10. MANAGEMENT OF INFECTION

Part of the written explanation of the surgery the patient is given, and must sign, tells that if there is a significant or severe infection, the implant will be removed. The infection is then treated until the patient is completely well, and then the  implant can be replaced. This requires going without the implant a minimum of three and up to six or more months.

We wait this long, not only to be sure the infection is entirely gone, but for the tissues to soften and recover. The alternative is to treat the patient with a swollen, red and tender breast with fairly large doses of antibiotics and usually to find that the treatment has failed. Several months of treatment may be required, and then in a month or two later the infection is back again and the patient has a tender swollen breast again, etc.

The probability of failure to medically eliminate infection around an implant is so great that it is not worth the time, effort, inconvenience, and continued illness of the patient.

When the implant is finally removed, the infection can be quickly controlled and the patient returned to a state of good health.

The patient may try to persuade the surgeon to try antibiotics for a few weeks or a few months and not take the implants out, but the surgeon can explain that it is an unhealthy situation, and that in the long run it will be much more quickly resolved if the implant is removed immediately. If the patient is to lose confidence in the surgeon over the presence of infection, it would be my preference to have the patient see someone else with no implant on one side, than with an infected implant, especially a recurrently infected one draining periodically over a period of months.

11. MANAGEMENT OF CAPSULE CONTRACTION

In previous chapters we have discussed the avoidance and prevention of capsules, but they occur anyhow, and then what can we do for them? Basically there are three alternatives:

1. Closed capsulotomy         

2. Open capsulotomy         

3. Do nothing

Closed capsulotomy before January 1992, when the FDA officially removed the silicone implants, was a common procedure. Now with the saline implants, anyone who presses on them and causes a deflation has a liability. Even if the compression is very light and insignificant, just the fact that it occurred (even a year after surgery) causes the person who pressed on the implant to have a liability.

Even before the salines with their deflation problems, it was inadvisable to do a closed capsulotomy. The first articles on the subject appeared in the late 1970s and seemed to recommend the procedure to anyone with a capsule. Then in the late 1980s, an article showed a 10% or more serious complication rate. So many doctors would decompress their own patients but not someone else's.

Once I did another doctor's patient and the next morning she came in with a hematoma. We had to operate.

Another friend did a patient a favor when she was seeing him for something else. She asked what could be done for the capsules and he offered to decompress them if she would like for no charge. After he had done it successfully she had a mammogram 8 months later and both implants were found to be ruptured. She had had a mammogram about 4 months before seeing him and they were intact. So she had them removed and replaced with salines. Then she sued him and finally after a prolonged trial , his insurance settled with her for $100,000.00. All this for trying to help her with the problem. Doing what was correct at the time. And doing it gratis - for free.

So don't do it. Whether saline or gel. Just don't. For a while we would have the patient sign a consent for surgery. But these days and especially with saline implants, it is probably not a good idea.

A special  closed capsulotomy inform consent is included in this manual for historical interest.  The most common complication of closed capsulotomy is  failure to decompress the implant. This needs to be clearly understood by the patient, as well as the very high recurrence rate.

The second most common complication is pain, and then distortion due to incomplete tearing, then abrasion,  bruising, hematoma, rupture of the implant, deflation (if saline or combination), and extrusion and extravasation of gel into the axilla and down the arm.

Many times the implants have been broken and this has not been realized by the surgeon or the patient until years later when it is discovered by what may be a different surgeon who performs an open capsulotomy.

If done after subcutaneous mastectomy the entire thin walled  breast skin can split open and expose the implant, or the gel  from the implant can then subsequently ooze and become expressible through the nipple ducts. Open capsulotomy has the same potential complications as the  primary operation.

The implant is removed, a new pocket is dissected open, and the implant is replaced. A small dose of steroid may help prevent recurrence. The implant can then be placed in a submuscular pocket at  the time if desired. If the capsule is very thick it may be  desirable to remove some or most of it.

Some capsules that have  been there for years are calcified partly, and can be dissected out intact. If, however, the skin is thin and there is not much  breast or subcutaneous tissue it may be advisable to leave most, if not all of the capsule, and enlarge the pocket by cutting it into sections.

One advantage to leaving the capsule as much in place as practical is that there is less bleeding if it is not removed. Sometimes if the capsule is of an implant in the submuscular position and the type of implants is changed to one that is textured, it may be advisable to place the implants from a submuscular position to a new freshly dissected pocket in the subglandular position.

Several patients of mine had muscle movement from being below the muscle with an areolar incision. The muscle had attached to a scar tissue band that extended up to the areola. When the pectoral major was contracted, such as when leaning forward on the hands, the areolae would be pulled in by this muscle movement phenomenon. No capsule was present.

Cutting the attatchments of the muscle to the areola and injecting kenalog to soften and prevent scar did not solve the problem, though it did improve it.

The only solution that I found for these patients was to take the implants out from the submuscular position and place them above the muscle. That solved the problem.

12. CHOICE OF IMPLANTS

If one type of implant were superior to the others I would  like to know it. There were seven implant manufacturers  and  all of them produced excellent products. The names and addresses of the implant manufacturers are listed in the FDA booklet on breast implants.

The choices of types of implants were primarily saline, gel, combination and the Meme. Most of these have been discussed and  all have their merits. Now all we have are the saline - smooth and textured.

All three manufacturers today since 1998 - PIP,  McGhan and Mentor have produced corrugated surface textured silicone implants as well as smooth in both saline and silicone filled.  McGhan's textured implant is called Biocel . Mentor's is called  Siltex.

They should stay softer and have less hard capsule contracture. But due to the thickness required for the textured effect the ripples of the implant show through the skin. This is referred to as wrinkling or rippling of the implants. It is present in smooth as well as textured implants and in silicone gel as well as saline filled.

Hence we still like to have the upper half covered by muscle if the tissues are thin and rippling is expected to show.

Speaking with the most reasonable, caring, and knowledgeable surgeons, you will get widely different opinions as to which are  the best implants to use. All are the finest highest quality from the best companies. There are some differences.

The texturing of the McGhan is much deeper than the Mentor. The Mentor Siltex textured is more likely to move in the pocket than the McGhan.

The McGhan Biocel is quite adherent to the tissues and the implant stays where it is put and does not move. If covered by adequate breast tissue, such as 1/2" thickness or more, rippling is usually not a problem and does not show.

The McGhan Biocel textured teardrop breast shaped 468 implant was brought onto the market in 1995. It was most like the meme. The meme was becoming very popular because they would not get hard. They were lined or covered by about 1/4" thickness of polyurethane. They were removed from the market because of the polyurethane in about 1992 by the FDA. A breakdown product of the polyurethane was found to be carcinogenic, and to cause liver cancer in mice.

The McGhan 468 is very much like that very successful meme implant. They are firmer than normal. They are more tightly filled with saline than the round. And because they are teardrop or breast shaped they do not become spherical balls as the round implants do with more filling with saline. But they are always more firm. And because of the biocel texturing, they stay in place and don't move. They are therefore less natural, except perhaps in the submuscular position and when covered by adequate breast tissue to mask the firmness.

The other saline inflatable implants are fairly thick walled and can show ripples or wrinkles through the skin fairly easily. They feel stiff.

The softest and thinnest wall implants are the pre-filled PIP. The incision for insertion must be a little larger because they are pre-filled. But they feel soft, especially the PIP smooth. The smooth PIPs are so thin they are like the silicone and double lumen we were accustomed to using in the 1980s. But they are saline filled. However, these are no longer available on the market.

Implants that are soft and feel more natural like the PIP smooth can be placed above the muscle and should not have hardness in the first one or two years in most cases if some long acting triamcinolone is injected in the pectoral fascia behind the implant. Some of them will never develop problem capsules. And those who do can then be treated as needed . This might require capsulotomy for a mild unilateral case. And for more dense capsules, replacement with textured implants under the muscle may be needed.

13. STEROIDS

Steroids have been widely recommended in breast augmentations for many years, and there are many reports on how effective they are in preventing capsules. Some of these are good studies comparing the same techniques with and without steroids and showing great benefit. We also know how well steroids work in preventing scar of  the esophagus in lye burns, and how effective they are in injecting scars and keloids.

The steroids that have been most widely used are Solumedrol  (methylprednisolone) and Kenalog (triamcinolone). The kenalog is more crystalline and longer acting. Both have been used in saline or in the saline compartment of double lumen implants, and in a part of a rinse, usually with an antibiotic solution to rinse the pocket before putting in the implant, thus leaving some in the pocket.

Even though they are effective in preventing capsules, they  have a significant complication rate that is usually, but not always, dose related. This is the atrophy, which is often a thinning of the skin and subcutaneous tissue to the point that a blueness of the implant can be seen and felt through the thin  skin. This may be referred to as a "blue window".

When it occurs several months after surgery and is not apparently progressing, it need not be treated, because the atrophy will subside as the steroid effect dissipates in time and the tissues will thicken.

Sometimes the implant is changed, and in time a capsule develops around the new implant, and the doctor and the patient  may wish they had left the blue window alone, because it can take care of itself and thicken up and go away in a period of one to three years, and never have a capsule develop.

Occasionally the atrophy will become worse and the breast  will begin to droop. This ptosis also can improve if left alone and is not a certain indication for surgery. Removal of the implant and replacement with a new one can hasten the resolution, and at that time the blue window can be repaired with a layer of superficial pectoral fascia sometimes.

The ptosis can also be corrected by sutures placed to lift the breast inside the pocket. A smaller implant may be suggested to give less downward  pressure, and if the implant is completely removed, the blueness and ptosis resolve most quickly and the atrophic appearance can return entirely to normal in a few weeks or months. Because the problems of atrophy and ptosis are more tedious and time consuming to solve, many surgeons avoid use of steroids altogether.

At the present time, my suggestion for steroid use is to use the long acting kenalog, in a dose of about 10 mg on each  side, injected into the tissues behind the implant.  Since the most  troublesome atrophy occurs inferiorly, very little of the Kenalog  is allowed to come in contact with the inferior portion of the breast. It is usually not placed in the implant.

The 10 milligrams of Kenalog are injected behind the implant into the pectoral major fascia if subglandular, or into the pectoral minor fascia if subpectoral before the implant is inserted.  It may be mixed with and diluted with local anesthetic, and injected  over a fairly large area behind the implant in the pocket wall where atrophy, if it occurs, will not show. In the subpectoral region, a smaller dose is used and it is injected in the under side of the thickest portion of the muscle, if it is used at all. Or, solumedrol 10 to 20 mg is added to each saline implant. This is a technique widely established in the literature. And it is recommended and being used by Dr., Jerry Johnson of Houston, Texas, who developed the umbilical approach according to his reports at our 1995 meeting in Baltimore, Maryland.

Since the pectoral muscle will be pushing  the implant down, atrophy due to steroids of the lower half of the breast may quickly lead to rather severe ptosis and stretch marks and develop. Every case of atrophy I have seen has been correctable and  restorable to normal and a good result without additional scaring  or deformity by conservative measures.

Excising thin skin has been proposed by others, who have not seen atrophy very much, and should be avoided. This could lead to scarring and deformity. It  would be better even to take the implant out than to have additional and unnecessary scar and deformity. If atrophy occurs with steroid in a saline or double lumen implant, the implant may be removed and changed to a gel and the atrophy can then be expected to go away completely in a few months.

14. SUBCUTANEOUS MASTECTOMY

It sounds great that all we need to do is take out everyone's  breast tissue, fill them up with implants, and not only will they  never have breast cancer, they will also have fantastic looking  breasts, and their insurance will pay for it. It sounds especially good to someone who wants implants and can't quite afford an expensive cosmetic cash up front operation, but if insurance will pay for it, why doesn't everyone do it?

The reason is, it doesn't work that way. After subcutaneous  mastectomy, the nipples are numb, the breasts are hard and cold, they are easily susceptible to injury because they are, for the most part, numb. They don't either look or feel normal and nothing can be done about it. They are not quite as bad a breasts reconstructed after radical mastectomy, but almost. Placing the implants under the pectoral muscle is not much  help.

The muscle only covers the upper half, doesn't look normal and can push the breasts down. They are unusually firm because  the skin over the implants is very thin. Some of the results can  best be seen in the slides shown with the lectures on this  subject.

One trap that doctors have fallen into is to leave enough breast tissue to prevent too many problems with the thin skin over the implants, bill the insurance for a subcutaneous  mastectomy, and have the patient wind up seeing your worst enemy  because of the inevitable hardness and poor result.

Then he says that this was no subcutaneous mastectomy, and not only is there a lawsuit, but a board of medical assurance action filed for fraud. 

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