FDA takes up decades-long debate over breast implant safety

WASHINGTON >> U.S. health officials are taking another look at the safety of breast implants, the latest review in a decades-long debate.

At a two-day meeting that starts Monday, a panel of experts for the U.S. Food and Drug Administration will hear from researchers, plastic surgeons and implant makers, as well as from women who believe their ailments were caused by the implants.

The panel will consider next steps, but for now, the FDA isn’t proposing any new restrictions or warnings. The agency’s longstanding position is that implants are essentially safe as long as women understand they can have complications, including scarring, pain, swelling and implant rupture.

But the FDA and other regulators around the world have been grappling with how to manage a recently confirmed link to a rare cancer and the thousands of unconfirmed complaints of other health problems.

In documents released before the meeting, FDA regulators said it is “impossible” for them to determine how frequently the cancer — a form of lymphoma — occurs because the U.S. does not track the total number of implants on the market. Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000.

Most confirmed cases of the disease, known as breast implant-associated anaplastic large cell lymphoma, have involved a particular style of implants with a textured surface, designed to reduce scar tissue and slippage. But the FDA said it has also received reports of the disease in smooth implants — which account for most of the U.S. market — raising questions about whether the cancer is a risk with both implant types.

The disease is not breast cancer, but a form of cancer that attacks the immune system and usually forms in the scar tissue surrounding implants. It grows slowly and can usually be successfully treated by surgically removing the implants.

Thousands of women have also blamed their implants for a host of ailments, including rheumatoid arthritis, chronic fatigue and muscle pain. In the documents, the FDA reiterated its position that “there is not sufficient evidence” linking them to breast implants. The agency also sidestepped requests from patients to add a boxed warning — the agency’s most serious type — to breast implants and to require manufacturers to give women a checklist of potential harms and complications before surgery.

“I’m a little discouraged,” said Jamee Cook, one of more than 20 patients set to speak at the meeting, after reviewing the FDA materials. “But I guess I’m hoping that what we have to say will prompt discussion on those action points.”

A former paramedic, Cook said she had an array of health problems after getting implants in 1998, including exhaustion, migraines and an immune system disorder. She said her symptoms either resolved or improved after the implants were removed in 2015.

Breast augmentation is the most popular form of cosmetic surgery in the U.S., with roughly 300,000 women undergoing the procedure each year. Another 100,000 women receive implants for breast reconstruction after cancer surgery. Most women choose silicone gel-filled implants, which are considered more natural looking than saline implants.