Black Box Warning

Plastic Surgery Insights from Dr. Slack

‘Black Box’ Warning on Breast Implants: What You Need to Know

The FDA recently asked for new “black box” warning labels on all breast implant packaging and has required Plastic Surgeons to deliver specific information about potential health risks posed by these devices. In addition, they updated their screening recommendations–now proposing an MRI or ultrasound 5-6 years after augmentation as well every 2 -3-year interval going forward.

The “Black Box” warnings have to do with two issues: the link between textured implants and an immune system cancer that can develop in the scar tissue capsule that forms around breast implants and the possibility that breast implants can cause systemic symptoms in patients. The immune system cancer is known as Breast Implant Associated Anaplastic Large Cell Lymphoma (bia-ALCL).  The issue with implants causing symptoms in patients is known as breast implant illness.

The issue with textured implants and bia-ALCL is relatively new. Although the first case was noted about 20 years ago a possible link between bia-ALCL and textured implants was not established until 2011. This was mainly due to the low number of women with textured implants that had developed bia-ALCL. The most recent FDA data states there have been 733 unique cases worldwide since the first case was recognized.

Breast implant illness, on the other hand, is not a new issue. The possibility that breast implants might cause systemic symptoms (brain fog, memory loss, fatigue, rashes, joint pain, fevers) dates to the early 1990’s when the FDA took silicone breast implants off the market out of concern that they may increase the risk of some individuals of developing autoimmune diseases. During the moratorium on silicone implants there were multiple studies by different investigators attempting to demonstrate a link between breast implants and autoimmune disease. In 2007, after reviewing 15 years of research, the FDA did not feel there was evidence of a link and allowed silicone implants back out on the American market.

In addition to bia-ALCL and breast implant illness, there are other potential issues to consider before having a breast augmentation procedure. These issues include implant rupture (leakage), capsular contracture, infection, hematoma, seroma, loss of sensation, impact on mammograms, implant malposition, asymmetry, animation deformity, extrusion, and the potential irreversible changes that implants can cause to breasts overtime. Part of the new informed consent will go over these issues along with reporting how often they can occur. It is important to know that The FDA chose to report the highest rates of occurrence to come out of multiple studies that have been done to evaluate these issues.

The possibility that breast implants could cause illness or other inherent risks of having breast implants over a lifetime has been part of my initial consultation with prospective breast augmentation patients since I started in practice. Bia-ALCL has been a part of that discussion for last 5 years or so.  I’ve always felt it was important for my patients to understand the pros and the cons of any procedure they were considering. I think this is particularly true for breast augmentation.  My intent is not to scare patients but to educate them so that they can make an informed decision for themselves about whether a particular surgery is right for them. It is important to know that the FDA chose to use data from studies with the highest rates of occurrence of these issues despite many other studies that demonstrated lower rates of occurrence.

If you or someone you care about has questions about a breast procedure, please reach out to us, especially if you are in Allen, Plano, McKinney, or Frisco, TX, or the North Texas area.  We would be glad to help you as well.  Call us at 214-495-6464 or contact us here.