Unique to Women
History of the FDA and Breast Implants
Breast implants were first sold in the U.S. in the 1960s, at a time when there was no government regulation of medical devices, including implants. When a law was passed giving the FDA that authority in 1976, the agency was overwhelmed with an enormous backlog of devices that needed to be evaluated. Most devices were allowed to remain on the market until those reviews were completed, and breast implants were generally considered a much lower priority than potentially life-saving devices such as heart valves and shunts.
Scientists and physicians started expressing strong concerns about the safety of silicone breast implants in the late 1970’s, and their concerns were discussed at a 1978 FDA advisory committee meeting. By the early 1980’s, most of the risks that eventually led to the removal of silicone gel implants from the market were known or suspected, and included in a proposed rule in the Federal Register.1
Finally, in 1988 the FDA finalized the proposed rule. At an FDA advisory committee meeting, the warnings of earlier years had become more urgent, and a lawyer, a former Dow engineer, and other experts testified that they had seen protected court documents indicating that manufacturers were hiding safety information from FDA and the public. Several women described their own terrible experiences with implants.
The November 1988 FDA advisory panel on breast implants expressed considerable concern about their safety. They recommended that the FDA establish a national registry of women who have breast implants. This was opposed within FDA as too expensive and unlikely to be useful, and as setting a precedent that might cause problems for the agency. Moreover, the FDA was concerned about the viability of a registry because the American Society of Plastic and Reconstructive Surgeons did not support it.
The panel also recommended a mandatory program to inform the public of potential risks of breast implants, possibly including informed consent prior to surgery. However, it was decided that the regulations required for a mandatory program would be so strongly opposed by the plastic surgeons and manufacturers, that it was more practical to develop a voluntary program instead. At the January 1989 panel meeting, the FDA announced plans to develop a brochure and videotapes to educate women about the risks of implants prior to surgery.
The brochures and videotape were to be distributed voluntarily in the offices of plastic surgeons. The educational materials were to be developed by consensus by a diverse group of 23 individuals representing consumer organizations, manufacturers, and health professionals; each representative was given the authority to veto any decision. Because of disagreement within this group about what the materials should say, the brochures and videotapes were never completed.
By 1990, almost one million women had breast implants and the numbers were increasing substantially, but the FDA had not yet required the manufacturers to evaluate their safety and no empirical studies had been published regarding their effects on human health.
Silicone Gel-Filled Implants
In 1991, pressured by Congressional hearings in the House of Representatives chaired by Rep. Ted Weiss (D-NY) and media reports of illness and complications, the FDA finally required the manufacturers of silicone gel breast implants to submit safety studies. FDA scientists pointed out that the studies were inadequate -- they included few women, the women had implants for very short periods of time, and many women were lost to follow-up. The law requires that products be proven safe and effective in order to be sold in the United States, but the FDA could not conclude whether the implants were safe or effective because of the shortcomings of the research. (There is no requirement that products be proven unsafe to keep them off the market.)
However, there was enormous pressure to keep breast implants on the market from manufacturers, plastic surgeons, and their Congressional representatives. In 1992, as a compromise, silicone gel breast implants were allowed to remain available as a "public health need,” with the FDA limiting their availability to clinical trials, primarily for women who have mastectomies, breast deformities, or to replace a broken gel implant. Any woman who has had implant surgery with silicone gel implants since 1992 is required to be regularly evaluated by her plastic surgeon as part of the study. Currently, a limited number of women can also receive gel implants for first-time augmentation as part of clinical trials.
In 2003 and in 2005, Inamed and Mentor again submitted research on silicone gel breast implants to the FDA and requested approval. The 2003 applications were rejected in January 2004, but by the end of the 2004 both companies resubmitted their applications. At a public meeting of the FDA advisory panel in April 2005, the panel recommended rejecting Inamed's application and approving Mentor's application. Several months later, the FDA announced its intention to approve both applications, but as of late July 2006, neither company has obtained approval for their implants. Meanwhile, the FDA has launched a criminal investigation of Mentor in response to allegations about the safety of their implants and the integrity of their research. In addition, a study of women with implants, published in May 2006, reported toxic forms of platinum in the breast milk, blood, and urine of women with silicone breast implants. Our Bodies Ourselves, the National Research Center for Women & Families, the National Women's Health Network, and other organizations have urged the FDA to replicate the research to determine the risks to women and their breastfeeding children.
Saline-Filled Breast Implants
In 2000, the FDA reviewed the safety of saline-filled breast implants for the first time. Saline implants have a silicone outer envelope and are filled with salt water. The FDA required studies of local complications, such as pain, infection, hardening, and the need for additional surgery. They did not require studies of diseases or other systemic health problems. Despite extremely high complication rates during the first three years (approximately three out of four reconstruction patients and almost half of first-time augmentation patients), the FDA approved saline implants. As part of the approval process, the FDA made information about the risks of breast implants more available. A consumer handbook and a brochure with photographs of common complications are available here.
Reposted with permission from the Implant Information Project.
1. The FDA's Regulation of Silicone Breast Implants: A Staff Report Prepared by the Human Resources and Intergovernmental Relations Subcommittee of the House Government Operations Committee, December 1992.
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