Breast Implants – Certain Labeling Recommendations to Improve Patient Communication

The Food and Drug Administration recently released a final guidance containing recommendations for the labeling components, such as format and content, of saline and silicone gel-filled breast implants. This guidance was developed with the intent to help provide information on these devices to ensure each patient is properly informed on the benefits and risks of breast implants. These recommendations are not intended to replace physician-patient discussion or prior regulations and labeling recommendations, but to complement and enhance existing information. Patients are still encouraged to discuss their questions and concerns directly with their doctor. If you are unsure what the best breast implant or augmentation choice is for you, our office is here to help you determine the right surgery for your desired results. Contact Dr. J. J. Wendel today to learn more about your breast augmentation surgery choices.

Learn more: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication