Making an informed decision about breast implants

FDA Consumer, Sept-Oct, 2004 by Carol Rados

Despite more than a decade of controversy over their safety, breast implants are more popular than ever among women who want to build upon what nature gave them or who want to restore what disease has taken away. Whatever the reason, opting for breast implants is a personal decision that should be made only after a woman fully understands and accepts the potential risks of the devices and the importance of follow-up evaluations with her physician.

Some people see an enormous benefit to getting implants and are willing to accept associated risks. They say that using breast implants to rebuild the breast (reconstruction), or change its size and shape (augmentation), significantly improves the quality of life for many women. Advocates of breast implants also say that a woman's con sent to the surgery should be considered valid as long as she weighs the risks and benefits of the procedure.

While every surgical procedure has potential risks, such as infection, bleeding, and scarring, there are risks that are specific to breast implants. Learning about them is key to being properly informed about the procedure.

A Primer on Breast Implants

According to the American Society of Plastic Surgeons (ASPS), there were nearly 255,000 breast enhancement implant surgeries in 2003, nearly twice the number done in 1998. Another 68,000 women received breast implants for reconstruction following mastectomy due to cancer or other disease.

But also in 2003, 45,000 augmentation patients and 17,000 reconstruction patients had their breast implants removed. The medical community and others, including the Food and Drug Administration, would like to better understand why.

Breast implants are designed for augmentation, a cosmetic procedure; reconstruction; and replacement of existing implants, called revision. There are two primary types: saline-filled and silicone gel-filled. Depending on the type of implant, the shell is either pre-filled with a fixed volume of solution or filled through a valve during the surgery to the desired size. Some allow for adjustments of the filler volume after surgery. Breast implants vary in shape, size, and shell texture.

At this time, there are two manufacturers with approved saline-filled breast implants. No manufacturer has yet received FDA approval to market a silicone gel-filled breast implant.

The Silicone Controversy

Breast implants were first marketed in the early 1960s, before the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act required a reasonable assurance of safety and effectiveness to be shown for certain medical devices. The 1976 law gave the FDA authority over such devices, but breast implants were "grandfathered" into the regulatory scheme, meaning that manufacturers were not required to provide the agency with scientific evidence of product safety unless questions arose about the safety and effectiveness of these already-marketed devices. Silicone was initially assumed by manufacturers to be biologically inactive and, therefore, to have no harmful effects.

But over the years, questions did arise about the effects of silicone on the body. In 1991, the FDA published a regulation that required manufacturers of silicone gel-filled breast implants to submit premarket approval applications (PMAs). This requirement meant that the FDA needed to agree that the manufacturer has presented data showing a reasonable assurance of safety and effectiveness ill order for the devices to remain on the market.

In January 1992, the FDA called for a voluntary moratorium a delay on the use of these implants--until new safety information could be thoroughly reviewed. The moratorium was not intended to "ban" the implants, but instead to allow time to review the new safety information.

In April 1992, the agency decided that no PMA yet submitted contained sufficient safety and effectiveness data to support approval. However, access to these silicone gel-filled breast implants would continue for women enrolled in certain clinical studies.

In the years that followed that decision, thousands of women filed lawsuits against the manufacturers of silicone gel-filled implants, claiming the devices had caused serious ailments, such as connective tissue diseases, neurological diseases, and cancer. Consumer groups repeatedly filed petitions urging more studies on the implants. But many women said they were pleased with their implants, including cancer patients who had pleaded for the opportunity to choose silicone gel-filled implants for reconstruction.

A Turn of Events

In October 2003, the FDA held a two-day advisory panel meeting to discuss a manufacturer's PMA for a silicone gel-filled breast implant. Some people complained that the meeting was premature in light of the fact that long-term studies had not been completed, but the FDA proceeded because the agency was required by law to consider the pending PMA within a specified time frame. The meeting also provided patients and others with timely access to information and expert analyses on the issue. The issues before the panel reflected much of the decades-long debate over the implants. Moreover, the meeting provided a valuable public forum for discussing the issue from many diverse perspectives and for raising important additional questions.