Despite evidence linking texture breast implants to a rare form of cancer, the United States Food and Drug Administration announced on Tuesday that the implants, which are designed to move around inside the breast less than smooth implants, will not be banned for sale in the U.S., according to a New York Times report.
The rough or grooved surfaces of textured implants allow the implants to adhere more tightly to scar tissue that forms around the implant, making them less likely to shift position in the implant “pocket,” according to Texas Medical Center News. Smooth implants, while giving the breasts a more “natural” appearance, are more likely to change position, possibily necessitating more surgery.
But a rare cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL, can grow in the spaces between the grooves in the implant and the scar tissue that surrounds it.
The FDA, however, said in a statement explaining its decision that there was not “definitive evidence demonstrating breast implants cause these symptoms,” and added that even though the “majority” of women who develop BIA-ALCL have received textured implants, “there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis.”
But one medical expert told The Times that the FDA is wrong, and that there are no known cases of the rare cancer occurring in women with only smooth breast implants. Plastic surgeon Dr. Mark Clemens, of M.D. Anderson Cancer Center in Houston, told the paper that the only known women with smooth implants who develop the cancer had previously had the textured implants, but had replaced them.
The textured implants have already been banned in several other countries, most notably France, which banned "macro-textured and polyurethane implants" in early April. Brazil stopped production of textured implants in 2015.
Rather than banning the implants, the FDA said that it would, “take steps to improve the information available to women and health care professionals about the risks of breast implants that would include addressing the risk of BIA-ALCL, the greater risk of BIA-ALCL with textured implants, and the risk of developing systemic symptoms that would contribute to the patient-provider discussion about breast implants.”
Photo By FDA/Wikimedia Commons Public Domain
