Link To Rare Cancer Causes Breast Implants To Be Recalled
Breast Cancer Awareness month is about bringing awareness to all aspects of breast cancer, not only the symptoms. For some breast cancer patients and breast cancer survivors, breast implants, augmentation or reconstruction have been part of their mastectomy experience.
The FDA has taken action to protect patients from the risk associated with certain textured breast implants due to a connection with a rare type of cancer.
These Breast Implants Have Been Recalled Because of Their Link to a Rare Cancer
Source: self.com
You never want to see the words “breast implant” and “cancer” next to each other in a headline. But such news stories have been circulating recently after the Food and Drug Administration (FDA) requested that a manufacturer voluntarily recall certain kinds of breast implants connected to a rare kind of cancer.
“The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL,” the FDA’s July 24 release reads. Allergan complied.
When SELF reached out to Allergan over email the week after the recall, a spokesperson from the company told us that they voluntary recalled the BIOCELL textured breast implants and tissue expanders “as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the [FDA].” By that point, there were already similar recalls to get this type of implant off the market in other countries, including France, Canada, and Australia, according to the FDA.
The idea of breast implants potentially causing cancer is genuinely scary, even more so for anyone who has them (or is thinking about getting them). Here’s everything you need to know about the recall, including the kind of cancer it’s been connected to and what to do if you have breast implants.
What exactly was recalled?
This recall applies to BIOCELL textured breast implants and tissue expanders (devices used to stretch a person’s skin before breast augmentation or reconstruction after a mastectomy) from Allergan.
Before we get into the details of what BIOCELL means, the first thing to know if you have breast implants and are worried: Textured implants are uncommon in the United States, making up only 10 percent of breast implants sold in this country, according to the FDA. Their texture can help the implant stay in place better and reduce the risk of a complication called capsular contracture, which happens when the scar capsule that naturally forms around an implant during the healing process begins to tighten, squeezing the implant, the FDA explains. But most people in the United States get what are called smooth breast implants, which generally feel the softest and may have the most natural movement out of all breast implants, according to the American Society of Plastic Surgeons (ASPS). (The United States is unusual in this regard—textured implants account for up to 80 percent of the market share in countries like France, Canada, and Australia, according to the FDA.)
To break things down even more, fewer than half of the textured implants sold in the United States—so, less than 5 percent of the total breast implant market share—are of the macro-textured variety that includes the recalled implants, the FDA says. A macro-textured breast implant essentially has bigger, deeper divots on its surface than a micro-textured or smooth implant.
OK, now about BIOCELL. BIOCELL refers to a unique type of macro-textured surface that only Allergan uses in its products, the FDA explains. The recall covers all styles of Allergan’s BIOCELL textured breast implants, including both silicone and saline-filled ones. It also includes BIOCELL tissue expanders (which are also macro-textured), the FDA explains.
You can find a complete list of recalled products at the bottom of the FDA’s safety communication here.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA principal deputy commissioner Amy Abernethy, M.D., Ph.D. said in the organization’s press release.
What is the link between these implants and cancer?
The potential connection between breast implants and breast implant-associated anaplastic large cell lymphoma is not new.
“The first case was reported in 1997, and for about the first decade we knew of less than a dozen cases or so,” Mark W. Clemens, M.D., a Fellow of the American College of Surgeons, and an associate professor of plastic surgery who co-leads a multidisciplinary clinical and laboratory research team investigating BIA-ALCL at MD Anderson, tells SELF.
The FDA first publicly noted the potential connection back in 2011 in a safety update on breast implants. But with only 60 reported cases worldwide, the agency didn’t have enough data to establish a link. “There was very little known about it, and it was questionable if there really was an association or if it was coincidental,” explains Dr. Clemens, who has been studying BIA-ALCL since 2014. Over the past eight years, the FDA has been monitoring the accumulating data and sharing updates. In February 2019, the FDA issued a statement with more information about BIA-ALCL but didn’t yet issue a request for a recall.
The action the FDA took was to help protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The BIA-ALCL characteristics occur in the breast area, but it is not actually breast cancer.
This is, however, relevant to any breast cancer patients or survivors who have the specific type of textured implant manufactured by Allergan, as well any anyone who has not been diagnosed with breast cancer, but who has these types of breast implants.
If you have breast implants and are unsure of the type of implant you have, or the type of expanded that was used, call your surgeon’s office to find out.
You can also take action by educating yourself on the symptoms of BIA-ALCL and monitor any changes to your implants. If you have any concerns, you should speak to your health care professional.
For more information on breast cancer resources or lymphoma resources, visit our resource library.