Eleven years after silicone-gel breast implants were tightly restricted by the federal government, the Food and Drug Administration is considering whether to allow them back on the market.
Since 1992, when the FDA banned the use of silicone implants except for breast reconstruction in cancer patients, two Columbia residents have been at the center of the debate over the safety of the devices.
One, a woman who blames silicone implants for her chronic illness, says that, for now, they should remain banned. The other, a prominent plastic surgeon, has long argued that the safety fears are unjustified.
Kathy Keithley-Johnston began speaking out against silicone after her implants ruptured, causing a disorder known as silicone adjuvant disease, or SAD. As a lobbyist for Toxic Discovery, a local group that researches medical device failure, Keithley-Johnston has called for patients who undergo breast replacement or augmentation surgery to be given more information about the risks and benefits of implants.
“We know more about what’s in a bottle of aspirin than we do about what is in a silicone implant,” said Keithley-Johnston. She is also a plaintiff in a global class-action lawsuit against silicone manufacturers, including Dow Corning, which is being sued by more than 10,000 Missouri women alone.
But one reason why the FDA is now reconsidering its position on silicone is the advocacy of Linn Puckett, chief of plastic and reconstructive surgery at University Hospital. A former president of the American Society of Plastic Surgeons, Puckett said silicone implants are more aesthetically pleasing, and have been shown to improve the quality of life of patients.
The majority of scientists and physicians now agree that silicone implants do not cause systemic diseases, those that affect the whole body, Puckett said.
“There has been an enormous amount of both scientific and epidemiologic study on the safety of breast implants and the abiding theme has been that they do not cause epidemiologic diseases in patients,” said Puckett, who met with the FDA on numerous occasions during the 1990s to argue that the ban on silicone should be lifted.
Silicone breast implants first appeared on the market in 1962, before the FDA required proof that medical devices be proven safe and effective. Researchers estimate that 1 million to 2 million women have received the implants. But after receiving complaints that the implants were rupturing or leaking, leaving thousands of women with chronic pains and illnesses, the federal agency banned silicone in 1992.
Last week, after two days of public testimony, 15 independent scientific advisers to the FDA recommended that silicone once again be offered as an implant option. Representatives for Inamed Corp., a California company that has asked the FDA for permission to sell its version of the implants, presented data that it says proves silicone implants have fewer complications than saline implants.
Yet, the arguments against silicone continue. Keithley-Johnston said that, in addition to downplaying the safety concerns, physicians often fail to provide their patients with information about other options. Missouri law mandates that doctors provide women with details about the implants and their manufacturer, along with an FDA booklet on breast implants, Keithley-Johnston said, but there are no consequences for physicians who fail to adequately inform their patients.
“Informed consent begins with informed people,” Keithley-Johnston said.
Puckett acknowledges that physicians prefer silicone implants over those made of saline, which first appeared on the market in the late 1960s. “The problem with all implants, gel or saline, is that they can fail and leak,” Puckett said. “If it’s saline, it is reabsorbed by the body; if a gel implant leaks, it is probable that nothing will happen. There are some people that have a fairly intense inflammatory reaction to the gel, and those patients might have to have additional surgeries.”
Indeed, Inamed’s own research shows that nearly half of breast cancer patients who received silicone implants, and one in five otherwise healthy women, needed additional surgeries to correct for product failure. The FDA is also concerned that Inamed didn’t adequately monitor the health of women who received the company’s implants. Inamed tracked the women for three years, while FDA studies found that breakage and leaking can occur up to 10 years after implantation.
Puckett said he doesn’t question that women who received silicone implants fell ill. But he finds little reason to believe it was the implants that made them sick. However, Keithley-Johnston said, the FDA shouldn’t allow Inamed to market its silicone implants as long as there are doubts about their safety.
“What we are trying to do is make women’s health a No. 1 concern, and we are asking the FDA to be very cautious,” she said.