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What New FDA Guidelines for Breast Implants Mean for You

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What New FDA Guidelines for Breast Implants Mean for You

Dec 16, 2021

In October 2021, the FDA released new safety guidelines regarding breast implants. For patients seeking breast reconstruction, revision, or augmentation surgery, these new rules will impact your experience with the procedure. Dr. Kirtly Jones explains the importance of the new rules and what they mean for breast augmentation patients.

Episode Transcript

If you are considering having breast implants, for whatever reason, how do the new FDA guidelines on breast implants affect you and your decision?

Breast augmentation is near the top of the most cosmetic surgical procedures. Although the number of women who had breast implants fell by one-third in 2020, probably related to COVID-19 pandemic, still 200,000 people had breast implants in the U.S. in 2020, down from the usual 300,000 implants per year. About 75% of the implants are for cosmetic reasons, and the rest are part of reconstruction after breast cancer surgery.

Recently, the FDA took some new steps to improve and strengthen the information guidelines about implants and short- and long-term consequences.

It's hard to know how women want to receive information about the risks of breast implants. They believe that they know the benefits, at least for the persons they believe themselves to be right now. They can't really assess the benefits to the woman they will be at, let's say, 60. However, the assessment of benefits is a completely personal process and will be different from woman to woman. And this includes trans women making the decision to have breast implants.

The risks are harder to communicate. Language is often very medical, numbers are hard to process, and some people don't even want to know the risks.

There are data from a randomized trial of information giving that women who received more information were happier with their decision, were less likely to experience preoperative anxiety, and were less likely to experience postoperative regret. So in the information era, I think more is better.

So what are the new components of these new FDA guidelines? First of all, they aren't exactly new. They've been worked on for several years now, and they went out for public comment and were published back in 2020. However, they became more official in the fall of 2021.

Firstly, the boxed warning, the ominous black box that comes on some package inserts of medications and devices that actually nobody really reads unless you stick it on their nose.

I'm going to quote here the example from the FDA with my own asides put in. "Warning," and this is in a big black box, "breast implants are not considered lifetime devices. The longer people have them, the greater the chances are they will develop complications, some of which will require more surgery.

"Breast implants have been associated with the development of a cancer of the immune system called breast-implant-associated anaplastic large cell lymphoma. This cancer occurs more commonly in patients with textured breast implants than smooth implants. Although the rates are not well defined, some patients have died from this." Okay, that's number two.

Three, "Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patients' risk for developing the symptoms has not been well-established. Some patients report complete resolution of the symptoms when the implants are removed without replacement." Okay, that's the black box.

Well, I would want to know more about the phrase that the implants are not considered lifetime devices. There are no recommendations that breast implants be removed after some certain years, not like IUDs that have a finite effectiveness with recommendations for removal at a certain time.

Eighty percent of women who've had an implant placed still have it at 10 years. Of course, the woman that you are at 25 will not be the woman that you are at 55, and neither are your breasts, as all of us know.

"The chance of complication increases over time." What does that mean? Your surgeon should explain those complications, what they are, how often they happen, and what can be done about them.

The common ones are hard fibrous walls around the implant that can be unnatural-looking and feeling, or rupture of the implant capsule.

The uncommon one is the cancer that's associated with the certain kind of implant with a textured, not a smooth, outer covering. That cancer, which is mentioned in the black box, is called breast-implant-associated anaplastic large cell lymphoma. This is a mouthful, but is lymph cancer that arises over time, rarely.

The incidence in women who have these textured implants is 1 in 3,000 to 1 in 30,000. So it's not common. We have a great interview with Dr. Jay Agarwal on this kind of cancer and breast implants. You can find this interview at The Scope if you want to know more.

"Breast implants have been associated with these systemic symptoms." What does that mean? Some women have experienced symptoms such as pain, autoimmune symptoms, chronic fatigue. In the past, this has been somewhat ignored. But there are some women who've had fewer symptoms after their breast implants are removed. This isn't very well understood, but here it is in the black box.

To help understand the black box warning about breast implants, the FDA has created a model patient decision checklist. I think this is really great if it's given to the woman well in advance so she has time to read it or have someone read it to her and explain it to her. This isn't something to be handed out in the pre-op visit just to sign, the way you sign your permissions to your software like Google or your phone. This should actually be read word for word.

The FDA created this checklist to add to that surgeon's counseling. It is meant to be a springboard for discussion, and the patient will read and check off that they've read it and understood it.

It is long, multiple pages, with places for the patients to sign at the bottom of each topic. It includes who shouldn't have implants, at least at the moment: women who have an infection, women who are pregnant or breastfeeding, women who are having chemotherapy or have a suppressed immune system. It includes more information about the rare lymph cancer and about long-term systemic symptoms.

Actually, the example in the FDA guidelines is a really, really good one. If you're an information junkie like me and you read at, at least, the 12th-grade level, it's great.

The long-term risks of complications are spelled out. The frequency at which these things happen are attached, such as painful scar tissue around the implant reported in 51% of patients, rupture or leaking of the implant 30%, need for reoperation 60%. But those are just the biggies.

It's a really great document. It's what your surgeon should have been telling you anyway, but in the heat of the moment in the office, they might not take the 30 minutes to talk to you about this. And you might not remember. This is a great chance to take it home and read it carefully and bring it back with your questions.

And with the FDA guidelines, there's an updated suggestion about management of breast implant rupture or leakage, that 30% of the time it happens.

And last but not least, there's a card for the patient to keep forever in her wallet or personal records about what kind of implant she has, what it's made from, and when it was placed.

Now, you think you'll remember all this stuff, but you won't. And maybe you'll have them still at 80 and your memory is fading. Your surgeon may have retired or gone on to surgeon heaven. Your medical records may be lost. But at least you have a document about what is existing in your body.

If I had implants, I would laminate mine and put it next to my driver's license or my organ donation card.

I think these are really good steps in the right direction in patient information and decision-making. I know you just want what you want and you wanted it yesterday, but it's a long-term decision with long-term consequences, some good, some not so good. You should take your time and try to get it as right as you can.

Thanks for joining us on the "7 Domains of Women's Health" at The Scope.