FDA Recall of Allergan Textured Silicone Breast Implants

Breast implants have been in the news. I wanted to take the opportunity to discuss a little bit about what you might be hearing and maybe clarify for you some of the issues that have gone on and educate you about what's going on with implants and how this might affect you or one of your friends or loved ones. Several days ago in the news, you heard that the fda, in conjunction with Allergan, which is one of the major manufacturing companies of breast implants, had a voluntary recall of all their bio cell textured breast implants. The first thing to tell you about is there's two different kinds of coatings on an implant. And you know this. If you've got implants in your surgeon, I'm sure talked to you about it, there's a smooth implant. These are not involved in the recall at all. And then there's a textured surface. It's almost a little grittiness to the implant. The Allergan company has what's called a bio cell texturing on their implant and their tissue expanders. And this is what truly is involved in the recall. Why is it recalled? Since 2011, we've noticed an increase in a cancer of the immune system called anaplastic large cell lymphoma. And at this point, there's been enough cases and enough data to guide us that the texturing surface on the allergy implant is more likely to be associated with this cancer. So to clarify, this is not breast cancer. Breast implants are not associated with breast cancer at all. The cancer that we're dealing with, again called anaplastic large cell lymphoma, is a cancer of the immune system. And we've seen it six times more likely in a patient with a textured allergan implant than in any other implants. To give you an idea of how rare this condition is, the first case was diagnosed in 2011. There have been 573 cases reported globally. And I will tell you that in the United States, we are the minority of these cases. More textured implants are utilized internationally than here in the States. But it's still important for you and for your health. And so therefore, we the in conjunction with the fda, we're voluntarily recalling these implants. Now, all texturing is not bad. Texturing of this particular type seems to be more likely to cause this cancer than. But texturing of other implants has not been implicated, and we're not recommending changes to our practice related to the texturing surface on other manufacturers. Specifically, an implant that I utilize very frequently is the anatomical Shaped implant and the Mentor version has not been implicated in this recall. And at this point, we have no evidence to suggest that their coating or their texturing surface is involved or anything to be worried about. So again, this just relates to the Allergan biocell texturing. What should you do at this point? If you have a textured implant in of Allergan, we want to see you, we want to talk to you, we want to talk to you about the signs and symptoms related to this disease process. If there's nothing going on and you're fine and there's been no change to your aesthetic outcome and you're satisfied with the implants, there's really nothing to do right now based on what we know. If you're worried though, and you want to have the textured Allergan implants removed, we're happy to talk to you about that process and what that might entail. If you have a smooth wall device, you don't need to worry about anything. Stay in touch with your plastic surgeon. See them annually, do normal self breast exams, the normal routine that we recommend. If you have textured devices from another company, again, right now we think you're fine. We don't need to do anything to adjust those implants. All in all, we're in a good place. We know the data, we know what we expect from you and how we should handle this. So at this point, we're available for you to answer any questions. But again, what I wanted to let you know about today was that the Allergan textured implants have been recalled and where we stand on the other devices. If you currently have Allergan textured implants in, or maybe you don't know that you have them in, the first thing you should do is reach out to the surgeon that placed them to confirm what your implants are and if they are textured or not. If you are not in touch with your surgeon, if you don't have that information, you can contact Allergan directly. And there's a registry with Allergan that can provide you guidance about those implants if they're textured or not. Currently, we don't. We're not saying that the texturing surface causes this anaplastic large cell lymphoma, but there is a six times more likely chance of you having this condition with these implants in place. If that concerns you enough that you want to do something about it, I'm available to see you. I'm the breast and body specialist at the Nadiri Center. We have offices both in Chevy Chase and here in Herndon, Virginia. I'm available to see you so that we can talk about either reassurance and tell you what kind of symptoms you might be looking at if you were going to develop this process. Or we can talk about immediately getting those implants removed and replacing them with a smooth walled device to give you that reassurance and peace of mind. Ultimately, it's about your health and about your breast health and we're here to help in any way that we can. I just want to take the opportunity to reiterate and emphasize that where we currently are, FDA and Allergan are not advocating that we remove these devices from people that are completely asymptomatic. However, your health and your peace of mind is important to me. If it bothers you or if you're concerned about having these implants in, I'm happy to see you about removing the textured device, the textured implant and replacing it with a smooth wall device for your ease of mind. I'm here for you.