A rare form of cancer associated with breast implants has been linked to nine deaths and hundreds of cases, the U.S. Food and Drug Administration (FDA) announced Tuesday.
The agency had originally identified a possible association between breast implants and a rare type of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma (ALCL) back in January 2011. Since then, more studies and research have come out solidifying the link, causing the FDA to release an update.
“Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants,” the FDA said in its March 21 statement.
Breast implant-associated anaplastic large cell lymphoma is a type of cancer that affects cells in the immune system. Although it is not considered a breast cancer, it can grow in the capsule of scar tissue next to the implant.
According to the American Society of Plastic Surgeons, there were 290,467 breast augmentation procedures in 2016 alone. While the FDA acknowledges there is a low risk of patients who receive breast implants developing the cancer, it says the risk is elevated.
“All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants,” the FDA said.
The cancer can be fatal but is often treated by removing the implant. Chemotherapy and radiation have also been used during treatment in some cases.
Hundreds of Cases of Breast Implant Cancer Reported
As of February 1, the FDA had received 359 reports of the breast implant-related cancer, which included nine deaths.
The agency made it clear that its medical device reports (MDRs) may not always be accurate or include every known case.
“While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data,” the FDA said. “Over time, we may gather more information about a report and thus the numbers listed above may change.”
However, the information it received did seem to confirm other reports that the cancer may be associated with the implant surface. Of the 231 reports that included information about the implant surface, 203 were reported to have textured implants while 28 were reported to have smooth implants.
At this point, it’s still unclear why textured implants may have a higher risk factor, but the FDA said recent articles have explored different possibilities.
“Most of the cases in the literature reports describe a history of the use of textured implants,” the agency said. “Several recent journal articles explore the risk factors for BIA-ALCL, including the methods used to create surface texture of the implant and the role of biofilm in causing disease, among others.”
With the FDA’s reports, the fill type did not seem to have any correlation. Of the 312 reports that included implant fill types, 186 were filled with silicone gel and 126 were filled with saline.
Explosion of Information Since 2011
Since the FDA first started investigating the link between breast implants and anaplastic large cell lymphoma, there’s been an increase in scientific literature about the subject. In 2016 alone, several organizations and regulatory bodies have released information about the association.
Last year, the World Health Organization determined breast implant-associated anaplastic large cell lymphoma was a separate diagnosis. The National Comprehensive Cancer Network and Plastic Surgery Foundation also released information about the cancer to better inform physicians about diagnosis and treatment.
Authorities in Australia similarly found connections and issued a warning about the link. In December, the Australian Therapeutic Goods Administration reported that since 2007 it had found 46 confirmed cases of the cancer in the country, including three deaths. Additional cases are still being investigated.
FDA Recommendations for Health Care Providers and Patients
In its recently released update, the FDA issued information to health care providers and patients on identifying and treating the cancer.
The agency told health care providers that the cancer is very rare and is identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
“Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended,” the FDA said.
The FDA encouraged patients to educate themselves on the topic of breast implants.
“Although it is rare, BIA-ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants,” the FDA suggested. “Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants.”
The agency reiterated that the cancer is very rare and no change to routine medical care or follow-ups is necessary. It continued to recommend patients get routine mammography screenings and periodic magnetic resonance imaging (MRI) to detect ruptures in silicone-filled implants.