On October 23, 2019, the US Food and Drug Administration (FDA) published a draft of their recommendations to improve patient communication regarding breast implants. Like most plastic surgeons who do a large volume of plastic surgery on the breast, my office was immediately inundated with phone calls from anxious patients who have undergone breast augmentation or breast reconstruction with implants. Does the FDA now know something about the safety of implants that they had not previously shared? Is there a NEW risk associated with breast implants? Is there now data that show breast implants, which are the most studied device in the history of the FDA, should be removed from otherwise healthy patients. The answer to all of these questions is a resounding NO! The FDA recommendation is merely a suggestion of standardized language that every patient needs to know regarding these devices.
What is a Box Warning?
One of the recommendations is that breast implant packaging contain a Box Warning (AKA a Black Box Warning) alerting patients and physicians on the risks associated with these medical devices. It’s important to understand that a Box Warning on a device does not mean that it’s somehow damaged or dangerous. This is merely a message that the FDA wants to make sure ALL patients and physicians receive. There are four major points that the FDA would like included the Box messaging:
- Breast Implants are medical devices and are not intended for lifetime use
- The chance of developing a complication increases with time
- Some complications will require additional surgery
- Breast implants can be associated with BIA-ALCL and may be associated with systemic symptoms
None of the above is NEW information. Women with implants will most certainly need their implants exchanged over time. Take a moment to read my blog “I Have 10-Year Old Breast Implants, Now What?” Most plastic surgeons discuss these issues with patients in their initial consult. However, it is important that ALL patients understand these issues.
Recommendations for Implant Labeling
In addition to the box warning, the FDA wants to make sure that the information disseminated to potential patients is consistent and standardized. The recommended language for package labeling includes:
- Patient decision checklist – This would assure that all patients understand the difference in types of implants, specific complications associated with implants and a group of decisions that women must make when choosing to undergo surgery with implants.
- Materials and device descriptions
- Silicone gel rupture screening recommendations
- Patient device card
These are all points that I discuss with my patients in their initial consult and in subsequent follow-up visits.
The final, and perhaps most important, point that the FDA is calling attention on is the importance of the training and experience of the surgeons performing these procedures. This was an important issue that was raised at the FDA implant hearings in March 2019. We know that complications secondary to implants can be minimized when the procedures are performed by board-certified plastic surgeons. Whether you are a patient that is considering surgery with implants, or you are a woman with implants looking for a surgeon to follow-up with, it is essential that you see a board-certified plastic surgeon.
In summary, patients should not be alarmed by this new communication. They should be optimistic that the FDA recognizes the importance of patient communication and patient safety. Most of us will not need to change our practice at all given these new guidelines. For those that have been remiss in fully educating patients, these new guidelines will assure all patients get the information they need to make a decision on implant surgery.
NOTE: Dr. Troy Pittman is a board-certified plastic surgeon who practices in Washington, DC. He is an internationally recognized expert in aesthetic and reconstructive breast surgery. Dr. Pittman frequently lectures on the topics of breast augmentation, revision breast reconstruction and breast implant safety.