Three types of breast implants – silicone gel, saline and metal and ceramic – are risky products, the US Food and Drug Administration told patients Friday.
Doctors and patients should inform themselves about possible complications with these types of breast implants, and any doctor who implants them should notify the patient about the risks involved, the FDA said.
In the statement, the FDA also issued a warning that surgery to remove a breast implant may be dangerous. It said complications include infection, severe burns and nerve damage.
At any time, a patient should have a breast implant removed unless she understands the reasons why, the FDA said.
“Infections from breast implants can be serious, even life-threatening, and surgeries to remove them can have serious consequences,” Dr. Georges Benjamin, executive director of the American Public Health Association, said in a statement.
“Every year, more than 20,000 women are given breast implants and more than 6,000 are harmed by them,” he said. “Informing women that they should take health action when risks are present – and not just listen to their doctors – is an important step to protect themselves and the women who put their health on the line by having breast implants.”
These disclosures are voluntary, and the agency will assess the effectiveness of its efforts in determining the level of risk to consumers. However, these efforts are necessary, the FDA said, because some women who have had silicone gel implants are endangering their lives by not seeking timely care.
“Three out of four women over the age of 40 who have been surgically removed have been given one of the three types of breast implants,” the FDA said. “In some cases, women who have had silicon gel implants continue to use them and seem to suffer less long-term complications than women who have not had them.”