Highlighting a “clearly established link” between the rare cancer and silicone breast implants, the French group called for a warning on the devices, and media reports suggest that France is considering a general ban on the implants.
So far, 18 women in France have been identified with breast implant–associated ALCL since 2011.
The US Food and Drug Administration and US plastic surgeons are currently taking active measures to determine the nature and or scope of any possible association.
“To date, the FDA still feels that currently approved breast implants are safe; however, the issue of this incredibly rare phenomenon, ALCL, needs to be carefully followed as we are doing,” says Michael C. Edwards, MD, FACS, President of American Society for Aesthetic Plastic Surgery (ASAPS) and a plastic surgeon at Anson, Edwards and Higgins Plastic Surgery Associates in Las Vegas.
There may be some smoke, but there is no evidence of fire yet, agrees Scot Bradley Glasberg, MD, a plastic surgeon in New York City and President of the American Society of Plastic Surgeons (ASPS). “We understand the concern of the French government as it has had several instances with the French breast implant manufacturer Poly Implant Prothèse (PIP), but we do not think women should be panicked or worried, just aware,” he says. “The reality is that the prevalence of ALCL in women with breast implants is exceedingly low, so low that there is no scientific evidence of a link,” Glasberg says.
So far, there are 61 identified cases across the globe, but there is only complete information for about half of them, Glasberg says.
Current risk estimates range from one in 500,000 to one in 3 million women with implants, according to research published in Plastic and Reconstructive Surgery (PRS).
Fallout from the PIP Scandal
Edwards agrees: “I think they are still in the shadows of the PIP fiasco, which had no effect on US patients.”
PIP implants were filled with industrial-grade silicone, and a result were significantly more likely to rupture. About 400,000 women in 65 countries received these implants, and 4,000 ruptures were reported. The company founder and chief executive was prosecuted, fined, and is now serving a 4-year jail term. The company shut its doors in 2010, and France banned the PIP implants.
To get a better grip on any possible connection between ALCL and breast implants, the ASPS is working with the FDA to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE), Glasberg says.
“The goals of the registry are to better characterize ALCL in women with breast implants and, thereby, possibly better understand the role of implants in the cause of ALCL,” he writes in PRS. “These types of data could yield valuable information in determining whether a link or association actually exists.”
The ASPS, in partnership with The Plastic Surgery Foundation, the FDA, and breast implant manufacturers, is also collaborating on the development of a National Breast Implant Registry that will look at any and all complications associated with silicone and saline breast implants.
ASAPS is also doing its part to better understand any possible connection between ALCL and silicone breast implants. “ASAPS is very involved in educating our member plastic surgeons about the rare condition, and The Aesthetic Surgery Education and Research Foundation is funding research in further characterization of ALCL,” Edwards says.