What the FDA’s New Breast Implant Recommendations Mean for Patients

After a Food and Drug Administration (FDA) panel hearing in 2019, patients and experts called for new protections for patients who could face potentially serious side effects including breast implant-associated anaplastic large cell lymphoma (BI-ALCL) and an autoimmune condition as a result of getting breast implants. This week, the FDA released a recommendation that the product labels on implants should make those issues clearer.

For an in-depth look at the FDA’s recommendations, read CURE®’s coverage here.

In an interview with CURE®, Diana Zuckerman, president of the National Center for Health Research, elaborated on the effort to protect patients and went into greater detail about how she believes the FDA’s “guidelines” should be more strictly enforced.

Transcription:

I will say that it's much better than what they came up with. In December, they had put together a proposal that we thought was not good at all. We think that what they've come up with now is much better. It's much more similar to what we had recommended. It's not identical. We think there are things that could be improved, and we hope they will be improved.

But honestly, the thing we're most concerned about is this. When the FDA puts out a guidance, they usually are very specific that this is not enforceable, this is a suggestion. (The FDA says) “We hope you'll do this, but maybe you won't do this.” But there is some wording in there that suggests that implant companies will have to abide by some of these suggestions. So maybe they're not exactly suggestions.

But that's a big question for us, because we know from experience that if it's a suggestion, there's just a lot of doctors who aren't going to follow through. And, I can tell you from looking at the patient booklets that different implant manufacturers have put out over the years, it's just amazing how inaccurate some of that information is. It’s often outdated.

I mean, I've seen patient booklets from a year or two ago, for example, that barely mentioned breast implant-associated ALCL and barely acknowledged that it was real. I mean, they were still saying, “Maybe it's associated,” which by, I guess, nine years ago, we knew for sure that it was real. And certainly, five years ago the World Health Organization and other groups were already saying this is a diagnosed illness. So, how a patient booklet from just a couple of years ago could be telling women considering breast implants maybe, possibly this is something that some few women get, (it’s) just very disturbing.

So, this is a long way of saying we think this needs to be required. And we will be working with the plastic surgeons’ medical societies to try to ensure that they urge their members in the strongest possible terms to use this checklist, either the FDA version of it or our version of it. We think our version is better and it was endorsed by the American Society of Plastic Surgeons. We think that this should be something that all plastic surgeons use.

Just to remind you, any doctor or dentist in the United States can call themselves a plastic surgeon. Only the ones that are members of these medical societies are the board-certified plastic surgeons. That's very important, because there certainly are plastic surgeons who used to do other kinds of treatment and they've started doing breast augmentation, not reconstruction I wouldn't think, but breast augmentation, because they can make a lot of money, but they're not board certified. And they don't have a medical society that tells them what they should be telling their patients.