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Healthy Living >>> Surgery Articles & News



Breast Augmentation: A Public Health Perspective



By: Diana Zuckerman, PhD

More than 150,000 women had breast augmentation surgery last year; an all-time high. At the same time, the number of teenagers who choose breast implants has more than doubled in the last two years.

And yet, the controversy about breast implants still rages. As is often the case when the media covers medical issues, there are experts on all sides of this issue, and the consumer is left totally confused.

As a Congressional investigator in the early 1990s, I had access to all published and unpublished studies of breast implants, and was appalled to learn that almost one million women had breast implants, but they had never been objectively evaluated in either clinical trials or epidemiological research. That situation has changed. After the FDA started restricting access to silicone gel breast implants, the implant manufacturers started to fund research in an effort to prove that they were safe.

As a scientist trained in psychology and epidemiology, I have studied both the desire for implants and the possible physical risks. Despite all the controversy and media coverage about breast implants, there are surprisingly few studies on the psychological benefits of implants, the local complications caused by breast implants, or the long-term risks. Instead, there is a great deal of misinformation in the media, and many women make the decision to get breast implants with unrealistic expectations about how it will change their lives, little awareness of the financial consequences, and without the resources to cope if problems do occur.



Breast Implants and Self-Image
Plastic surgeons claim that breast implants have a very positive impact on a patient’s self-image. It would be easy to study this objectively, by evaluating women’s self-esteem and body image before, after, and several years after getting breast implants. No such study has ever been conducted.

Surveys indicate that when plastic surgeons ask their patients if they are satisfied, most say that they are. However, that is not an objective way to study the impact on breast implants. There is no doubt that some women are very satisfied with their breast implants, but any evaluation of patient satisfaction should be conducted by someone other than the plastic surgeons or their staff. If you want honest and accurate answers, it is important for patients to feel that their answers are anonymous. Since implants are a lifetime commitment, it is also important to study them several years later, since that is when problems become more likely.

From a psychological point of view, improving one’s appearance, with plastic surgery or other means, can help a person feel better about himself or herself. On the other hand, there are individuals who feel unattractive because of a particular physical shortcoming, who then “solve” that problem, and then focus on a different shortcoming. There are other potential problems specific to implants: a woman who changes her appearance by getting breast implants may find that men treat her so differently that she feels uncomfortable. If the implants seem obvious (for example, because of the swooshing sound of saline, hardness from capsular contracture, or because they don’t feel the same as natural breasts) she may become more self-conscious rather than self-confident.



Are Breast Implants Approved by the FDA?
It may surprise you to learn that there are almost no published studies of the safety of saline breast implants, and that no breast implants were ever approved by the FDA until a few months ago. In May 2000, for the first time, the FDA approved several styles of saline breast implants made by two manufacturers, Mentor and McGhan. The FDA decided to give women the choice of buying implants even though FDA advisors expressed a great deal of concern about the complications experienced by many women with implants. The FDA did not approve saline implants made by other manufacturers, and did not approve some of the styles of implants previously sold by either Mentor or McGhan. That means that many women are walking around today with implants that never were approved by the FDA and probably never will be.

Saline breast implants are made with silicone outer shells with saline inside. The implants, commonly called “silicone implants,” have the same kind of silicone outer shells, with silicone gel on the inside.

No type of silicone gel breast implant has ever been approved by the FDA. When the FDA reviewed the safety research in 1991, they determined that the studies did not prove that implants were safe. The sale of silicone gel breast implants was therefore restricted to mastectomy patients, patients with breast deformities, and any augmentation patient who had a broken silicone gel implant that she wanted to replace. All of those women are required to participate in a study of the health risks. A small number of first-time augmentation patients were recently included in these studies.



Saline Implants
FDA approval of some Mentor and McGhan saline breast implants is based on studies that are not published. For detailed information, check out the FDA Web site or the summary on the Web site of the National Center for Policy Research for Women and Families.

The manufacturers studied local complications such as pain, implant rupture, and the rate of subsequent surgery and implant removal. Mentor reported that 43 percent of the augmentation patients in their study experienced local complications within the first three years, including:

* asymmetry, scarring, or wrinkling (32 percent)
* needing additional surgery (13 percent)
* severe capsular contracture (10 percent)
* implant removal (8 percent)

Even more women (60 percent) with McGhan implants reported at least one serious complication in the almost four years of that study. In the first three years, McGhan patients experienced the following:

* asymmetry, scarring, or wrinkling (27 percent)
* needing additional surgery (21 percent)
* severe capsular contracture (9 percent)
* had at least one implant removed (8 percent)

The complication rates were even higher for patients who got new breast implants to replace previous implants, and higher still for women getting implants for reconstruction after a mastectomy.

If these complication rates sounds very high to you, you’re not alone. The FDA decision to approve saline implants has been questioned by members of Congress because one of the manufacturing companies is under a criminal investigation and because the FDA did not require long-term studies or studies of whether saline breast implants cause serious diseases. Long-term research is essential, because many of the implant patients who have had problems, complain of systemic diseases that developed years after getting their implants.

Instead, the FDA apparently relied on studies that had been reviewed by the Institute of Medicine, which did not find a significant increase in systemic diseases among implant patients. However, the Institute of Medicine only reviewed studies that had been conducted previously, and these studies were not conclusive.



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Silicone Gel Implants
The Institute of Medicine report primarily focused on silicone gel breast implants, and found no statistically significant relationship to systemic disease in most of them. However, several studies found an increased risk of connective tissue diseases, although the risk was not always statistically significant. These trends can mean several things:

* Illness could occur by chance (in other words, whether or not the person has implants)

* The sample could be too small to detect a real risk (this is especially likely when rare diseases like scleroderma (connective tissue disorder) are studied)

* The study is not well designed—for example, most of the studies include women who had implants for a few months or years, which is probably too short a period of time to develop connective tissue disease or cancer.



Whether or not silicone gel implants cause systemic disease, a new FDA study shows that they break more quickly than has been acknowledged. The new FDA study, published in September, 2000, showed that many women with silicone gel implants walk around with broken and leaking implants without knowing it. Using magnetic resonance imaging (MRI), researchers determined that almost half (48 percent) of the women who had silicone gel-filled implants for only six to ten years had at least one ruptured implant, even though they didn’t know it. Even more of the women (79 percent) who had gel-filled implants for 11 to 15 years had at least one ruptured implant. What was surprising was that the women had not realized the implants were broken and had not sought any medical care. Since this study excluded any women who had already reported implant problems or removal, the actual breakage rate is even higher.

Even more worrisome is that more than one in five of women had silicone gel “migrating” away from the broken implant capsule. The long-term risks of migrating silicone are unknown, but there are studies documenting serious health risks and fatalities when liquid silicone migrates to vital organs. Since silicone gel can break down to liquid form, this is a serious concern, especially since these women were not aware of what was happening and only found out because they were randomly selected for a study.



What Are the Local Complications of All Implants?
There are some known risks of implants that are true for either saline-filled or silicone gel-filled implants:

All surgery for breast implants, whether silicone gel or saline, has risks. These include the risk of infection, hematoma (blood or tissue fluid collecting around an implant), the risk that one or both of the implants will have to be removed (requiring additional surgery), and the potential costs of repeated surgeries if the implants are replaced.

All breast surgery, including implants, can interfere with a woman’s ability to breast-feed a baby. Women with implants are less likely to be able to nurse than women who have not had breast surgery.

All breast implants will eventually break, but it is not known how many years the breast implants that are currently on the market will last. As shown in the recent FDA study, most implants last seven to 12 years, but some break during the first few months or years, and some last more than 15 years.

The most common complaint is capsular contracture, which occurs when a woman's body reacts to the “foreign body” by forming a capsule of scar tissue around the implants that can become too tight. If that happens, the breasts can become very hard, misshapen, and painful as a result, often requiring surgery or removal. The appearance is common among actresses and models, who sometimes look like they have two balls attached to their chests instead of natural breasts. The result is especially unattractive if one breast has contracture and the other doesn’t, or if the contracture causes the breast to feel very hard or to change in shape. View a photo of capsular contracture on the FDA Web site.

Although the epidemiological studies have not proved that systemic disease is caused by breast implants, several European studies have indicated that breast surgery (whether for breast implants or to reduce the size of breasts) may be associated with an increased risk of connective tissue disease or rheumatism. If these disorders, which include diseases such as scleroderma and fibromyalgia (a syndrome characterized by chronic fatigue and body aches and pains), are related to breast surgery, all women with implants would be at increased risk, regardless of whether the implants are filled with saline or silicone gel. Since women with implants often have multiple surgeries, the risks of systemic illness are potentially increased even further.

All breast implants interfere with mammography, because implants can obscure the view of a tumor. Implants, therefore, have the potential to delay the diagnosis of breast cancer. Although specially trained technicians can perform mammography in ways that minimize the interference of the implants, not all women have access to a mammography technician with this expertise. Unfortunately, even with expert technicians, about 30 percent of the breast will still be obscured. Experts estimate that 20,000 to 40,000 women who already have implants will have a delayed diagnosis of breast cancer because of their implants.

Although there are no long-term safety studies of saline implants, it is assumed that they are safer than silicone gel implants because if they break, they can be more easily removed. In contrast, silicone gel can be very difficult or even impossible to completely remove from the body once an implant has ruptured. In addition, it is not always obvious that a silicone gel implant has broken, and the gel can migrate slowly over time into various parts of the body. However, there is research evidence that bacteria and mold can grow in a saline-filled implant, and nobody has studied what happens when the implant breaks in a woman’s body. In addition, even saline implants can leak small amounts of silicone or platinum into the body, which come from the outer shell (the “bag” that holds the saline) of the implant. The long-term health risks of those leaks are unknown.



Financial and Insurance Concerns
Breast augmentation usually costs $5,000 to $7,000 and many physicians will sell the procedure on the installment plan. However, the initial cost is small compared to the lifetime costs, even for women who like their implants.

Since implants can break at any time, and are almost assured of breaking within seven to 12 years, a woman needs to consider the lifetime expense of additional surgery and replacement. Although unusual, some implants break within a few days, weeks, or months of surgery. Some implant manufacturers promise to replace the implants for free, but the expense of the implant may be a small percentage of the total cost of augmentation. Some doctors also promise to provide their replacement services for free, but that does not include the cost of the medical facility, anesthesiologist, and so on.

Augmentation is almost never paid for by health insurance, so the costs of additional surgery can be very expensive. Women with implant problems can have many surgeries within a few years.

An even greater problem is that breast implants can make a woman uninsurable. While many insurance policies will merely exclude the implants, or the entire breast area from coverage (a terrible problem if the woman later gets breast cancer), some major insurance companies have decided to totally exclude any woman with breast augmentation from their policies.

The costs of removing a broken silicone gel implant are substantial. If the implant breaks and the silicone gel spills out, it can mix with the breast tissue and other tissue and be almost impossible to remove. Surgical efforts to remove broken gel implants can take hours and cost tens of thousands of dollars. In addition, a mastectomy may be necessary to remove the silicone in an otherwise healthy breast.



What Have I Got to Lose?
Many cosmetic changes are easy to undo. Breast implants are not. Once the skin and natural breast tissue have been stretched by breast implants, they will never look the same as they did before the implant surgery. Most plastic surgeons try to persuade their patients to replace a problem implant, warning them that they will be depressed by their appearance if they are taken out and not replaced. This should be of particular concern to parents who are considering implants for their daughters. If a 17-year-old dyes her hair, she can dye it back or grow it out. If she decides to get breast implants, it is a decision that will permanently change her body. If she wasn’t satisfied with the size of her breasts before implants, imagine how she will feel to have breasts that are just as small and also sagging.



Why Weren’t Implants Studied Before They Were Sold to Women?
With all the problems and unanswered questions about breast implants, the obvious question is “Why weren’t implants studied first and improved before selling them to women across the country?”

The FDA did not have the authority to regulate any kinds of implants or medical devices until 1976. Implants had been sold since the 1960s, so they were allowed to stay on the market until the FDA reviewed them. Meanwhile, there was a substantial backlog of products that the FDA needed to review, and cosmetic products like breast implants were not a priority. Unfortunately, the manufacturers did not conduct long-term studies until the FDA required them.



Conclusion
The more than one million women who have breast implants are, without their realizing it, part of a natural “study” to learn what the risks are. Women deserve to be told what is known, and what is not known, before they make this decision. And, if a woman with implants complains of symptoms, she needs to find a plastic surgeon who has a reputation for helping women with implant problems.




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