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.



Doreen Wu (00:00):
Welcome to another episode of Park Avenue Plastic Surgery Class, the podcast where we explore controversies and breaking issues in plastic surgery. I’m your co-host Doreen Wu. And I’m excited to be here with Dr. Lawrence Bass Park Avenue plastic surgeon, educator, and technology innovator. The title of today’s episode is understanding the FDA’s new breast implant regulations and black box warning. Breast augmentations are one of the most popular and commonly performed surgical cosmetic procedures in the United States when considering breast implants, people often have many questions such as whether to get silicone or saline implants, what size to get, which style, what the aftercare looks like and the long term risks associated with implants. So, Dr. Bass, what is the news about breast implants? What do I need to know to make an informed decision?

Dr. Lawrence Bass (00:56):
Well, the FDA was concerned that, uh, a lot of the information about the performance of breast implants and some new things that we’re learning about the behavior of certain types of breast implants were not being communicated adequately to every patient that was considering whether or not they wanted to have breast implants placed. The first important thing to remember is breast implants are used for cosmetic use. That’s about three quarters of the breast implants. And the other 25% is for breast reconstruction after breast cancer surgery. So breast implants are an important part of, of medical care for those patients. And we want them to be around available, and we want to know everything about what’s involved in their use. So we can adequately communicate that to patients. And FDA was wondering though, what are patients being told? How much of that information did the average surgeon tell them how much variation was there? And there were some new developments like anaplastic large cell lymphoma, or ALCL, uh, which is a new development that we became aware of over the last several years. And they wanted to be sure that information about that was available to patients as well,

Doreen Wu (02:30):
In response to this concern, what did the FDA decide to do? What did they put on this black box warning?

Dr. Lawrence Bass (02:38):
So the FDA decided to in their recent regulation, which came out the very end of October in 2021 and fully went into effect. 30 days later, they decided to take several steps. They did put a black box warning, or what’s called a boxed warning officially at FDA on breast implants. They required that there be a patient decision checklist that’s followed as part of the consent process to provide patients a step by step process for considering all of the important information in FDA’s view about breast implants before they decide whether to go ahead or not. They provided, uh, regulation on presenting information on the materials that are in breast implants and device description, so that people understood what they’re putting in their bodies, what the materials are. Uh, they added a patient device card regulation that was somewhat updated from the existing device cards. Um, they wanted patients presented with manufacturers specific performance data after the initial approval studies, which look at the patients out to a typical length of time and many FDA studies that six months or a year. But these implants of course remain in patients for decades. So FDA required each manufacturer to complete a post-approval study following patients for years and years after implants had been placed. So they wanted patients to see some of that performance data to understand what kind of problems developed with breast implants down the line. And finally, the FDA updated some of their screening recommendations for how to perform surveillance on breast, on silicone gel, breast implants, to determine if there’s a hidden rupture of the implant or not

Doreen Wu (04:54):
Earlier, you mentioned anaplastic large cell lymphoma. What is the story behind ALCL? Is it breast cancer?

Dr. Lawrence Bass (05:03):
Uh, so ALCL is not breast cancer. Uh, it is a form of cancer that can form in the capsule or scar tissue that heals around a breast implant. At this point in time, it has only been identified in patients who have received the textured breast implant or who had one point in time, had a textured breast implant in their body. Patients who have only had smooth breast implants, uh, currently have not identified a case of ALCL although theoretically, it might be possible. So this tumor develops in the capsule. It may show as a lump or, uh, hardening of the breast overlying skin rash, or sometimes there’s a fluid collection around the implant, which could produce breast enlargement. So if any of those signs are seen in anybody who has a breast implant in, they should see their plastic surgeon to be evaluated. Typically this is treated by removing the implant and the capsule.

Dr. Lawrence Bass (06:19):
And if that’s caught early, that’s all the treatment that’s required. If it is found very late in the game, sometimes other treatments are required. So this is something that we’ve just seen in the last several years. It’s very, very rare, but FDA felt that this new finding needed to be part of the consent process. The current risk, as we understand at the time of this recording is that the lifetime risk of getting breast implant associated ALCL is somewhere between one in 2,200 and one in 86,000. So very uncommon, very low risk, but certainly something to factor into decision making.

Doreen Wu (07:05):
What are the big items on risks and outcomes that the FDA wants patients to consider and be aware of in deciding whether or not to get breast implants?

Dr. Lawrence Bass (07:17):
So ALCL was, was one of them. And there’s also some concern nowadays, uh, in some patients that the implants have produced sort of a brain fog or fatigue, other kinds of systemic symptoms. This is called breast implant illness, which is controversial, but they wanted patients to at least be aware that their, that some people believe that the implants themselves can cause some of these symptoms. The other really important features that FDA was keying into was the following that the implants are not expected to be a lifetime implant, like any device it can wear out and fail and that necessitates more surgery, anesthesia, recovery, time, more money out of pocket. Um, and I’ve always told my patients, you know, if you like the idea of having bigger breasts, but you never want to think about the implants again, this is not a good idea.

Dr. Lawrence Bass (08:31):
If you like the idea of adjusting your breast size and you accept that, it means somewhere in the future, more surgery, more tinkering with the implants, potentially implant, removal, or replacement, then, you know, patients love their breast implants and typically are very satisfied, but you have to understand what you’re signing up for. Uh, they also wanted patients to understand that you should undergo regular surveillance, plastic surgeons, typically like to see their breast implant patients once a year and at any time, if there’s a change in the implant. And they wanted patients to understand that the screening for possible rupture of silicone gel implants, not saline implants, uh, involves more testing, more out of pocket expense. In most cases,

Doreen Wu (09:32):
The term black box warning sounds ominous. Should it make patients afraid or does it mean that the product is dangerous?

Dr. Lawrence Bass (09:41):
It’s not so much that the product is dangerous, but you know, there are some significant considerations with implants as I just described, as well as other things that can happen, uh, rupture, capsular contracture, and, you know, these are important and because of the importance and because this is in the case of cosmetic breast surgery, a completely elective treatment, they wanted to be sure that patients factored this into their decision making and by highlighting it in, in a boxed warning, uh, it makes sure that that information is part of what all patients are notified about prior to deciding they, they think it’s a good idea to go ahead and get breast implants.

Doreen Wu (10:34):
There’s a lot of complexity here. I can see how confusing it can be. Are these regulations a good thing? Are they worth the time and effort?

Dr. Lawrence Bass (10:44):
So I think anything that standardizes care and makes sure nothing slips through the cracks is a good idea. I typically have a very extensive discussion with my patients about breast implants, because I think they really need to know what they’re signing up for. And as I said, you know, my patients love them. They have a great time, but if you get into trouble with an implant, it can be a very frustrating experience and can really put people through the ringer. And out of fairness, it’s important to recognize that like everything in life, there are risks and the FDA’s new requirement to show for the individual manufacturer’s implant exactly what the performance is like, which put another way means exactly what the frequency or incidence of different kinds of problems and complications are as the implant ages is a really good idea, uh, because this isn’t supposed to be an impulse decision. It’s supposed to be something that’s well thought out it is elective. So there’s the luxury of time to make sure you’re making the right decision. So it doesn’t mean that implants are bad or intrinsically problematic, but we do have enough experience to be able to say what the problems are and people can decide before they’re in trouble with an implant, whether this is a risk they’d care to take or not.

Doreen Wu (12:17):
It is reassuring to know that the FDA has taken a number of steps to address the risks and strengthen their safety requirements. Can you give us some important takeaways before we close?

Dr. Lawrence Bass (12:30):
So I think the concept that this could be a lifetime implant is disingenuous. I’ve always told patients that the implant will wear out eventually, uh, typically implants replaced in people who are going to be alive for many decades. And so the likelihood is high that eventually, and it often does take decades on multiple decades, but eventually the implant will probably wear out and need to be either removed or replaced. And interestingly, almost every patient, even if they’re now well into their senior citizen years, typically requests to have the implants not just removed when they fail, but also replaced because this is part of their self image that they’re accustomed to now, and they don’t want to give that up. So I think that’s a very telling detail about the experience with breast implants, despite the fact that there can occasionally be problems.

Dr. Lawrence Bass (13:37):
Um, the other takeaway is it’s important to get the surveillance have a really an ongoing relationship with the plastic surgeon who placed it, get the imaging, if you have silicone gel implants, but even though FDA made many of these new recommendations and requirements, um, more demanding, the surveillance actually became more liberal based on the post-approval study data and based on improvements in ultrasound technology where ultrasound can be used as well as MRI to screen for hidden or occult implant rupture, although MRIs still the most sensitive test and still probably the right move for someone who’s symptomatic. If the, uh, ultrasound is equivocal or does not find to rupture, but that ability to do the ultrasound, which increasingly can be done in the plastic surgeon’s office is a, a way that reduces the inconvenience and expense of doing the surveillance.

Doreen Wu (14:45):
Well, this was certainly an informative episode for people who are considering breast implant surgery. I hope today’s episode provided some valuable information and insight. If this episode sparked any unanswered questions, please contact us and we would be happy to discuss them in a future episode. This is Doreen Wu, thanking you for joining Dr. Bass and me for this discussion of the FDA’s new rules and regulations for breast implants. Be sure to join us next time. And don’t forget to subscribe to our podcast to avoid missing all of the exciting content that is coming your way.

Speaker 3 (15:21):
Thank you for joining us in this episode of the Park Avenue Plastic Surgery Class podcast with Dr. Lawrence Bass Park Avenue plastic surgeon, educator, and technology innovator. The commentary in this podcast represents opinion. This podcast does not present medical advice, but rather general information about plastic surgery that does not necessarily relate to the specific conditions of any individual patient. No doctor patient relationship is established by listening to or participating in this podcast, consult your physician to advise you about your individual healthcare. If you enjoyed this episode, please share it with your friends and be sure to subscribe to our podcast on Apple Podcasts, Google, Spotify, Stitcher, or wherever you listen to podcasts.

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