NCHR Testimony at FDA on Artecoll

My name is Elizabeth Nagelin-Anderson. I’m a Public Policy Fellow with the National Center for Policy Research for Women and Families. Thank you for the opportunity to speak to you today about this very important decision that you are going to make that will affect the lives of thousands, perhaps even millions, of women and their families.

Our Center receives mail from women across the country who contact us when they have health problems and need advice. Of course, we don’t provide medical advice. We try to provide them with information that will help them in a given situation. Every day I hear from women who have cosmetic surgery of various kinds, and most of them are very happy with their implant or other device until two, three, five, ten years later, when they start to have complications. The cosmetic surgery they elected to have in order to look better or feel better about themselves can turn out to be a real nightmare years later when they need to have additional surgery to correct cosmetic problems that resulted from their original treatments or to have their implant removed.

I hear from these women every day. Many can’t afford to have their cosmetic disasters repaired. They’re not asking us for medical help. They’re asking us to find a doctor who will help them for free, and most of the time we are not able to help them.

A one year long study on a permanent product is simply not sufficient to rule out the possibility of long-term risk to the health or well-being of the many men and women who want to look younger and feel more attractive. Unfortunately, African-Americans were apparently not included whatsoever, and there was only one Asian in this study.

This is a cosmetic device intended to enhance attractiveness, but if something goes wrong a few years later, the attractiveness desired could be replaced by something quite ugly, even something permanently disfiguring. While the data suggests short-term success in one area of the face, if approved, Artecoll will surely be used elsewhere, even in areas that this study suggests would not be as successful. Many of the problems of granulomas that have been in medical journals and mass media involve injections in the lips, which are not even studied. Unfortunately, Artecoll is likely to be used for lip augmentation if it is approved for any other use. A 16 percent adverse reaction rate isn’t good for a product that is purely cosmetic and not statistically better on most measures. Some people dropped out because of problems, so there are actually more adverse reactions than were counted in these statistics.

Women are often told by their doctors that cosmetic procedures have very minor risks, but none of us in this room can look a woman in the eye and say this about Artecoll, based on one year of research, and on such a small sample. At least two years of research and at least an 80 percent response rate should be required for products like this. You should not approve a permanent product that is to be injected into the faces of healthy men and women based on such little research.

If FDA approval is to mean anything, it should mean that the benefits outweigh the risks. The benefits are purely cosmetic, and most are not statistically-significant. We don’t know exactly what the risks are yet. The manufacturer may be in a hurry to get their product into the lucrative U.S. market, but your role should be to consider the alternatives. There are already many other products on the market. I think that American women can wait another one or two years for the company to gather at least one year of additional data, look into the cause of granulomas and find out how often they happen over a two-year period.

The fact that Canadian doctors have already started to avoid Artecoll, and that the Swiss Government Health Agency, the Swiss Society for Dermatology, the Swiss Society for Plastic Reconstructive and Aesthetics Surgery, and the Swiss Society of Aesthetic Medicine advise against its use for wrinkles suggests that the FDA should not be in a hurry to approve this product.

If I have an additional minute, I would just like to say that based on the e-mail we receive, particularly from women with breast implants, if women actually receive the informed consent brochure from their surgeons, the chances of them really understanding their risks aren’t great. Thank you.