Canada Halts Sales of Cancer-Linked Breast Implants
Posted: Thursday, April 25, 2019
Studies have shown that patients with textured breast implants face a higher risk of a rare type of cancer—breast implant–associated anaplastic large cell lymphoma (BIA ALCL). The U.S. Food and Drug Administration (FDA) estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia have placed the risk as high as 1 in 1,000.
Canadian regulators have now halted the sales of textured breast implants. Textured implants produced by manufacturers other than Allergan remain on the market worldwide, with the exception of brands banned in Europe. Textured implants produced by Allergan were suspended from the European and Brazilian markets in December 2018 after losing their European certification. This February, a French government inquiry recommended that one brand of textured implants, Allergan Biocell, be permanently banned.
The French government inquiry that issued its report in February called for a European-wide system of classification to be applied to textured implants. This proposed system would classify textured implants on a scale from 1 to 4, with higher numbers indicating greater surface and roughness and therefore greater risk of BIA ALCL.
At a recent 2-day meeting on breast implants held at the FDA, a panel of federal medical advisers offered wide-ranging suggestions for addressing known, suspected, and claimed risks from these products. Although some panel members called for a ban on certain products, others emphasized the lack of data, and a range of different opinions were expressed.
At least one clear message emerged: physicians must help women to better understand the risks and shortcomings of breast implants, including the risk of developing a rare cancer. Patients need to have more “realistic expectations” about these devices, said Frank R. Lewis, Jr, MD, Chairman of the FDA’s General and Plastic Surgery Devices Advisory Committee.
One member of the panel, Stephen Li, PhD, a biomaterials expert, noted: “It’s not yet firmly established that the texturing on the surface of implants is the culprit in BIA ALCL.”
