After a request from the U.S. Food and Drug Administration (FDA), the pharmaceutical company Allergan has officially issued a worldwide recall for its textured breast implants.
The recall comes after confirmation that the textured breast implants are associated with a rare type of cancer called “breast implant-associated anaplastic large cell lymphoma” (BIA-ALCL). According to the FDA’s statement, 573 cases of this cancer had been reported as of this month, 481 of which were attributed to the Allergan implants specifically.READ MORE
Of these ALCL cases, the FDA reported that 33 have resulted in death—and the agency was able to confirm that 13 of these deaths occurred in people with the textured implants, all but one of which were products of the company Allergan.
Among people who have been closely monitoring the cancer risks associated with textured breast implants, there’s been a lot of anticipation in the lead up to this recall. Women who have been diagnosed with ALCL after getting textured breast implants have been calling on the FDA to take action for several years now, and this past spring, the FDA held a hearing on the issue that quickly became dramatic. Doctors and patients became angry with the FDA for failing to ban the products.
The issue began to feel all the more urgent in the U.S. as other countries—including France, Canada, and Australia—issued their own bans on textured breast implants over the past few months.
The reason for the FDA’s delay in recommending a total recall, according to the statement issued today, was that the agency did not have substantial proof that these cancers were indeed a result of the implants. The agency needed indisputable evidence to recommend something as drastic as a total recall.
Now the FDA has that proof—and is recommending providers remove these implants from their offices and stop putting them in women’s bodies.
“The FDA has been diligently monitoring this issue since we first identified the possible association between breast implants and [this specific cancer] in 2011,” Dr. Amy Abernethy, the FDA’s Principal Deputy Commissioner said in the statement issued today. “At that time, [the FDA] communicated to patients and providers that there is a risk for women with breast implants, more frequently occurring in women with textured implants, for developing this disease.”
Dr. Abernethy went on to say that, “based on our new data, our team concluded that action is necessary at this time to protect the public health.”
Allergan Inc., the company that makes these implants, has specifically recalled the following products: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants, Natrelle 133 Plus Tissue Expander, and Natrelle 133 Tissue Expander with Suture Tabs.
Women Who Already Have Textured Breast Implants Should Not Worry, FDA Says
Importantly, while the FDA has recommended a recall of the products themselves, it has not recommended that people who already have the implants take action.
That is, if you have the implants, you don’t need them removed.
“If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL,” the FDA announced in a safety document alongside the recall recommendation. “However, if you have any questions, talk to your health care provider.”
The safety guidance went on to share some common symptoms of ALCL that people with textured breast implants should look out for, including “persistent swelling or pain near the breast implant.”
The FDA also recognized that this recall could, naturally, result in fear among anyone with breast implants—or anyone considering breast implants. Preemptively addressing these fears, the FDA reminded patients and providers that, while these confirmed cancer cases were enough to issue a recall, the number was still very low. And in the U.S., the statement noted, the specific type of textured implants, “macro-textured implants,” that have been linked to cancer only make up 5 percent of all breast implants.
Why Do Textured Breast Implants Cause This Rare Cancer?
While many people think of the silicone or saline filling inside of a breast implant that makes it dangerous, it is important to know that the ALCL risk is not associated with what’s inside the implant. Instead, it’s the textured outer shell of the implant (meant to keep the implant securely in place rather than moving around within the breast) that has been the cancer risk factor.
Given the potential cancer risks of textured breast implants, Dr. Alyssa Golas, a plastic surgeon at NYU Langone Health told SurvivorNet back in March—around the same time as the hearing, but before the official recall—that she found it “very hard to find a compelling reason to use textured implants.”
All the risks aside, Dr. Goals shared that it was her view that the smooth breast implants—which can flip around inside the breast, but have not been linked to cancer—actually seem more natural to her than the fixed-in-placed textured versions.
“I don’t see breasts as fixed objects,” Dr. Golas said. “I think they’re more natural when they move around.”
Of course, aesthetics are subjective, and for many women in the past, the textured choice has been preferable.
But in the wake of the official recall, women who opt for breast implants—be it as a part of breast reconstruction, perhaps after a mastectomy, or as a cosmetic breast augmentation procedure—will no longer have the option to elect Allergen’s risky macro-textured implants.