Experts now agree that breast implants can cause a type of cancer of the immune system known as anaplastic large cell lymphoma (ALCL). The Food and Drug Administration (FDA) finally admitted this risk of cancer in 2017, but other experts – including plastic surgeons – were aware of the risk years before. 1 Why did it take so long for the FDA, the media, and women with implants to find out that choosing breast implants could increase their chances of developing a potentially fatal disease?
Anaplastic large cell lymphoma (ALCL) is a rare type of cancer of the immune system that was estimated to affect 1 in half a million women. It usually develops in the lymph nodes, skin, lungs, or liver. However, ALCL sometimes develops in the breast area of women with breast implants.
In 2008, Dutch researchers published a report of 11 women with breast implants and ALCL, and concluded that the implants seemed to be associated with ALCL.2 Although published in the Journal of the American Medical Association (JAMA), this information was not widely reported.
The link between ALCL and breast implants was first reported by the FDA in January of 2011. In 2013, researchers at MD Anderson Cancer Center studied 60 women with breast implants who were diagnosed with ALCL in the breast. Since ALCL was thought to be diagnosed in only 1 woman in half a million, this was much higher than would be expected.4 In 2016, the World Health Organization (WHO) officially recognized BIA-ALCL.5 In 2017, the National Comprehensive Cancer Network (NCCN), a nonprofit network of cancer experts, released a worldwide oncology standard for surgeons and oncologists to test for and diagnose “breast implant associated ALCL (BIA-ALCL).” NCCN includes a guided algorithm for surgeons and oncologists to test for and diagnose the disease. They concluded that any abnormal accumulation of fluid or a mass that develops near the breasts in women with breast implants must be evaluated.
And yet, it was not until March 2017 that the FDA finally updated its website to officially report that breast implants could cause ALCL. At the time of the FDA announcement, the agency reported that they had received 359 reports of ALCL among women with breast implants. Reports to the FDA of problems from medical devices are acknowledged to be the “tip of the iceberg” since surgeons frequently do not do these online reports.
Diagnosing and Treating ALCL
How did the women find out they had ALCL before the official announcement of BIA-ALCL was made? Most of them approached their doctors with symptoms such as pain, lumps, swelling, or asymmetry in their breasts years after getting implants. Since breast implants are a “foreign body,” the body forms scar tissue around the implant to protect their body from this “foreign invader.” The scar tissue surrounding the implant is known as the scar capsule. It is natural for the body to form scar tissue, and the scar tissue is only a problem if it tightens or hardens around the implants, causing pain and hardness known as “capsular contracture.” Breast implant-associated ALCL is almost always found in the scar capsule surrounding the implant, not the breast tissue itself, and has been reported in women both with and without capsular contracture.3
ALCL is diagnosed by testing the fluid that collects around the implant, called a seroma.4 Seroma is usually not caused by ALCL. It is important to understand that even when ALCL is in the breast, it is not breast cancer, but rather a cancer of the immune system. Most breast implant-associated ALCL has cancer cells within the fluid inside the scar capsule. That ALCL can be treated by removing the implant and the surrounding scar tissue. This surgery is known as a capsulectomy.
One study of nine women who had a capsulectomy after being diagnosed with breast implant-associated ALCL found that all nine were healthy and disease free when they were studied 3.5 years later, and neither chemotherapy nor radiation treatment was necessary. However, some types of ALCL are more aggressive and need to be treated with chemotherapy or radiation. NCCN oncologists also state that even if the BIA-ALCL is confined to the scar capsule that surrounds the implant and even if that capsule is totally removed through proper explant surgery, the patient must be followed for 2 years.5
In December 2013, the study of 60 patients with breast implant-associated ALCL showed that the ALCL was more likely to be fatal for women who had a solid ALCL tumor than for women who had ALCL cancer cells in the surrounding fluid (known as effusion ALCL). All of the patients with effusion-type ALCL were still alive 5 years after their diagnosis, compared to only 75% of the patients with solid ALCL tumors. ALCL returned in only 14% of patients with effusion-type ALCL, compared to 50% recurrence of solid ALCL tumors.6
Longer studies with more patients are needed to determine if some kinds of breast implants are more likely to cause ALCL. However, current research suggests that BIA-ALCL is more common in women with textured breast implants. Meanwhile, women with all types of implants should have routine follow-ups and should immediately see a doctor if one or both of their breasts become swollen.
A statement on ALCL from Allergan, a manufacturer of both smooth and textured, silicone and saline breast implants, said, “A woman is more likely to be struck by lightning than to get this condition”.7 However, 400 people are injured or killed by lightning every year, which is why most people avoid situations where lightening can harm them.8
Should All Textured Implants be Banned?
In July 2019, the US Food and Drug Administration (FDA) requested that Allergan recall their Biocell textured breast implants and tissue expanders. The FDA made this request after concluding that the Biocell textured implants are six times as likely as other textured breast implants to cause BIA-ALCL.
This was just 7 months after these breast implants were taken off the European market. In Europe, breast implants are allowed to be sold if one country provides what is called a CE mark. The CE mark does not require clinical trials and is based on a private company’s review of the product to ensure health, safety, and environmental protection standards are met. The CE mark for Allergan’s textured breast implants was suspended after the company failed to provide French health officials with requested data regarding the textured implants and their link to lymphoma.9
Following the FDA request for a recall in July 2019, Allergan announced a worldwide recall of their Biocell textured breast implants and tissue expanders. See a full list of recalled models here. The FDA also published an updated safety notice, informing patients to communicate with their health-care professionals if they have any concerns or symptoms of BIA-ALCL.
The controversy about whether other types of textured breast implants should remain on the market has focused on what percentage of women with these implants will develop ALCL. That is not known, because some women who developed ALCL did not know what brand of breast implants they had. Other types of textured implants are still being sold in the United States, although the FDA recommends women with textured implants have routine check-ups with their doctors.
Although rare, it seems that BIA-ALCL is not “very rare.” The Australian version of the FDA (called the Therapeutic Goods Administration) estimates that between 1 in 1,000 and 1 in 10,000 women with breast implants will develop ALCL.10 More than 300,000 women get breast implant surgery every year. If the Australian estimates are correct, about 30-300 of those women will develop ALCL every year. The estimates were much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S. Given the dramatic increase in diagnoses, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years. Although awareness of BIA-ALCL is increasing, many doctors are still unaware of the risks and symptoms.
As of July 2019, the U.S. Food and Drug Administration (FDA) reports that it has received 573 reports of ALCL, including 33 deaths, in women with breast implants.
Many women would not want to take the chance of developing cancer as a result of breast implants, and this is especially true for women who underwent mastectomies that were not medically necessary in an effort to reduce their chances of cancer returning.
What are the Implications for other Diseases?
The link between breast implants and autoimmune diseases has been hotly debated for two decades, with many women reporting serious autoimmune symptoms that went away when their implants were removed.11 The scientific evidence regarding ALCL and implants once again raises questions about the possible impact of breast implants on autoimmune disease or symptoms such as joint pain, body pain, memory loss, and chronic fatigue.
For many years, women with breast implants were assured by implant companies, plastic surgeons, and the FDA that breast implants did not cause breast cancer or any other type of cancer. Evidence of a link to some types of cancer and to autoimmune diseases, including studies conducted by researchers at FDA and the National Cancer Institute, was dismissed. However, as everyone knows from data on lung cancer, emphysema, and smoking, it can take decades to determine if an exposure causes cancer or other serious diseases. Even a very strong carcinogen, such as tobacco, is very unlikely to cause lung cancer for at least 30 years. For this reason, it is essential that physicians and researchers take a closer look at the link between breast implants and cancer of the immune system, as well as other immune disorders.
Read the FDA’s report on the risks of ALCL here
To read more about what you need to know about ALCL, click here.