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The scientific evidence linking textured breast implants to a rare form of cancer continues to grow, with a recent study published by Australian researchers providing a “strong link” between anaplastic large cell lymphoma (ALCL) and the type of surface for the implant women receive.
In a study published earlier this month in the medical journal Plastic and Reconstructive Surgery, researchers indicate that the risk associated with specific implants was connected to the surface area size and roughness.
Researchers looked at data on new cases of ALCL diagnosed among women with breast implants in Australia and New Zealand from January 2017 to April 2018, and also looked at updated sales data from Allergan, Mentor and Silimed, the three leading breast implant manufacturers in that region to estimate implant-specific risks.
The researchers reviewed data on 26 new cases of breast implant lymphoma in the two countries during that time period. Overall, there are 81 known cases of breast implant-associated ALCL from those two countries.
According to the findings, over the course of the study period, the implant-specific risk for Silimed polyurethane implants was 23.4 times higher, and the risks of Allergan’s Biocell implants were 16.5 times higher than non-textured implants.
“The number of confirmed cases of BIA-ALCL in Australia and New Zealand continues to rise,” the researchers reported. “The implant-specific risk has now changed to reflect a strong link to implant surface area/roughness as a major association with this cancer.”
The study comes as Australian regulators conduct an intensive look at the risks and benefits of breast implants, including BIA-ALCL problems, to determine whether textured breast implants should be banned in that country.
That review was announced about a month after French health officials announced a macrotextured breast implant recall and ban in that country, saying that textured breast implants have been overwhelmingly associated with BIA-ALCL in that country and provide little to no benefit over smooth surfaced implants.
At about the same time, Canadian health officials made a similar decision, banning all Allergan Biocell breast implants in that country after linking the devices to 86% of BIA-ALCL cases in that country.
However, in the U.S. the FDA recently decided against a complete ban, indicating textured breast implants make up only a small number of U.S. sales and noting that it has found cases of BIA-ALCL linked to smooth textured implants as well. The agency instead opted to place stronger warning labels on the implants.
In March, the FDA held a two-day hearing on breast implant safety and benefits, revealing that it has received tens of thousands of reports of breast implant complications.
Despite growing concerns, the panel of FDA advisers decided against recommending any breast implant recalls, indicating that it was too early to determine whether the risks were limited to specific breast implant designs.