December 19, 2012
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 January, 2004, the FDA announced it would not approve silicone gel breast implants, because of the lack of long-term safety data. However, in April 2005, the FDA held a public meeting to once again consider approval of silicone gel breast implants, with almost the same data that they had rejected the year before. In November 2006, the FDA announced that they were approving silicone gel breast implants made by two manufacturers, Allegan and Mentor. However, the approval was on the condition that the implant makers each study 40,000 women with silicone gel implants for 10 years. In addition, the FDA stated that silicone breast implants were not approved for women under the age of 22.
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 online at www.fda.gov/CDRH/breastimplants.
New Developments in 2011
In June 2001, the FDA released the preliminary results of the long-term studies of silicone breast implants that were required as a condition of approval in 2006. This includes continuing the two and three-year studies that were the basis of approval for Mentor and Inamed/Allergan silicone gel implants. It also includes each company’s study of more than 40,000 breast implant patients, that were started after the 2006 approval decision and that will be followed for 10 years.
The results indicated that complications were frequent and increased as the implants aged in the body. The most common complications were capsular contracture (hardening of the area around the implant), reoperation (additional surgeries) and implant removal.
The results also indicated that three out of four women with Mentor implants that were enrolled in the study had dropped out by the third year of the study, thus making the results meaningless. The Allergan study of augmentation patients was slightly better, with just over half of the patients still participating in the study after two years. The Allergan study of reconstruction patients was the only one that could provide useful information, with more than 70% of those patients still enrolled after 2 years. For our summary of this report, click here. You can also read the FDA’s update on silicone breast implants. executive summary and full report.
In January 2011, the FDA announced that women with breast implants seem to be more likely to have ALCL (anaplastic large cell lymphoma), a rare cancer of the immune system. The risk of developing ALCL is very low, but much higher in women with implants than it is in the general population. ALCL is especially rare in the breast area, but for women with implants it has been found in fluid surrounding the implant and in the scar capsule, but not the breast tissue itself. There is not enough evidence to suggest that ALCL is more likely in a particular implant type, or to determine its cause in women with implants. As a result of this concern, the FDA is now requesting that providers report cases of ALCL in women with breast implants, to determine how great the risk is compared to women without implants.
All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.