic results make this filler extremely interesting for aesthetic interventions."

A 46-year-old female patient before receiving initial suboptimal correction with Ellansé-S. One touch-up was done one month after the initial procedure.

"Ellansé can offer the cosmetic patient a personalized and tailored treatment with aesthetic results intended to last at least twice as long as any other leading filler. Though these are still early days, I believe that this filler will stand up to the more established fillers and likely surpass them," says Ali Pirayesh, M.D., F.C.C., consultant plastic, reconstructive and aesthetic surgeon at the Dutch Clinic, Amsterdam, and University Hospital, Gent, Belgium.

The same patient 15 months after the one-month touch-up. No additional touch-ups were performed between the one-month touch-up and the 15-month photo. Approximately 1.78 mL of Ellansé-S was used for treatment of the nasolabial fold.