The FDA Says It Won’t Ban Textured Breast Im...
The FDA Says It Won’t Ban Textured Breast Implants, But Will Keep Collecting Data
Published May 3, 2019
The United States Food and Drug Administration has announced that it won’t be banning textured breast implants, which have been linked to a rare type of blood cancer.
In making its decision, the FDA said that it would take measures to collect and disseminate information about the possible risks. Furthermore, “textured” implants, a subgroup of silicone implants whose rough surface allows the reconstructed breast to maintain a desirable shape and position, are far more unusual in the U.S. than in some other countries. And cancer cases that may be linked to these implants are infinitesimal in number.
“While the F.D.A. doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed,” the agency said in the statement, issued by principal deputy commissioner, Dr. Amy Abernethy, and Dr. Jeff Shuren, director of the center for devices and radiological health. “We believe women considering a breast implant should be aware of these risks.”
The announcement comes after a hearing on textured breast implants and the risk of causing cancer, where patients who were diagnosed with cancer after receiving the implants told their stories to an FDA panel. “Cancer was not a choice, and we sure as heck didn’t elect to get it,” Dawn Criss of Alberta, Canada, told the panel.
The FDA’s Dr. Binita Ashar said in a statement earlier this year that there are now 457 women in the U.S. diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), up from 414 cases in the last report. There have been more than 600 cases of BIA-ALCL, a cancer of the immune system, reported worldwide. Sixteen women have died, nine in the U.S.
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” Dr. Ashar said.
Indeed, implant-linked ALCL is rare — ALCL is a rare type of non-Hodgkin lymphoma; it’s a subtype of T cell lymphoma. It is a rare disease, making up only 1% of all non-Hodgkin lymphomas and 16% of all T cell lymphomas.
Other countries where the textured implants are more popular have already banned them. France was the first country to ban textured implants in early April, after the safety of the implants came into question internationally. Canada followed suit with its own ban shortly thereafter.
For some doctors, the risks of textured implants seem greater than the rewards. “I find it very hard to find a compelling reason to use textured implants,” Dr. Alyssa Golas, plastic surgeon at NYU Langone Health told SurvivorNet.
But it’s also important not to worry too much if you’ve had textured breast implants, according to Dr. Golas. “ALCL is a very rare type of cancer, that’s been found to be associated with a specific kind of implants, meaning textured. So as long as you stay away from those, there is very little reason to worry,” she says.
And even with textured implants, your risk of developing cancer is still fairly low. “There is a 1 in 1,000 to 1 in 10,000 risk with textured implants that you could get cancer, and as long as people are aware of that they are still okay. But patients have to be okay with it, and if they aren’t okay with it, you have to do something else.”
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The United States Food and Drug Administration has announced that it won’t be banning textured breast implants, which have been linked to a rare type of blood cancer.
In making its decision, the FDA said that it would take measures to collect and disseminate information about the possible risks. Furthermore, “textured” implants, a subgroup of silicone implants whose rough surface allows the reconstructed breast to maintain a desirable shape and position, are far more unusual in the U.S. than in some other countries. And cancer cases that may be linked to these implants are infinitesimal in number.
“While the F.D.A. doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed,” the agency said in the statement, issued by principal deputy commissioner, Dr. Amy Abernethy, and Dr. Jeff Shuren, director of the center for devices and radiological health. “We believe women considering a breast implant should be aware of these risks.”
The announcement comes after a hearing on textured breast implants and the risk of causing cancer, where patients who were diagnosed with cancer after receiving the implants told their stories to an FDA panel. “Cancer was not a choice, and we sure as heck didn’t elect to get it,” Dawn Criss of Alberta, Canada, told the panel.
The FDA’s Dr. Binita Ashar said in a statement earlier this year that there are now 457 women in the U.S. diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), up from 414 cases in the last report. There have been more than 600 cases of BIA-ALCL, a cancer of the immune system, reported worldwide. Sixteen women have died, nine in the U.S.
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” Dr. Ashar said.
Indeed, implant-linked ALCL is rare — ALCL is a rare type of non-Hodgkin lymphoma; it’s a subtype of T cell lymphoma. It is a rare disease, making up only 1% of all non-Hodgkin lymphomas and 16% of all T cell lymphomas.
Other countries where the textured implants are more popular have already banned them. France was the first country to ban textured implants in early April, after the safety of the implants came into question internationally. Canada followed suit with its own ban shortly thereafter.
For some doctors, the risks of textured implants seem greater than the rewards. “I find it very hard to find a compelling reason to use textured implants,” Dr. Alyssa Golas, plastic surgeon at NYU Langone Health told SurvivorNet.
But it’s also important not to worry too much if you’ve had textured breast implants, according to Dr. Golas. “ALCL is a very rare type of cancer, that’s been found to be associated with a specific kind of implants, meaning textured. So as long as you stay away from those, there is very little reason to worry,” she says.
And even with textured implants, your risk of developing cancer is still fairly low. “There is a 1 in 1,000 to 1 in 10,000 risk with textured implants that you could get cancer, and as long as people are aware of that they are still okay. But patients have to be okay with it, and if they aren’t okay with it, you have to do something else.”
Learn more about SurvivorNet's rigorous medical review process.