The General and Plastic Surgery Devices (GPS) Panel met on March 25, 2004 at the Hilton Hotel located at 620 Perry Parkway in Gaithersburg, Maryland. The panel met in order to provide advice and recommendations to the Agency for a premarket approval application for Dermik Laboratories Sculptra (poly L-lactic acid) facial filler implant.
The meeting began with introductory remarks by CDR Stephen P. Rhodes (Branch Chief, Plastic and Reconstructive Surgery Devices Branch). He summarized FDA actions related to this committee since the last GPS panel meeting in November 2003. These included an update on Q-Med’s Restylane post approval study, the updated breast implant guidance document and FDA’s not approvable decision on Inamed’s silicone gel breast implant application. CDR Rhodes introductory remarks were followed by statements from a number of members of the public during the open public session.
The sponsor presented a summary of their PMA and FDA presented their review of the data in the PMA application for Dermik Laboratories’ Sculptra injectable filler implant. The presentations highlighted the results obtained from the preclinical studies and 5 clinical studies identified as the Vega Study (France), Chelsea & Westminster Study (England), APEX-001 Study (US), APEX-002 Study (US) and San Francisco Study (US). These studies were non-randomized studies and enrolled 50, 30, 96, 100, and 95 patients, respectively. Effectiveness in all studies was assessed by various means that evaluated improvement in facial appearance by reduction of the appearance of lipoatrophy. Safety in all studies was assessed by a tabulation of adverse events. In each study long-term correction of facial lipoatrophy was achieved with minimal observation of adverse events. Adverse events included bruising related to product injection, hematoma, and the appearance of palpable small papules, however, not visible, in a substantial number of patients.
The panel moved into deliberations and addressed the FDA’s questions. The consensus of panel opinion regarding the Sculpra product, in response to the FDA questions, was that it was safe and effective for the indication of correction of contour deformities resulting from fat loss (lipoatrophy) in people with human immunodeficiency virus. In regards to other FDA questions, the panel consensus of opinion was that a post market study and physician training would be advised. An additional three speakers addressed the panel following panel discussion.
The PMA was recommended for “approval with conditions” by a 9 to 0 vote. Among the conditions of approval were a physician training program to include warnings regarding off-label use, a post-market study that would enroll additional patients to include women and people of color, the publication of precise final product specifications, and labeling modifications to include clear warnings against off-label use and a description of the device as reconstructive rather than cosmetic. A consistent theme of the panel’s recommendations to the FDA was that off-label use of this medical device should be clearly discouraged since there are no data available regarding use in the general population. The only data presented in this application was for HIV positive individuals suffering from lipoatrophy.
Contact: David Krause, Ph.D., Executive Secretary, 301-594-3090, x141
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.