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Proliferation of published articles on fillers mandates evidence-based review

Article-Proliferation of published articles on fillers mandates evidence-based review

Key iconKey Points

  • Training, technique paramount in polymethylmethacrylate microspheres due to its permanent nature
  • Two controlled level 2 studies in Europe showed superiority of calcium hydroxylapatite to various hyaluronic acid products for correction of nasolabial folds

Accompanying expansion in the armamentarium of injectable fillers is an increase in the number of published articles on these products. However, surgeons looking to the literature for information on the use of injectable fillers would do well to review the available articles with an evidence-based perspective, taking into account the type and quality of the report, according to Z. Paul Lorenc, M.D., and Miles H. Graivier, M.D.

Dr. Graivier
"When aiming to apply published information to clinical practice, it is important to weigh the level of evidence. Results from level 1 studies of injectable fillers, represented by prospective, randomized, double-blind controlled trials, have been reported, but the majority of published papers on filler agents consist of expert opinions and case studies," says Dr. Lorenc, a board-certified plastic surgeon in private practice in Manhattan and attending surgeon, Lenox Hill Hospital, New York.

Dr. Lorenc
"Fillers are particularly amenable to level 1 and level 2 studies, in part because there are well-established controls available and risk is relatively low," says Dr. Graivier, a board-certified plastic surgeon in Atlanta. "Hopefully, we will see the number of higher-level evidence studies of fillers increase so that we can improve our knowledge about their best use." Drs. Lorenc and Graivier participated in a panel discussion providing an evidence-based update on fillers at Plastic Surgery 2010, the annual meeting of the American Society of Plastic Surgeons.

TALKING PMMA, PLLA Focusing on polymethylmethacrylate microspheres suspended in bovine collagen (PMMA; Artefill, Suneva) and poly-L-lactic acid (PLLA; Sculptra Aesthetic, Sanofi-Aventis), Dr. Lorenc says both are safe products when used correctly.

"Training and technique are important when using any injectable filler, but are especially paramount with the use of PMMA because of its permanent nature," Dr. Lorenc says. He notes that PMMA product formulation has evolved since it was first introduced as Arteplast in 1989; Artefill, a third-generation iteration approved by the Food and Drug Administration (FDA) in 2006, differs significantly from the original with respect to microsphere uniformity, size and surface characteristics.

"There remains some misconception about the characteristics and safety of the present PMMA-based filler. As a bottom line for surgeons and patients, the product modifications have resulted in a significant reduction in the granuloma rate, which has decreased from 2.5 percent with the original formulation to just 0.01 percent with Artefill," Dr. Lorenc says.

A recent article reporting results from prospective follow-up of 1,008 patients provides higher-level evidence on the safety of the current version of the PMMA-based filler (Narins RS, et al. Dermatol Surg. 2010;36 Suppl 1:S766-S774). The report, which describes 18-month interim results from a five-year FDA post-approval study, showed a 6 percent incidence of device-related adverse events, with just a single granuloma that resolved with medical treatment. In addition, patient satisfaction remained high, at about 80 percent throughout follow-up.

For PLLA, the recent published literature includes only a single level 2 study (Lee JY, et al. Ann Plast Surg. 2010;64(4):435-441) that reported favorable 12-month outcomes from a prospectively followed cohort of 40 patients treated for non-HIV-related facial lipoatrophy using a cross-fanning technique. Overall, however, Dr. Lorenc says the literature indicates the importance of reconstitution volume and injection depth in determining the safety of PLLA, with both higher dilution and deeper injection (subcutaneous or supraperiosteal versus intradermal) technique being beneficial for reducing the risk of nodule development.

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