May 10, 2000 (Washington) -- The FDA announced Wednesday that it will allow two makers of saline breast implants to keep their products on the market. But women need to be given enough information about high complication and failure rates so that they can make informed decisions about whether the implants are right for them.
The FDA made its decision based on research conducted by the two California companies that produce saline implants, McGhan Medical Corp. and Mentor Corp.
Studies looked at about 9,000 female subjects, examining their experiences with short-term complications such as infection, hardening of the tissue surrounding the implant, leakage, or deflation, and complications necessitating removal of the product. Researchers weighed these factors against others, like patient satisfaction and self-esteem.
"With the data that have been presented, women and their physicians will be able to make informed decisions about whether the benefits are worth the risks," said FDA Commissioner Jane E. Henney, MD.
David Feigal, MD, the FDA medical devices chief, added, "It's clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications."
The FDA reports that after three years in the studies, there were about 700 patients still being followed. One-fifth required additional surgery; 16% reported breast pain; 11% reported wrinkling; and about 10% each had hardness, non-symmetric breasts, leakage, or a need to remove the implants.
The government's decision to approve saline implants is a long time coming. Saline implants, like their more controversial silicone cousins, have been on the market for nearly three decades, long before the FDA started to regulate medical devices in 1976. So doctors, patients, and industrialists have waited until now for the government's official OK.
About 130,000 American women received saline-filled breast implants last year, even though the FDA had never declared the implants safe.
The risk is greater for women who get the implants after breast cancer surgery than for women who choose cosmetic breast enlargement, the FDA warns. Some 39% of cancer survivors need additional surgeries within three years of their original breast implant.
And the longer women have implants, the more likely they are to suffer a side effect, the FDA says. Up to 73% of patients in one study suffered at least one side effect.
Women's health advocates condemned the FDA's decision.
"The standard of safety is at a new low at FDA," said Diana Zuckerman, of the National Center for Policy Research for Women and Families. "Here you have the benefit, which is cosmetic, and the risks, which are serious health problems."
In March, WebMD reported that Leroy Young, MD, makes a point of telling his patients that their new implants will most likely have to be replaced within the first decade of receiving them. The professor of surgery at Washington University in St. Louis notes that more surgery means risks with anesthesia, infection, bleeding, clotting, and other complications.
But in their decision, FDA officials said they approved the implants because, despite the complications and the risks of undergoing repeated surgeries, many women in the companies' studies insisted they were happy with the implants.
In March, the FDA's independent scientific advisers recommended that the products stay on the market, despite declaring that they break open and leak at "alarmingly high" rates. The panel heard hours of testimony from dozens of women claiming the implants left them in dire pain and disfigured them -- while a few cancer survivors said the implants were important for their emotional recovery.
For most women wanting breast implants, saline-filled products are the only option, since the FDA banned use of silicone gel-filled versions in 1992. No other implants are sold in the United States.
The controversy over breast implants arose in the early 1990s, when thousands of women claimed the implants gave them serious diseases, from arthritis to cancer. But after repeated scientific studies, the Institute of Medicine last year declared that implants, whether silicone gel- or saline-filled, do not cause major diseases. So the FDA's concerns about saline implants center on breast-related side effects -- pain, infection, deflation, and repeat surgeries.