Understanding The FDA’s New Breast Implant Regulations And Black Box Warning

Breast augmentation is one of the most popular and frequently performed cosmetic surgery procedures in the United States.  Information about the performance and safety of breast implants has been systematically collected over the past 30  years.  Overall, implants  are used for cosmetic applications like breast augmentation 75% of the time.  Reconstructive uses like breast reconstruction after breast cancer surgery and treatment of congenital deformities represents approximately 25% of the use.

In October 2021, FDA came out with new regulations on the use of breast implants.  They had expressed concern about what information was provided to patients and how much variation in this was taking place.  FDA wanted to insure a more uniform disclosure to patients about various types of important information about breast implants so patients would be better empowered to make an informed decision.    The new FDA regulations had several main features:

  • Mandated use of a patient decision-making checklist
  • Added a black box warning (boxed warning) about possible side effects including anaplastic large cell lymphoma (ALCL) with breast implants
  • Requirement to present information about materials present in implants
  • Requirement to present manufacturer specific performance data on their implants
  • Some changes to the existing patient device card that is provided to patients
  • Provided an update to screening recommendations for surveillance of silicone gel implant rupture.

There are many important points to understanding what the new regulations provide and why they were put in place.  A recent development in our understanding of breast implants is the possibility, although rare of developing anaplastic large cell lymphoma (ALCL).  This is not breast cancer but rather a tumor (cancer) that forms in the implant capsule –the scar tissue that heals around breast implants.  Over many years this rarely produces a tumor that requires removal of the implant and capsule for treatment or sometimes further measures if detection has been delays and the tumor is more advanced.

We believe this is associated only with textured breast implants but the warning applies to all breast implants because theoretically it is possible to form this tumor with any implant.  Data is evolving on they incidence of this problem but it is currently believed to occur in 1 in 2,200 to 1 in 86,000 patients who have breast implants.

There are several signs that should lead you to immediately seek evaluation from your plastic surgeon:

  • Lump
  • Hardening of the breast
  • Overlying skin rash
  • Fluid collection around implant
  • Breast enlargement.


General risks that are part of the implant performance data:

  • ALCL
  • Capsular contracture
  • Implant failure
  • Systemic symptoms (often referred to as BII -breast implant illness)


One of the most important points here is that implants are not lifetime devices.  They will wear out and fail eventually, necessitating more surgery, anesthesia, recovery time and cost, at some point in the future.  I have always had this conversation with my patients during the consultation, telling them that if they want to enlarge their breast size or tailor the shape with implants but never want to think about the implants again then breast augmentation is a bad idea for them.  If they can accept the trade-off of some future surgery for removal and replacement of the implants, then they may get a great deal of happiness and satisfaction from the procedure.  It’s just important to understand what you’re signing up for and factor that into your decision making before deciding to go ahead with the procedure.

Another important issue relates to the need for regular surveillance with breast implants.  Everyone with a breast implant or implants should see the plastic surgeon once a year.  Screening for silicone gel implants also requires more testing and out of pocket expenses associated with surveillance for rupture and leakage of silicone gel.  Traditionally an MRI was called for starting just a few years after placement of the implant.  The imaging requirements have been slightly relaxed based on the performance data and use of high resolution ultrasound is now deemed an acceptable and simpler, less expensive alternative based on improvements in the technology.

What is a black box warning?  Technically, this is called a boxed warning which is added to the information from FDA  – featured in a black box that is printed around the information to draw attention to it.  The boxed warning highlights important information about possible serious side effects associated with a medical product.  In recent years, the FDA has shown a willingness to add these warnings especially for things like elective cosmetic procedures and treatments to aid the public in personal decision-making about their healthcare.


Dr. Bass’ takeaways:

  • Anything that standardizes information disclosure is a good idea.
  • I have an extensive discussion about these issues with my patients. The beauty of elective procedures is that there is ample time to sort through the details and make sure you are making a good decision for you.  Cosmetic surgery should never be an impulse decision.
  • Nowadays, there is extensive knowledge about the behavior of implants as they age including the frequency or incidence of various problems exists. Consider these issues carefully in terms of whether you want to take that risk before you are committed to breast implants or are in trouble with a known risk.
  • The implant is a device that must be present for decades and will eventually wear out. Breast implants are not lifetime devices.  They often last decades, but not always.  When the implant fails, you are committing to more cost, surgery, anesthesia, and recovery time.
  • Most people with a failed implant request not just removal but also replacement –even senior citizens –since t his has become part of their self image for many years.
  • Make sure to get the proper surveillance. See your plastic surgeon and get the required imaging.  Have an ongoing relationship with your plastic surgeon.