The Skinny on Textured Breast Implants
- The FDA requested that Allergan recall some of its textured breast implants due to the risk of BIA-ALCL, a cancer of the immune system
- Oncologists and surgeons tell SurvivorNet they do not recommend getting the textured implants removed if women are asymptomatic
- In isolated cases, some women are having implants removed as a personal choice
This is despite some prominent cases in which women have elected to remove their implants due to personal concerns.Read More
The reason for the recall is the implants’ link to a rare cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, a type of non-Hodgkins lymphoma.
“The true risk of developing [BIA-ALCL] is extremely low,” Dr. Niamey Pender Wilson, director, Breast Surgery Quality & Research at Hartford HealthCare Cancer Institute, tells SurvivorNet.
And the cancer, she says, “is extremely treatable. So rather than having thousands and thousands of women undergoing a procedure that is not really necessary, it seems reasonable to monitor and see how someone is doing clinically. If they appear to be having a problem –the symptoms of ALCL are pretty obvious — then it should be removed expeditiously.”
To help you understand what was recalled, the concerns surrounding textured implants, and why most women are safe, here’s a SurvivorNet guide to the latest information.
So, Which Implants Were Recalled, and Why?
While several companies make textured implants, the U.S. Food and Drug Administration requested only that one company, global biopharmaceutical manufacturer Allergan, remove some of its textured breast implants and tissue expanders from the market.
This was “based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices,” according to the FDA release announcing last July’s voluntary recall.
“Based on the currently available information, including data submitted in 2019, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.,” an FDA spokesperson wrote to SurvivorNet in an email.
You can find a full list of recalled styles here.
Last year, the FDA reported 573 cases of BIA-ALCL with 481 of them being attributed to the Allergan Biocell implants. There were 33 deaths reported and in the 13 cases in which the implant type was clear, 12 of the people had Allergan implants. However, it also noted that “the overall incidence of BIA-ALCL appears to be relatively low.”
By the way, this isn’t the first time Allergan has recalled its textured breast implants. In 2018, the company suspended its sales of all textured breast implants and tissue expanders, and withdrew its supply from all European markets.
That withdrawal decision “follows a compulsory recall request from Agence Nationale de Sécurité du Médicament (ANSM), the French regulatory authority. The suspension of sales stems from the expiration of the company’s CE Mark for these products,” Allergan announced at the time.
Removing — Or Not Removing — Your Textured Implants
Like Dr. Wilson, Dr. Leslie L. Popplewell, a hematologist and oncologist at City of Hope, tells SurvivorNet that “currently the recommendation is not to remove implants unless a problem has developed. The risk of the lymphoma is still quite small even in patients who have had implantation of the recalled product.”
Plus, she says, “unless there is a problem identified, insurance may not pay for the removal.”
“There is a 1 in 1,000 to 1 in 10,000 risk with textured implants that you could get cancer,” Dr. Alyssa Golas, a plastic surgeon at NYU Langone Hospital—Brooklyn, told SurvivorNet in a previous interview.
Still, she said, “I find it very hard to find a compelling reason to use textured implants.”
Information About BIA-ALCL
BIA-ALCL is a rare and highly treatable cancer of the immune system and is not a breast cancer.
According to the FDA, “In most cases, [the cancer] is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body.”
Symptoms include pain, redness and swelling around the implant or breast area.
Action Is Critical
For anyone who develops BIA-ALCL, taking quick action is critical.
“When the diagnosis is made, it is important to remove the implant as well as that capsular material. Often no additional treatment is required, especially if it is caught early,” says Dr. Popplewell.
For those who have no symptoms and elect to have their implants taken out and exchanged for smooth implants, “it’s a very straightforward procedure,” says Dr. Wilson, which could take approximately one to two hours. “It’s removing scar tissue around the capsule and placing the new one in a different plane.”
Full recovery, she says, is just a of couple of weeks.
Why People Choose Textured Implants
There are a variety of implant options available to breast cancer survivors. Below is the entire list of breast implant options, according to the American Society of Plastic Surgeons:
- Structured Saline
- Gummy Bear
Textured breast implants have a rough surface that is sometimes compared to sandpaper. Unlike smooth-surfaced implants, their surface adheres to the tissue that surrounds them, preventing them from moving around within the implant pocket created by the surgeon
Textured implants are a popular choice for breast implants due to their lack of movement.
“Sometimes people want tear-drop shaped [breasts], (called “anatomic” implants) instead of round implants, and because the narrow part has to be at the top and the round part at the bottom, [a textured implant] prevents them from flipping around inside the body, Dr. Alyssa Golas, plastic surgeon at NYU Langone Health, previously told SurvivorNet.