FDA Recommends Warnings on Labeling for Breast Implants
Posted: Thursday, October 24, 2019
Yesterday, the U.S. Food and Drug Administration (FDA) issued a draft guidance proposing labeling recommendations to manufacturers of breast implants to help ensure women receive and understand information regarding the benefits and risks of these devices. Among the numerous recommendations proposed are incorporating a boxed warning and other elements in breast implant labeling.
To help inform conversations between patients and health-care professionals when breast implants are being considered, the FDA first proposes a noticeable and easy-to-read boxed warning be included in labeling for breast implants. Manufacturers are asked to identify certain risks in the boxed warning, including that breast implants are not lifetime devices; the chances of developing complications increase the longer a patient has the implant and additional surgery may be required to address the complications; and that breast implants have been associated with the risk of developing breast implant–associated anaplastic large cell lymphoma and systemic symptoms (eg, fatigue or joint pain).
Additionally, the draft guidance recommends that manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure. This checklist is intended to help guide discussion during a patient’s consultation with a surgeon.
Another recommendation described in the draft guidance focuses on revising the rupture screening recommendations for patients with silicone gel–filled breast implants. The FDA proposes that patients without symptoms be screened using either ultrasound or MRI at 5 to 6 years after implantation and then every 2 years thereafter. If a patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.
Finally, the draft guidance includes a recommendation that breast implant manufacturers include product ingredient information in the device’s labeling in a way that is easy for patients to understand. The FDA believes that improved access to this descriptive information will help better inform patients of the types and quantities of chemicals and heavy metals that are in breast implants.