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COMPLICATIONS

The next point of information we supply our patients is a brief explanation of the common standard complications with the approximate rates of occurrence for each one:

1. Infection, 1%

2. Hematoma, 4%

3. Noticeable scars, 10%

4. Asymmetry, 10%

5. Numbness, 10%

6. Deflation with saline implants, 30%

7. Excessive firmness, 50%

8. Steroid atrophy, implant rupture, pneumothorax, seroma, 2%

9. Shape problems, position problems, double-fold, synmastia, 10%

10. Blue window, extrusion, 1%

11. Palpability and immobility, 20%

12. Rippling, 50%

These complications are explained and mentioned in the written consent forms the patient is asked to sign before surgery, and copies of these forms are provided in your workbook.

 

1. Infection 1 %

Actually, in more than 500 consecutive operations performed on an outpatient basis in an office surgery suite, there have been only three post-operative infections from the surgical procedure in the immediate post-operative period.

Still, it is a very good idea to have the patient understand what happens with an infection, because it can happen anytime and is not necessarily within the control of the doctor, especially when the operation is performed in a hospital. Some of the infections can occur later (perhaps years after surgery), and could be related to trauma or minor injuries such as a scratch. Such trauma can induce infection, beginning in the skin of the chest and spreading into the breast.

Other infections have been related to hospital-performed surgery or surgery in the presence of previous silicone injections, or with silicone extravasated into the tissues from a ruptured implant. Also, primary breast infection or mastitis (which may or not be related to nursing, but frequently is), may occur.

At times a breast implant begins to extrude years after surgery due to a possible foreign body type reaction or apparent indolent chronic infection around the implant. Whenever there is infection around a breast implant, it is best to remove the implant, and leave it out until all the infection is completely gone and the tissues are soft and pliable again.

This would take a minimum of three months for most cases, and six months or more when there is induration, gross pus, resistant organisms or an otherwise bad or difficult infection. The patient with an infection finds this very hard to accept, especially when there had been no warning that this was a possibility.

The idea of having only one implant in place for six months or so is not appealing to the person who was so motivated to look better as to voluntarily under go this surgery. Generally once it is determined that an infection exists around the implant, it is best not to temporize and give antibiotics to delay the inevitable.

While it is not impossible that antibiotics will allow the implant to remain and not be removed, the chances of this are very small, somewhere in the range of less than 1%. And while the weeks go by and the swelling, redness and pain return every time the antibiotics are stopped, and the expense and complications of taking the antibiotics are taking their toll, the patient may become more and more depressed, anxious and angry.

Not only is the unhappy prospect of having the implant removed looming in the future, but the presence of the persistent infection is ever-present. This is an uncomfortable illness, with tenderness and redness and perhaps fever and fatigue. If the implant is doomed to be removed, then this discomfort and illness is unnecessary and should be avoided by early removal of the implant.

It is better to do what is needed quickly and forthrightly, and then by the time the patient on antibiotics would be getting depressed and angry over the prospect of losing the implant while having been on antibiotics for about six weeks, the patient who has been without an implant all that time is already well and free of pain and swelling and is scheduling the date to have herself restored with a new implant.

Patients tend to be more accepting of this scenario when they are forewarned of this possibility, and the patient who is treated decisively tends to have more confidence in her treatment and is more likely to remain with the same surgeon.

 

2. Hematoma 5%

Hematomas occur fairly frequently. They are said to occur more often in redheads, patients who have taken aspirin, ibuprofen, vitamin E or estrogens, and in those patients with elevated blood pressure.

Other causes are coagulopathies, and excessive heat or exertion after surgery. It can be explained to the patient that this is a result of a blood clot around the implant due to a broken blood vessel usually within the first three weeks after surgery.

The patient may also be reassured that this is not life threatening, either from the blood clot going to the lungs as an embolus or from blood loss, since it occurs within a closed space. If hematoma occurs, the patient will notice swelling of one side, with pain, tenderness, firmness and bruising or discoloration.

Small clots occur without any of these signs. Sometimes the normal side without the hematoma will transilluminate much more than the side with the hematoma, distinguishing the clot from a seroma or fluid around the implant. The patient with these signs is seen, either within a few hours or within a day, or as soon as possible, depending on the level of discomfort. For one breast to have more bruising or discoloration and more swelling than the other is expected and normal.

The patient who will need evacuation of a hematoma will usually be moderately or very uncomfortable with a hard swollen breast on one side. As soon as it is determined that a significant hematoma (in my opinion, any of a size to reduce transillumination and cause symptoms) exists, it is either drained or the implant is removed under sterile conditions, with eradication of the hematoma and implant replacement.

If the hematoma is drained, it will not all come out. A drain will probably be left in place for a number of days, requiring the patient to stay home or wear sterile pads in her bra to collect the drainage for up to a week. And still with drainage, some may remain behind to cause capsule contracture. Another consideration is that while it is draining, infection is always a possibility, which could lead to removal of the implant for months.

If the patient, when seen, can wait until the next morning (which usually only requires reassurance and adequate pain and anxiety relief), the implant can be removed under sterile conditions in the operating room.

The hematoma is completely removed. The pocket is flushed with dilute peroxide, which can eliminate some of the discoloration, and the implant is replaced and the crisis is over. The patient is recovered in a few hours, and can return to usual activities the next day with little bother and no mess.

 

3. Noticeable Scars, 10 %

Someday one of our patients is going to have a hypertrophic or keloid scar that is quite noticeable and troublesome. Others will be self conscious of scars that may be almost imperceptible. The location of the incision is important in preventing scar formation.

The areola skin is much less likely to have a hypertrophic scar or keloid than the peri-areolar skin. The axillary incision is the most hidden, and it too seems much less likely to form a thick scar than the infra-mammary incision.

In a patient who is not known to heal without visible scar formation from other surgeries that have been done on them, the inframammary or periareolar sites can give very unattractive results. Sometimes a single revision can make a lot of improvement, and in other instances, the scars persist and are troublesome.

Scars of the areolae that are lighter in color than the color of the areola can be tattooed to match, and this works well, especially in the person who persists in forming a white line in the areola in spite of the most carefully performed revision.

Only a few patients will need revision. The incidence of 10% is arbitrarily chosen to include patients with almost invisible scars who still feel they are noticeable. Actually 100 % have scars, and whether or not they are noticeable is a matter of opinion.

 

4. Asymmetry, 10%

As with scars, all breasts are to some extent unlike. It can be mentioned that God made no two snowflakes, grains of sand or anything else we can see alike. Whether or not there is significant asymmetry is a matter of opinion.

It is advisable to mention this possibility to patients prior to surgery, pointing out asymmetries that already exist. We try to make the breasts more symmetrical with the operation. The one factor that can be controlled is volume.

We can use implants of different volumes to help correct asymmetries in size. Another factor is the position and shape of the infra-mammary fold that can be made more equal when indicated, and this may help the appearance quite a bit.

Factors that cannot be controlled with augmentation alone and would require other surgery are the size and position of the areola, the protrusion of the nipples, pigmentation, shape, and many other inequalities and asymmetries.

One of the best ways patients with a certain shape can tell what kind of result they are most likely to have is to see before and after photographs of patients who have a shape similar to theirs before surgery.

 

5. Numbness, 10 %

Many surgeons will say they have no problems with numbness, and this is partly because the surgeon cannot feel it and he is unaware of it. It is not the surgeon's personal problem, and yet it may be a patient's problem. All patients have a little bit of numbness with almost any surgery when there is an incision.

With augmentation mammoplasty the most common numbness occurs in the lower half of the breast inferior to the areola, especially when there was not much breast tissue to begin with and the infra-mammary fold is lowered, or if a large implant is used.

This mostly goes away and doesn't bother many patients. Numbness of the nipples does bother some patients, and occasionally the sensation of the nipples is very important to the patient, and they need to know there is a risk it may be reduced, or even absent (though rarely).

The nerve to the nipple primarily comes from the fourth intercostals nerve, and should be preserved if at all possible. In testing patients who have noticed some numbness (and I often ask), I cannot remember ever seeing complete anesthesia when a pinprick of the areola is given. Probably the trans-axillary sub-pectoral and the umbilical approach cause the least numbness, and the other sub-pectoral approaches may result in less numbness than pre-pectoral. However, numbness occurs with the subpectoral approaches too.

The areola incision itself does not increase the incidence of the complaint, and need not be avoided for that reason. Most sensation returns in one year, and may continue to return for up to two years, and the patient with early numbness should be reassured.

 

6. Deflation with saline implants, 30 %

While the incidence is not exactly known, the deflation rate with saline implants is so high that in spite of the other advantages of their use (i.e. no gel bleed, softer than gel, lower capsule contracture rate), they are seldom used. Even with combination implants, when the saline makes up more than 10 % of the volume, a unilateral deflation usually means another operation.

Probably the pre-filled saline implants with no valve will have less of a deflation rate.

 

7. Excessive firmness, 30 %

Capsular contracture is the major complication of breast augmentation with a wide range of incidence reported. The most widely quoted classification of grades of firmness is from Baker (P&R Surg Vol. 65, No. 1, Jan 1980). The incidence in Baker's series of grades II to IV was 27% or more (especially since there was not a long follow-up period recorded and the fact that sometimes capsules do not appear for 2 years post-surgery).

This was in spite of up to 40 mg of Kenalog instilled into the pocket of each side, antibiotics, etc. The prevention and treatment will be more thoroughly discussed elsewhere.

What the patient needs to know is her chances of having this problem, what can be done for it, and what it will cost. I show the patients an article by dear Abby that quotes a 50 % incidence of hard breast implants, and the case of one patient who had the implants removed in disgust because of the hardness.

My patients are assured that if they ever want the implants removed, I will do it for them at very low cost to them. To my best knowledge, in spite of the hardness problem, all my patients still had them in, and had elected to keep them even though there had been some problems.

This was true until 1992 with the FDA saline scare. Since then, four have had the implants out and not replaced.

The reason I offer to remove them at very low cost is that I don't want them to have to go somewhere else to have it done. I want to follow the patients with breast implants and keep in contact with them, especially those who have had some complication or who are in some way displeased with the results.

 

8. Rippling, 50%

The rippling problems that we are seeing with breast implants first began with the introduction of textured silicone gel implants in 1989.

The texturing was introduced to prevent capsule contracture. It was noted that the polyurethane implants would not allow capsule formation and they would not become very hard.

If the standard silicone implants of the 1980s were used without some sort of special technique to prevent hardness such as submuscular placement or use of steroids, the incidence of grade III and grade IV moderately severe and severe capsule contracture was more than fifty percent.

Some surgeons such as Richard Dolsky and Gary Fenno from the early 1980's exclusively used polyurethane implants because of this capsule contracture problem. During the latter of the 1980s more and more surgeons were moving toward the polyurethane implants. The plastic surgeons who wrote most articles on breast implant surgery, such as Bostwick and Tebbets, started routinely using the polyurethane implants in primary augmentations to prevent capsules.

It was discovered that the texturing of the polyurethane as compared to the slick surface of the gel had a lot to do with preventing capsules. Therefore, the textured silicone implants were made available by Mentor and McGhan in the last two years of the 1980s.

Though the texturing does seem to prevent capsule formation, the additional thickness of the silicone bag causes waves or ripples of the bag that show through the breasts, especially in a slender woman.

With round implants, over-filling can result in less rippling, but when they are over- filled they form a ball or a sphere like an orange and become firm and unnatural in appearance.

Rippling from breast implants is the appearance of the implant through the patient's tissue, and is proportional to the thickness of the implant wall and the thinness of the tissues covering the implant.

When a saline or gel filled silicone textured implant is held up, you can see vertical folds. If the patient has thin tissues above the nipple overlying the implant, these folds will show through. To prevent this rippled appearance above the nipple, the implant can be placed below the muscle.

Ripples occur with silicone textured implants as well as with saline. The saline textured implants ripple the most, but saline without texturing can also ripple.

Even if the implants are below the muscle, the rippling can still show in the lower part of the breast, especially laterally in the area of the anterior axillary line. And this shows most when the patient leans forward.

The McGhan 468 implant is teardrop in shape and is filled more tightly without spherical distortion. It is firmer than the more loosely filled implants. But as a Biocell it is a very deeply textured implant. It is probably the least likely to have a capsule of any on the market today.

Certainly if I were revising a patient for a capsule problem, I would consider the 468 implant to prevent recurrence. Capsules frequently recur. Because of the tight fill of the 468, this implant will not show rippling very much at all. The trade off is the firmness and immobility that is present with the 468.

The PIP pre-filled soft, smooth implant seems to have the least thickness of the implant wall. Therefore, it has the least amount of rippling and the most desirable softness altogether. Surely with this implant being very much like the natural feel and softness of the silicone implants we were using in the 1980's, the capsule rate is going to be fairly high.

At the present time of this writing, March 11, 1998, the PIP smooth implants are not available because of FDA questions about the methods of manufacturing of these implants.

In summary: Rippling is due to the thickness of the implant. Texturing doubles the thickness and increases the chance of rippling. Even the smooth inflatable saline implants are thick enough and stiff enough to ripple if the tissues covering the implant are thin. The textured implant that does not ripple is the tightly filled 468. The soft, smooth pre-filled implant that does not ripple is the PIP smooth, which right now is not available.

 

9. Seroma, 1-2%

Seroma is the accumulation of serum-like fluid around an implant. It frequently occurs years after surgery.

The incidence is in about one or two percent of patients. In over one thousand patients, I have seen seroma in about six.

The usual patient with a seroma is one who previously had a very good result and four to twelve years later develops a swelling of one side. On examination the one side with a seroma is larger, but usually not very tight or very tender. Most often there are no signs of redness or inflammation such as fever.

A swollen breast after surgery is usually a hematoma. The hematoma will not transilluminate. The normal breast with a clear saline or gel implant transilluminates very well. Even if the implant is under the muscle, a hematoma will transilluminate a lot less than the opposite side. Since the lower half of the breast is not covered by muscle, the transillumination can be detected with the light going transversely through the breast rather than from the bottom up.

With seroma the transillumination is preserved. A seroma transilluminates just as well as the other breast with an implant and no seroma. The fluid around the implant with seroma is serum or straw-colored and usually cloudy. Those I have cultured have shown no growth.

Very often all that is needed is a course of antibiotics and of steroids to eliminate the seroma. If it comes back, the steroids and antibiotics can be repeated. If the seroma persists and will not diminish with steroids and antibiotics, then it may be necessary to remove the implant and leave it out for several months as we would do with infection. A new implant can then be replaced at a later date.

Two other steps can be taken before the drastic measure of implant removal must be considered. One is to use a blunt, small needle-like instrument, such as a liposuction canula or micro-lipo canula. This can be inserted through a tiny incision just posterior to the anterior axillary line where it will not leave much of a mark. As well, through a tract down to the breast implant (so that leakage will not occur), the capsule can be perforated and the seroma aspirated and drained.

While this small canula is present in the capsule, the pocket can be irrigated with saline thoroughly. Also, we can also instill a small amount of our favorite antibiotic, such as Rocephin, and of our favorite steroid, such as 20 mg of Solumedrol or 5 mg of Kenalog. This can solve the problem.

Another slightly more conservative option to total removal of the implant for several months would be to remove the implant, thoroughly irrigate the implant, and replace the implant.

The cause of seroma is probably different from one case to another. But it might be from hematogenous bacterial invasion of the foreign body area. Or, it could be from some very late reaction to some very tiny particles of foreign bodies that are left at the time of surgery.

 

10. Blue Window, 1%

A blue window is a simple thinning of the tissues so that the implant can be seen as a bluish color. The skin over the implant can be so thin that it would seem that the slightest scratch or puncture of the skin would perforate the skin, if not the implant itself.

Blue windows can be divided into those that are soft and those that are firm.

Soft blue windows occur especially frequently when steroids have been used in the implant. A blue window may also occur from steroids that are long acting, such as triamcinolone. This crystalline steroid will settle down to the bottom of the pocket and cause thinning.

The firm blue window occurs when there is some reaction to the implant, causing a capsule to form; this is a sign of impending extrusion.

Both types of blue windows usually occur in the lower thin portion of the breast, near the infra-mammary fold. This is where the tissues are thinnest.

Whenever the blue window is due to steroids, it can be eliminated quickly and easily by removing the implant and by washing out any steroids that are in the implant or in the surrounding pocket. Within a week of replacing the implant the blue window will be gone.

The blue window that is associated with a firm capsule can be followed and will probably result in breaking open at the site of thinning. And when the implant is exposed, it will extrude.

From my own experience I have seen only one implant from another surgeon extrude, and I have had only one patient of my own experience extrusion of one side following pregnancy.

Of soft blue windows, I have seen several dozen. This is because from about 1975 through 1986 I used double lumen implants made of gel in the center and covered by saline in almost all of my patients. To prevent a capsule, I put steroids into the outer saline compartment routinely. The steroids would prevent capsules from forming in the first two or three years in nearly all of the patients. The breasts would remain soft and natural and there were very few problems. In the early 1980s, because a couple of patients developed capsules several years after surgery, I decided to increase the dose of steroids to prevent this problem. That is when I started seeing blue windows.

Because we wanted a long-term anti-capsule or anti-scar tissue effect due to the steroids, I chose to use long acting steroids in the implants. Kenalog (10 mg) was used in each implant in most cases. This would produce a blue window in less than ten percent of patients. A mild faint small blueness and thinning of the tissues would be followed and would usually go away within a year.

As I lowered the dose to 5 mg, the capsule prevention was almost as good and there were no blue windows.

At one time I increased the dose to 20 mg of Kenalog in each implant. And all of these patients developed blue windows and steroid atrophy. They were all corrected by washing out the steroids and replacing the same implant with fresh saline in the outer compartment. And in every case the blue window and steroid atrophy was almost completely gone in one or two weeks. None of these patients to my knowledge had persistent problems or ptosis.

In the case where there is a blue window and no steroid inside the implant, I think that if it is mild and not progressing, it can just be watched and will by itself go away over a period of months without surgery.

Many surgeons have advocated the use of steroids in and around implants. If using non-textured implants, I will put triamcinolone injection into the tissues behind the implant where steroid atrophy would not show to keep a capsule from forming. This is done in most cases still today.

Capsules are going to form even around smooth saline implants in a high percentage of cases. Long acting steroids injected behind the implants in a dose of 10 mg of Kenalog for each side will prevent many capsules. Sometimes Solumedrol 10 or 20 mg will be put in each implant instead of the Kenalog injections.

 

The Persistent IMF or Double Fold or Double Bubble:

A double bubble or double fold is the original infra-mammary fold that has not been pressed out. It is a fold in the dermis primarily, but also in the subcutaneous tissues attached. It is not due to any mysterious ligament or fascia. Whenever the dissection is below the muscle along the chest wall with no specific attempt to press out or stretch out the IMF, the implant can follow the chest wall and leave the previous IMF intact causing the double fold. The freeing of the original IMF is a subcutaneous dissection, not a sub-muscular one. The proper plane is to dissect the subcutaneous fat free from the underlying muscle and fascia, leaving the fat attached to the skin. By double fold, it is meant that the new IMF and the old IMF (infra-mammary fold) exist together; the result is a double-bubble appearance. It is the old subcutaneous and dermal fold persisting that causes the problem, nothing more. No imaginary fascial bands or ligaments are the culprit. The deep and persistent IMF cannot always be corrected, because the dermis can only stretch so far. If a surgeon were called upon to create a Ubangi lip in one operation at one time, it would not be possible. But if after surgery a double fold is prominent and McGhan textured implants were used, it will not move. The implant that is fixed like velcro (as these implants are) will not act as an obturator or dilator to stretch things out. They will remain fixed in position and whatever double fold there is after surgery will probably remain. On the other hand, if you get it dissected out and want it to stay in place, the McGhan textured will hold it in place and prevent a late occurring capsule or double-fold from developing. A smooth non-textured implant can allow this to happen. The usual mild double bubble is not a big problem, fortunately. All that is required is pressing or stretching out the previous persistent subcutaneous and dermal infra-mammary fold as describe above. Even though we know that inferior to the 5th rib the dissection is more difficult and the tissue is more fibrous, as well as we could search in the cadaver or in the live patient we could not discern a structure. We will just find dense fibrous tissue that we have always known was there. The author of an article in the 1995 PRS Journal (on the Infra-mammary crease ligament) is in error by saying that, "Separation of this ligament from the fifth rib periosteum will result in the "double-bubble" phenomenon." The problem of the double-bubble in his patient was not that some imaginary ligament was transected, but that the subcutaneous and dermal infra-mammary fold were not released - pushed out or stretched out as they must be. The author remained sub-muscular and sub-fascial until he was inferior to the IMF. Therefore, he just pushed it out on top of the muscle. Maybe he has not seen the double fold with the above muscle implant, but it is just as common as below. One needs to penetrate the pectoralis muscle and fascia attachments the 5th rib and then the implant and dissection are subcutaneous and the IMF is corrected. He did not do this. So with his dissection plane he did not release the skin fold from the underlying muscle and fascia. He was below the muscle in this area.

In our dissection of eight breasts with our cadavers over the past four years under the guidance of our anatomist Earle Davis Ph.D., we have not found anything to suggest that there is an "infra-mammary crease ligament." We find that the dermis of the fold and below it are firmly attached to the underlying fascia of the rectus abdominus, serratus anterior and pectoralis major. This is obvious in palpation of your own chest wall as well as in surgery or dissection of cadavers.

In the "Intradermal Anatomy of the Inframmary Fold" by Boutros, Sean (prs1998), with both dissection and histological study, there was "no evidence of any ligamentous structure in the area of the inframammary fold."

So in summary, it is not failure of transection of the imaginary ligament in below the muscle dissection that caused the problem, but failure to release the dermis from the fascia in that plane and failure to correct the original IMF by simply pressing it out with blunt dissection. The double-bubble is simply the persistent IMF made of skin, primarily dermis. It is the result of the patientís inframammary fold not having been stretched out to a round shape to fit the contour of the new breast. It is made only of skin. The dermis retains its shape, and will not easily stretch out to the rounded contour we want. But like the Ubangi lip, with pressure and time, many persistent inframammary folds that are causing a double bubble appearance will stretch into the rounded shape covering the augmented breast. Sharp dissection can be used to release the tissues so they can be pressed out, but more is needed. Blunt dissection is needed. The previous IMF must be bluntly pressed out; sharp dissection alone has no pressure to accomplish this. Transecting sharply or with cutting cautery or laser is often not enough to expand the previous IMF. Also, by forming more scar tissue, cautery and laser cutting can add to the fibrosis that will make the double-bubble even more persistent. Much more can be gained by actually stretching out the skin that makes up the previous IMF with blunt dissection. The most gentle blunt dissection or simple pressure from the implant itself can over time have a great effect on the persistent IMF (double-bubble) as well as the constricted lower breast that does not easily round out, as is common with a tuberous breast. The pushing out and stretching of the skin of the IMF is the solution to avoiding or correcting the double-bubble. Like the Ubangi lip or the stretching of the abdomen in pregnancy or with use of an expander, sharp dissection not only will not accomplish the desired result, but is potentially destructive. Cautery and sharp dissection induce scar tissue that will inhibit stretching that could occur from the pressure of the implant over a period of time. In summary, as shown above, the persistent IMF is not only in the transaxillary subpectoral or submuscular case. It has shown to be just as much a problem above the muscle and with any incision site. It is unrelated to any imaginary ligaments described in the literature. And thinking there is a ligament or a structure that should be searched for or dealt with is not helpful and is a distraction to the surgeon, and therefore counterproductive. The treatment of the high or persistent IMF is simple and direct. It must be dissected free and pushed out.

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