NCHR President Testimony at FDA on Artecoll

My name is Dr. Diana Zuckerman, and I’m President of the National Center for Policy Research for Women and Families, which is a think tank dedicated to using research information to improve the health of women, children, and families. Our Center has great respect for the important work of the FDA, and we look to this Advisory Panel to help the FDA in its mission to protect the health and safety of women and men across the country.

As an aging baby-boomer, I think it would be wonderful if I could look 10 years younger, and do that on a permanent basis easily and safely, but as an epidemiologist, if asked if Artecoll is a safe product, based on the data that you’re going to be hearing today, I would have to respond it depends on what you mean by “safe.”

There’s about a 16 percent chance of an adverse reaction in the first year, and there are no data presented after that. Based on published medical journal articles, which I have brought today, and talking to physicians who have used the product, and talking to many hundreds of women who have had cosmetic procedures, I’m very concerned about the long-term risks.

I have copies of a statement made by the Swiss Society for Dermatology, the Swiss Society for Plastic Reconstructive and Aesthetic Surgery, and the Swiss Society for Aesthetic Medicine. All three medical societies advise against the use of permanent implants, such as Artecoll and silicone, for use in the face. Theirs is a very strong statement, and I brought copies for you. I have also brought copies of just three of many medical journal abstracts describing case studies of women whose Artecoll injections caused granulomas that resulted in unsightly bumps on their face. In one case these bumps appeared suddenly, more than five years after the procedure. I also have a letter from Dr. Michael Weinberg, former President of the Ontario Society of Plastic Surgeons, who describes a survey that he did of the Society’s members regarding Artecoll, and he personally told me yesterday that the better plastic surgeons in Ontario are avoiding Artecoll because their use for lip augmentation resulted in so many unsightly lumps and bumps on their face, and most, he said, had to be surgically removed.

For more than a dozen years, I have received letters from women asking for help in dealing with the sequelae of cosmetic procedures. Many of these women were very happy with the results for the first few years, but after that they had cosmetic problems that ranged from embarrassing to truly hideous. Of course, they were never told that no long-term studies had ever been conducted on the implant or the product that they happened to use. You’ve just heard from one physician; he says a perfectly safe product. When they were told there was a small chance of a bad reaction, they never thought that would happen to them.

Many of these women now can’t afford to have surgery to correct their cosmetic disaster, and some ask us for help: How can they get free medical help? And others ask us to make sure that other women will never have to go through what they went through, and that’s why I am here today — to represent them.

The studies presented today are small studies of just a few hundred women and men followed for one year. If this product is approved, it will be used on tens of thousands of people, at least, and yet we really have no idea what these long-term effects might be in two or three or four or ten years — this is a permanent product in their face.

Cosmetic products are very popular and doctors tell us that people want them, and that they are willing to take risks. But if they are disfigured a few years later, that will be the responsibility of the FDA and this Panel. We can’t expect patients or even physicians to understand the risks of a cosmetic procedure that has the seal of approval of the FDA. Unfortunately, the approval of Artecoll for even one use, as you know, would result in many other uses of the product in the face. The FDA can’t regulate off-label uses, and, of course, it can’t stop the use by physicians who are not as skilled, whose technique is not as good. So what is shown as a 16 percent adverse reaction rate in the study presented today, which we all know is done by the best physicians that the manufacturer could find, that rate is bound to be much higher when used off-label and when used by less-skilled and less-well-trained physicians.

And so in your deliberations today, I ask you to consider if the cosmetic benefits, as described in the research, really outweigh the risks. Would you want someone that you love to use this, based on such small samples and such a short followup? And please remember that there are alternatives available that are not permanent. So even though they have risks, those risks are not permanent. The fact that the Canadian and Swiss doctors who have used this product have already started to avoid Artecoll should be a warning for us. There’s no urgent need to approve this product, and so I strongly recommend that you require longer-term research to get a better sense of what the long-term risks are before making any decision to put this on the market.