Over the years, many attempts have been made to help prevent the tightening up of scar tissue around the implant, an event called "capsule contracture". The proportion of women who experience this contracture problem is low, approximately 5% ie one out of every twenty women.
The methods used to try to prevent contracture can be divided into external or internal.
External methods include massage, Ultra sound, Diathermy, Vit E, MSM, compression devices, and Singulair, Papaverine or Accolate.
Internal methods have included chemicals, and structural elements. The chemicals used (including antibiotics, steroids, and antiseptics) have been placed either inside of the implants, or inside the pocket outside of the implants. Structural elements have included alterations of the implant surface (such as texturing, or polyurethane foam covering), and also inserting between the outside of the implant and the surrounding body tissues various foreign materials, including Polyurethane and Teflon.
Here is a tabular overview of these methods to help prevent contracture:
The external methods have been covered on other pages. Each of the internal methods will be discussed below.
Antibiotic:
It is known with a high degree of medical certainty that it is possible for infection around an implant to lead to capsular contracture. (This is precisely the explanation for the rare but unfortunate situation whera a woman may have soft breasts with no hint of any capsular contracture around her implants for many years - and then she has a deep teeth-cleaning done and within a few weeks all of a sudden one or both breasts get rapid capsular contracture. Hence the recommendation that women with implants should take antibiotic when they get a dental cleaning.) Many women who have capsular contracture are found at operation to have bacteria inside the scar capsule. But it must be noted that many women have some bacteria around their implants yet have no capsular contracture, so a full understanding of this problem is still years away. Because the hardening problem can be so difficult for the patient, most plastic surgeons prefer to use antibiotics in one way or another for their implant patients. Several methods have been used: first, giving the patient antibiotics before, during, and after operation; second, rinsing the pocket out with an antibiotic before putting in the implant; third, putting antibiotic inside saline-type implants.
Most plastic surgeons do give the patient antibiotics. These are only given for a brief interval, so the development of resistance is not an issue.
Many plastic surgeons rinse the pocket with an antibiotic solution. The potential problem there is that the patient might have an allergy that she does not know about, and if so the irrigation can be a massive challenge to her immune system and be dangerous for her. One example is an antibiotic called Bacitracin, allergies to which are very rare, but potentially fatal. This one is of increasing concern because Bacitracin is now being put into so many cosmetics, powders, lip gloss etc, (to retard bacterial growth) giving the patient long-term repeated exposure that could stimulate an allergy.
Putting antibiotics directly into the saline implants was a very common practice at one time. This practice may have delayed the onset of contractures, but has not been demonstrated to actually decrease the percentage of it. The FDA requires the manufacturers to recommend against putting antibiotics inside the implants. An interesting historical side-note is that most of the antibiotics that were commonly put into implant eventually turn a deep brown almost black color. This has fooled more than one junior plastic surgeon into thinking that there was bacteria or mold inside the implant, when in fact there was no such thing. (There was even a misleading and poorly-researched article in a national magazine many years ago on that very topic.) Putting antibiotics inside the implants is a practice not done very often now.
In summary, antibiotic use around implants has been practiced for many years, yet there are no truly controlled studies proving that it is effective, and there are some concerns about use in the pockets or inside the implants.
Steroids:
In view of the evidence that capsular contracture involves some element of inflammation, plastic surgeons have tried putting anti-inflammatory steroids either inside the saline implants, or in the pocket around the implants. This practice may have delayed the onset of contractures, but has not been demonstrated to actually decrease the percentage of it. The FDA wants the manufacturers to strongly discourage putting steroids inside the implants.
In summary, steroids do not have any long-lasting effect in reducing capsular contracture, only delaying the onset somewhat.
Antiseptics:
Chemicals that have antiseptic characteristics have been tried, based on the proven concept that one factor that could contribute to capsular contracture is bacteria around an implant causing an inflammatory response. The most popular antiseptic is one or another type of iodine solution, for example "Betadyne". Many plastic surgeons like to rinse out the pocket with this chemical, and a few plastic surgeons like to put some "Betadyne" inside the saline implants. There have been reports suggesting (but not yet proving) an effect in reducing capsulat contracture.
Using Betadyne is a simple and inexpensive maneuver, so why not just do it for everyone? It was discover a few years ago that the kind of silicone of which certain portions of some types of implants are made, can become weaker when exposed to Betadyne, so the manufacurers do not want the implants to be in contact with any Betadyne. That means that Betadyne should not be put inside of the implants, and if it is used to irrigate the pocket, then it must be so thoroughly rinsed out that it is doubtful that it would do any good.
In summary, Betadyne antiseptic should not be placed inside an implant due to damage concerns. If used for pocket irrigation, it should be thoroughly rinsed out afterwards.
Textured surface:
Many years ago a scientific theory emerged that formation of scar tissue around the implant could be disrupted by making the outer surface of the implant rough instead of smooth, called "texturing". There were theoretical considerations that seemed to be sensible, and so textured-surface implants were (and still are) manufactured.
Eventually it was learned that while the texturing did indeed decrease the early hardening of the scar capsule, that was only delaying the onset, and eventually the breasts got hard in the same percentage as with smooth implants. In addition, the texturing of the surface often produced a very obvious kind of rippling called "traction wrinkling" that was difficult to correct. Also, some reports indicated a higher failure rate with textured surfaces.
It should be noted that non-round implant shapes actually must have a textured surface to help decrease the chance that they will turn over or rotate inside the pocket. This is a valid use for the textured surface.
In summary, the textured surface has been in use for a long time and has been well studied. A valid use of texturing is to decrease rotation or flipping of an implant. Texturing may delay the onset of capsular contracture, but has not been shown to actually decrease the chance of it happening.
Polyurethane sheeting:
Polyurethane was tried as an external coating on the outer surface of the implant. This was once considered such a great idea that a line of implants was produced with an integrated covering of polyurethane. The advocates of the polyurethane believed that it had promise for decreasing the chance of capsular contracture.
Unfortunately over the years it was learned that the rate of contracture eventually was the same, it was just slower in coming on, the polyurethane was only delaying the development of the contracture. In addition, the polyurethane was found to become incorporated into the scar capsule and eventually disintegrate, and removal of the implants plus the scar capsule became fairly difficult. There were also worrisome reports about possibly harmful break-down products. Those implants were taken off the market years ago, and now there are none with FDA approval.
In summary, the polyurethane covering is a concept that has been thoroughly tried and tested in the past, and has been proven both ineffective and problematical.
Teflon sleeves:
An external Teflon mesh called Gortex has been advocated as a covering device to be wrapped around the implant. The advocate of this device believes that it has promise for reducing the chance of capsular contracture. (The doctor who advocates this calls his device a "pocket protector" and that name has by now probably been patented and trade-marked.) Like all interesting concepts, the usefulness and validity will have to be proven, and that process has not yet taken place with this device, and has not yet been published in a reputable medical journal.
Board-certified plastic surgeons have several concerns about this device, all of which will have to be addressed and clarified before the device can be considered safe and effective. For example, all of the methods that have been tried in the past for reducing capsular contracture have merely delayed the onset of the problem, and did not really reduce the frequency. Another is that even though the foreign material will be incorporated into the scar tissue, some of it may still be constantly rubbing against the implant, which would shorten the implant lifespan. For that reason the manufacturers probably would not honor the implant warranty, especially if their standard microscopic examination of a returned failed implant shows the kind of wear that the mesh might cause.
Another concern is that the doctor who is promoting the use of this device has revealed that with his regular augmentation patients (the ones who do not have the device) about 40% of them get capsular contracture! This is an extraordinary and astonishingly high percentage, because Board-Certified Plastic Surgeons have only about a 5% rate. It is not clear why that doctor's rate is so high, but that does make it difficult to evaluate any treatment that he advocates for prevention of Capsular Contracture. For example, say that by using his device that doctor manages to drop his percentage from his current 40% down to the plastic surgeon's norm of 5% - that does not necessarily mean that plastic surgeons with a rate of 5% could drop their rate even lower by using that device.
Certainly that doctor has patients who believe that the Teflon sleeve has helped them, for example patients who had previous episodes of hardening and now have soft breasts with the Teflon sleeve. But plastic surgeons also have many such patients for whom they have achieved the same result without use of such a sleeve. More to the point, I have received letters of complaint from patients into whom he had placed his device, who had severe problems and poor outcomes. Perhaps those patients are a tiny proportion of his patients and may not represent the whole picture? I do not know of any Board-Certified Plastic Surgeon who uses that sleeve device.
Of all of that doctor's claims for the device there is one that makes no sense: that his device would make replacement of a failed implant easier. Currently, replacement of a failed implant is already as easy as it can get: just slide out the old implant through a small incision and slide in the new one, stitch it up and the patient goes home! With saline, the incision can be less than an inch in length. How using that doctor's device could make replacement any easier than it already is not obvious. I am not understanding why that doctor finds replacement of a failed implant at all difficult.
In summary, so far I am aware of no justification for increasing the cost of breast augmentation by another $1000 or whatever he is charging for his device. However I will keep an open mind and will be watching the medical journals for verified proof of the effectiveness and safety of the device. Once all the studies have been completed, I will look forward to reading the full report. If effectiveness is ever verified, I will of course revise this page accordingly.
Collagen matrix:
Collagen matrix material ("Alloderm" and others) is basically cell-free collagen matrix. It is made from the skin of a deceased person who donated their body to science, just as some people do with kidneys or corneas etc. The key difference is that all cells, proteins, and other materials have been stringently removed, so no donor matching or allergy testing is needed. Only inert collagen is present, and the material is free from any bacteria or viruses. This material is ideal for reinforcing weak areas of a scar capsule, but has also been advocated as part of the solution to preventing capsular contracture. Advocates of this approach believe that by placing some of this tissue next to an implant, that capsular contracture will be lessened. This has not yet been shown to be true.
In summary, the use of collagen matrix for reducing capsular contracture has not yet been shown to be effective. More time and experience with this approach is needed. I will be watching the medical journals closely for evidence that it proves successful, and will revise this page accordingly.
Silicone bleed barrier:
It is known that all implants, especially the silicone gel filled implants, "bleed" tiny amounts of small-molecular silicone through the implant surface and into the scar tissues and into the body. There was debate in the past about whether this could be harmful to a patient's health, but all the studies have so far shown no effect. Another theory held that the gel bleed could contribute to capsular contracture, and studies indicate that there may be some validity to that concept. Therefore in an attempt to help prevent capsular contracture, gel-filled implants are now made with "low gel bleed" shells, that provide some additional barrier to gel bleed. In therory this should prove helpful, but it is much too early to know for sure, and the necessary studies will require many years to show valid results.
In summary, the use of low bleed surface barrier for silicone gel implants seems to be theoretically sound, but has not yet been shown to be effective in reducing the chance of capsular contracture. I will be watching the medical journals closely for evidence that it proves successful.
Conclusion:
The fact that there are so many different approaches to the problem is proof that no method is completely 100% effective.
One of the frustrating aspects of studies concerning capsular contracture is that it takes many years before results show up, and gathering the very large number of cases needed for a valid analysis can take decades. Another frustrating aspect of studying capsular contracture is the need to establish a "control", that is, for every breast for which a new device is used, there has to be an equivalent breast without that device. Unfortunately for most of the art and science of breast augmentation, the best valid "control" is always the woman's opposite breast. This would mean that patients would have to agree to have in one breast an implant plus a preventive measure, and in her other breast an implant without any such device or measure. It will take years to find enough patients willing to have that done, and perhaps it never will be done.
The other way to study and evaluate the effect of something new is to accumulate an extremely large number of patients, perhaps tens of thousands, half of whom have the device, and the other half do not. Then a medical report can be written, in which the two groups are compared. That report would then be reviewed and critiqued and if found to have merit and validity, it would get published in a reputable medical journal.
To repeat: The fact that there are so many different approaches to the problem is proof that no method is completely 100% effective.
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