A little over two years ago, the Food and Drug Administration claimed that it had identified an association between textured breast implants and anaplastic large cell lymphoma, which is not a breast cancer but a rare type of non-Hodgkin's lymphoma that starts in white blood cells and is commonly referred to as BIA-ALCL.
In connection with these findings, today the FDA has called on breast implant manufacturer Allergan to recall a number of its BIOCELL textured breast implant products from the market. Allergan has complied with the request for recall, now calling on suppliers and doctors offices to halt the sale and implantation of its various models of textured implants, including Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders that are used by patients prior to breast augmentation or reconstruction, like the Natrelle 133 Plus Tissue Expander and the Natrelle 133 Tissue Expander with Suture Tabs.
"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, MD, said in a statement.
In response to the news, Allergan issued this statement to Refinery29: "The company is taking this action 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 U.S. Food and Drug Administration (FDA). Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients. Patient safety is a priority for Allergan and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns.”
Research shows that cases of BIA-ALCL are more specifically linked to textured implants, which were developed in response to earlier models that had smooth surfaces and were prone to scarring or firmness. "[It] appears to be, from a lot of the data and studies, related to stimulation, chronic inflammation, or chronic irritation of bacteria," William Adams, MD, a board-certified plastic surgeon who has studied BIA-ALCL, told us in 2017. The reason why it's associated with textured implants is because they have a higher surface area and could therefore permit high numbers of bacteria around the implants, Dr. Adams adds.
In a chart that's just been updated on the FDA's BIA-ALCL page, the government agency notes that there have been 573 unique cases of BIA-ALCL reported globally and 33 patient deaths, which is an increase of 116 cases and 24 deaths compared to reports released earlier this year. Of the 573 unique cases of BIA-ALCL, 481 had Allergan implants at the time of diagnosis. Of the 13 deaths in which officials identified the manufacturer, 12 were confirmed to have an Allergan breast implant. There are no reports of deaths associated with tissue expanders.
The same FDA study also found that the risk of BIA-ALCL with Allergan's textured implants was approximately six times greater than the risk of the cancer associated with other manufacturers' textured implants marketed in the U.S. However, the FDA is continuing to monitor all cases. "We are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants," Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the FDA statement. "We continue to advise women and health care professionals that the use of breast implants is associated with a risk of developing BIA-ALCL and that the risk is greater with textured implants."
As of right now, the FDA is not recommending that women who currently have the recalled implants and are asymptomatic get them removed due to "the low risk of developing BIA-ALCL." However, as with all implants, it is important to maintain regular breast exams and seek medical attention if you experience persistent swelling or pain, which tend to be the first symptoms of BIA-ALCL. BIA-ALCL is rare, but when detected early, it's easily treated, and in most cases, simply removing the implant and scar tissue can cure it, says Debra Johnson, MD, a board-certified plastic surgeon in Sacramento, CA.