FDA: Women should be warned of breast implant hazards

Potential serious complications include risk of rare type of cancer, other ailments, agency says.

Women considering surgery to receive breast implants should be warned in advance of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration said Wednesday.

What happened

Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants and to provide a checklist spelling out the risks for prospective patients to review before making a decision and putting down a deposit on the surgery.

Why it matters

Millions of women have implants, silicone sacks filled with saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomy for breast cancer.

Breast augmentation with implants is the most popular cosmetic surgical procedure. Some 313,000 augmentations were performed in 2018, a 4% increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.

Thousands of women with implants have reported developing debilitating illnesses, such as severe muscle and joint pain, weakness, cognitive difficulties and fatigue, a constellation of symptoms some experts call “breast implant illness.”

Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune diseases. Implants have also been linked to a rare cancer of the immune system called anaplastic large cell lymphoma, which can be fatal. Most of the cancer cases developed in women with textured implants.

Zuckerman has found most breast implant studies did not track long-term outcomes or lost so many participants that results were not meaningful.

The agency wants manufacturers to warn patients that implants do not last a lifetime, that the chances of developing complications increase the longer they have the implants and may require another operation to resolve, and that implants are linked to anaplastic large cell lymphoma.

What’s next

The measures are not mandated by the agency; they are proposals now open to public comment and industry input. Advocates for women with complications linked to breast implants called the FDA’s proposals “an important step” but noted the action is only a recommendation.

Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune diseases.