Mentor Responds to New FDA Safety Requirements

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Mentor fully supports U.S.FDA requirements that aim to improve the information available to patients and health care professionals about the risks associated with breast implants. Nothing is more important to Mentor than the health and safety of the patients who choose our breast implants. We are committed to doing our part to ensure every patient understands the risks associated with breast implant prior to deciding whether to move forward with implantation.

We have worked collaboratively with FDA to update our physician and patient labeling to meet the agency’s new requirements in anticipation of this announcement. We are also enhancing the safety information available to patients on our website,, including the addition of an interactive learning tutorial for patients.

Mentor will continue to collaborate with surgeons, societies and patient advocacy groups to further patient education and transparency around breast implants and breast implant surgery, as well as identify additional ways to ensure patients have consistent access to updated information that will support a meaningful conversation with their surgeon.

About Mentor Worldwide LLC

Mentor Worldwide LLC, part of Johnson & Johnson Medical Devices Companies, is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation.  For more information, visit

Media Contacts:

Rachel Hooper
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Tracy Garcia Gale
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