The Case for Polyurethane Foam Covered Silicone Gel Breast Implants

Aug 9, 2011 by

Quick disclaimer- I am not compensated by this doctor or the breast implant company he uses, I am posting parts of his paper and a link to the paper as he makes a very compelling case for Polyurethane foam breast implants based on his own personal experience and the clinical data and studies he references.

I will make comments about his article- anything I use directly from his article will be italicized.

The following is taken from The Case for Polyurethane Foam Covered Silicone Gel Breast Implants by Dr. Daniel Fleming

A bit about Dr. Fleming:

Dr Daniel Fleming has Australia’s largest breast augmentation practice. He has performed more than 3000 breast implant operations using smooth, textured and polyurethane foam covered implants. 

3,000 is a big number of breast implant operations. The Furry Brazilian is a quantitive guy, if a doctor works 52 weeks a year and performs 3 breast implants operations per week, that is 156 annually; at that rate it would take 19 years to reach 3,000. Why this is important- he must be good or patients would have spread the word not use him for breast augmentation, he never would have reached 3,000 breast implant operations.

This is a very good paragraph regarding Polyurethane foam implants:

The long term evidence has consistently shown that PU foam implants dramatically reduce contracture rates compared with both smooth and textured implants. Surgeons who use these implants have also found they reduce the incidence of displacement and rotation compared with implants with other surfaces, allowing them to use anatomical implants without the fear of early or late rotation. Evidence accumulated from more than 40 years of in vivo experience with these implants has proved conclusively that they are safe and, with the exception of a temporary rash in 1% of patients, have no greater incidence of other complications compared with smooth and textured implants.

Many women don’t consider Polyurethane implants as they are not used (anymore) in the USA; but they have been used for over 40 years! Longer than the textured implants.

One reason I like Dr. Fleming’s report is his common sense approach to capsular contracture following breast implant operations and how he shares his own experience:

How common is capsular contracture? Some surgeons do not feel capsular contracture is much of a problem anymore. You can find a published paper to support any figure you like from 1% to 50%. When I talk to surgeons having given presentations about the foam many of them tell me that they don’t see much capsular contracture in their patients but, “I see a lot from other doctors”. They often fail to make the connection that “other doctors” may well be seeing their contractures!

All of the evidence shows that when independent assessments of a surgeon’s contracture rate are made they always are much higher than the surgeon had thought. This was brought painfully home to me when I was involved in the trial of titanium coated gel implants. Because these patients were in a trial follow up was formalised and comprehensive. My one year grade 3 and 4 rate was 7% (incidentally no different for titanium and non titanium implants). Previously I would have estimated my one year rate to be about 3 or 4 %. Other doctors in the trial had the same experience. Were we bad doctors? How come we were not replicating the very low rates sometimes published by the so called leaders in the field?

Interesting, right? Is part of the issue with capsular contracture based on doctors not seeing their own patients that encountered capsular contracture after breast augmentation? I am not pointing blame at the doctor- the patient might have re-located or just decided they wanted a different opinion. I don’t think there is systematic under-reporting of capsular contracture by doctors, possibly just not full awareness of capsular contracture in their patients following breast augmentation or a re-operation.

All the data submitted to the FDA says capsular contracture is a major issue and is reported as high as 16% within 7 years following the breast implant operation. Dr. Fleming’s honest approach to sharing the data is refreshing and fully supports the statistics sighted by the USA FDA.

And so here is some pretty technical speak about why Polyurethane foam breast implants have a lower rate of capsular contracture than smooth or textured implants:

Why should the foam reduce contracture rates so much? This is revealed by histological analysis of the normal capsules associated with different implant surfaces. The collagen fibres which make up the capsule around both smooth and textured implants are aligned end on end. If a stimulus to contract occurs (whatever it may be), the fibres can shorten over one another concentrically around the implant causing a shrink wrap effect and the consequences with which we are all too familiar. PU foam implants work because the foam becomes integrated into the full thickness of the capsule. The foam is a 3D matrix or lattice and the collagen fibres wrap around the foam struts. They are no longer end on end but disjoined and cannot shorten over one another causing the concentric shrinkage. Thus contracture rates are literally decimated at least. A strong Velcro effect between the capsule and the implant invariably occurs. When removing these implants after some months there is a cleavage plane between the implant surface and the capsule. The explant is no longer covered in foam as this now resides in the capsule. This creates a stable marriage between the implant and the capsule. Rotation has not been described and the medium to long term downward displacement commonly seen to a greater or lesser extent with smooth and textured implants has also not been reported.

Please read the full report (link at the end of this post) for pictures. Let me give my layman comments on what Dr. Fleming is stating in very non-technical terms- your body “attacks” the implant the same way it attacks any foreign substance that enters your body >> it surrounds it with a capsule. I always think about a head cold- your body generates mucus to surround a bacteria and force is out. Well, your body can surround the implant but not force it out…at least right away.

A capsule is formed around the implant- the capsule will keep the implant in place and the capsule should remain soft. What Dr. Flemming details is what happens- and the exact cause of event is not known- when the collegen in the capsule begins to contract. The difference in Polyurethane breast implants and smooth or textured implants is the interaction with the capsule formed around the implant.

Polyurethane foam implants have a different capsule, as Dr. Fleming states “this creates a stable marriage between the implant and capsule”. This “different” capsule prevents the concentric pressure on the implant that leads to a Baker Grade III or IV capsular contracture that causes a re-operation and removal of the implant; the Polyurethane implant capsule reduces implant rotation (so important when using anatomical shaped implants) or malposition.

Here is a very interesting point and advantage to Polyurethane foam implants- they “stay where they are put” and do not drop or settle, this allows the doctor to evaluate the result that will be achieved during the surgery, not have to guess how much the implant might drop or settle post operatively:

The learning curve for using these implants is not difficult as long as you know that these implants stay where they are put. They do not “settle” into the pocket. If they are too high the day after surgery they will remain so. Because smooth and textured implants often do “settle”, subconsciously we may tend to put them in slightly high to allow for this. When surgeons start using the foam if they are not made aware of this they may place the implants too high. However, if you know about it and sit the patient up before closing it should not be a problem. In fact I would argue that this is an advantage since it affords control and predictability of implant position to the surgeon.

Regarding safety:

Are polyurethane foam covered implants safe? Unequivocally yes. They have been used in hundreds of thousands of women for up to 4 decades. The Handel 2006 data2,7 and Vazquez and Pellon’s 18 year experience3 show that other complications occur, at worst, at the same rate as for other implant surfaces. The temporary rash in 1% of patients is the only exception to this. Handel was using an older incarnation of foam implants from Surgitek, a division of Bristol Myers. Vazquez and Pellon were using Silimed implants which is what we have available today. Their results in a large number of patients closely followed for 15 years, all in front of the muscle, show a contracture rate of 1%. The attachment of the foam to the Surgitek implant surface was less reliable than Silimed’s vulcanisation process and this may explain why Vazquez and Pellon got even better results than Handel.

As the Furry Brazilian has detailed in other posts, if Polyurethane foam implants were not safe we would know this based on their use in over 35 countries and the over 110,000 Polyurethane foam implants used on women in the USA during the late 1980’s and early 1990’s.

Dr. Fleming touches on some negatives of Polyurethane foam implants:

What are the real disadvantages? The temporary rash over the breasts occurs in about 1% of patients in the second post operative week and lasts for one to two weeks. It is itchy and the patient is well so it is easily diagnosed and distinguished from infection. It is treated symptomatically with anti-histamines or topical steroids, has no long term effects and does not recur. Removal of foam implants, although much less likely than with other implants, is sometimes, but not always slightly more difficult than with non foam implants. It is however perfectly possible. If all of the prosthetic material needs to be removed then a capsulectomy will be required if the implants have been in for more than 3 weeks as the foam will have started to integrate into the capsule. In cases of infection this is not always necessary as removal of the prosthesis alone and appropriate antibiotic treatment is usually enough to allow successful re-implantation after 3 months. Late infection with atypical mycobacteria however would require total capsulectomy.

Another doctor using Polyurethane foam implants on a regular basis said at a lecture that he sees the rash in around 8% of his patients but that it is not a problem to treat.

This is the best part of Dr. Fleming’s paper- the personal experience part:

I have used these implants for more than 5 years in both primary and secondary patients. In the last 18 months I have used them in more than 500 patients and now use them exclusively. They are not a panacea but I have yet to see my first capsular contracture. I have had one unilateral downward displacement which occurred the day after the surgery presumably due to over dissection of the pocket on my part combined with suture breakage. I have not seen the insidious slight downward displacement over time which detracts from the final long term results with non foam implants. Other complications have occurred with the same incidence as with other implants. In short, my results have simply mirrored the results of surgeons overseas who have used these implants for longer than me. Whereas previously I was loath to use anatomical implants unless they were really necessary because of the risk of rotation, now the majority of implants I use are anatomical. The ability to control three dimensions with an anatomical implant rather than only two with a round, allows me to get better results in many patients.

No comment needed, this seems to be a very successful doctor that has used Polyurethane implants to reduce capsular contracture following breast implant operations.

Click here for the download of the PDF that features the full report and references: Dr. Daniel Fleming- The Case for PU Foam Covered Silicone Gel Breast Implants

1 Comment

  1. Great The Case for Polyurethane Foam Covered Silicone Gel Breast … site, really like it . I will spread the word about your site Keep up the good content, furryb, very interesting.

Leave a Reply

Your email address will not be published. Required fields are marked *