Kristie L. Kahl: Can you offer some background on the (Food and Drug Administration; FDA) hearing in 2019, on breast implant-associate lymphoma?
Lisa Schlager: To give some history, last March, the FDA held a two-day meeting to review the safety of breast implants and the mesh that is often used for implant-based reconstruction after someone has had a mastectomy. It drew attention from, not only the US, but worldwide. The goal of that hearing was to explore some new research and increase awareness around a condition that occurs in a small percentage of women who have implants, specifically they thought it was textured implants. However, they now believe that some women with smooth implants may also have this issue. It is a breast implant-associated lymphoma.
The truth is, it only occurs in women with implants. It’s almost like man-made lymphoma. The estimates are that this occurs in less than 1% of women with breast implants and certain implants seem to be more prone — these textured implants. So, the FDA reviewed the data, brought in some of the world’s top breast implant manufacturers and evaluated the safety of these products for the US population. It’s important to note that this is specifically focused on the US through the FDA. The European safety issues are managed completely separately under their own health care system. They do have different products in the US versus Europe, so we have to differentiate.
That March hearing yielded some new recommendations and some announcements around breast implants. Specifically, Allergan was asked to recall all of its textured breast implants. Textured implants were sort of the newfangled thing in some ways, but because of safety concerns, they’ve basically pulled those off the market and attempted to raise awareness around this type of breast implant-associated lymphoma among women with these implants. They are not recommending that women who have implants and do not have complications go out and have surgery to remove them. They are actually advising that they are perfectly safe as long as you are not having any symptoms. If you are having symptoms, you should see your surgeon be assessed to potentially remove those implants.
Kristie L. Kahl: Why were textured implants the new rave?
Lisa Schlager: Supposedly they gave better results because of the texture. They gave better cosmetic results. I do think it’s important to note that these implants are used not only for breast reconstruction but also augmentation, so we really have an interesting dichotomy of women who have (undergone surgery) for cosmetic reasons as well as women who have done it for breast reconstruction reasons.
Kristie L. Kahl: Are there any laws requiring coverage?
Lisa Schlager: The Women’s Health and Cancer Rights Act is a law that requires insurers to cover breast reconstruction for any woman for whom they would cover a mastectomy, whether or not she had cancer or did a risk-reducing mastectomy because she was high risk. In addition to covering that reconstruction, the insurers are legally obligated to cover revisions or any sort of complications that occur. So, in fact, they should be covering removal and a replacement of these implants if a woman does in fact counter issues. Where we occasionally encounter problems is if a woman isn’t having complications, but she feels uncomfortable keeping the textured implants. Sometimes the insurers are giving some pushback. For the most part, we are seeing the insurers covering this.
On the flip side, women who are doing this for augmentation are having significant issues getting insurance coverage because the insurers did not cover the augmentation to begin with. I know some people have approached Allergan with concerns about covering those costs. They are covering the costs of replacement implants, but of course, there are far more costs than that because you have to go through surgery to remove or replace these. So, it’s something to think about. But any woman who has these implants should absolutely talk to her plastic surgeon about it to see if replacement is advisable.
The other thing to look for is symptoms — swelling or fluid or change of shape in the breast, that is a warning sign. So, if you have any concerns, then you should absolutely seek out professional expertise from either your breast surgeon or plastic surgeon.
Kristie L. Kahl: What are some resources women can access so that they can have these discussions with their surgeons?
Lisa Schlager: Every breast implant comes with informed consent and a pamphlet that gives an overview of the benefits and risks of breast implants. What we’ve heard from a lot of women is either they weren’t given that information or they just glossed over it because it was 30 pages of a seven-point font. So, one of the things that we are working in with the FDA is a better type of informed consent. One of the things that the FDA just did was put out a draft guidance that focused on some improvements. One would be having a checklist that goes with the informed consent so that the woman and their doctor have more of a conversation about the different pros and cons and the benefits and risks with breast implants so that a woman goes into this with the most information possible.
Among the things on that checklist is “my surgeon has discussed alternatives with me,” such as no reconstruction or choosing a flap surgery and using their own tissue for reconstruction. Now, that might not be an option for everyone, but at least it’s important to have that conversation with the doctor. There are different types of implants for you to understand specifically what type of implant you are getting and if there are any specific risks around that.
The other thing that the FDA has proposed is actually a black box warning. A black box warning is reserved for some of the potentially most dangerous drugs we have. It’s the first time we’re seeing one recommended for a device like this. It’s an interesting concept. I think my concern is that a lot of patients don’t see the box that their implants come in. There is an opportunity to comment on this, and the industry, as well as the cancer community, is giving feedback. So, the FDA will evaluate all of that input and make a decision.
Kristie L. Kahl: If someone does have concerns, what are your recommendations for next steps?
Lisa Schlager: First and foremost, there are certain types of people who might be predisposed to complications to breast implants. These might be people who have autoimmune diseases, or blood flow problems, and that type of information is typically outlined in the surgical information when they are considering the breast implant. It’s also important if a patient isn’t feeling confident in the information, they are getting from one plastic surgeon, they should seek out a second or a third opinion to make sure that they have the most information possible to make a decision. With that said, if a person ultimately does experience issues, the first people to turn to are your health care providers. And then it’s important to register your implants, believe it or not. You should register your implants with the manufacturer so that if there is a problem, they can contact you. And then there can be follow-up and dialogue. It’s really important so that women can have the information should there be a recall or some other sort of complication.
Transcription edited for clarity.