Roni Caryn Rabin, NY Times: October 23, 2019
Women considering surgery to receive breast implants should be warned 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 on Wednesday.
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 patients considering surgery. It will be left to doctors to review those risks with women seeking breast implants.
The measures are not mandatory and are now open to public comment and industry input. But the recommendations reflect a growing acknowledgment at the agency that implants may cause more harm in women than previously known.
Several years ago, the agency linked implants to a rare form of immune system cancer called anaplastic large cell lymphoma. In July, at the request of the F.D.A., one manufacturer, Allergan, recalled textured breast implants linked to the cancer.
More recent studies have reported higher rates of autoimmune disease among women with breast implants. Advocates for women with these complications called the F.D.A.’s proposals on Monday “an important step,” but noted that the action is only a recommendation.
“What matters most is what happens next,” said Diana Zuckerman, president of the National Center for Health Research in Washington, who has analyzed breast implant studies and has been advising patients.
She said surgeons should be required to go over the checklist with prospective patients before they put down a deposit.
“If breast implants can cause cancer of the immune system, doesn’t it make sense they can cause other systemic problems of the immune system?” Dr. Zuckerman asked.
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 percent increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.
But 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 conditions.
Dr. Zuckerman has found that most breast implant studies were carried out by manufacturers or plastic surgery associations and did not track long-term outcomes, or lost so many participants to follow-up that results were not meaningful.
The studies focused on well-defined illnesses, she said, ignoring debilitating symptoms that lacked specific diagnoses, and most were too small to detect rare diseases.
Earlier this year, the agency warned two implant manufacturers that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.
The proposed checklist and boxed warning were developed in response to demands by patients who testified last March at an advisory panel meeting about illnesses they blamed on their implants.