Capsulectomy Update

Summer Hardy (00:01):
Welcome to Park Avenue Plastic Surgery Class, the podcast where we explore controversies and breaking issues in plastic surgery. I'm your co-host, Summer Hardy, a clinical assistant at Bass Plastic Surgery in New York City. I'm excited to be here with Dr. Lawrence Bass, Park Avenue plastic surgeon, educator and technology innovator. The title of today's episode is Capsulectomy Update. So I'm gathering this has something to do with breast implants. What is the basic topic, Dr. Bass?

Dr. Lawrence Bass (00:30):
Well, this episode is about capsulectomy surgery. This is done to the capsules that form around implants. It's about some guidance for patients who are thinking about removing their breast implants because of health concerns, and there are some recent new advisory recommendations.

Summer Hardy (00:52):
Okay. So let's start at the beginning. What is a breast implant capsule?

Dr. Lawrence Bass (00:58):
The breast implant capsule is a white glistening membrane comprised of rows of collagen fibers that the body forms around the breast implant. The body recognizes that the implant is not a natural part of the body, and it lays down some collagen around the implant to wall it off. And the way this appears to the surgeon when the capsule is healthy is as a thin pliable white glistening membrane.

Summer Hardy (01:30):
Okay, thanks for explaining Dr. Bass. So why is this surgery done?

Dr. Lawrence Bass (01:36):
Well, there are lots of reasons we do surgery on the breast implant capsule. Sometimes we do this for an implant malposition, an implant that either didn't settle in the right position or that has distorted over time. One of the main reasons that an implant distorts over time is because of capsular contracture. Basically a thickening and tightening of the breast implant capsule that makes the breast feel firmer, but also can shift the implant out of symmetric placement. So those are very, very common reasons that capsule surgery is done, and there's not a lot of controversy about that. But there are also newer issues that are under a lot of discussion these days and for the past several years. So one is something, and we've mentioned these on the podcast before and again, brought updates about this before. One is breast implant associated illness, so that's one item. And another is breast implant associated ALCL or a tumor that forms in the capsule, not in the implant, but in the capsule around the implant. And that ALCL is anaplastic large cell lymphoma. It's a very rare tumor that can form around the capsule. And more recently, breast implant associated squamous cell carcinoma has been demonstrated, which is even more rare than ALCL. And all of that seems to be associated with textured implants, by the way.

Summer Hardy (03:29):
Okay, that makes sense. But could you provide some definitions about these things?

Dr. Lawrence Bass (03:35):
So let's go back and discuss in a little more detail breast implant associated illness. So this is a syndrome of symptoms, more than 90 different symptoms that have been attributed to breast implants in one way or another. And it's controversial. We don't understand exactly what causes it. We don't understand exactly what the spectrum of symptoms are, but a number of people who have implants in place felt very strongly that the implants were responsible for fatigue, weakness, all manner of illness symptoms, and that they got better when the implants were removed.

Summer Hardy (04:26):
Okay, got it. So what are the causes and what is the treatment?

Dr. Lawrence Bass (04:32):
So again, this is controversial and I don't think we fully understand this scientifically. It's immensely difficult to study an illness that can have 90 different diagnosable symptoms. So that's so broad and so many of those symptoms are things that all of us experience from time to time that it makes it very difficult to rigorously study this scientifically. But some of the possible reasons that have been cited for causing breast implant illness are impurities and heavy metals in the implants or mold that's associated with the implants or bacterial colonies that live on the surface of the implants. And these are called biofilms. And biofilms live on all medical implants, not just breast implants. They live on our teeth and that's why we brush our teeth all the time to try to keep those to a minimum. But they've been listed as possible causes for this problem. In terms of treatment, the treatment relates to removing the implant and possibly to removing the capsule.

Summer Hardy (05:59):
Okay. And overall, you mentioned that this is controversial. What's the controversy around these procedures?

Dr. Lawrence Bass (06:06):
So the issue is how much improvement or what percentage of patients we can expect to improve if we remove the implant. And also there's a controversy about whether there's a need to perform a capsulectomy and whether that has a benefit in alleviating the symptoms. In particular, one of the procedures that's sometimes done for breast implant associated illness includes what's called en bloc capsulectomy. So this is taking out the capsule in a single piece, including a rim of normal tissue around the capsule. And that's traditionally used in cancer surgery. We use that for example, for cases of breast implant associated ALCL or squamous cell carcinoma.

Summer Hardy (07:05):
Okay. Well, if that's the case, then why not perform the biggest removal possible?

Dr. Lawrence Bass (07:12):
The reason is this, everything we do has a cost or a risk as well as an advantage. So it seems like a great idea to take out the most tissue you can for the greatest chance of helping patients with breast implant associated illness improve, but that won't necessarily provide more improvement, and there's definitely increased risk to en bloc resection. So it's only worth it if there's a proven benefit. And in many ways, this echoed the experience with cancer therapy. If you went back to the middle of the 20th century, there was this notion that the more you take out, the greater your chance of cure. And when it was carefully studying, it's more like Goldilocks and the three bears, not too much, not too little, just right. So more wasn't necessarily better, but it definitely has more risk, more recovery, more potential for deformity or medical complications.

Summer Hardy (08:20):
Okay. I'm starting to get an understanding of the issues here. So what's the news?

Dr. Lawrence Bass (08:26):
Well, there's been a consensus statement on breast implant capsulectomy from the breast surgery collaborative community.

Summer Hardy (08:35):
Can you explain what this group is that's putting the statement out?

Dr. Lawrence Bass (08:40):
FDA has developed a very strong priority to create these collaborative communities, to bring together all the stakeholders to help solve challenges, controversies, basically to get input from everybody involved rather than saying, well, let's ask the manufacturer, or let's ask the doctors, or let's ask the patients. Well, no, you really need to ask all of those groups. All of those groups need to be looking at the data, discussing it, providing input from their perspective, probably to get to the right answer, certainly rather than excluding anybody. So this breast surgery collaborative community is a consortium of patient advocates, board certified plastic surgeons, medical device manufacturers, and others with a vested interest in enhancing breast surgery safety. So they were assembled to clarify some of these issues and examine the data.

Summer Hardy (09:49):
Gotcha. That makes a lot of sense to me. So what are their recommendations?

Dr. Lawrence Bass (09:54):
So they did two things. They provided definitions for different types of capsulectomy procedures, and they provided management recommendations.

Summer Hardy (10:06):
Let's start with the capsulectomy definitions.

Dr. Lawrence Bass (10:09):
The statement defines four basic types of capsulectomy. There's the total intact capsulectomy. This is complete removal of the breast implant capsule as a single unit with the implant contained within it. This has often been done historically when there's a ruptured implant, particularly with the old non cohesive gel implants to help contain the silicone gel. Then there's a total capsulectomy. So that's complete removal of the implant capsule, but not necessarily all done in one piece. So you're getting all of the capsule out, but you're taking it out. Whatever is easiest and least traumatic without any need to keep it in one piece. Third, there's a partial capsulectomy. This is probably most commonly performed. This is removal of the breast implant capsule where some capsule is left behind. And as I said, this is probably the most common. What we generally do when we remove implants, most commonly probably in the United States when there's no issue, but we're just removing the implants for preference or for a rupture, is we examine the capsule. And if the capsule's thickened or calcified or in any way looks unhealthy, that portion of capsule is removed. If the capsule looks thin, pliable, glistening, healthy white membrane, like it looks early after the implant is placed, that's left alone and remains and seems not to create an issue for patients. Final, the procedure I already described, the en bloc capsulectomy, this is removal of the breast implant capsule with a margin of uninvolved tissue, and that's the last of the four types of capsulectomy.

Summer Hardy (12:08):
Wow, I didn't realize that. There are four types. That's really interesting. And now can we go to the management recommendations?

Dr. Lawrence Bass (12:15):
So I'll bottom line the management recommendations, because again, there's been a lot of controversy about this, and some people have suggested that if you do an en bloc capsulectomy, it's somehow better at improving the symptoms. And basically the consensus group stated that the absolute and only indication for an en bloc capsulectomy is for an established or suspected breast implant associated cancer after appropriate medical workup. In other words, after you've demonstrated some proof that there is or likely is a breast implant associated cancer. So that specifically excludes any recommendation for en bloc capsulectomy for breast implant associated illness.

Summer Hardy (13:14):
Okay. Could you share anything about how they arrived at these recommendations?

Dr. Lawrence Bass (13:19):
So these recommendations were based on a bunch of recent research on outcomes in a very large number of patients who had different types of capsulectomies trying to treat breast implant associated illness. And a lot of this research was done by a plastic surgeon in St. Louis named Patricia McGuire, but there are some other researchers who have been examining this as well. And that data and research was cited, in other words, referenced or listed in the consensus statement. And that basically supports the notion that there's no improvement with outcomes doing an en bloc capsulectomy compared to a total capsulectomy or potentially a partial capsulectomy.

Summer Hardy (14:16):
Okay. You've given a lot of information in this episode. What does it mean overall, Dr. Bass?

Dr. Lawrence Bass (14:21):
So these recommendations are things that surgeons are going to bring up to patients when they have a consultation requesting breast implant removal. Patients can decide how they want to be treated, but doctors generally feel best when they're making decisions that are based on recommendations that are based on data. So data-driven decision making, in other words, where there's some medical proof that patients do better with a given option or do the same with one option or another, generally guides most surgeons and their decision making. But given the careful review by all the stakeholders here of what the data shows, and we didn't have this data five years ago or 10 years ago, this is data that's only been obtained in the last few years, but now that we've got it, that's hopefully going to let us be much more precise in giving patients what they need to be healthy and feel their best without anything excessive that's not needed to help them.

Summer Hardy (15:36):
Thank you for this update. We always like to keep our listeners aware of the latest information in plastic surgery. Thank you for listening to the Park Avenue Plastic Surgery Class podcast. Follow us on Apple Podcasts, write a review and share the show with your friends. Be sure to join us next time to avoid missing all the great content that is coming your way. If you want to contact us with comments or questions, we'd love to hear from you, send us an email at podcast@drbass.net or DM us on Instagram @drbassnyc.