Belotero® Balance, manufactured by Merz Pharmaceuticals, LLC,  may be the next hyaluronic acid (HA) dermal filler on the market for cosmetic treatment for wrinkles and lines or folds in the skin. Merz is hoping to get FDA approval in September 2010.

The touted difference between Belotero® Balance and the rest of the HA fillers on the market is  Belotero®’s ability to place HA more superficially in the skin. Belotero® Balance does not seem to have a “Tyndall Effect,” which causes skin that is injected too superficially with dermal fillers to appear slightly bluish, bruised, or as if there are blood vessels on the surface on the skin.  In the past, some superficial HA dermal fillers have caused this appearance but it has not appeared to be an issue with Belotero® Balance in European clinical trials.

Belotero® Balance is seeking FDA approval for injection into the mid-to-deep dermis for correction of moderate to severe skin wrinkles and folds.

If Belotero® is approved, it will be interesting to see how it competes with other more established HA fillers in a crowded cosmetic treatment marketplace. If it can distinguish itself, Belotero®  should enjoy the continued explosive growth in the HA filler area of non-operative plastic surgery.

Jeffrey J. Roth, M.D., F.A.C.S.

Las Vegas Plastic Surgery

(702) 450-0777

www.jjrothmd.com

References:

Merz USA

Plastic Surgery Practice

Belotero® Balance PMA filing accepted for review by FDA

As if one needed another reason to not go abroad for elective surgical treatment, the identification of a new “superbug” has recently been reported among medical tourists who traveled to Asia.  “Superbug” is a bit of a misnomer.  The superbug bacteria is a common one, E. Coli or Klebsiella pneumonia.  However, this bacteria happens to have acquired a gene, NDM-1, that secretes an enzyme that destroys most antibiotics, including those usually saved as a last resort for treatment. The NDM-1 bacteria has been found to be susceptible to a few older antibiotic treatments.

As reported in the noted British medical journal, The Lancet, 29 patients in the United Kingdom were identified with the new strain of bacteria. Most of the patients had traveled to India, Pakistan, or Bangladesh for medical procedures, including medical tourists who received elective cosmetic surgery.  There were also dozens of patients from Asia who were identified with the particular strain.  The new strains are mostly confined to hospitals, and are a concern only for people receiving medical care or plastic surgery in those regions.

The Lancet authors concede the growing popularity of travel for medical purposes, including patients who seek elective plastic and cosmetic surgery procedures abroad.  They warn that such travel should be discouraged; noting the establishment of bacteria with the NDM-1 strain around the world is a “clear and frightening” possibility.

There are many safe, reliable,and skilled medical surgeons and facilities around the world.  Infections can happen anywhere, even under the best of circumstances.  They are a known risk of surgery.  This is why so many precautions are taken prior to any surgery or procedure and why members of the American Society of Plastic Surgeons (ASPS)  and the American Society of Aesthetic Plastic Surgeons (ASAPS) only operate in certified surgical centers.  With multiple levels of prevention, surveillance, and when needed, intervention,  these certified facilities undergo constant scrutiny to make them as safe as possible for patients. Unfortunately, these health and safety regulations are not always present in medical facilities across the globe, and this places medical tourists traveling to under-developed countries for surgical procedures at a considerable risk for infection or illness.

Jeffrey J. Roth, M.D., F.A.C.S.

Las Vegas Plastic Surgery

(702) 450-0777

www.jjrothmd.com

References:

cnn.com

The Lancet

Dracula Smiles On Plastic Surgery’s Latest Trend

Vampires and the myths surrounding them have fascinated human culture for centuries. The popular Twilight book series and HBO’s “True Blood” demonstrate the vampire genre is not dead, even if its icons are supposed to be. In fact, the vampires on “True Blood” survive and “mainstream” by living on artificial blood, something modern medical science has been trying to create for decades. Hopefully real life can imitate art in the future, at least in the sense of artificial blood being available for medical emergencies. In the meantime, it is not surprising that vampire pop culture has made its way into the field of plastic surgery.

A new cosmetic procedure, known as the “Vampire Facelift,” has been touted to plastic surgeons and their patients.  Recently, UBS Aesthetics released their patented SELPHYL system.

Basically, when a patient arrives at their plastic surgeon’s office, a vial of blood is drawn, similar to a regular blood test.  The plastic surgeon then uses the SELPHYL kit and a centrifuge to separate out a few of the components found in blood. These components are Autologous Platelet-rich Plasma (PRP) and an activated Platelet-rich Fibrin Matrix (PRFM).

These components can be used for cosmetic procedures to correct skin depressions, wrinkles, and acne scars and to promote skin volume and rejuvenation.

Although this is a new spin on an old cosmetic procedure, the facelift, it is not a new idea.  For years various blood components have been studied by scientists and physicians in hope of finding one that would aid in healing.  Different companies have provided kits to take blood from a patient, process and separate the components of the blood, and ultimately give the blood components back to the patient. The Cascade and CryoSeal Systems are two that come to mind.

The literature on Autologous Platelet-rich Plasma (PRP) and an activated Platelet-rich Fibrin Matrix (PRFM) has been mixed.  Some clinical reviews say it helps, others say it does not.  Currently qualified, randomized, double blinded studies on the process are lacking.  Likewise, long term studies are hard to find on the effectiveness of PRP and PRFM.

What is new is that SELPHYL is now being marketed to physicians and plastic surgeons as well as directly to potential patients as a cosmetic treatment.  Patients receive components of their own blood for augmentation, typically filling and volumizing, of skin tissues.  We lose volume in our face as we age.  By placing volume back into the face, we often see an improvement in appearance.

It is not a facelift.  A facelift is a cosmetic procedure which surgically lifts the facial tissues back to where they used to be, or where the patient might like them to be.

Intriguing may be a good word, both for the mystique of vampires, and for new takes on old modalities to help improve the way we look.  The modern use of blood may help us combat the age old process of getting old after all.

Jeffrey J. Roth, M.D., F.A.C.S.

Las Vegas Plastic Surgery

(702) 450-0777

www.jjrothmd.com

References:

Platelet-rich therapies in the treatment of orthopaedic sport injuries. Sánchez M, Anitua E, Orive G, Mujika I, Andia I. Sports Med. 2009;39(5):345-54.

Platelet Rich Plasma: Myth or Reality? Wang HL, Gustavo A. Eur J Dent. 2007 October; 1(4): 192–194.

Platelet-rich fibrin matrix for improvement of deep nasolabial folds. Sclafani AP. J Cosmet Dermatol. 2010 Mar;9(1):66-71.

Applications of platelet-rich fibrin matrix in facial plastic surgery. Sclafani AP. Facial Plast Surg. 2009 Nov;25(4):270-6. Epub 2009 Nov 18.

Use of tissue sealants in face-lifts: a metaanalysis. Por YC, Shi L, Samuel M, Song C, Yeow VK. Aesthetic Plast Surg. 2009 May;33(3):336-9. Epub 2008 Dec 17.

Face and neck revitalization with platelet-rich plasma (PRP): clinical outcome in a series of 23 consecutively treated patients. Redaelli A, Romano D, Marcianó A. J Drugs Dermatol. 2010 May;9(5):466-72.

Platelet-Rich Plasma: A Review of Biology and Applications in Plastic Surgery. Eppley, BL, Pietrzak, WS, Blanton M. Plastic Reconstructive Surgery, Volume 118(6), November 2006, pp 147e-15

Police Seek Two Women in Connection With Unlicensed Silicone Injections

Los Angeles homicide detectives are seeking two sisters accused of operating a low-cost, unlicensed cosmetic surgery clinic in their San Fernando Valley home.  The suspects fled the Los Angeles area after a patient died over the weekend.  Police believe the accused, Guadalupe Viveros, 53, and Alejandra Viveros, 50, of Sylmar, CA may have fled to Mexico after the death.

Guadalupe Viveros reportedly said she was licensed as a physician in Mexico.  There has been no confirmation of her medical credentials in Mexico. More importantly, she is not licensed to practice medicine in the United States.

22 year old Mayra Lissette Contreras of Pacoima, CA  died Friday from  apparent respiratory complications. Previously the unlicensed plastic surgeon sisters treated Mayra with silicone shot injections to enlarge her buttocks.  Mayra is survived by her husband Gerardo Olvera and two young children.

The silicone injections were done in a private home in a residential neighborhood.  This unlicensed clinic was advertised with flyers placed on cars and on walls in the area which touted a “revolutionary treatment.”

The two sisters had been arrested June 21, a month before the fatal procedure, on charges of practicing medicine without a license.  They were released on $20,000 bail.  Los Angeles police investigated the sisters last month after patients complained that they fell ill after being injected with unidentified fillers in the face or buttocks.  Earlier, police said the “victims identified have complained of becoming ill as a result of being injected by these fillers. In some cases, these fillers have hardened into solid plastic and have developed infections in the victims.”

This event is a great tragedy and my heart goes out to the family of Mrs. Contreras. Unfortunately, her death may have been preventable.

Unforeseen complications can occur during any medical procedure. Physicians, surgeons, and licensed practitioners in the United States receive years of education and training and are regulated by strict guidelines to prevent unnecessary risk. Having an illegal (in the state of Nevada it is illegal to inject silicone for cosmetic purposes), and potentially dangerous treatment performed by an unlicensed plastic surgeon or practitioner eliminates all of the safety procedures established by state medical boards.  In the case of Mrs.Contreras, silicone was not a good substance to use as liquid injectable silicone can be placed into the vascular system, causing breathing problems if it travels to the lungs.

Furthermore,  having any cosmetic surgery procedure done at an unlicensed and unregulated clinic usually involves a lack of appropriate personnel and equipment.  Professionally trained and experienced practitioners can identify patients who may have potential for problems.  If the patient does have a complication, properly trained and equipped personnel can help to identify and resolve the issue.

This is why it is important to seek out a board certified plastic surgeon.  They will evaluate your goals and come up with the appropriate plastic or cosmetic procedure that is safe and promises health and well being for the future.  Any potential financial cost saved by seeing an unlicensed cosmetic practitioner is clearly not worth putting yourself at risk or compromising your personal health and safety.

Jeffrey J. Roth, M.D., F.A.C.S.

Las Vegas Plastic Surgery

702-450-0777

www.jjrothmd.com

References:

http://www.ktla.com/videobeta/?watchId=1335f711-ca46-4f54-850e-99620d01b774

http://inyourface.ocregister.com/2010/07/29/another-buttock-injection-death/19567/

http://articles.latimes.com/2010/jul/30/local/la-me-silicone-death-20100730

Xeomin,  manufactured by Merz Pharmaceuticals, LLC.  of Greensboro, North Carolina, has received FDA approval to be sold in the United States.  The FDA has approved the drug to treat Cervical Dystonia, a disease related to abnormal head position, and blepharospasm, which causes  muscle spasms around the eyes.  Xeomin works the same way that  Botox and Dysport do by relieving the muscles that cause wrinkles and “frown lines” in the face.  There is no official word yet if Xeomin will be available for cosmetic use anytime soon. If Xeomin is approved for use in cosmetic procedures it could become a competitor for Botox.

If you are interested in learning more about Xeomin or cosmetic face and skin treatments, please feel free to call or e-mail my office with any questions.

Jeffrey J. Roth, M.D., F.A.C.S.

Las Vegas Plastic Surgery

702-450-0777

www.jjrothmd.com

References:

http://www.merzusa.com/pdf/FDA_Approval_of_Xeomin.pdf

http://www.botoxmedical.com/

http://www.botoxcosmetic.com/home.aspx

http://www.botoxseveresweating.com/

http://www.dysport.com/

http://www.drugs.com/newdrugs/fda-approves-dysport-therapeutic-aesthetic-uses-1336.html

Restylane and Juvederm Facial Fillers Can Now Be Injected With Lidocaine

One of the latest advancements in facial fillers for cosmetic plastic surgery is the addition of lidocaine, a pain numbing agent, to the filling product.  This enables facial filler products, like Restylane and Juvederm, to have a uniform consistency of numbing medicine throughout the entire filler.  The use of lidocaine with the facial filler injection should ease the temporary discomfort and pain some patients feel when they recieve facial filler injections. This is not a new concept, as the makers of collagen fillers added lidocaine to their products several years ago.  Allergan’s Zyderm/Zyplast (made with bovine, or cow collagen) and Cosmoderm/Cosmoplast (made with human collagen) both have lidocaine in them.

In July 2009, the Food and Drug Administration (FDA)  approved a method for physicians to mix lidocaine with the filler Radiesse (made with calcium hydroxylapatite). Up until this point, the Hyaluronic Acid (HA) fillers that most plastic surgery patients are familiar with, such as Restylane and Juvederm, did not have lidocaine inside of them.  Previously, many physicians and plastic surgeons who performed facial filler injections numbed the treatment area with ice or a topical numbing agent to decrease patient discomfort. Now, the makers of these products have FDA approval to market their HA facial fillers with lidocaine agent in the United States.

Allergan’s HA filler, Juvéderm XC had been available in Europe for around a  year before garnering FDA approval in February 2010. Restylane-L and Perlane-L, manufactured by Medicis Aesthetics Inc. also acquired FDA approval that same month. In the clinical trials of the products, the inclusion of lidocaine has provided less pain with injection. These products performed similarly to their lidocaine-free predecessors in terms of safety and efficacy.  During facial filler injections with lidocaine, most patients did feel the first pinch, and then subsequent sticks were less painful as the lidocaine took effect.

At our Las Vegas based plastic surgery practice, we still numb the facial filler injection treatment area with topical medicine and blocks in addition to using the product with lidocaine which provides the least amount of discomfort and the the best experience possible.  Although originally there were some hypothetical concerns about bruising when the lidocaine formulations were introduced because lidocaine is a well known vaso-dialator,  we have seen no added bruising with patients who use these products.

The popularity of facial filling agents is undeniable.  Today’s facial fillers continue to evolve in terms of safety, efficacy, and decreased discomfort with application. We look forward to further advancements in the cosmetic and plastic surgery industry, and we will keep you informed as they develop.

Please call or email us with any questions.

Jeffrey J. Roth, M.D., F.A.C.S.
Las Vegas Plastic Surgery
702-450-0777
www.jjrothmd.com

References:

A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.  Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK.  J Cosmet Dermatol. 2009 Sep;8(3):205-10.

A split-face comparison of a new hyaluronic acid facial filler containing pre-incorporated lidocaine versus a standard hyaluronic acid facial filler in the treatment of naso-labial folds. Levy PM, De Boulle K, Raspaldo H.  J Cosmet Laser Ther. 2009 Sep;11(3):169-73.

RESTYLANE-L Injectable Gel with 0.3% Lidocaine [Instructions for Use]. Scottsdale, AZ: Medicis Aesthetics Inc.; January 2010.

PERLANE-L Injectable Gel with 0.3% Lidocaine [Instructions for Use]. Scottsdale, AZ: Medicis Aesthetics Inc.; January 2010.

The FBI took out an ad in Plastic Surgery News, April-May edition.  The ad reads “Have You Treated This Women?”  They are looking for a woman named Catherine Greig, (age 59), believed to be in the company, and an accomplice of , one of The FBI’s Top Ten Most Wanted Fugitives, gangster James “Whitey” Bugler, (age 80). 

Bugler was a longtime FBI informant.  He is wanted in 19 murders in the ‘70’s and ‘80’s.  He fled before his January 1995 federal racketeering indictment in Boston.

They have been on the run for 15 years.  The woman is known to have had; a face lift, liposuction, and eyelid surgery, and has aged implants, (placed in 1982), that may need to be replaced at some time.  The FBI included the product and lot number of the implants.

The ad includes photos of Greig before and after surgery.  It asks anyone who might recognize her to call the FBI.  The reward is currently $2 million.

Allure magazine was the first to report on the ad.  Their headline was “Nip/Tuck Meets America’s Most Wanted.”

Time will tell if the ad pays off.  In the meantime, one has to hand it to the FBI for creative, “out of the box,” thinking to catch their most wanted criminals.

References:

Plastic Surgery News.  April-May 2010 Edition, p.4.

The Boston Globe. May 13, 2010.