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According to a recent FDA safety warning, breast implants may be linked to an increased risk of cancer.

What Does the FDA Warning Say?

The FDA warning letter, published on Feb. 6, is directed towards health care providers in multiple medical fields, including cosmetic surgery, radiology, plastic surgery, obstetrics and gynecology, and oncology.

According to the FDA, many women who have been implanted with textured breast implants have later been diagnosed with a certain kind of implant-related cancer.

Can Breast Implants Increase the Risk of Cancer?

According to the FDA letter, the particular type of cancer found to be connected with implants is called breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). Reports from patients and doctors indicate that the condition may initially occur within the scar tissue surrounding the implant.

After breast implants are inserted into the chest, scar tissue begins to form around them. This scar tissue is called a capsule and often grows until it completely separates the implant from the rest of the breast tissue. It is within this capsule where BIA-ALCL may develop.

According to the FDA letter, patients with textured breast implants may be more likely to develop cancer than patients with smooth implants. Textured implants have a rough surface that promotes adherence to the surrounding tissue. This prevents the implants from moving around in the chest cavity.

What is BIA-ALCL?

BIA-ALCL is a type of cancer known as lymphoma. Lymphoma begins in the cells of the immune system that fight infections. BIA-ALCL is not a cancer of the breast tissue. It generally begins in fibrous scar tissue surrounding breast implants.

What are the Symptoms of BIA-ALCL?

Many patients who have been diagnosed with BIA-ALCL have had symptoms including pain, swelling, abnormal lumps in the breast or armpit, breast asymmetry, changes in breast appearance, skin rash, fluid build-up, or hardening of the breasts.

Doctors may check for ALCL by using a variety of imaging tests, including ultrasounds and MRIs. Biopsies may also be necessary to confirm a cancer diagnosis.

Why Is This Cancer Developing in Women with Textured Breast Implants?

Textured breast implants tend to have a larger surface area. And because they are textured, the relative roughness of the surface may give rise to increased inflammation of the surrounding tissue, which can increase the risk of cancer. Researchers also wonder if some people are genetically more prone to develop BIA-ALCL, according to UTSouthwestern Medical Center’s Jeffrey Kenkel, M.D., a plastic surgeon.

“The lifetime risk of a woman with a textured breast implant developing the disease is between one in 3,817 and one in 30,000,” wrote Kenkel on UTSouthwestern Medical Center’s website.

He said those figures don’t indicate that every woman with textured implants should immediately have them removed if they are asymptomatic. Still, he writes that the risk is still a real risk, and that continued observations of any changes in breast size or shape should be brought to the attention of a plastic surgeon.

Researchers believe constant inflammation of the tissue around the implant and the capsule cause fluid to rush to the site. As fluid accumulates, cells become damaged to the point cancerous cells begin to develop within that fluid, according to Kenkel. If the cancer progresses and invades the capsule, the cancer may spread to other tissues, including the lymph nodes.

To determine whether or not the retained fluid is cancerous, the surgeon will draw a sample of the fluid to be tested for CD30, a cell membrane protein associated with lymphoma.

If the cancer has not spread to the lymph nodes or other parts of the body, BIA-ALCL is most often successfully overcome with the removal of the implant and the capsule.

Who May Be Affected?

BIA-ALCL is estimated to occur as often as one per every 3,817 patients. Most of the patients who have been diagnosed with BIA-ALCL have also had textured breast implants, although there have also been reports of this cancer occurring in patients who have smooth implants. Any type of breast implant may increase a patient’s risk of cancer.

Reportedly, textured breast implants are most likely to be associated with anapestic large cell lymphoma. The FDA says that when breast implants are inserted into the body, they are placed behind the breast tissue or under the chest muscle, and a fibrous scar called a capsule forms around the implant over time. This scar tissue separates the implant from the rest of the breast.

The FDA says that people with textured breast implants are at a higher risk of developing ALCL in the scar capsule adjacent to the implant. 

ABC explains that textured breast implants are popular in some parts of the world than others. So, those in some countries may be at a higher risk of developing breast implant associated anapestic large cell lymphoma (BIA-ALCL) than others.

Reportedly, there have been 572 cases globally of BIA-ALCL, and 33 deaths connected to BIA-ALCL around the world.

Around the world, health authorities have taken action to protect residents from possible health effects of breast implants — particularly textured ones. France has made a move to ban a small number of textured breast implants, and Canada has banned one brand. Australia also considering taking textured implants off the market, over the same concerns.

For its part, the U.S. FDA has not banned any breast implants, but is further investigating possible risks associated with implants, taking note of responses from health organizations around the world.  Allergan breast implants are currently at the heart of this discussion; in fact, in July, the FDA requested that Allergan, the manufacturer of one type of textured breast implant, voluntarily recall and stop selling one implant model in the US because of the risk of BIA-ALCL. 

In addition to cancer, patients who have breast implants may also experience side effects including arthritis, connective tissue disease, fibromyalgia, multiple sclerosis, sarcoidosis, and scleroderma.

If you have rough or smooth breast implants and have been diagnosed with cancer, including BIA-ALCL, you may qualify to participate in a breast implant lawsuit investigation.[/vc_column_text]

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