Fw: Breast Augmentation: A Public Health Perspective ~ by Zuckerman, PhD

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From: " Kathi " <pureheart@...>

Sent: Thursday, September 26, 2002 8:20 PM

Subject: Breast Augmentation: A Public Health Perspective ~ by

Zuckerman, PhD

> Thank you for sending us the following. . .Myrl

>

> ----

>

> Breast Augmentation: A Public Health Perspective

>

> Written by: Zuckerman, PhD - National Center for Policy Research

> for Women and Families

>

> Introduction Breast Implants and Self-Image Are Breast Implants

> Approved by the FDA? Saline Implants What Are the Local Complications

> of All Implants? Financial and Insurance Concerns What Have I Got to

> Lose? Why Weren't Implants Studied Before They Were Sold to Women?

> Conclusion

>

>

> Introduction

>

> 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 published and unpublished studies of breast implants, and was appalled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.

>

>

> 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.

>

>

>