Oct. 13, 2003 -- Silicone breast implants are back in the spotlight this week as FDA mulls whether or not to put the controversial breast enhancers back on the market.
Implant manufacturer Inamed corporation has filed an application with the FDA to put its silicone gel-filled breast implants back on the market in the U.S. and will present new information on the safety of the devices to an FDA advisory panel on Oct. 14 and 15.
Concerns about potential health risks associated with the use of silicone breast implants prompted the FDA to ban the implants in 1992 until more data became available on the long-term effects of the devices.
"There is so much more information available today than there was in the early 1990s," says JoAnn Khune, Inamed's senior director of regulatory and clinical affairs. "A great body of evidence now shows that there is no link between silicone breast implants and any type of systemic disease."
Inamed's own study on silicone breast implants as well as other research to be presented at the meeting was released on the FDA web site Friday. But women's health advocates say they still aren't convinced that the devices are safe.
"Now that I've seen the data, I can't imagine how they could approve them under these conditions," says Diana Zuckerman, PhD, president of the National Center for Policy Research for Women & Families.
In fact, several public interest groups have joined together to launch a media campaign highlighting both the known and unknown dangers of silicone breast implants in response to Inamed's application. These groups include the National Organization of Women, Public Citizen, and Command Trust Network.
The groups argue that too little is known about the risks associated with silicone breast implants, and short-term studies are not adequate enough to test the safety of long-term devices.
Silicone Implants and the FDA
Silicone gel-filled breast implants were introduced in the U.S. in the early 1960s, before medical devices became subject to FDA regulation in 1976.
By the early 1990s concerns about potential health risks associated with silicone breast implants began to emerge, including leakage and rupture problems, reports of connective tissue disorders, and a possible cancer risk among women with the implants.
These concerns caused the FDA to ban the sale of silicone breast implants in 1992, except for use in clinical trials. The ban also prompted a string of lawsuits against implant manufacturers from women who said they suffered health problems or disfiguration as a result of their silicone breast implants.
In December 2002, Inamed filed a product marketing application with the FDA for a silicone implant based on the results of their own study of 1,000 women with the implants who were followed for at least three years as well as other research published since the ban was enacted.
Inamed's competitor, Mentor, says it plans a similar filing later this year for its silicone breast implant.