Implants

By Kerry McGinn, R.N., B.S.N., O.C.N., Pamela Haylock, R.N.

For other women, an external prosthesis is not enough. Either before a mastectomy or at any time afterward, these women turn to the reconstructive (plastic) surgeon for help. They want to look "normal" and "like myself" again. They find the absence of a breast or a major indentation in the breast after a lumpectomy a constant and unwelcome reminder of the cancer, when they want to move on with life. Or they feel "less a woman" without breast curves, and flinch at changing at a gym or having a sexual partner see them without clothes.

Perhaps they find an external prosthesis an intrusive nuisance, or uncomfortable. Or they suffer from backaches or other problems from not having a breast on one side. Virtually every woman -- no matter how old she is, how long ago she had breast surgery, and how much the chest area was damaged -- is a candidate for some kind of breast reconstruction if she wants it.

Anne thought that people might laugh at her for wanting breast reconstruction at age 65, "But the people I cared about thought it was a great idea. They knew it was important to me, my gift to myself. Before this, I wore a good prosthesis, but it never felt like 'me.'

"I didn't expect or want to be a beauty queen after reconstruction, so my expectations were pretty reasonable. I really like the way I look and feel now. Sure, it's not quite the same as my other breast, but I'm mighty happy with it -- in clothes and even out of them."

On the other hand, many women do not want reconstructive surgery. They may be quite content without it, or even be strongly opposed on feminist grounds, and see no need for it. They may not want any more surgery, or may be concerned about possible risks. It is strictly an individual choice.

What does reconstruction offer? The first step is to create a breast mound, using one of several possible techniques. The challenge is making a breast that looks like a breast, with some droop and a normal "crease" underneath. If the woman simply wants something that looks normal under clothes, a mound may be enough for her, but many women want a nipple and areola as well. Finally, making the reconstructed breast reasonably symmetrical with the other breast may mean surgery to make the remaining breast smaller or less droopy.

Implants

How does the surgeon make a breast mound? Occasionally, if the woman has enough skin remaining after the breast is removed, the surgeon may be able simply to slip a breast-shaped implant into a pocket in or under the chest muscle. While it is easier initially to put an implant above the muscle, it is more prone to slippage, rupture, and other complications there. If the woman can flex her breast -- an unusual talent indeed -- the implant has been placed in the chest muscle. An implant can be inserted during the mastectomy surgery or in a separate surgery later. Inserting an implant is a relatively simple procedure but, as with any surgical procedure, carries with it the risks of possible infection, bleeding, and buildup of fluid in the area. When a woman does not have enough skin remaining after a mastectomy to fit over a standard implant, she may undergo tissue expansion. The idea behind a tissue expander is that the body will recruit more skin over a gradually expanding implant -- rather like what happens to the skin of the abdomen during pregnancy.

Breast Implantation

When first inserted in a pocket in the chest muscle, the silicone tissue expander looks like a small, collapsed balloon, connected to a port that rests under the skin. Over the course of several weeks, the expander is filled with sterile saline (salt water) injected by syringe through the skin and into the port, two or more ounces at a time. Each injection, spaced every week or so, stretches the skin a little as the new breast enlarges. (Rather like being 13 years old again, but the process is certainly faster!)

This tissue expander is often a temporary measure to prepare the chest pocket for a final silicone gel or saline implant, inserted during a second surgery. Some, however, are made so that the expander stays in place permanently while the port is removed. There are many kinds of expanders, including double-lumen expanders, ones with an inner empty chamber for saline, and an outer chamber filled with a small amount of silicone gel to give the breast a more natural shape.

After the expander has reached the desired size, the surgeon often continues inflating it until it is about one-third overfilled and then leaves it that way for several weeks. The theory is that this helps the breast develop a natural droop when the permanent implant is inserted or the permanent expander is deflated to its final size.

Many women complain of minor discomfort and a "tight skin" sensation for a few hours after each injection. The major complaints come during the overinflation period, when the breast can be quite uncomfortable and may look rather like a large baseball perched on the chest. The same surgical complications can occur as for the regular silicone gel implants.

How do these assorted implants compare with a "natural" breast? It very much depends not only on the surgeon's skill but also on how an individual woman's body responds. The implanted breast rarely matches the other breast perfectly; it is typically firmer and has less of a droop -- "perkier" or "more youthful" is how the surgeon might put it -- but many look and feel quite natural, both in and out of clothes. It is important to remember, however, that while the "real" breast may change with aging or weight gain or loss, the implanted breast stays the same.

The body normally forms a fibrous scar capsule around any implant. However, in some cases, the body is too enthusiastic about "walling off" this "intruder" and, in time, the new breast comes to feel rock-hard. This is the most common complication of implant surgery; whether or not it occurs depends on the woman's body and the type of implant.

Many people are questioning the long-term safety of silicone implants, especially if there is a rupture or a slow silicone "bleed." Others believe they are generally safe for women in most cases, but that safety studies need to continue.

The sensational media and lawsuit publicity about breast implants has not made it any easier to find out the facts. Breast implants filled with silicone gel were first marketed in the 1960s and, when the U.S. Food and Drug Administration (FDA) began requiring premarketing approval for new medical devices in 1976, silicone implants were "grandfathered" in -- that is, since the implants were already in use and considered safe, the manufacturers did not need to apply for approval.

In the 1980s, a few anecdotes about women with silicone gel breast implants and connective tissue disease began appearing, and the first multimillion dollar suit against implant manufacturers was filed. The issue snowballed, with more women claiming problems and more lawsuits, public outcry, fear, and distrust. Women with implants reported feeling like walking time bombs and as if any ache or pain, whatever its cause, must be related to their implants.

In 1992, after impassioned public hearings, FDA Commissioner David Kessler banned silicone gel implants altogether for the time being, except for use in clinical trials of breast reconstruction after breast cancer. Breast implants filled with saline remain available, although they faced new safety tests also.

What got lost in the shouting was Kessler's clear statement that the ban was imposed not because there was any clear scientific evidence that the implants were unsafe, but because they had not yet been proven safe. Now the manufacturers would have to carry out clinical research under very strict conditions to see whether the implants were indeed safe, something that should have been done years before.

Women making personal decisions about implants need to look at the quality of the evidence, pro and con. To date, much of the evidence against implants has been clinical case studies (individual cases), usually considered the least reliable form of evidence. For instance, connective tissue disease develops in about 1% of all women, which makes it difficult to tell whether an implant caused the disease in an individual woman -- or whether it would have happened anyway, implant or not. Some animal studies and immunological investigations have been reported, but many questions remain about the quality of the research.

The most believable research on implants would be epidemiological studies, which compare two otherwise similar groups of women, one group with and one group without implants. That research, which is going on now, asks these questions: Do groups of women with breast implants develop connective tissue disease at a higher rate than women without breast implants? Is there any increased risk of cancer? Are there any new syndromes that can be linked to implants?

Any research must set clear criteria for diagnosing a disease or syndrome to avoid the natural tendency people have to report more symptoms when they feel anxious (in this case, because they have implants and have heard so many scary reports about them). In fact, most major epidemiological studies to date (such as the Mayo Clinic Study and the Nurses' Health Study) have not shown a link between either cancer or connective tissue diseases and breast implants, although research is ongoing. One large study, the Women's Health Cohort Study, did show a slightly higher rate of women with implants reporting connective tissue diseases, but did not check whether these were medical diagnoses or not; the investigators in that study agreed that this was a problem and are currently restudying their results. Studies take years, however, so the final answer probably will not be available soon.

In the meantime, the smart woman who is trying to sort out genuine information from hysteria will ask -- not cynically, but realistically -- who is doing the study, how it is being done, who is paying for the study, and whether that is likely to make a difference in the results. It would not be surprising if a study funded by trial lawyers, for instance, found more risk in implants than one carried out by manufacturers or reconstructive surgeons! Currently, the woman who wants an implant for reconstructive surgery can usually get one, although silicone gel implants are available only through clinical trials.

One thing that most people agree on is that current implants are not lifetime devices. They must be replaced from time to time, perhaps every ten years or so, even if there is no obvious problem, because older implants are more likely to leak. If there is evidence of leakage, the implant is usually removed. However, because the body normally forms a fibrous capsule around the implant, even if there is leakage, the leakage usually stays within the capsule and does not travel elsewhere in the body.

More about Implants and Flaps

However the breast mound is made, the surgeon has a choice of techniques for making the nipple and areola later, when the breast shape has settled. The nipple can be constructed from the nipple of the other breast (one nipple makes two); sometimes it comes from a small flap of breast skin twisted on itself or from the ear lobe or from somewhere else in the body. The areola can come from a doughnut of skin removed from elsewhere, often from the thigh, and/or from medical tattooing of minute dots with a dye to match the areola. Since the new nipple and areola have no nerve supply, they do not have any sensation.

There are two bodies of opinion about whether reconstruction should be done at the time of mastectomy, if possible. One point of view holds that it is safe to do it at the same time and that it saves the woman both an extra surgery and some unnecessary mourning for her lost breast. The other point of view is that, if there is a chance the woman will undergo chemotherapy, she could be at greater risk for infection because of the reconstructive surgery, and that she will appreciate her new breast more if she waits.

In any case, to be happy with the results, a woman needs accurate information and reasonable expectations beforehand. Besides listening to the reconstructive surgeon, who is typically sincerely enthusiastic, she might want to talk to a woman or two who has undergone the same surgery. There is plenty of information readily available, both pro and con. The Food and Drug Administration, (800) 532-4440 or (301) 827-4420, has a hotline and a packet of information available. ACS, the Cancer Information Service, the Y-ME Breast Cancer Support Program, the American Society of Plastic and Reconstructive Surgeons, and the National Women's Health Network are other sources. Women with implant problems and those interested in hearing about problems may want to contact Command Trust Network or a similar organization. Among the books available are Bruning's Breast Implants: Everything You Need to Know and Berger and Bostwick's A Woman's Decision: Breast Care, Treatment, and Reconstruction.

Copyright © 1998 Kerry A. McGinn and Pamela J. Haylock. From Women's Cancers: How to Prevent Them, How to Treat Them, How to Beat Them, by arrangement with Hunter House Inc., Publishers. Women's Cancers