The C.A.M. Report
Complementary and Alternative Medicine: Fair, Balanced, and to the Point
  • About this web log

    This blog is intended as an objective and dispassionate source of information on the latest CAM research. Since my background is in pharmacy and allopathic medicine, I view all CAM as advancing through the development pipeline to eventually become integrated into mainstream medical practice. Some will succeed while others fail. But all are treated fairly here.

  • About the author

    John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at www.Vicus.com, a complementary and alternative medicine website.

  • Common sense considerations

    The material on this weblog is for informational purposes. It is not medical advice or counsel. Be smart, consult your health professional before using CAM.

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FDA reports on the safety of dermal fillers

They are the ultimate complementary medicine.

First, some background.

  • Injectable dermal fillers have been around for 20 years, most for at least 10 years.
  • They include the following products, which the FDA categorizes as devices.
    • Poly (methyl methacrylate) microspheres (Artefill)
    • Hydroxylapatite (Radiesse)
    • Poly-L-lactic acid (Sculptra)
    • Hyaluronic acid (Restylane and others)
    • Collagen (Cosmoderm and others)

In general they’re used to smooth out wrinkles and folds on the face and hands, as well as some bizarre places. One, Sculptra, is approved for use in people with HIV.

Now, the details.

  • FDA reviewers identified 930 reports of side effects (between 2003 and 2008) associated with the use of dermal fillers.
  • The reports covered 763 women and 41 men.
  • Age ranged from 17 to 86 years, mostly between 50 and 60 years old.

And, the results.

  • 0 deaths
  • 88% injuries
    • Most often: swelling, inflammation, redness, allergy
    • Less often: infection, pain, vascular events (bruising, bleeding, black and blue, cell death [necrosis]), scars, blanching, discoloration, and ischemia
    • Uncommon: lumps/bumps, blister/cycst, numbness, movement of the injected material, bleeding
  • 10% product malfunctions: clogged or dislodged needle, splashing product on the patient or injector.

The bottom line?
Facial rejuvenation using these products is not merely a trivial indulgence. Physical appearance, for example, has been documented to affect a woman’s earnings.

When injected by a qualified dermatologist, plastic surgeon, or ophthalmologist, these products are reasonably safe. But nobody should be fooled into thinking that being stuck 20 or 30 times with a drug-filled needle is free of risk.

According to the FDA, “While many of reported adverse events, such as minor swelling and erythema, are expected,… there are a number of adverse events that are serious and unexpected such as facial, lip, and eye palsy; disfigurement; retina vascular occlusion; as well as rare but life-threatening events such as severe allergic reactions and anaphylactic shock.”

Of the 823 injuries reports, 638 required treatment ranging from topical application of steroid cream to multiple courses of antibiotics, anti-inflammatory or antihistamine drugs, and steroid injections.

Surgery was needed in 94 of 823 reports, including opening an abscess to drain pus, removal of nodules, and biopsy of the lesions.

Choose your therapist carefully.

11/17/08 11:49 JR

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