Breast Implants: The View From the FDA

Binita Ashar, MD, MBA, FACS; David Krause, PhD; Laurie Scudder, DNP, NP


July 17, 2013

Editorial Collaboration

Medscape &

In This Article


Medscape: What are the recommendations for monitoring women who have received breast implants? You alluded to differing recommendations in monitoring for rupture with these newer devices.

Dr. Ashar: Both patients with saline-filled and silicone gel-filled breast implants should continue routine mammography for breast cancer screening as recommended by their healthcare provider, based on age and risk factors. Patients with silicone gel-filled breast implants should also have periodic MRI screening examinations to detect "silent rupture" of the breast implant. The FDA's recommendation is that the first MRI screening should be conducted 3 years following implant placement, and then every other year after that. This is an across-the-board recommendation -- all women, regardless of the reason for the implant and personal factors, such as age, should receive MRI screening on this schedule until enough scientific data are collected to determine a predictive timeline for rupture risk.

Medscape: What resources do you recommend for clinicians providing education and counseling to women considering breast implantation?

Dr. Krause: The FDA has a breast implants Webpage with resources that include:

Links to patient information and data for each product;

Information about risks and complications;

Questions for patients to ask healthcare professionals regarding breast implant surgery; and

Contact information for manufacturers of FDA-approved breast implants and related professional organizations.

Acknowledgment: Drs. Ashar and Krause would like to thank Janette Alexander, MD, Plastic & Reconstructive Surgery Branch, Office of Device Evaluation, Center for Devices and Radiological Health, FDA; Plastic Surgeon (BC- ABPS), Clinical Reviewer for FDA, for her contributions to this article.