Although the devices have been linked to a possible increased risk of a rare form of lymphoma, a definitive association remains unclear, and any possible risk appears to be extremely small, the FDA said.
The safety of breast implants has long been controversial. The FDA banned them for most U.S. women in 1992 amid concerns that they could be linked to health problems such as cancer and rheumatoid arthritis. But after subsequent studies appeared to exonerate the implants, the FDA allowed sales to resume in 2006, despite protests from consumer advocates.
Between 5 million and 10 million women worldwide have received implants, either in reconstructive surgery after breast cancer or for breast augmentation. Nearly 400,000 women received the devices in the United States last year.
In January, the FDA said that implants might increase the risk of developing a rare form of lymphoma known as anaplastic large cell lymphoma, a cancer of the immune system.
On Wednesday, the agency announced the results of a review of data on the devices, including a preliminary analysis of information from studies the FDA had required from Allergan and Johnson & Johnson’s Mentor Corp. to conduct as a condition of the agency approving their devices.
“Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have reasonable assurance of safety and effectiveness when used as labeled,” the agency said.
The FDA said that women considering getting implants should know that one in five recipients has them removed within 10 years.
“Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications,” the FDA said.
Among the the most common are capsular contracture, a painful hardening of the area around the implant, the FDA said. The devices can also rupture, wrinkle, shift out of position and cause scarring, pain and infections, the FDA said.
Larger, longer studies are needed to make sure that implants do not cause more serious long-term complications, the FDA said.
Diana Zuckerman of the National Research Center for Women and Families, a Washington-based consumer group, noted that many of the women in the studies ended up dropping out, raising questions about the usefulness of the findings.
“The studies don’t provide most of the safety information that they were required to provide,” Zuckerman said.
The FDA acknowledged problems with the studies and said it will convene a panel of outside experts in the next few months to discuss how studies can be more effective.
In the meantime, the agency said that women who have implants should undergo regular MRIs and immediately report any problems to their doctors.