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2016 ASLMS FDA Update

ASLMS / ASDSA / FDA Session Summary

October 13, 2016

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Robert Weiss MD, ASLMS Past President

Suture Designs for Facelift, Brow Lift, etc.; Are They Being Used in Practice and What are the Real-World Problems With Them in Terms of Pain Score, Side Effects and Efficacy?

Dr. Robert A. Weiss of the Maryland Dermatology Laser Skin and Vein Institute discussed face lifting sutures and what is available. He went over the history of the Aptos threads, contour threads, ePTFE threads and the newer absorbable type of biodegradable threads or sutures.  Issues regarding the percentage that slip or need to be pulled out were reviewed with data on the newer absorbable threads showing a much better safety record.

The first barbed sutures were approved in 1961 for tendon repair and they were applied to facial cosmetic applications in 2002.  These threads were non-absorbable, unforgiving and contained sharp points which could irritate the dermis.

There were a lot of adverse events reported including breaking threads, self-extrusion and lack of efficacy over time.  As a result, manufacturing was stopped in 2007 and the FDA clearance was withdrawn in 2009.

The main resorbable suture that is currently in use is the Silhouette InstaLift. These are resorbable sutures and cones made of poly (L-lactic-co-glycolic acid) 82:18% and are bidirectional sutures.  They contain cones in opposite directions to anchor into the subcutaneous tissue and allow immediate suspension of sinking tissue.

Dr. Weiss discussed who comprises the ideal patient with a certain skin thickness, the proper placement along the cheek, and the fact that most patients need three sutures which are placed in the mid cheek to suspend above the nasolabial fold.

Adverse events include swelling, dimpling at entry and exit points, as well as misplacement of the sutures and bruising. Dr. Weiss reported that his patients reported that they had significant pain on the evening after the suture placement.  He has had some patients with a projection or elevation at the point of entry in which case he had to puncture with a needle under local anesthesia and remove a knot or cone that occurred 1 to 2 weeks’ post.  Dr. Weiss summarized stating that patients were happy in general with the results, and that no serious adverse events have occurred.

The FDA had very little follow-up questions and seemed satisfied with the report of what has been happening to date.

Gender-Based Differences in Safety and Aesthetic Outcome Measures with Respect to Dermal/Soft Tissue Filler

The next topic was gender differences in the demand for cosmetic procedures. To summarize, Dr. Weiss went over the cosmetic concerns of men which includes #1 hair loss, #2 forehead wrinkles, #3 a strong and masculine chin and #4 double chin or subcutaneous fat of the neck.  Dr.  Weiss also summarized that men only comprise about 10% of patients seeking cosmetic procedures and other clinical participants on the call agreed. Dr. Weiss stated that as a dermatologist who mainly does cosmetic dermatology, the number one request was to reduce frontalis muscle lines on the forehead using botulinum toxins or neuromodulators.

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Arisa Ortiz, MD, ASLMS 2017 Conference Co-Chair

Radiofrequency Fractional Devices and Their Place in the Current Practice of Aesthetics

Dr. Arisa Ortiz from the University of California, San Diego reported that fractional radiofrequency is a technology that uses microneedling with radiofrequency heat to create thermal wounds in the dermis in a fractional pattern. This stimulates wound healing, dermal remodeling and new collagen, elastin, and hyaluronic acid formation. As with other fractional technologies, intervening areas are unaffected to serve as a reservoir of cells that promote and accelerate wound healing. Fractional radiofrequency lies somewhere between nonablative and ablative fractional resurfacing in both downtime and results achieved.

The majority of the devices on the market have a disposable tip with parallel rows of microneedles arranged in a bipolar array. Some devices are available with a monopolar setting. The depth of treatment is determined by the length of the needle and the density is determined by the number of needles in the tip. Typically, optimal results are achieved by treating at varying depths during one treatment setting. Some devices have coated pins so that the heat is only delivered in the dermis and the epidermis is preserved. This is recommended in darker skin types to prevent dyspigmentation. Fractional radiofrequency is indicated for skin tightening, rhytides, scars and photoaging and is commonly used to safely treat the neck skin. In general, these devices are safe for all skin types.

Patients with mild to moderate laxity do best. Patients with pacemakers and/or cochlear implants are contraindicated. When counseling patients, it is important to emphasize that these treatments are not equivalent to surgical lifting procedures and results may take 3 to 6 months to see the full benefit. Antibiotic and antiviral prophylaxis is recommended. Depending on the treatment settings, topical, local and/or nerve blocks are required for patient comfort. Downtime varies from 2 to 10 days depending on the setting and tends to be less than fractional ablative procedures.

In summary, fractional radiofrequency devices approach results seen with fractional ablative laser but are better tolerated due to less downtime. They seem to be more consistent than other tissue tightening technologies but comparison studies are warranted.

 

The American Society for Laser Medicine and Surgery is the world’s largest scientific organization dedicated to promoting research, education and high standards of clinical care in the field of medical laser applications. It provides a forum for the exchange of scientific information and participation in communicating the latest developments in laser medicine and surgery to clinicians, research investigators, government and regulatory agencies, and the public.

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