The U.S. Food and Drug Administration (FDA) is calling for more stringent warnings on breast implant products that have been linked to a rare cancer of the immune system known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In a recent proposal, the FDA recommended that the makers of breast implants identify the potential risks associated with their products in a “boxed warning,” which is the most serious type of warning issued by the FDA. Boxed warnings are typically used to alert doctors and patients about serious side effects associated with pharmaceutical drugs or medical devices, and in light of new information about the potential health risks tied to breast implants, the FDA is taking action to ensure that women considering breast implants are better informed.
According to the FDA, certain textured breast implant products have been linked to, among other potential complications, a rare type of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma. This condition has been so closely linked to breast implants, in fact, that the condition diagnosed in women with breast implants is commonly referred to as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The cancer is typically found in the scar tissue and fluid near the implant, but in some cases the cancer can spread throughout the body, which significantly increases the risk of death. According to the FDA, “An individual’s risk of developing [cancer from breast implants] is considered to be low. However, this cancer is serious and can lead to death, especially if not treated promptly.”
Anaplastic large cell lymphoma is a condition that develops when T-cells, a type of white blood cell that is of key importance to the immune system, become abnormal. The most common first symptom of ALCL is painless swelling in the armpit, neck or groin, sometimes accompanied by fatigue and a loss of appetite. Some people with ALCL experience night sweats, weight loss or fever. In women with BIA-ALCL, the condition may result in swelling or pain in the area of the breast implant, sometimes occurring years after the initial placement of the implant.
Since the link between breast implants and cancer first came to light nearly nine years ago, federal regulators have been trying to figure out how to address a growing body of evidence indicating that textured breast implants can trigger this rare form of lymphoma in the scar tissue surrounding the implants. The FDA has identified approximately 450 cases of BIA-ALCL worldwide, including 12 deaths, and almost all of the cancer cases involve a type of textured breast implant that is designed to minimize scar tissue and prevent the implants from slipping. However, the FDA has also received some reports of the cancer in women with smooth implants, which account for most of the U.S. market.
In March, the breast implant issue was brought back into the spotlight, during a two-day FDA hearing involving breast implant manufacturers, plastic surgeons and cancer experts. The hearing came about following hundreds of reports of women with textured breast implants developing BIA-ALCL, several of whom died from the cancer. After reviewing the latest research on the potential risks associated with breast implants, the FDA panel did not recommend any immediate restrictions on the devices. This was despite arguments by the panel’s consumer representative, who stressed the risk to women who opt for implants after undergoing breast cancer surgery, only to potentially face a second cancer due to the implants themselves. In July, the FDA called on breast implant manufacturer Allergan to recall its Biocell textured breast implants and tissue expanders after it was discovered that women who received the implants faced an increased risk of developing BIA-ALCL. According to FDA Principal Deputy Commissioner Amy Abernathy, while the overall incidence of BIA-ALCL is low, Allergan’s implants “appeared to be directly linked to significant patient harm, including death.”
This new proposal is the FDA’s latest attempt to deal with the potential safety issues associated with breast implants. “We have heard from many women that they are not fully informed of the risks when considering breast implants,” the FDA said in a statement detailing the latest recommendations. As a result, the FDA is calling for breast implant manufacturers to include side effect risks in the boxed warning section on the device packaging, most notably the fact that breast implants have been associated with a risk of developing ALCL, that the chances of experiencing complications increase the longer the patient has the implant, and that additional surgery may be necessary to address any complications that occur. In the United States, approximately 400,000 women get breast implants every year, about a quarter of them after breast cancer surgery. “Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants [and] help patients better understand breast implant benefits and risks,” Abernathy said.