The Food and Drug Administration is suggesting new warnings for the first time in more than a decade for people considering breast implants, after years of complaints about serious complications and illnesses linked to implants.
The changes for saline and silicone gel-filled breast implants include a boxed warning and a patient decision checklist to review with doctors, according to the FDA.
The agency is also recommending potential patients receive information on implant ingredients, including the quantities of chemicals and heavy metals contained in or released by leaking implants, and rupture screenings for silicone implants.
“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 Wednesday, according to the San Francisco Gate.
Breast augmentation with implants is the top cosmetic surgical procedure with more than 310,000 people undergoing the operation in 2018, according to The New York Times, with another 100,000 surgeries performed after breast cancer surgery.
The new recommendations are “designed to help inform conversations between patients and health care professionals when breast implants are being considered,” Abernathy and Shuren said.
Implant risks include cancer, such as non-Hodgkin’s lymphoma, breast pain, additional surgeries, scar tissue formation and implant rupture and deflation.
Breast implants won’t last a lifetime, the FDA said. The older an implant the higher risk for complications and need for removal. The agency warns people needing additional implant surgeries face uncertain cosmetic outcomes.
The FDA’s suggested changes in implant guidance is open for public comment until Dec. 23.
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