The need for up-to-date, accurate information is more important than ever given ongoing concerns about health problems linked to breast implants and recent U.S. Food and Drug Administration (FDA) warnings linking implants to rare cases of cancer and systemic illness, says Andrew Da Lio, MD, chief of the UCLA Division of Plastic and Reconstructive Surgery. The FDA has issued new guidance to help women and their doctors better understand and monitor implants to safeguard women’s health.
“There is a lot of misinformation on breast implants,” Dr. Da Lio says. “Despite all the warnings and FDA recommendations, too few women are having discussions with their doctors about monitoring their implants. You simply can’t assume everything is going to be OK.”
Breast implants can be used to replace breast tissue after surgery related to breast cancer or to increase the size or shape of breasts. Implants can be filled with saline or silicone gel, while the shell of the implant is made of silicone. Roughly 400,000 women in the United States undergo breast-implant surgery each year, with most choosing silicone gel-filled implants.
The FDA placed a moratorium on silicone-filled implants for cosmetic purposes in 1992 due to insufficient long-term safety data to address concerns that silicone materials, particularly from ruptured implants, may trigger health problems. That moratorium was lifted in 2006.
Cases of BIA-ALCL and BIA-SCC are relatively rare, but they do occur, says Michael DeLong, MD, assistant professor-in-residence of plastic surgery, who sits on the FDA’s Advisory Committee for General and Plastic Surgery Devices.
In 2020, the FDA issued new labeling guidelines for breast implants that included a black box warning — the agency’s highest warning — and mandated that physicians use an “informed-decision checklist” to counsel their patients about potential risks linked to implants. More research is needed on all the potential risks linked to implants, Dr. DeLong says.
“They are technically a Class-3 device, the FDA’s highest category of risk,” he says. “Part of that is because of the unknowns surrounding silicone implants. Long-term safety is difficult to study due to the numerous factors involved.”
Dr. DeLong is conducting research on a test that can measure silicone metabolites in patient blood and urine samples, a development that would simplify implant-safety monitoring. He is also studying patients with implants to gain a better understanding of the possible mechanisms and genetic influences of implant-related illness.
“We’re trying to determine what are the implications of an implant rupture,” he says. “Does it increase the chemicals, the trace silicones, circulating in the bloodstream?”
The most common problems with implants, he notes, are rupture and capsular contracture — in which the tissue surrounding the implant hardens, causing pain and visible changes in the breast.
Some patients may not realize that breast implants are not lifelong devices, Dr. Da Lio notes. “Eventually, they will fail and need to be replaced,” he says.
Younger women considering silicone implants for breast augmentation should carefully weigh the pros and cons of surgery, he suggests. “It’s one of the operations you know has a built-in revision rate. You’re going to have a few revisions over your lifetime.”
The new, mandatory informed-decision checklist should improve patients’ understanding of the risks and maintenance issues, Dr. DeLong says. Consumers should follow the updated guidance, including:
- Monitor your breast implants for as long as you have them.
- Talk to your physician about any abnormal changes in your breasts or implants. Telehealth consults are available.
- Obtain your “medical-device card” that bears specific details about your implants.
The new FDA recommendations include revised monitoring protocols to make it easier on women. Previously, an MRI scan was recommended every other year to identify implant rupture or leakage. The new guidelines recommend ultrasound — which is quicker and costs less — or MRI imaging five to six years after implant insertion and every two to three years afterward, Dr. DeLong says.
Insurance will cover monitoring for women who have implants due to breast cancer surgery or prophylactic mastectomy. Insurance may not cover breast-implant related care for women who have implants for cosmetic purposes.
Learn more about plastic and reconstructive surgery at UCLA.
Shari Roan is the author of this article.
