January 2004 Press Release
CONTACT: Nikki Hudak, 202-223-4000, info@center4policy.org
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WHAT’S NEXT FOR BREAST IMPLANTS?
FDA SAYS SILICONE BREAST IMPLANTS NOT PROVEN SAFE
FDA explains decision is based on the evolving science:
“It’s important that the people who use these products know how they will perform.”
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WASHINGTON, DC: The U.S. Food and Drug Administration (FDA) announced last week that silicone gel breast implants are not proven safe (Click here for coverage of announcement), and released a 46-page guidance document (Click here for guidance document) for breast implant makers, asking them to “provide a reasonable assurance of safety, and to allow women and physicians to make informed decisions about silicone implants.”
Dr. David Feigal, director of the FDA’s Center for Devices and Radiological Health explained that their new data requirements are “based on the science, and the science is not perfect. It evolves. … It’s important that the people who use these products know how they will perform. Women who have complications from these types of products should understand what they can expect.” (Click here for quotes/coverage of FDA press conference)
This is “strike two” for the only companies that are still selling breast implants in the United States, Inamed Corporation and Mentor Corporation. Both companies were rejected by the FDA in 1992 when they applied for FDA approval of silicone gel implants and the new FDA guidance was issued in response to the companies’ latest request for FDA approval. The FDA’s new data requests are likely to delay approval for at least several years.
Although research conducted by the implant companies and by Dow Corning (which makes silicone and made breast implants prior to its $3.2 billion settlement) have concluded that silicone breast implants are safe, research by scientists at the National Cancer Institute (NCI) and the FDA have found reasons for concern in their studies of women with implants. NCI found statistically significant increases in several fatal diseases among women with silicone implants for at least seven years. FDA found significant increases in fibromyalgia and other autoimmune diseases among women with leaking silicone gel breast implants compared with women with implants that are not leaking. These studies are part of the “evolving science” that raised questions about the long-term safety of silicone breast implants.
The exact risks of silicone gel implants are unknown, but FDA approval requires companies to prove their products are safe; proof of danger is not required to reject an application for approval. Although the FDA will approve a medical product that has dangerous side effects, the benefits must outweigh the risks. That can’t be determined unless the FDA has clear information about how often the risks occur. As Dr. Feigal stated during a press conference announcing the new guidance, the FDA needs more information about breakage and the health risks of leaking “so that consumers can make an informed choice and so the surgeons know what to do for that subset of patients that have problems.” (Associated Press, 1/9).
FDA is now notifying any breast implant company that wants approval that they want the following information:
Tests that can predict what will happen to the implant when it is in the human body for many years, such as how long breast implants will last before they break or leak.
Analysis of implants that have been removed after causing problems, to better understand why problems occur and the health implications for women with implants.
“The FDA decided not to approve silicone gel breast implants because too many questions were left unanswered. The company had only studied women with implants for 2 or 3 years, even though they had been selling virtually identical implants for at least 12 years. FDA’s decision creates an incentive for companies to develop safer implants, and we hope that they will respond by developing breast implants that are truly safe for long-term use,” said Dr. Diana Zuckerman, president of the National Center for Policy Research (CPR) for Women & Families, a think tank that has criticized the lack of research on long-term safety of medical implants.
Inamed’s own research, submitted with its application, included a “Core” study of only 221 breast cancer reconstruction patients, 494 augmentation patients, and 225 revision (replacement) patients. Within the first three years, 46% of breast cancer patients required at least one more operation to fix implant problems, 25% had removal or replacement, 6% had a broken implant, 6% had breast pain, and 6% were diagnosed with necrosis, a painful and disfiguring condition where the skin or tissue dies. Augmentation patients also had serious problems within 3 years; for example, 21% needed additional surgery.
The FDA’s rejection of silicone gel breast implants comes after the chairman of the FDA advisory panel, Dr. Thomas Whalen of the Robert Wood Johnson Medical School, said the panel’s 9-to-6 recommendation to approve the implants was “misguided.” He told the FDA Commissioner that “to approve this device poses threats to women that are clearly unknown.” (Click here for Dr. Whalen’s letter)
Mentor Corporation submitted its application for approval of silicone gel implants in December 2003, but the FDA’s new implant guidelines mean that Mentor will also need to conduct additional research before its product can be considered safe.
The FDA’s decision does not change the status of saline breast implants, which were approved by the FDA in 2000. Saline implants are made of silicone but filled with salt water, which is expected to create few risks when the implant leaks or breaks. The FDA decision also does not change the status of silicone gel breast implants. The silicone gel devices are still available in the U.S., but restricted to clinical trials for unlimited numbers of women recovering from breast cancer surgery and women who need to have their silicone gel implants replaced. They are available but more restricted for women who are seeking breast augmentation for the first time. The FDA estimates that 40,000-50,000 women have received silicone gel breast implants in the U.S. since the FDA restricted their availability in 1992.
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