October 24, 2019
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 (FDA) said on October 23, according to a report by The New York Times.
Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, the Times said, 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.
The measures are not mandated by the agency; they are proposals now open to public comment and industry input.
Millions of women have implants—silicone sacks filled with either saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomies for breast cancer.
Breast augmentation with implants is the most popular cosmetic surgical procedure, the news outlet notes: 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.
In turn, 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.
The agency warned two implant manufacturers earlier this year that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.
At an advisory panel meeting in March, women with breast implants testified about their illnesses and implored the agency to take action. More than 70,000 women signed a petition demanding the F.D.A. to require the checklist.
Advocates urged agency officials to require the long-term safety studies that were promised and to start patient registries to track outcomes. Some women asked the F.D.A. to ban breast implants altogether.
The F.D.A. also wants implant manufacturers to list the ingredients in implants, in an easy-to-understand format for patients, so that women know about chemicals and heavy metals in the products.
The agency also is proposing new screening recommendations for women who already have silicone gel implants, saying they should undergo imaging scans to look for ruptures beginning five to six years after the surgery and every two years after that, the Times reported.
Research contact: @nytimes