A Word from Establishment Labs on the FDA's Announcement About ALCL

Establishment Labs has been closely following recent reports by media outlets concerning a rare form of non-Hodgkin lymphoma called breast implant associated anaplastic large cell lymphoma "BIA-ALCL", following a statement published by the FDA.

Establishment Labs understands that these reports could generate questions or concerns for women with breast implants, and, true to our patient-centric code, we would like to address potential concerns directly.

The FDA safety communication noted that BIA-ALCL has occurred “more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.”

To date, there have been no reported cases of BIA-ALCL in women with Motiva Implants®. This is detailed in our post-market vigilance data report, provided as a matter of transparency, which is issued in quarterly updates, and includes all reported possible complications since our product launch in 2010.

We are committed to the safety of our products and the health of women who choose them by offering advanced technologies like our proprietary SilkSurface®. Establishment Labs has spent the last decade developing and improving novel manufacturing processes that supersede traditional salt-loss macro-textures.

Women with breast implants should continue their routine breast health monitoring evaluations, including follow-up care such as mammography screening. As has always been recommended, please also continue to visit your plastic surgeon every year for a breast health check-up.

If you have not downloaded our MotivaImagine™ App we encourage you to do so, and get access to the most comprehensive breast health app for women with breast implants that securely stores the specific information on your Motiva Implants®.