Breast implants and BIA-ALCL: textured versus smooth

Most questions people bring to a breast augmentation consultation are about size and shape. One question rarely gets asked, and it is the one a regulator would want you to ask: what is the surface of the implant?

The answer matters because of a disease with an unwieldy name, breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. It is rare. It is also the reason one family of implants was pulled from the market, and understanding it takes about five minutes.

What is BIA-ALCL?

The first thing to get straight is what it is not. The US Food and Drug Administration is explicit that BIA-ALCL is not breast cancer. It is a type of non-Hodgkin’s lymphoma, a cancer of the immune system.

When any implant is placed in the body, a thin layer of scar tissue forms around it. This capsule is normal. In the cases described in the medical literature, BIA-ALCL is usually found there, near the implant and inside the capsule, not in the breast tissue itself.

The FDA first flagged a possible link between breast implants and this lymphoma in 2011, when so few cases were known that nothing could be said about what raised the risk. In 2016 the World Health Organization recognised BIA-ALCL as a distinct lymphoma that can develop after breast implants.

Why does the surface matter?

Implant shells come in two finishes. Smooth shells are what they sound like. Textured shells have a roughened surface, designed to grip the surrounding tissue so the implant is less likely to rotate or shift, which mattered most for shaped, “teardrop” implants.

As case reports accumulated, a pattern appeared. In an FDA update in 2017, the agency had 359 reports of the disease; the implant surface was recorded in 231 of them, and 203 of those were textured against 28 smooth. The FDA’s current position follows from that: the risk of BIA-ALCL is higher for textured surface implants than for smooth surface implants.

Researchers have theories about why, but as one academic medical centre puts it, they are not sure why the surface plays such a key role.

What is inside the implant seems not to matter. The FDA says that on current data the type of fill, silicone gel or saline, does not appear to be a risk factor, while noting that no large epidemiological study has settled the point.

What happened in 2019?

In July 2019 the FDA asked the manufacturer Allergan to recall specific models of textured implants and tissue expanders from the US market because of the BIA-ALCL risk. The implant type concerned accounted for less than 5% of breast implants sold in the United States. At that time the agency was reporting 573 cases worldwide and 33 deaths.

The FDA told surgeons to stop implanting the listed products immediately. It did not tell patients to have them taken out, and that distinction is the part most often lost in headlines.

How rare is it?

Rare enough that exact figures are hard to pin down. The WHO, when it classified the disease, noted that the number of cases remained difficult to determine. The counts regulators and surgical societies publish have risen over the years as awareness grew and reporting improved, so an older number and a newer one are not directly comparable.

Two things can be said with confidence. The risk for any one person with implants is low, and it is not evenly spread: estimates differ by implant type, with the highest risk attached to textured surfaces. A patient-advocacy summary of surgical society data adds that most people diagnosed have an excellent prognosis once the implant and its capsule are removed.

What are the symptoms?

The FDA lists three main ones: persistent swelling, a mass, or pain in the area of the implant. Some reports also describe a lump under the skin, or the capsule becoming thick and tight.

The timing is what makes this easy to miss. These changes can appear well after the surgical wounds have healed, and the FDA notes that most cases occur years after the implants were placed. Somebody who had surgery abroad and feels fine for six years may not connect a newly swollen breast to an operation they think of as long finished.

Evaluation typically involves a physical examination, imaging, and testing of the fluid or tissue around the implant. If you have implants and notice one breast swelling, tell the doctor that you have implants, when and where they were placed, and, if you know, the make and surface.

What does the FDA advise people who already have implants?

• If you have no symptoms, the agency does not recommend removing implants because of concern about BIA-ALCL. That applies to the recalled products as well as other types.
• Know the symptoms and keep an eye on the area around your implants for changes.
• If you do notice changes, see a doctor promptly.
• For confirmed BIA-ALCL, treatment is removal of the implant together with the surrounding capsule, a more extensive operation than implant removal alone.

Other cancers have also been reported in the capsule around implants, including a rare squamous cell cancer. They are rarer still, and the same advice applies: report late changes.

What should you ask a clinic in Korea?

If you are considering augmentation abroad, the paperwork matters more than usual, because you may need it a decade later in another country.

• What is the manufacturer, model and surface of the implant you propose?
• Is that product approved by the Korean regulator, and by the regulator in my own country?
• Will I be given the implant’s identification card or sticker, with the serial number, to take home?
• If you are recommending a textured implant, why, and what is the alternative?
• What follow-up do you advise over the years, and who should do it where I live?

A surgeon who answers these readily is showing you how they handle the unglamorous end of the job. To see who you are dealing with, look up the clinic’s public record in our clinic directory.

The honest summary of BIA-ALCL is undramatic. The risk is small, it is concentrated in one kind of surface, the warning signs are recognisable, and treatment usually works when the disease is caught. What turns a small risk into a real problem is not knowing what was put in your body. Keep the card.