The US Food & Drug Administration (FDA) has declined to ban the sale of textured breast implants. This is contrary to other countries, including France and Canada, doing so due to concern that they cause a rare form of cancer, breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).

The implants, which have a textured surface, rather than a smooth covering, have been associated with the cancer. The vast majority of these cases have occurred in women with textured implants, but the FDA said that the risk, although increased, was still low, and that there was not enough evidence to justify banning the implants.

About 10 million women around the world have implants, either for cosmetic breast enlargement or post-mastectomy reconstruction. Only about 10% of the implants used in the United States are textured, but in other countries the figure can be as high as 80%.

The FDA announcement followed a two-day public hearing in March, in which researchers and implant companies presented data, and women described a number of illnesses they developed after getting implants, including BIA-ALCL.

The FDA statement acknowledged that in some women, implants may be associated with ‘breast implant illness’, which includes symptoms like chronic fatigue, pain, cognitive and immune problems, as well as BIA-ALCL, and that the systemic symptoms may resolve when the implant is removed.

The FDA also stated that women and healthcare professionals need to be better informed about the risks of implants, although they did not commit to a specific course of action.

 

To read the statement in full visit www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas