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Procedures

Breast surgery can be accomplished using any one of four incision sites: 

1. Nipple (areolar) 

2. Axillary (armpit) 

3. Inframammary (under the breast)

4. Umbilical (belly button)

Four types or shapes of implants in both saline and silicone are available:

1. Smooth

2. Textured

3. Round in shape

4. High profile, teardrop, or "anatomical shape"

Three sites of placement are  routinely used

1. Above the muscle

2. Below the muscle

3. Below the fascia

There are many options (4 x 4 x 3 = 48 total) and many other less common variations, plus the range of implant volumes possible.

Silicone implants are still available in special circumstances and in most all other countries around the world. 

You and your surgeon should have the same goal of achieving the most beautiful and natural result possible. And the surgeon will explain why some of these alternatives may be better for you than others. 

The following information may help you understand the differences in the approaches described above. 

 

Site of incision

Allowing the patient to choose the site of the incision may sound like an upsetting idea to some surgeons, but more than 98% of the patients will accept the doctor's recommendation anyway, so why not allow the patient to have as much say in the matter as possible?

For the patient whose breasts droop enough so that the skin of the breast is touching the skin of the chest wall when standing erect, the inframammary incision placed slightly up on the breast just 1/2 to 1 cm above the new inframammary fold should be almost completely hidden, and may be the preferable and most recommended sight.

In the patient with very small areolae, the areola incision may be nearly impossible. It is preferable to have this incision at least 2 cm long, and if it is to be less than 1.5 cm and the patient really insists on not having it under the arm, we may insist on permission to extend it laterally as much as 1/2 to 1 cm in each direction because it may not be possible to get an implant of over 200 cc volume through it.

Ordinarily we tell our patients the following: 1.) The areola incision made in the wrinkles of the brown skin of the areola heals with the least scar, 2.) The inframammary incision is most visible of all except in pendulous breasts, and 3.) The axillary incision is the least visible of all, unless the patient is a ballet dancer or for some other reason has her arms in the air with the axillae exposed very frequently.

The techniques of the different approaches and associated problems will be discussed in detail in further chapters. The patient may wish to know that the areola approach is the only one of the three that invades the breast tissue; yet in performing this in hundreds of women and knowing others who have also done hundreds with this approach, I have yet to see or hear of breast nodules or cysts developing in the lower portion of the breast because of this approach. Many patients I have done with this approach have subsequently become pregnant and were able to breast-feed.

Also, with the areola approach there has been no greater incidence of hypaesthesia (numbness) of the nipple or lower breast skin than with the other approaches in my experience of performing more than 500 surgeries using areola incisions.

There is an article in the literature that states that patients who have the areolar approach have more difficulty breast-feeding than those with the axillary or inframammary incisions. This is a retrospective study and is unreliable, but the suggestion may still be correct.

 

Type of Implant:   

(Also see breast implants in the FDA web site at http://www.fda.gov)

Almost always the patient will accept the doctor's recommendation for the type of implant. There were seven implant manufacturers before 1992 and the FDA. Now there are only four - McGhan, Mentor, PIP and Hutchinson. And their names, addresses and phone numbers are listed in their web sites. The choice of implants for the surgeon is discussed in chapter twelve of our handbook on breast implant surgery.

At times these companies will have videotapes on how to do the surgery. Wells Johnson supplies endoscopic equipment for the umbilical approach and has videotapes of that approach.

What the patient wants is the best possible result, with no future problems. Many of the reasons for choosing a saline over a gel, or a combination, or the meme is because of the rationale each one has for reducing the chance of or preventing the capsule contracture problem. The meme was the best. But since it was covered with polyurethane foam, it was removed from the market and will probably never return. It was this interface of texturing that led to the textured silicone implants.

Historically, in the beginning, after it was discovered that silicone injections could lead to unacceptable complications and silicone was first placed in a silicone bag, the first implants in the early 1960s were silicone gel. They were firm and teardrop shaped. The capsule contracture rate was greater than 90%, with most being as hard as your elbow, except for whatever breast tissue was overlying them. So, softer implants were developed in the late 1960s.

These softer implants would assume a teardrop position in the upright position, and so the teardrop shape was no longer necessary. Dacron patches were popular at that time to hold the implants up, and while they did this to a certain extent, the capsule contracture rate again approached 100% because of tissue reactions to the Dacron. As well, the breast tissue continued to sag over the implants, even when the implants stayed firmly fixed to the chest wall; this resulted in distortion. Dacron patches are very rarely used now.

In the early 1970s, saline filled implants were introduced and were softer than a gel implant in the same patient when independent observers compared one side to the other. The problem with the saline implants is the leakage and deflation rate (which seems to be about 50% over a period of 10 years in my experience with about 100 pure saline and around 500 combination gel and saline implant surgeries). Yet many of the pure saline and many of the combination implants that I used 20 to 25 years ago are still intact.

Implant deflation necessitates an additional operation, and since there is no doubt that some capsule contraction occurs with saline implants, why do we have the additional problem of deflation? For example, I removed some saline implants that had been put in previously and had already required one revision because of deflation; one side was completely collapsed and the other had a capsule. The implants were small, and the patient could have tolerated the firm side but was chagrined to have the asymmetry of a complete collapse of the other, so we replaced them both with silicone gel implants. The gels formed more and harder capsules, but were more popular than saline implants because of the reduced deflation problem, not because the result was more natural or softer. The saline implants were, in fact, softer than the gels.

When considering gel bleed as a cause of capsule contraction, please note that many patients have a capsule develop only on one side, and usually the capsule firmness and thickness is unequal on the two sides. Not only are a few capsules unilateral, but most patients have unequal firmness, and often it is markedly unequal with a soft breast on one side and spherical contracture and deformity on the other. These well-known findings must be considered for any theory of capsule contracture. Gel bleed would occur almost equally and could not cause such asymmetry in capsule formation.

The choices as of the year 2000 are all saline - textured or smooth, and to be filled with a valve or pre-filled.

We see and have seen rippling from textured silicone as well as saline implants. But the saline implants ripple to a greater extent and are more palpable, i.e. they can be felt and detected by feel more easily. 

Textured implants have thicker walls and can ripple more. The McGhan textured is deeper and the implant will not move or flow in the pocket. This appears sometimes slightly less natural. But this deeply textured implant is less likely to have distortion and capsule contracture, we believe, but one study from Sweden shows this not to be true.

The McGhan 468, or anatomical implant, is textured but still can ripple. It feels more firm and is more palpable below the nipple, where the tissues are thin. The 468 is a shaped, overfilled, fairly firm implant, but it does not allow much of a “stuck-on” appearance. Because it is overfilled and less mobile, it does not seem quite as natural as the softer, smooth salines. But in selected patients, it can be the best implant made. 

The smooth implants have less rippling than many of the textured, and are less palpable and less firm than the McGhan 468. But they could be subject to more capsule contracture.

As noted by the FDA, August 1991 BG pp. 2, "Since the saline filled implants do not have the silicone gel, they are probably even less likely to increase the risk of autoimmune diseases or cancer. But since both types of implants have the silicone rubber envelope, such effects cannot be totally ruled out, even for the saline filled implants." For an FDA update and a lot of information on implants, see breast implants at the FDA web site: http://www.fda.gov

So the FDA presumption or suspicion was that the silicone gel is more likely to cause autoimmune disease or cancer than solid silicone. Yet these reactions on the immune level are microscopic, and the difference in the gel and the solid silicone chemically on the level of the molecular structure is analogous to the difference in ice and water. And if the chemistry is the same, the molecular reaction is approximately the same.

Saline implants are the only type approved by FDA as of the year 2001, and at the FDA web site (http://www.fda.gov) there is a thorough discussion of the reasons for this. There is a history of implants and a presentation of McGhan and Mentor, the only manufacturers now approved for implants. 

Other factors for the choice of implants will be discussed further elsewhere.  Even if gel were to return, many probably would continue to use saline because they are good implants, they may cause less capsule contracture, they require smaller incisions, and they have an overall reputation of greater safety from all the unproven but suspected problems associated with gel.

 

Thursday March 2 6:54 PM ET

FDA Panel Deems 2 of 3 Breast Implant Brands Safe

By Lisa Richwine

GAITHERSBURG (Reuters) - The two most popular brands of saline-filled breast implants are safe and effective and should stay on the U.S. market, a federal advisory panel said Thursday after reviewing new data on possible complications.

The committee said, however, that the company that makes a third brand of saline implants did not present enough information to prove the benefits of its product outweighed its risks.

Saline implants first hit the market more than 25 years ago when the FDA had no authority to determine whether they were safe. The agency is scrutinizing them now because of concerns about complications such as infections and rupturing.

The FDA usually follows its panels' advice and is expected to decide whether to officially approve the implants later this year.

Breast implants are more popular than ever. About 150,000 women received them last year. Most are filled with saline, or salt water. Silicone-gel implants were banned for most women in 1992 over safety concerns.

The panel recommended the FDA approve implants made by Inamed Inc.'s (NasdaqNM:IMDC - news) McGhan Medical unit and Mentor Corp. (NasdaqNM:MNTR - news), two California companies that lead the breast implant market.

“The data shows these implants are reasonably safe and effective,” said panel member Dr. Phyllis Chang of The University of Iowa College of Medicine after studying McGhan's results.

But panelists said they were not reassured by data from Poly Implant Prostheses (PIP). They said the U.S. study the company presented did not include enough patients that were followed for an adequate time to truly evaluate the device risks.

Panel member Boyd Burkhardt, a plastic surgeon from Arizona, said he wanted to support PIP's implants because he thought their design would “dramatically'' reduce the rate of infections. But he found the company's data incomplete and found it difficult to understand that the company was “as ill prepared as you appear to be.''

PIP President Rick Hawk responded by saying the study results showed there was, “reasonable assurance of PIP's implant safety and effectiveness.”

Earlier, McGhan said a one-year study of more than 2,500 women showed the most common problem was contraction of scar tissue around the implants, which can cause changes in breast appearance and deflation. That occurred in 7.2 percent of women who had breast augmentation and in 12.5 percent of women who had breast reconstruction.

Leakage or deflation happened to 3.6 percent of women who had augmentation and 2.6 percent of reconstruction patients.

An FDA official who analyzed the company's studies said the risk of complications increased over time. Dr. Sahar Dawisha said 95 percent of reconstruction patients had reported some type of complication after five years.

Studies on serious ailments such as connective tissue or autoimmune diseases were not designed well enough to draw any conclusions about whether they were related to the implants, Dawisha said.

 

Scientific American September 1999

SILICONE SAFE

A major report finds that silicone breast
implants don't lead to cancer

 

Women who have silicone breast implants are no more likely than the rest of the population to develop cancer, immunological diseases or neurological disorders, a committee of the Institute of Medicine (IOM) reported on June 21. Moreover, mothers with implants may safely breast-feed their infants, as there is no evidence of toxicity in the milk. The IOM committee drew its conclusions after holding public hearings (during which women with implants told of their experiences) and reviewing scientific literature on silicone breast implants (first made in 1962) and silicone.

The analysis--funded by the U.S. Department of Health and Human Services and the National Institute of Arthritis and Musculoskeletal and Skin Diseases--is the latest in a series to have found such results. Similar announcements were made last year by scientists who were appointed by judges overseeing implant liability litigation in the U.S. and by researchers in Britain reviewing implant safety for the British Department of Health.

Still, the IOM committee points out, breast implants are not without risks. The tissue around the implants may contract, causing pain and disfigurement and leading to infection by skin bacteria that normally reside in the lactiferous ducts of a healthy breast. Also, implants have a finite life span, and rupture rates of gel implants and the deflation frequencies of current saline models have not been determined. Problems lead to additional surgery to replace or remove them.

Not everyone is convinced by the IOM report. Some believe that a study based on other studies--called a meta-analysis--is inherently flawed because of assumptions made about the quality of previous research. In any case, implant manufacturers have already agreed to a total settlement estimated at $4 billion with plaintiffs who claimed physical harm; now-bankrupt Dow Corning will be paying the most, some $3.2 billion.


--Christina Reed

 

  SUBGLANDULAR, SUBPECTORAL or SUBFASCIAL

 

Originally when augmentations were first performed in the early 1960s with silicone breast implants, they were placed in the subglandular position over the pectoral muscle.

They were hard or became hard. They were hard to begin with. If you look at the old Dow-Corning product descriptions of the implants, there were no soft implants in the early sixties. They were teardrop shaped, often with Dacron patches on the back, and they all became hard, and were quite firm before they were implanted.

Since the early type implants were firm to begin with, they were expected to be firm, and capsule contracture was not felt to be a major problem.

This may be one of the secrets of the polyurethane coated  Meme implant. That is that they are firm to begin with, and therefore do not contract into a ball so easily like the softer implants do. In those early days, firmness was thought to be desirable to a certain extent anyway.

Then in a few years, in the late sixties, the patients were asking if something couldn't be done about the hardness, and softer implants were soon on the market. Then in 1967, C.O. Griffiths first reported the submuscular implants in augmentation.

As the capsular contracture problem became more common with the softer implants, more surgeons shifted to the submuscular technique, until now (since the 1980s) there are and have been many articles and opinions in the literature that the implants tend to remain softer in the submuscular position. The advantages of the subpectoral position are:

 

1. Dissection is just as easy as pre-pectoral position.

2. Bleeding is no greater.

3. Hemostasis is as easily obtained.

4. It is substantiated in the literature.

5. It is about as popular as pre-pectoral, if not more.

6. The muscle over the implant reduces the feel of hardness if contractures occur.

7. The muscle movement presses on the implants and may thus keep them a little softer.

8. The muscle over the implants provides a smoother, straighter contour from clavicle to nipple, without a demarcation line (especially as seen with capsule contracture) - no “stuck-on” look.

9. The muscle force pushes the implants down, counteracting the tendency of the capsule contracture to push the implants superiorly.

10. The implants are further removed from breast tissue, with less chance of being involved in breast diseases, lactation, or breast biopsy.

11. There may be less numbness of the nipples due to less damage to the third, fourth, and fifth intercostal nerves.

12. It is said to be better for mammography to have implants placed below the muscle.

 

The main disadvantages of submuscular implants are:

 

1. Anesthesia, especially local, is more difficult to achieve.

2. Post-operative pain maybe greater.

3. The muscle may be weakened.

4. The muscle force may push the implant down too far.

5. There appears to be less cleavage, but this is debatable.

6. Patients may have a flatter appearance, with less projection of the breasts forward.

7. The muscles may be visible over the implants when contracted, and press the implants laterally. This can usually be prevented. It occurs more frequently with an areolar incision.

8. The breasts may not feel as soft or move as freely.

9. If capsule contracture occurs, closed capsulotomy is more difficult.

 

With all these different debatable considerations, one can see that there is no definite best way for all patients. Each patient's special circumstances may determine which implant position is best for her.

For example, if the patient is very slender with very little subcutaneous or breast tissue covering the upper chest, the patient is a good candidate for submuscular implants. If capsule contracture occurs and the amount of tissue covering the breasts is exceedingly thin, the condition will be more noticeable; a sharp demarcation line may occur at the superior margin of a spherical contracture, causing a stuck on, coffee-cup like appearance. The submuscular position can partly prevent this from happening.

If, however, the patient has considerable subcutaneous and breast tissue to cover the implant and is particularly desirous of cleavage, the submammary position might be better. For the patient who is a professional or serious amateur athlete who uses her arms often, such as with bowling, golf, tennis, swimming, etc., thorough counseling is needed to choose the best approach.

A newer approach has now emerged in  since 1996, and that is the subfascial approach.

The subfascial placement of breast implants has many of the advantages of submuscular position without lifting the muscle attachments from the ribs.  The subfascial placement has become the preferred position for the placement of breast implants in our practice. The advantages and disadvantages of this position compared to above and below the pectoral major muscle are discussed. The clinical experiences with more than 1000 breast augmentations in the subfascial position are reported.  The indications for this technique are proposed. The incidence of complications are described from clinical experience and compared to other methods. The longest term of after surgery observation has been more than three years. The average time of observation of these cases has been about eighteen months. We have used the subfascial position through axillary, areola and inframammary incisions. As implants are placed routinely below the muscle through the umbilical approach, it can be done through that incision as well.

 

The subfascial position prevents the stuck on appearance caused by the interruption of the clavicle to nipple line just as the submuscular does. It is a little less potent in this because it is not as thick as the muscle.

 

 

The subfascial position prevents rippling above the areola just as the submuscular position does and probably as well.

 

The SF (subfascial) position does not push the implant down as the muscle does in the submuscular position (SM). This pressure of the muscle provides some hemostasis right after surgery. This force of the muscle also massages the breast implant and may help keep it soft. It also prevents the rising up and too early healing of the inferior breast pocket at the inframammary fold by the muscle pressure pushing down the implant against the area of the fold. It may help prevent capsule contracture by pressing the implant down. All these factors are logical and reasonable and clinically seem to be correct but are unproven and may or may not be important.

 

The subfascial is definitely less injury to the patient than the submuscular. It has less morbidity. The patient is less uncomfortable. Also it prevents the muscle movement that is sometimes visible after submuscular placement of implants.

 

 Also see the  The Subfascial Approach in Augmentation under Text and Articles

 

 

 

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