WASHINGTON — The Food and Drug Administration, under fire from women who say they were harmed by breast implants, proposed on Wednesday that manufacturers detail possible complications from the devices, including rare cancers, a range of other symptoms and the need for additional surgeries.
The agency recommended that manufacturers use a boxed warning — the FDA's strictest caution — to clearly spell out the risks of implants, including that they are not lifetime devices and that the chances of complications increase over time. The warning also would list the devices' association with a rare form of lymphoma and say some patients have reported fatigue, muscle aches and joint pain.
The agency also proposed that patients be given a checklist to guide conversations with their surgeons about the risks and benefits of implants before women put down deposits for their surgeries. The move is a response to complaints from patients who said they weren't adequately told about potential problems before surgery.
"We have heard from many women that they are not fully informed of the risks when considering breast implants," FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the agency's Center for Devices and Radiological Health said in a statement. The new recommendations are "designed to help inform conversations between patients and health care professionals when breast implants are being considered," they added.
The FDA's steps are the latest effort to deal with reports of complications involving devices that have been at the center of sometimes angry debate and legal actions for decades. The devices are used in about 400,000 surgeries in the United States every year, with 75% of the women involved getting implants for cosmetic reasons. Most of the rest get them as part of reconstruction after surgery for breast cancer.
Over the last few years, patients who say they were harmed by the devices have become increasingly active on social media sites that have enabled tens of thousands of patients to exchange information. The emergence of a rare cancer linked to implants in recent years also has increased attention to potential health problems associated with implants.
The FDA has said that 573 cases worldwide have linked the implants to a rare cancer since the agency began tracking the issue in 2011. The vast majority of those cases involved Allergan textured implants, which have been recalled. Thirty-three women have died of what's known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system, the agency said. At the same time, thousands of women have complained of fatigue, brain fog and other problems that collectively are called "breast implant illness."
Nicole Daruda, an activist from Vancouver, Canada, who runs one of the most popular websites for women who have had trouble with implants, welcomed the FDA's announcement, but said it was long overdue. "This is what needs to happen," said Daruda, who had her implants removed after experiencing several health problems. "But I don't think it would have without our putting intense pressure" on the agency.
Diana Zuckerman, president of the nonprofit National Center for Health Research who has been working on implant issues for 30 years, said the FDA's moves are "very important." But she expressed concern they might yet be weakened, and are not legally binding because they are in the form of "guidance" to the industry. Whether the implant makers actually follow the recommendations "depends on how much pressure the FDA puts on the manufacturers," she said.
The FDA's steps are the latest in the agency's stepped-up scrutiny of the devices, which included a dramatic two-day hearing in March during which many women demanded the FDA take steps to ensure patients have more information about the devices. About the same time, Zuckerman and Dr. Scot Glasberg, a past president of the American Society of Plastic Surgeons, formed a working group that included activists to make recommendations to the FDA, including for a boxed warning and a patient checklist of possible problems.
What the FDA is proposing "is very close to what we gave them," Glasberg said, adding that other groups also made suggestions to the agency.
More than 70,000 women also signed a petition asking the FDA to require a checklist. The FDA, in issuing its recommendations on Wednesday, asked for public comment for 60 days before finalizing the guidance.
Breast implants became available in the United States in the 1960s. Three decades later, after years of reports about ruptured devices and possible links to autoimmune diseases, the FDA called for a moratorium on their use, saying manufacturers had not proved the devices' safety and effectiveness. The devices were only available for cancer patients who were undergoing reconstruction, and even then, only as part of a clinical trial. In 2006, the agency lifted the ban, approving two new silicone implants.
In 2011, the FDA issued a safety communication saying that women with breast implants might have a small increased risk of developing the rare lymphoma. In July, implant maker Allergan announced a worldwide recall of its Biocell textured breast implants after the FDA found a sharp increase in a rare cancer and deaths linked to the products and asked the company to pull them from the U.S. market.
The FDA, in its proposed guidance on Wednesday, also called for new screening guidelines for possible ruptures, as well as a recommendation that manufacturers include product ingredient information in the device's labeling that is easy for patients to understand.