The Food and Drug Administration on Wednesday strengthened safety requirements for breast implants, mandating that manufacturers and plastic surgeons warn prospective patients of possible complications, including that the devices do not last a lifetime.
One part of new FDA rules restricts the sale and distribution of breast implants to providers and facilities that provide patients with a checklist of risks published by the FDA — essentially mandating a discussion around each of its points. The health provider must review the checklist with patients to ensure they understand “the risks, benefits and other information about the breast implant device,” the agency said in a statement.
Warning labels must also accompany several types of breast implants, along with the decision checklist and advice that patients with silicone gel-filled implants get periodic screenings to detect possible ruptures. Patients must also be told that such screenings may not be covered by insurance. Companies have 30 days to post updated labels on their websites.
“This is information that every patient contemplating breast implants should know,” said Binita Ashar, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health. “We want patients to make informed decisions about whether or not breast implants are right for them.”
The new rules were cheered by women who say they endured debilitating illnesses from implants.
Nicole Daruda, of Vancouver Island, had a lumpectomy while pregnant when she was 26 but held off getting breast implants until she was done having children. In her 40s, she decided to get them after “I was told that implants are completely safe.”
But within a couple of years, Daruda said she began suffering chronic fatigue and brain fog that made it impossible to work. Seven years after her surgery, she had the implants taken out and her health immediately improved.
“Right after they were removed, my surgeon brought my implants to me and they smelled of toxic chemicals,” said Daruda, now 57. “And the shell was tacky, you could tell that the silicone was coming through the shell.”
Since then, Daruda has advocated for others with similar problems. She started a website called Healing Breast Implant Illness, as well as one of the largest Facebook groups for patients who believe they have systemic health problems caused by breast implants.
“We’re really glad that they’re now taking the step to make it a requirement that the public be informed of the potential dangers,” Daruda said.
Wednesday’s announcement added teeth to earlier FDA recommendations. Last year, regulators had recommended manufacturers use the FDA’s strictest caution — a warning enclosed in a black box on the product’s label — to list the possible complications associated with the devices. That guidance also recommended doctors use a patient decision checklist to walk consumers through potential hazards.
Those changes were put in place after hearings in 2019, when multiple women who said they had serious health problems from breast implants told the FDA that physicians’ failure to discuss the risks had left them vulnerable. About three-quarters of those who get the implants do so for cosmetic reasons; the rest get them as part of reconstruction after breast-cancer surgery.
The patient checklist describes common risks associated with breast implant surgery, such as pain, scarring, asymmetry and infection. It also warns about rare risks that include a cancer of the immune system called Breast Implant-Associated Anaplastic Large Cell Lymphoma. Most documented cases of the rare cancer and more than a third of the related deaths were tied to textured breast implants produced by Allergan, which have since been recalled from the market.
Breast implant-linked lymphoma is rare. Doctors in the United States perform about 400,000 surgeries using the implants each year and, as of early 2020, the FDA had documented 573 cases of the cancer worldwide, with 33 patients dying from it.
More commonly, patients report a host of systemic symptoms including joint pain, fatigue, rash, memory loss and brain fog.
The FDA checklist also cautions that “a breast implant is NOT a lifetime device” and may eventually require removal or replacement. According to the FDA’s guidance, 1 in 5 women who get implants have them removed within eight to 10 years. Both silicone gel- and saline-filled implants may also leak or rupture. Leaks are harder to detect in silicone gel-filled implants, however, so women who receive that type of device should get periodic imaging to check for leaks, according to the checklist.
The new requirements may also benefit doctors, says Scot Glasberg, who sits on the executive committee of the American Society of Plastic Surgeons and has spoken with FDA officials about breast implant regulations.
“Surgeons have a liability risk and this helps to decrease their liability risk,” Glasberg said. “That’s good for patients and that’s good for surgeons.”
Some states have also passed more stringent requirements for providers. The Arizona legislature passed a bill that was signed into law last year that required doctors to pass along warnings from manufacturers or the FDA to their patients before breast implant surgery.
“All of the forces are heading toward this” Glasberg said. “I actually believe this is good for everyone.”
