The US Food and Drug Administration (FDA) just announced that Allergan is recalling all BioCell textured breast implant products from the United States and around the world, due to the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
The FDA said that to date, 573 unique cases of BIA-ALCL and 33 deaths have been reported around the world. This figure is up from 457 cases and 24 deaths in February 2019. Eighty-four percent of the 573 unique cases of BIA-ALCL (481) have been linked to Allergan implants. Of the 33 patient deaths, 12 of the 13 patients for whom the manufacturer of the implant is known are confirmed to have had an Allergan breast implant at the time of their BIA-ALCL diagnosis.1 The FDA said in a statement that the recall will help ensure that unused products are removed from suppliers and doctors’ offices, adding:
“Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BioCell textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the US.”
The recall includes the 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 used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.1
RELATED STORY:
Allergan’s textured breast implants have been off the market in ALL European countries since December 2018, following a recall order from a French regulatory body. In May 2019, the company pulled its textured breast implants off the market in Canada.
Following a two-day advisory committee meeting on breast implants in March 2019, the FDA announced in early May 2019 that based on evidence, it did not believe the device met the standard for banning as set forth in the US Federal Food, Drug, and Cosmetic Act. Thus, they continued to allow sales of textured breast implants to continue.
FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in today’s announcement:
On the basis of the latest data, the agency has now concluded that pulling the textured implants from the market is “necessary at this time to protect the public health.”1
RELATED STORY:
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said the agency is continuing to evaluate whether the risk of developing BIA-ALCL is limited to specific models of textured breast implants or applies to all textured breast implants1, adding:
“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.”1
Today, the FDA also issued a safety communication that outlines the known risks and what steps healthcare providers and patients should consider when monitoring for symptoms of BIA-ALCL, including breast pain and swelling. The FDA does not recommend removal of the recalled implants for women who do not have symptoms.
The FDA stated that it has been monitoring the issue since 2011 when it first identified the potential connection between breast implants and BIA-ALCL. Abernethy added:
“Since that time, we have worked to increase awareness and encourage reporting of all cases to the FDA so that we could continue to monitor this potential safety signal.”1
