Testimony at the FDA Advisory Panel Meeting on Dermal Fillers

I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families. Our nonprofit research and education center does not accept contributions from companies that make medical products, and so I have no conflicts of interest.

Our Center is dedicated to improving the health and safety and adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments, and to compare their safety and effectiveness.

In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, and a board member for two nonprofit organizations that work to improve resources for the FDA: the Alliance for a Stronger FDA, and the Reagan Udall Foundation.

I was trained in epidemiology at Yale Medical School; I was on the faculty of Vassar and Yale and a researcher at Harvard, and I have worked on federal health policy issues in Congress, the White House, and for nonprofit organizations for 25 years.

The FDA’s summary regarding dermal fillers is consistent with articles published in medical journals and calls we have received by patients — some people are having serious, unexpected adverse reactions. These include potentially lethal allergic reactions, as well as cosmetic problems such as lumps on the face. The FDA has approved these products on the basis of small, short-term studies, so it is not surprising that these adverse reactions were not obvious prior to approval.

In addition, these products were approved primarily on the basis of studies of white patients, even though there was reason to believe that patients with darker skin might have more adverse reactions. Post-marketing studies of people with darker skin were required but unfortunately are not well-designed. However, they seem to indicate more cosmetic problems such as pigmentation changes and lumps, even during the first 6 months. But the bottom line is that people of color should have been studied before these products were approved, not afterwards. And, if the studies are not adequately done, these products should be removed from the market, or at least have large clear warnings that the products may not be safe for people of color.

It is the FDA’s job, and your job as an FDA Advisory Panel, to determine whether these products are proven safe and effective. Since these products have benefits that are cosmetic — not medical — any serious side effects need to be taken seriously. Even side effects that are cosmetic need to be taken seriously. Patients don’t want to risk their lives to reduce their wrinkles, but they also don’t want to risk large lumps on their face as a result of using a wrinkle filler.

Unfortunately, the FDA has been rushing these products to market as if they were life-saving medical products. The FDA standards have been lower than for life-saving products, when they should be higher. The FDA should be requiring better studies, since these products have only relatively minor cosmetic benefits but potentially lethal or life-changing risks.

Our Center has been contacted by patients who were seriously harmed by some of these products, especially Artefill. Some of those men and women are not willing to leave their homes to be seen in public, and some are suicidal. We’ve also heard from doctors who have seen patients with large granulomas on their faces caused by these injections and frankly don’t know how to undo the damage. I hope that there are doctors on this panel who have the expertise to discuss these side effects.

The biggest weakness of the approval process used for these products is that FDA has relied on studies of patients who were treated only once or twice, and were studied for a year or less. In real life, most of these wrinkle treatments are used every 6 months and continue for many years. As FDA’s MAUDE data base indicates, allergies and other problems can arise after 2 or 3 treatments, not necessarily after the first treatment. And for permanent fillers, lumps the size of a cherry — or even larger — have been reported on patients’ faces years later.

These products have benefits, and if you believe that these products have benefits that are great enough to outweigh some risks, then it is still important to determine whether some products have a better safety profile than others. Americans want the FDA to approve products that are safe and effective. It is not helpful to patients to have a wide range of dermal fillers to choose from if they don’t know which ones are safer and which ones are more dangerous. The FDA should not be approving dermal fillers on the basis of small, short-term studies if that means more patients will be harmed in the long-term.

My final concern is that these products are being approved on the basis of inadequate research, with the understanding that post-market studies and surveillance will provide information about whether they are safe. However, the FDA Commissioner and other FDA officials have made it clear that the post-market surveillance system is broken, because FDA lacks the staff and computer resources that system needs. It will be years before the post-market surveillance system works, and until then, FDA should not be approving products that are not proven safe.