Polymethylmethacrylate Injections - Skin Care, Wrinkles
November 11, 2011 firstname.lastname@example.org
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Polymethylmethacrylate beads (PMMA microspheres): PMMA is a non-biodegradable, biocompatible, man-made
polymer. This material is used in other medical devices, such as bone cement and intraocular lenses. PMMA beads
are tiny, round, smooth particles that are not absorbed by the body. For wrinkle filling, PMMA beads are suspended in
a gel-like solution that contains cow (bovine) collagen and injected into the wrinkle.
Product Name: ArteFill®
PMA Applicant: Artes Medical, Inc.
Address: 4660 La Jolla Village Drive, Suite 825 San Diego, CA 92122
Approval Date: October 27, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020012a.pdf1
ArteFill® is a filler that is injected into the nasolabial folds around the mouth to smooth these wrinkles. The device
contains small polymethylmethacrylate beads, collagen and lidocaine. ArteFill® works by adding volume to nasolabial
folds and restoring a smoother appearance. ArteFill® is injected by a doctor into the facial tissue around the mouth
(i.e., nasolabial folds). The device adds volume to the skin and can give the appearance of a smoother surface.
ArteFill® will help smooth nasolabial folds around the mouth. In a clinical study most patients needed more than one
injection to achieve optimal wrinkle smoothing. The average number of treatment sessions was 2.28.
Side effects of ArteFill® include: Lumpiness at injection area more than one month after injection, Persistent swelling or
redness, Increased sensitivity and Rash, itching more than 48 hours after injection
ArteFill® should not be used in patients who have: A positive response to the ArteFill Skin Test, Severe allergies with a
history of anaphylaxis or presence of multiple severe allergies, Allergies to bovine collagen or lidocaine and
Susceptibility to form keloid or hypertrophic scars2
ArteFill® should not be used for: implantation into blood vessels, because it may obstruct blood flow and lip
augmentation or injection into the vermilion or the wet mucosa of the lip
MAUDE Adverse Event Report
Event Type Other
Report Date 06/13/2007
Report Number MW5004961
I served on the fda panel that in oct of 2003 voted to approve the use of artefill with limitations. Artefill is a filler that is
injected into the nasolabial folds around the mouth for cosmetic purposes to smooth wrinkles. The device contains
small polymethylmethacrylate beads, collagen and lidocaine. I write to you as a doctor and member of the medical
community, with concern that artefill poses a danger to the public and our patients if used anywhere other than the
nasolabial folds. Respectfully, i request the fda conduct a prompt public hearing to re-examine the safety of artefill and
that you order a post-market study with tracking. I look forward to your prompt response.
SOURCE FDA Website November 2011