Update On FDA Final Guidance

October 2, 2020

Dear Valued Partner,

Last week the U.S. FDA issued its final guidance for labeling recommendations for breast implants, to help ensure women receive and understand information regarding the benefits and risks of breast implants.

These recommendations include:

• A boxed warning added to breast implant labeling to help ensure physicians and patients are aware of certain risks associated with breast implants.
• A patient decision checklist that highlights key risks and complications associated with breast implants and informs the patient about other options for consideration.
• Revision of the rupture screening recommendations for patients with silicone gel-filled breast implants to include screening using either ultrasound or MRI at five to six years following implantation, and then every two to three years thereafter for patients without symptoms.
• Inclusion of product ingredient information in the patient brochure that is presented in a way that is easy for patients to understand.
• Addition of information on the patient’s device card to include a link to the manufacturer’s website where up-to-date versions of the patient checklist and product labeling will be located, and a reference to the existence of a boxed warning.

At Mentor, we are committed to doing our part to ensure every woman understands breast implant safety prior to deciding to move forward with a breast implant operation. We have been actively collaborating with surgeons, societies and patient advocacy groups to further patient education and transparency around breast implant surgery, which led us to launch our patient-focused website in the United States – BreastImplantsByMentor.com. This site includes an enhanced safety section that includes information that patients should review and discuss with their surgeons prior to – and following – breast implant surgery.

The site also includes information about the ingredients used in our products, an overview of common complications, and information about rare complications that should be considered. In addition, we continue to make available the important safety information women should know in brochure form so that you can provide the brochure to your patients and refer to it during your informed-consent conversations. You can find electronic copies of these on our website here and order hard copies via Mentor Direct.

We have been working to update our labeling to meet FDA recommendations in anticipation of this final guidance, and we are committed to keeping you updated as we implement these changes.

If you have any questions or would like to share feedback on how we can collectively ensure that women have the information needed to make informed choices about their breast surgeries, don’t hesitate to reach out to me.

Sincerely,

Diane Gomez-Thinnes
Worldwide President, Mentor
[email protected]