Monday, April 07, 2008

Does an Accolate a day keep the capsular contracture away?


Capsular contracture, an exaggerated hardening of the tissue around a foreign body, continues to be one of the most stubborn issues to stomp out with breast augmentation and reconstruction surgery. It's also been one of the most difficult things to study in a way that's useful because of a relative lack of a clear understanding of why it happens.

Forming a capsule is a normal physiologic process. It happens around everything your body doesn't recognize as "self" when it's implanted and is mediated by a well established interaction among signaling proteins on cell surfaces and your bodies immune system cells. When this process goes haywire, you get thickening and shortening of the capsule which can become painful and distort the shape of the breast.

There's a couple things we know clearly cause high rates of hard capsules with breast implants:


  • post-operative hematoma

  • infection around an implant

  • a history of breast irradiation

  • older silicone devices (1970's-19080's) with high rates of "gel bleed"

  • rupture of silicone implants



What's more complex is trying to "reverse engineer" how to prevent capsules. Suggestions to reduce high grade capsule rates have included:


  • textured implant surfaces

  • placement of the implant underneath the pectoralis muscle

  • polyurethane-coated implants

  • antibiotic irrigation of the implants during insertion

  • the use of contemporary "4th generation" implants with thicker "low bleed" shells and more cohesive fillers

  • saline implants


The data on textured implants and position of the implant relative to the muscle have been somewhat mixed. At this point it's hard to definitively say that either make much difference long-term. Polyurethane foam works very well, but it's use in the US is likely DOA in the long-term due to liability issues over a (now debunked)risk of breast cancer. Antibiotic irrigation works well in the short-term, but it's not clear that it could affect capsular contracture years out from surgery.

It's been very interesting to see the performance of the "5th generation" silicone devices in published studies. These are the "gummy bear" implants which are semi-rigid and textured. Whether it's a synergistic effect or what is not clear, but these implants have dramatically lower rates of capsular issues almost a decade out. These devices appear to offer an improved solution to capsular (and rupture) issues and hopefully the FDA will give the green light sometime in 2008 for their US debut.

So what else do we have to offer?


There's a class of drugs used to treat asthma called leukotriene inhibitors (LTI) that has shown some promise in prevention or treatment. The two most common LTI's are Accolate and Singulair. Accolate has a small potential for liver problems and has mostly been avoided in favor of Singulair. Singulair was in the news as it's been alleged to cause suicidal ideation by people suing Merck. (How you prove a negative here is anyone's guess, but call me the skeptic.)

Anyway the genesis of this post was a study I saw in a European journal showing dramatic inhibition of capsule thickening in an animal model using zafirlukast (aka Accolate) which you can see view here). This is the first basic science model I've seen actually showing this idea of LTI's can work. This information gives us another option to discuss in the high risk capsule former which is good!

Rob

8 comments:

Dr. Tony Youn said...

Hi Rob-
Actually, one of my mentors, Dr. Richard Ellenbogen, was one of the first to describe using Accolate for capsular contractures back 4 years ago. It was printed in a Aesthetic Surgery Journal. The explanation of capsule prevention was described in that article. I've used Singulair regularly in my practice whenever a patient has a sign of an early capsule. I do think it may help reverse a very early (Grade II) capsule, but by the time a patient is in Grade III-IV the cat is out of the bag. There was also another article within the past year which showed (if I remember right) about a 75% rate of improvement on patients on Accolate.

Dr. Rob Oliver said...

Yeah Tony I was familiar with Dr. Ellenbogen's observation (I was going to talk about it, but the post was getting a little long). I know many people have kind of dabbled with these two drugs (singulair & accolate) but the experimental data was not there yet supporting what was being talked about. A lot of people were also somewhat unimpressed with their effect as well.

Like you, I've had a low threshold for putting people on singulair with early capsules. The FDA publicity last month re. suicidal ideation has made this a little more complex from a medico-legal aspect. This basic science study was the first to design an experimental model which is why I think it's important.

thanks for the note!

Rob

Tom Fiala said...

Hi Rob-
I also am a fan of these agents. I typically use singulair for all first time breast augmentation patients for the first 3 months. I do use accolate and even papaverine for the ones with troublesome recurrent capsules. I feel it helps somewhat, but unfortunately it is not a "magic bullet".

Interestingly, there is now some data suggesting that capsular contracture may be at least partially related to biofilm production from Staph. epidermidis, which lives on and in the breast tissue. Maybe future therapies will be able to address this....

Great blog! Keep it up!
Tom Fiala, MD

Marissa M. said...

I'm loosing my mind. I was very much so set on having silicone.... I wish i remember why my dr recommened it (maybe my weight or wrinkle prevention?)

i personally like it more than saline because its soooo much softer.

Which makes more sense from a health stand point?

Tim Weyant, MS PT said...

Our practice has seen these anti-asthmatics prescribed quite often as well for Capsular Contracture or implant fibrosis and have seen mixed results. As Physical therapists our practice has specialized in the non surgical and non medicine based management of CC via new external Ultrasound technology, capsule manipulation (not closed cap!)and prolonged static splinting of the contracting pocket or capsule.

Interestingly Dr Fiala mentions Staph Epi. and CC.We spoke with Mentor's toxicologist Dr Roger Wixtrom and their work on Staph Epi and CC. It seems the Ultrasound technology does have a good base for sucessful treatment of CC.

For research and more info on our practices work, feel free to access our website at: www.AspenAfterSurgery.com

Regards, Tim Weyant MS PT

Anonymous said...

Hi!
I have been diagnosed with Capsular contracture, and am currently taking Accolate twice a day. Do you have any idea of a general timeframe in which one could expect to see a positive result of taking this? I have heard that it can take up to three months, but would appreciate some personal experiences on this....

Anonymous said...

I just recently had reconstruction of my R breast and an implant placed in my L. (I had previously had saline implants in 1993 with the R rupturing in 2005). Due to recurrent hematomas in my R breast (& a JP drain), I was placed on Accolate 20 mg BID and Keflex 2000 mg. QD. I am optimistic about the outcome. Any thoughts? Any oral or topical treatments for keloidal scarring?

Anonymous said...

I just recently had reconstruction of my R breast and an implant placed in my L. (I had previously had saline implants in 1993 with the R rupturing in 2005). Due to recurrent hematomas in my R breast (& a JP drain), I was placed on Accolate 20 mg BID and Keflex 2000 mg. QD. I am optimistic about the outcome. Any thoughts? Any oral or topical treatments for keloidal scarring?