The new breast implants with a MUCH lower risk of capsular contracture [Dan Zegzula, MD, Portland]

Eva Sheie (00:00):
You're listening to Where Before Meets After. The rate of capsular contracture with Motiva implants is 1% or less?

Dr. Zegzula (00:08):
Yes.

Eva Sheie (00:08):
What's the usual rate that we've been accustomed to in the United States?

Dr. Zegzula (00:13):
When you're talking about capsular contracture rates, you have to realize it's not just a single point in time with all implants. The longer an implant is in, the higher the capsular contraction rate is going to be. So these studies, typically when they end, then they'll look broadly across the survey and say, okay, what's the capsular contraction rate? So it's a little like comparing apples to oranges if you just ask what the rate is with every implant. But probably on the studies, the FDA studies for the other companies, the capsular contracture rate was between five and 15%. And it does vary pretty broadly, and it also tends to be somewhat surgeon dependent. I tell my patients the risk of capsular contracture is an ongoing risk, and every year there's a certain percentage of patients that will develop capsular contracture. By 10 years, probably 50% of patients will have some degree of capsular contracture, whether that bothers them or not. So if you boil that down, I say, well, maybe there's a 5% per year risk, and the Motiva implants having a 1% risk, and I think their study went six years. So that's a pretty low rate. How it boils down to the surgeons in the general population and their experience with Motiva implants still remains to be seen, but if the early data is suggestive of what the shared experience is going to be with the surgeons, that's a very low rate. They really feel like it's their new shell technology that's keeping the rates so low.

Eva Sheie (01:40):
Are the causes of capsular contracture largely known, or is it still a bit of a mystery?

Dr. Zegzula (01:47):
Largely known, but there's always, sometimes when we don't know, meaning there's always an idiopathic capsular contracture, we really just don't know why that one happened. Two of the bigger culprits is chronic inflammation around the implant, and one of the main causes for chronic inflammation around an implant would be bacterial biofilms. The biofilm is made by the body with the bacteria. So the bacteria comes first and then there's a body's immune response, and then the bacteria will make this biofilm, which it can hide in, and it becomes resistant, or it becomes like a protective layer surrounding the bacteria to protect it from your body's immune system. And even antibiotics, the bacteria can hide inside this biofilm where they're being insulated from antibiotics or any white blood cells or body's immune response. And therefore, because the body can't clear it, the biofilm, despite the body's best efforts, it's still there, so then the body starts laying down scar tissue. So rather than destroying the bacteria, it'll wall the bacteria off. Body's laying down scar tissue layers upon layers, and then that's capsular contracture. The implant gets firmer and harder because it's surrounded by scar tissue and it's surrounded by scar tissue because the body identifies the implant and the biofilm as foreign and it can't get rid of it, so it tries to wall it off and protect it from the body. The four micron architecture of the Motiva implants preventing bacterial adhesion to the implant seems to be one of the main reasons why there's low inflammation and low capsular contracture rate.

Eva Sheie (03:29):
What other kinds of things do you do in your OR to keep capsular contracture away?

Dr. Zegzula (03:35):
There's some fairly standard things that many plastic surgeons will be doing, and they all seem to be used to reduce these bacterial biofilms. First off, before the operation even starts, we'll put a shield over a patient's nipples. Nipple shields prevent bacteria from within the nipple ducts coming out onto the skin during the operation. We of course prep the skin with an antibiotic solution before we start the operation. Once the pocket is made, my practice has been to irrigate the pocket with an antibacterial solution or an antiseptic. Currently I'm using Betadine. And then before the implant is placed, the skin gets prepped a second time, the surgeon's gloves get changed, so there are brand new gloves that are touching the implant. And we always insert the implant with an insertion sleeve, and that allows you to sort of inject the implant through the incision without the implant ever touching the skin. The bacteria, if there's any bacteria contamination, the most likely place that that's going to happen is with contact with the skin. And so by preventing the implant from touching the skin, you're probably preventing the largest reason why there might be bacteria on the implant after the operation is over.

Eva Sheie (04:46):
Are there similarities in breast reconstruction where you're preventing cancer cells? Is there something that happens in the OR in a breast reconstruction, or am I thinking of specifically when it's the mastectomy and the recon and the same surgery where they do a bunch of safety measures between those two operations to keep the contamination of the breast cancer cells or the cancer cells away from the reconstructive part of the operation?

Dr. Zegzula (05:16):
Not so much. There is a separation of the cancer side versus the non-cancer side, meaning in the operations where I'm performing breast reconstruction at the time of the mastectomy, the surgeon doing the mastectomy, their instruments and their scrub tech, their surgical nurse are separate from mine. I have my own team and the other surgeon has their own team. And the surgeon performing the mastectomy will generally start on the non-cancer side first and then move to the other side. So the instruments are not bringing any chance of cancer cells from one breast to the other. So they start on the non-cancer side, then proceed to the cancer side. And then I'm reconstructing the non-cancer side, and our instruments never cross paths. And then when I'm finished and the other surgeon is finished with the first side, then I'll go from the completed non-cancer side and finish the operation on the cancer side. So there's trying to limit the opportunity for shared instruments or sponges or anything like that from bringing cancer cells from one side of the body to the other.

Eva Sheie (06:28):
I think what startled me about this whole procedure is that it never occurred to me that cancer cells were treated as contagious almost.

Dr. Zegzula (06:36):
Yeah, almost like it's a bacteria. You don't want to transfer it from one side to the other.

Eva Sheie (06:42):
Thanks for listening. I'm your host, Eva Sheie. Follow the show and submit questions for our experts at wherebeforemeetsafter.com. Where Before Meets After, is it production of The Axis.