RealSelf is Saving Lives
Article by Arnold W. Klein, MD
Beverly Hills Dermatologic Surgeon
The use of fillers has always involved both art and science. The art is both in determining the areas requiring volumetric /structural enhancement and creating reproducible injection techniques for implanting the material, Science is also vital in that the agent must be pure and biocompatible with an acceptable low level of adverse reactions. Initially Sculptra received FDA approval for treatment of HIV associated lipodystrophy. This was a critical indication in that this condition had essentially become the Scarlet Letter of the 90′s and was in need of a method of cosmetic management. It has now been approved for indvididuas without HIV who are seeking cosmetic enhancement. Daily I get phone calls, emails and letters from women and men who have had a disastrous result from Sculptra.
Case Report DP is a 45 y.o. male who has been maintained on HAART for 5 years. His therapeutic regimen did initially include a protease inhibitor. Over 2 years prior to being seen he had noted significant volumetric loss in the cheeks combined with increased abdominal girth. Finally, he noted significant accumulation at superior aspect of his back (dorsocervical fat pads or “buffalo hump”). Though the protease inhibitor was replaced in his therapeutic regimen there was no improvement in” HIV associated lipodystrophy.” 7 months prior to seeing the patient he had undergone a series of three monthly injections of Sculptra to the cheeks, nasolabial folds, and perorbital areas. By the third visit he developed severe swelling in the periorbital area and refused further treatment When the patient was first seen by me he had 3 nodules (>10mm) in inferior periorbital area of his left eye and 2 on his right (fig 1). The original physician had attempted to treat these nodules with intra-lesional steroids with no response. Under local anesthesia these lesions were incised revealing a white gelatinous material. This was excised from the nodules walls and submitted for histopathologic analysis (Microscopic analysis) revealed “a foreign body granuloma.” The patient was seen a week later and had an excellent response. Presently by using a combination of injectable 5FU + Kenalog I have developed an effective non-surgical manner in which to treat these reactions
Discussion The need for an injectable agent to treat HIV- associated lipodystrophy was of critical importance. Nevertheless it was very difficult to equate the supposed increase in skin thickness as presented to the FDA as a mechanism of action for Sculptra. The company claims neocollagenesis as the mechanism of action. To the contrary, it is the “foreign body reaction” that in this case was noted 7 months after implantation in my patient that caused the increase in volume.In the initial studies for HIV lipodystrophy in the USA nodules were visual and or palpable in many individuals in the pivotal trials. As presented in the literature 52 percent in the VEGA study, and 31 percent in the C&W study. The average on-set was up to 218 days, with a range from 9 to 748. This supports mechanism of correction or manner in which Sculptra works is by creating a foreign body reaction. In patients with HIV the ability to augment a” foreign body reaction” is restored once they have been placed on HAART therapy and HAART therapy creates lipodstrophy. The exact immunologic mechanism of a foreign reaction is not firmly understood at this point but again the ability to augment such a response is restored in treated patients with HIV. Furthermore we are dealing now with patients with intact immune systems who are having Sculptra injected. The present cases could have been avoided if proper education had been given to the physicians and nurses about avoiding injectables that can elicit an allergic response.More importantly, since this disastrous injectable has now been approved for use in immunocompetent individuals. I as well as others have seen large nodules above lip, in the cheeks, under the eye and elsewhere in countless patients. Prior to its approval in the USA a European literature did exist. In a series of 100 patients treated, 5 cases of infection, 12 cases of granuloma and 3 cases of long term allergic reactions were noted (Aesth Surgery). I firmly believe these reactions must be reported by affected individuals directly to the FDA. Arnold William Klein