On Monday, breast implant manufacturer Allergan announced the launch of a digital campaign to reach patients currently or formerly implanted with Biocell breast implants, which were recalled worldwide in July 2019.
The campaign, which includes digital and social media advertisements, is intended to inform the public about the recall, alert patients about breast implant associated cancer risks, and improve breast implant tracking.
Concerned patients are directed to Allergan’s Biocell information website, where they can register their breast implants, learn more about the recall, and access patient resources.
BIA-ALCL, or breast implant associated anaplastic large cell lymphoma, is an immune system cancer that can develop around breast implants, especially textured breast implants such as Allergan’s Biocell implants. The American Society of Plastic Surgeons reports 903 suspected and confirmed BIA-ALCL cases worldwide and 33 known deaths. BIA-ALCL is not a form of breast cancer.
Under Mounting Pressure, Allergan Finally Takes Action
While Allergan’s action is certainly beneficial to patient health, it also begs the question: What took so long?
Nearly a year has passed since the company’s Biocell breast implant recall.
Then, just two weeks ago on May 14, the U.S. Food and Drug Administration issued a warning letter to Allergan, citing failure to comply with patient follow-up study requirements.
Four days after the FDA letter, on May 18, Fortune magazine published a major investigation into breast implant dangers.
The FDA “asked Allergan to develop a strategy to contact patients who may not have heard about the recall” and plans to work with the manufacturer to “amplify the message and outreach,” Fortune reported.
Allergan is currently facing 48 lawsuits regarding its recalled breast implants and BIA-ALCL, several of which are class-action claims. This pressure, along with that of the FDA, is cause enough to question the push for a patient health campaign 10 months post-recall.
"We are determined to make sure every woman has the information they need related to the Biocell voluntary recall and we will continue to encourage women with breast implants to determine their implant type and opt-in to our device tracking system. Patient education is a priority,” Carrie Strom, senior vice president at Allergan parent company AbbVie, and president at Allergan Aesthetics, said in the release.
Longtime critics of breast implant safety aren’t sold on the campaign, according to Fortune.
“I don’t know how visible it’s going to be,” Diana Zuckerman, president of the National Center for Health Research, told Fortune. “Will the kind of money and effort be put into this in a way that’s comparable to ad campaigns when they’re selling something?”
To further signal boost Allergan’s efforts, Fortune reported that the FDA recently held a conference call with breast implant regulation advocates to spread word of the ad campaign — a new and welcome step in advocating for patient safety.
The launch has also been announced on the FDA’s website.