With now over 25 synthetic injectable fillers available in the U.S., one would think there is little need for further filler products. But the ability to modify hyaluronic acid filler structures to create different aesthetic effects assures that more such filler products will continue to become available.
Juvederm Vollure XC has just become FDA-approved for injection into moderate to deep facial wrinkles such as the nasolabial folds. It is formulated with proprietary Vycross technology, which blends different molecular weights of hyaluronic acid, contributing to the filler’s long duration.Juvederm Vollure XCwill be available in the United States in April 2017. This specific filler is not new in other parts of the world as it was first approved in Europe under the name of Juvederm Volift in 2013.
In the clinical trial that led to its approval, 59% of patients saw improvement in moderate to severe nasolabial folds for up to 18 months, with 82% of patients saying they were very satisfied at 6 months and 68% at 18 months. With a duration that has been shown to last up to 18 months from the initial or touch-up injection in a majority of patients, this is the longest lasting result shown in a clinical study in the nasolabial folds to date.
Like all injectable fillers it has typical side effects such as swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching. Other than lumps of the material these side effects resolved within one week after injection.
With over 25 synthetic injectable fillers on the US market it can be argued that how may more do we really need. But each new injectable filler offers some advantage and thus there is room for more. These growing number of injectable fillers has led to the concept of a toolkit of injectable treatments that allows customized use for specific facial aging indications and applications.
The most recently approved filler is Restylane Refyne and Restylane DeFyne. These have been FDA approved for the treatment of nasolabial folds. The main difference with these Restylane products and other hyaluronic acid fillers in in their inherent flexibility due to the proprietary XpresHAn technology. (X = cross-linking, Pres = pressing gels through mesh for calibration, HA = hyaluronic acid) This allows facial expressions (smiling, frowning, etc) to not feel stiff and more natural due to the flexibility of the filler material. While new to the U.S. the product has been used in Europe for years under the name of Emervel.
Restylane Refyne is the most flexible and provides support for moderate lines while Restylane Defyne is less flexible and is intended to support deeper lines. Their advantage amongs injectable fillers is their ‘Natural Expression in Motion’. Most patients treated felt that their facial expressions were unaffected and the location of the filler was not detectable.
Silicone breast implants continue to evolve both in its external shell and the gel that resides inside it. The silicone gel has become far less like the liquid it originally was many years ago. The silicone has become more firm or cohesive through increased crosslinking of the silicon molecules. The urban term for these newer type of breast devices is known as ‘gummy bear breast implants’. But the manufacturers of them use the term ‘highly cohesive’ or more form stable.
Allergan has offered silicone breast implants for years, known as the Natrelle breast implants line. They have had a highly cohesive gel in their shaped implants since 2013. (Natrelle 410 Anatomically Shaped Breast Implants) They have recently introduced this more highly cohesive gel in a round implant form. (Natrelle Inspira Round Gel Implant) The purpose in so doing is to achieve two effects: 1) hold the implant’s shape better, particularly in an upright position, to maintain upper pole fullness, and 2) for the gel to stay in place when the implant is either ruptured in vivo or cut in half when outside of the patient.
Allergan’s tested comparative physical features show it is 51% more cohesive that Mentor Memory Gel and 37% more cohesive than Sientra’s style 106 implant. Comparing form stability (what happens when the implant sits straight up), the Allergan implant was 47% more form stable than Mentor Memory Gel and 28% more form stable than Sientrs style 106 implant.
It is clear that increased gel cohesiveness is a desirous feature of a silicone breast implant. This is true both for how the implant performs long-term in the patient but also in how it is perceived by potential patients. (patients want ‘gummy bear’ breast implants) Each manufacturer now has their own version of them and they actively compare their gel cohesiveness and form stability. Natrelle breast implants now has a very competitive round silicone gel implant that is truly a gummy bear type.
Augmentative rhinoplasty requires either a graft or implant to perform. In most cases the use of the patient’s own septum or ear donor site is adequate. In more substantative dorso-columellar augmentations consideration must be given to either rib grafts or synthetic implants to achieve the desired effect. In some cases even an amalgamated approach can be used combining an implant (dorsal) with a cartilage graft. (tip)
There are well known advantages and disadvantages to both rib grafts and implants. Neither one is perfect. Rib grafts require a donor site and can be prone to warping. (if not diced) Implants have a higher risk of infection and can become displaced over time.
A third alternative does exist, however, that marries the benefits of both rib grafts and implants….that of cadaveric costal cartilage grafts. Harvested from cadavers through the Musculoskeletal Transplant Foundation (MTF), this allograft costal cartilage has several advantages. It eliminates the need for a donor harvest site which decreases operative time and lessens patient’s postoperative pain and scarring. They are minimally processed which helps preserve their biologic and mechanical integrity. (unlike irradiated or freeze-dried rib grafts from the past)
What is really surgically convenient and for the patient’s benefit is how the form in which the grafts are prepared. They come in either segments or sheets in a variety of lengths, widths and thicknesses. The costal cartilage sheets are greater than 3cms in length, 1 to 2 cms in width and around 2mms in thickness. The costal cartilage segments are greater than 3 cms, have widths up to 3 cms and thicknesses up to 20mms. It has a comparative cost to that of many nasal implants.
The costal cartilage allograft is another augmentative rhinoplasty option between rib grafts and synthetic nasal implants.
Jaw surgery has a long association with the need for maxillomandibular fixation. (MMF) Wiring the jaws together is an essential first step in many types of maxillofacial surgery. Whether it is in elective orthognathic procedures, the treatment of jaw fractures or in the reconstruction of the jaw after cancer reconstruction, the application of maxillomandibular fixation is essential. Putting the teeth together in the correct occlusion (bite) ensures that the jaw realignment/restoration surgery results in a satisfactory functional outcome.
The historic and standard approach to the application of maxillomandibular fixation is the application of arch bars to the teeth with multiple interdental wires. (usually 26 gauge) This ‘gold standard’ MMF technique has been used with various modifications for over 100 years with no real changes in the concept or technique. While unquestionably effective, it is tedious and time-consuming to apply and always involves some glove integrity violation and even skin penetration. It is by far the most despised maxillofacial techniques by all surgeons of any specialty. I have applied MMF on over 1,000 cases in my career and can do in an average 15 to 20 minutes. Those plastic surgeons with far less experience (e.g., residents and young surgeons) can easily take 45 minutes to an hour of operative time to get the bars and wires correctly applied.
In addition arch bars and interdental wires pose hygiene challenges for the patient after surgery and their high compressive forces on the teeth and gums results in significant occurrences of periodontal (gum) recession via papillary blood flow compromise.
The Omnimax MMF system (Zimmer Biomet) represents breakthrough technology and is a real game changer for getting the jaws and occlusion properly aligned. While other hybrid MMF systems have emerged in the past five years, I find that they have more limited uses with their own set of problems. (e.g., mucosal tissue overgrowth of the plates and screws and a high number of screws used per arch to name the top two)
The Omnimax system overcomes these MMF issues by several design innovations. The plates have a better segmentalized design with extended screw slots and are composed of an anodized titanum, all factors which contribute to less soft tissue irritation. But the key breakthrough design feature is the EXTENDED SCREW INSERTION SLOTS. This permits the MMF plate to stand off of the soft tissues while still being stabilized to the bone. This is a brilliant innovation in screw design that is proprietary to the Omnimax MMF system. Not only does the plate no longer compress the soft tissues but the stand off feature allows intermaxillary wires to be applied without creating compressing and necrosing gingival tissues.
The Omnimax MMF system with the innovative plate standoff feature due to the screw design finally overcomes the traditional problems with hybrid plate and screw MMF approaches. It decreases the number of screws needed for application (from 14 in other systems to 8) and improves intraoral hygiene and tissue health for the patient after surgery. But of equal importance in terms of operating room efficiency it changes the application of MMF from an average 45 minutes to 15 minutes (or less) with a far less risk of glove puncture.
In my opinion the new gold standard for maxillomandibular fixation has finally arrived. The simplicity and innovative design of the Omnimax MMF system will change the perception of this basic maxillofacial technique from one of contempt to possibly even pleasure.
The most common expected early outcomes and complications from many types of plastic surgery are various types of undesired fluid collections. These are caused by bleeding (bruising and hematomas) as well as prolonged lymphatic leaks. (seromas)
While the body has many natural clotting and healing mechanism to limit the occurrence or extent of these fluid collections, they can be frequently overwhelmed or not optimally effective. Plastic surgeons are well aware of this potential and employ a variety of strategies to help including intraoperative electrocautery and hemostatic materials as well as the use of postoperative drains and pressure dressings.
The past decade has seen the advent of adjunctive biologic approaches that can be applied during surgery to work with the body’s natural hemostatic and healing mechanisms. One such agent is VITAGEL.This is an FDA-approved, composite liquid hemostat that combines the thrombin and collagen with the patient’s own plasma. When applied to human tissues, Vitagel creates an adherent gel and an impermeable barrier to blood flow. This helps control bleeding and facilitates healing using the patient’s own biology.
Vitagel is promoted as a surgical hemostatic product that combines microfibrillar collagen with thrombin, fibrinogen, and platelets. This unique combination of components forms a 3-D scaffold of collagen and fibrin which is augmented with activated platelets.This is created during surgery by using a draw of the patient’s blood which is spun down by a centrifuge to create an extract of plasma and platelets. This is then mixed with prepackaged thrombin and collagen to create the final hemostatic product. By using the patients own blood, the risk of viral transmission associated with products containing pooled human donor components is eliminated.
One very unique component of Vitagel is the microfibrillar collagen. Collagen is a well known essential element for both inducing the coagulation cascade as well as promoting healing. The microfibrillar structure allows for better coherence of the collagen fibers to irregularly shaped bleeding sites.This type of collagen also aids the healing process through the formation of a biologically active 3-D scaffold for cellular ingrowth and fibroblast attachment. Such a scaffold becomes a template for new tissue growth. This is unlike any other surgical hemostatic agent.
Vitagel can also be applied to the surgical site in a variety of ways including a standard spray and a powered aerosolized mist. This ensures optimal coating of the tissues even into the smallest crevices.
Vitagel has great application for many plastic surgery procedures that involve the creation of large skin and tissue flaps. Such procedures as tummy tuck and facelifts, for example, involved the undermining of large tissue flaps for which drains are commonly used and the risk of hematomas and seromas are well known. The use of Vitagel would help decrease these risks and may either eliminate the use of drains or reduce the length of time they are in after surgery. At the least the amount and duration of postoperative bruising and swelling may be lessened.
Lip augmentation is one of the most common and historic procedures for hyaluronic acid-based injectable fillers. It would surprise many then to find out that despite its popularity and common usage, few of these injectable fillers are actually FDA-approved for use in the lips. There are a variety of reasons for this lack of approval but safety and effectiveness are not among them.
On October 1, 2015 the US FDA has approved Juvederm Ultra XC for injection into the lips and perioral (mouth) area for aesthetic augmentation in adults. Juvederm Ultra XC and Juvederm Ultra Plus XC injectable fillers are already FDA-approved for injection for moderate to severe facial wrinkles and folds around the nose and mouth. (nasolabial folds) Juvederm Ultra XC is a well known modified form of hyaluronic acid with prolonged duration (up to a year) that has lidocaine in it to improve the comfort of the treatment.
In FDA trials of Juvederm Ultra XC for lip augmentation, almost 80% of patients had visible improvement in lip fullness three months after injection. A near similar percent, (78%) stated that they had persistent improvement in lip size one year after injection. The most common adverse effects for Juvederm Ultra XC injectable filler are the same as other hyaluronic acid gels such as temporary swelling, redness and lumps and bumps.
What is unique about Juvederm Ultra XC injectable filler is that it offers long-term retention of lip augmentation results. Many hyaluronic acid-based injectable fillers are used for lip augmentation but their results often last six months or less.
The anticipated approval of new injectable fillers shows no sign of stopping with the development of ‘niche’ filler products. This was demonstated this week as the FDA (US Food and Drug Administation) approved Restylane Lyft for cheek augmentation. Restylane Lyft, formerly known as Perlane-L, was approved for the standard injectable filler indications of treating nasolabial folds.
Per the manufacturer Gladerma In a clinical trial of 200 patients, almost 90% of treated patients with Restylane Lyft showed increased and persistent fullness in the cheeks. More than half of the treated patients demonstrated such persistent fullness out to one year followup. Adverse reactions for this hyaluronic-based injectable filler were typical with a low incidence of redness, swelling and itching, all of which resolved within two weeks after injection.
Restylane Lyft is the fifth member of the well known Restylane brand name that has been approved over the years. Other well known companion injectable products include Restylane, which is used to correct smile lines and augment the nasolabial folds, and Restylane Silk for lip augmentation and wrinkles and lines around the mouth.
Restylane Lyft is clearly a competitive analogue to Allergan’s Juvederm Voluma. It is ongoing evidence that all companies offering injectable filler products will need to develop and market a broader spectrum of treatment offerings for very specific facial indications. What differentiates the injectable filler products is that the viscosity or so called G prime of the filler is modified to treat the array of soft tissue defects from superficial fine wrinkles to deeper areas of volume loss. Long gone are the days when one tried to use one type of filler for every aesthetic facial need.
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.
One 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.
Radiesse 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.
An 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.
As 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 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.