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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study P521-01

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Study Status Completed
Application Number P020012 / PAS001
Date Current Protocol Accepted 10/27/2006
Study Name Study P521-01
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a multi-center, non-randomized, non-controlled post-approval study.
Study Population Description Subjects who agree to participate and are consecutively treated with Artefill in nasolabial folds (NLF). All subjects must have a negative Artefill skin

test prior to treatment.

Sample Size The sample size is 1,000 subjects who agree to participate and are consecutively treated with ArteFill in nasolabial folds. There are to be 25 investigational sites.
Data Collection Endpoints include the incidence of granuloma, incidence of serious unanticipated adverse events (including their severity and relation to the implant product), incidence of anticipated adverse events at each follow-up, and subject's assessment of satisfaction characterized by using a five point non-parametric scale at each follow-up.
Follow-up Visits and Length of Follow-up 5 years

Patients will be evaluated at baseline before treatment is administered. Follow-up starts at the completion of treatments. The first follow-up visit is at a 3 months after the last treatment, and then using a mail patient questionnaire the sponsor will assess adverse events and subject's satisfaction with treatment at the following intervals from the last treatment:

6, 12, and 18 months, and then 2, 3, 4 and 5 years. at the end of 5 years of follow-up, a final office visit is conducted. During the follow-up period, if a subject indicates the presence of a potential adverse event of a

questionnaire, the sponsor or its representative will contact the investigator caring for that subject. For serious adverse events related to the treatment, the investigator will contact the subject to schedule an appointment to have the event evaluated clinically at the site in a timely manner.

Interim or Final Data Summary
Interim Safety Information The 36-month report indicates that as of October 1, 2009, 264 treatment emergent adverse events were reported in 187 subjects. Of these an assessment of device relatedness produced the following results: 82 were deemed device-related, 153 not device related, 15 indeterminate and 14 pending categorization by the investigator (subject pending evaluation after receipt of the subject follow up questionnaire (SFQ), which noted the possibility of an adverse event). No Unanticipated Adverse Device Effects (UADE) have been reported on subjects enrolled in the study.

Four (4) subjects were biopsied, two (2) were viewed as unremarkable at biopsy, one (1) with respect to histology had no evidence of granuloma and one (1) had histologic changes consistent with granuloma. This case is the first documented granuloma reported to date in this study. The subject (B-Y, #13) with a documented granuloma was medically treated and completely responded to a single treatment of itra-lesional triamcinolone and with 5 follow-ups in conjunction with oral antibiotics for approximately two (2) weeks, with no sequelae (an aftereffect of disease, injury, procedure or treatment). Eleven (11) additional serious adverse events (SAE) have been reported since October 2008, making the total number of SAE reported in the study 15. This includes the four (4) SAEs reported previously in the October 24, 2008 Post Approval Study Status Report. It is important to note that one (1) of the four (4) reported was skin tested and not injected with Artefill due to subject's death (not related to Artefill). These new events were evaluated by the investigator, all of the fifteen (15) SAEs have been deemed not to be device-related.
Actual Number of Patients Enrolled 1,008
Actual Number of Sites Enrolled 23
Patient Follow-up Rate 87% at 5 years
Final Safety Findings Granulomas were encountered in 17 of 1,008 subjects (1.69%). A total of 887 adverse events (AEs) were

noted among 416 (41.3%) treated subjects. There were 177 AEs among 118 (11.7%) treated subjects that were considered device쳌]related. In general, the majority of these events were typical of dermal fillers, mild in severity and resolved during the study period. A total of 101 serious adverse events (SAEs) were noted among 75 (7.4%) treated subjects. In addition to the 7 deaths, there were 94 other SAEs.

The 94 other serious adverse events included one event of difficulty breathing, shortness of breath, or

tightness in the chest, four events of severe illness or trauma, 43 other local complications, and 46 other systemic complications. None of these SAEs were determined to be device쳌]related.

Final Effect Findings Subject satisfaction remained high throughout the study. The majority (>83%) of subjects were very satisfied or satisfied (scored 1 or 2 on the 5쳌]point scale) with their treatment outcome at the 5쳌]year follow쳌]up.
Study Strengths & Weaknesses This is a prospective, multicenter study that provides long term data up to 5 years on the safety and effectiveness of the device. The follow쳌]up rate at 5 years was relatively high (87%). The weakness of the study was the lack of a comparison group.
Recommendations for Labeling Changes The labeling will be updated based on the 5쳌]year safety and effectiveness results reported in the PAS

final report.

Study P521-01 Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 10/27/2007 11/09/2007 Overdue/Received
2 year report 10/26/2008 10/27/2008 Overdue/Received
3 year report 10/26/2009 10/28/2009 Overdue/Received
4 year report 10/26/2010 10/26/2010 On Time
5 year report 10/26/2011 10/28/2011 Overdue/Received
6 year report 10/25/2012 10/25/2012 On Time
7 year report 10/25/2013 10/28/2013 Overdue/Received
final report 05/14/2014 05/20/2014 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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