Allergan Textured Implant Recall

Dr. Robert Schwartz
September 20, 2019

I'm sure a lot of you have heard about the breast implant recall that happened last month. I know we've gotten a lot of calls in our office about it from patients who are concerned and wondering what they should do. So I wanted to make this video for several purposes.

1) To let you know exactly what's going on so you can have the complete information.

2) For women who have textured implants, to let them know first of all, that if you're spending a lot of time worrying about this, there's no need to. The risk has not increased in any way.

3) To let you know what your options are going forward because Allergan has just offered a new program for you to change out your textured implants to smooth ones.


4) To let you know how you can go about getting more information and how we can help with that if you're interested.

Okay, so a little history on this. In the last 10 years, we've discovered that breast implants appear to be related to an increased risk of a very rare cancer that can happen in the breast called ALCL. Now, breast implants have been around for well… since the 1960s, and there have been more than fifty million breast implants placed around the world...and this was never detected until very recently. And the reason it was never detected is that, even in women with breast implants, ALCL is extraordinarily rare. There have been roughly 500 cases of it reported around the world ever. So we're talking 500 cases out of tens of millions of breast implants. In the scheme of risks that we all face, this is really, really low.

Okay so, at first all anyone could tell was that women with breast implants whether they were silicone gel or saline were at this higher risk for ALCL. But over the last several years, as the data has gotten a little more refined, as we got some more information, it's come out that the women who were at risk for ALCL are a subset of women with these implants, specifically those who have textured implants. And then we further discovered that the women who are at higher risk for ALCL are the women who had textured implants that have a more aggressive texturing on the surface.

So I should probably say that what texturing is. It’s just a roughening of the surface of the shell of the implant that's done for reasons...well, that aren’t worth going into in this video...but just know some implants have a smooth surface and some have a textured surface and it's the ones with a textured surface that put you at higher risk for ALCL

In the US, there are two major breast implant Manufacturers - Allergan and Mentor. Of these two manufacturers, Allergan has used a more aggressive texturing and their implants have been associated with more - but not all - of the cases of ALCL. But even with their implants, the risk of ALCL is so very low that the FDA has not felt that there was any need to act. Nonetheless, last month, Allergan, in conjunction with the FDA, decided to voluntarily recall these implants. Now, understand that when they recall these implants what they're doing is removing, from the shelves of plastic surgeons, textured implants that haven't been used. So, in other words, until they've changed their texturing process - which they're doing right now - they're not selling or recommending that anyone use their textured implants.

Okay, it's really important for you to know that nothing has changed in the data. Because it would be natural to think that this recall happened because someone just discovered something that would suggest that these implants are much worse and much more dangerous than we previously thought. Based on all the data that's out there right now, that's just not the case. There is no new data and no increased risk. So if you have Allergan textured implants, yes you have a higher risk of getting ALCL than someone who doesn't have breast implants but it's still very, very, very low and very few women out of the - again - tens of millions of women who have these breast implants are ever going to get this.

Okay, so what should you do with this information? Well, the first thing you should do is know or find out what implants you have. Your surgeon should have given you an information card at the time of your surgery that has your implant type, size, serial number - all of that information. Okay obviously a lot of people will lose this card over time but, if you don't have it, you should be able to get it from your surgeon. In my office, we keep a database of all of our patient's breast implants going back to 2006. If any of my patients are watching this, then, by all means, call our office and we can tell you exactly what implants you have.

So, if it turns out that you have smooth implants and not textured then, as best as anyone can tell, none of this relates to you. What if you do have textured implants? What should you do then? Well, you should do what every woman with implants does and monitor what's going on with your breasts. This is actually true for women who don't have breast implants as well. You want to, at least once a month, do a self-examination. And if you notice changes in your breasts, you want to contact your family physician, your gynecologist, or your plastic surgeon and let them know. So if I get a call from a patient who has noticed a change in her breasts, then we bring her in for an examination and see if anything is, in fact, going on. If someone were to get ALCL it will typically cause swelling of that breast. And the reason it does that is that it generates fluid around the implant. So if your surgeon suspects this is going on it's straightforward to diagnose. He'll send you for an ultrasound. The ultrasound will show if there's fluid or not. And if there's fluid, the radiologist can put a needle in under ultrasound and draw out some of the fluid. You can send some of that fluid to a lab that can look for specific markers that show if ALCL is present or not. The vast majority of cases the fluid won't be because of ALCL. But if it is, then in almost all cases, removal of the implant with the scar capsule around it will cure it.

But let's say you'd prefer not to have to think about this or worry about it. Well then it might make sense to take out your textured implants and replace them with smooth shelled implants. If that's something that interests you, there's very good news that's come out in the last week.

Allergan has announced that they are starting a program for women who have Allergan textured implants and want them replaced with smooth. Allergan will provide you with a new pair of smooth implants completely free. That means you can get your implants replaced for significantly less money. Even better, Allergan will let you change the size of your implants the profile of the implants, even the level of cohesivity ( or gummy bear-ness) of the implants. So if you have textured implants you can actually get an upgrade to a more expensive implant on Allergan.

Allergan just announced this program and we don't know how long it's going to last so I would suggest, that if this is something you're thinking about, you should act on it.

If you're one of our patients, and you're interested in this program, or really if you have any questions about what's going on with textured implants in general, please give my office a call.

We can tell you exactly what implants you have and can help you decide if this Allergan replacement program is something that makes sense for you.

If you had your surgery somewhere else, the obvious place to start is by contacting your plastic surgeon. If you don't want to do that or if, for whatever reason, that doesn't prove helpful, we would be happy to help you find out what implants you have and to help you decide what the best thing you should do is.

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