Breast Implants: What We Now Know

After more than 50 years in the spotlight, breast implants have been the subject of much debate. Here’s what we now know about this sometimes-controversial topic.

By Juliana Hansen, MD

Breast implants. In the roughly 50 years since they first took the medical stage, they have been applauded, banned, modified, filled with different substances, and studied extensively. They have been the reason for the bankruptcy of a major company, the subject of a $4.2 billion settlement, the mainstay of cosmetic breast surgery, and an essential component of reconstructive breast surgery. They have generated headlines, lawsuits, myths, and millions of satisfied customers. Throughout this saga, they have been used without restrictions or hesitations everywhere in the world except the United States. So what has a half century taught us about breast implants, and what should women considering their use know today?

Myths

Let’s start with the myths that can be easily dispelled.

• Implants cause cancer. FALSE. Breast implants do not cause cancer.
• Implants make people sick. FALSE. Breast implants do not cause other diseases.
• Women with implants shouldn’t breast-feed. FALSE. Breast implants do not place breast-feeding babies or their mothers at risk.
• Implants are dangerous. FALSE. Breast implants are not inherently dangerous, though any surgical procedure can have complications and should be performed by a qualified practitioner.

At the Beginning

The story of breast implants truly begins with silicone, which has long been recognized as a relatively inert material that is compatible with human tissues. Silicones can be processed into several forms—with end products ranging from a hard rubber to a liquid. Silicones have been used in many medical devices that are implanted in the body, including urologic implants, joint prostheses, and vascular ports in large veins for long-term access to the bloodstream. Silicones are also found in other widely used medical devices such as syringes. Their application to cosmetic surgery began with explorations for their use in breast augmentation.

If you were a woman who desired a breast augmentation in the 1950s, you might have found a surgeon willing to inject liquid silicone directly into your breasts. This was at a time before implants as we now know them existed. This form of augmentation proved reckless; the liquid form of silicone, in direct contact with breast tissue, incited an inflammatory response, and some women even underwent mastectomy (breast removal) to remove all the damaged tissue. These early procedures taught us the first thing we learned about the liquid form of silicone: it can cause inflammation when in direct contact with tissue. Despite the failure of these early ventures, the vision to use this material in a safer way led to the design of the first breast implants.

Advances in Technology

Today breast implants have a thin, pliable sheet of silicone that encases the silicone gel filling. The shell keeps the gel material contained and prevents direct contact with the breast tissue. But this safe, effective model is not the only idea developers of implants have devised. Since 1963, when the first generation of implants was released, a number of different types have been created, varying in the type of shell used and in the material filling the shell (vegetable oil was even studied as a possible filler but was abandoned when it was found to go rancid). Ultimately, no other filler has proved equal to silicone. It is the silicone model that millions of women throughout the world have opted to use for both augmentation and reconstructive purposes.

Controversy and Debate

During the 1980s medical journals published a number of articles describing various autoimmune disorders in women with silicone implants, including rheumatoid arthritis, fibromyalgia, scleroderma, and lupus. A cause-and-effect mechanism was proposed, theorizing that the leakage of silicone gel from implants was causing a widespread (systemic) response in the body. These published reports received a huge amount of attention from the media, personal injury lawyers, and ultimately government regulatory agencies. A 1990 Face to Face with Connie Chung television program linked silicone implants with autoimmune diseases, sparking a frenzy of lawsuits. Dow Corning, the largest manufacturer of implants at that time, lost a high-profile $7.3 million lawsuit for alleged immune system damage.

In January 1992 the Food and Drug Administration (FDA) placed a voluntary moratorium on the implantation of silicone gel implants, citing the need for more study on the health effects. A few months later, this moratorium was lifted to allow the use of silicone implants for certain urgent-need criteria; however, their use was authorized only under a research protocol, and all surgeons using the implants had to be registered participants in the study. In the same year, a class action lawsuit with more than 13,000 claims was filed, and a $4.2 billion settlement was offered. In 1998 Dow Corning filed for bankruptcy. It is interesting to note that throughout all this, no other country issued a ban on the use of silicone implants.

In 1999 Congress enlisted the help of the Institute of Medicine (IOM), a private, nonprofit agency that provides advice on health policy. The IOM formed a panel of 13 scientists to review all the pertinent existing data related to silicone implants. Based on the results of this rigorous review, the IOM released a report clearing silicone implants of any direct causal relationship with other diseases. Specifically, the report stated that there was no increased risk of disease among women with silicone breast implants, no evidence of increased breast cancer risk, no threat to nursing babies, and no evidence of any novel autoimmune disease caused by implants. What became clear was that autoimmune diseases tend to affect young women—the same group within the population who are more likely to have breast implants. Between these two large groups of people, there is a large area of overlap; in other words, many women who are diagnosed with autoimmune disorders also happen to have breast implants. There also happen to be many women (and men) who have autoimmune diseases who don’t have implants.

The IOM report was issued in June 1999. Seven years later, in November 2006, the FDA released the ban on silicone implants. What had appeared to be a plausible relationship turned out to be a coincidence. Once scientific methods were applied, silicone implants were cleared. Since that time silicone implants have been available for general use in women age 22 and older. Patients continue to be enrolled in studies to follow the long-term outcomes of implants. Additionally, there are new-generation silicone implants being studied.

Implants Today

Two types of implants currently exist: silicone implants and saline implants. Both types have a shell made of silicone, formed from a thin layer of a pliable but solid form of silicone. They differ in the material used to fill the shell. Silicone implants are filled with a gel form of silicone, which is thick and squishy with a consistency like bread dough. Saline implants are filled with saltwater and have a consistency more like a water balloon. Both types are widely used, and both have advantages. Silicone implants have a more natural feel and blend in better with natural tissue.

Saline implants do not present the same concern for leaks as silicone implants do, so there are no recommendations for routine monitoring or exchange. They are the only implants available for women under the age of 22. Saline implants have always been available for women of all ages, even throughout the silicone implant ban. Both silicone and saline implants come in a variety of sizes, diameters, and projections. They come in either a smooth form or a textured surface and are either round or “anatomically” shaped, with a narrower top and a fuller bottom. Surgeons tend to have preferences for implants based on what they feel (in their hands) will give their patients the nicest results and have the lowest chance of complications.

Possible Complications

What have we learned about implant leak and rupture? The longer an implant has been in place, the more likely a leak or rupture is to occur. Factors that may influence rupture include stress on the implant during insertion, scarring around the implant, folds that create weak points, and severe external pressure or trauma to the chest. A leak may not be obvious with silicone implants, which is why doctors call this occurrence a “silent rupture.” Women who have undergone screening tests with magnetic resonance imaging (MRI) to look for signs of leak show a 0.5 percent incidence of rupture at three years for augmentation patients and 0.9 percent among reconstruction patients. Some women experience symptoms associated with rupture, such as knots surrounding the implant, lumps in the armpit, a change in breast appearance, or a hardening, tingling, burning, or numbness of the breast. To date, the data available from multiple studies show that when leakage occurs, the problems remain localized to the breast and nearby lymph nodes.

When a woman suspects an implant rupture, she should seek a medical evaluation that includes a physical exam and imaging (likely an MRI or ultrasound). If a rupture is confirmed, the implant should be removed and exchanged. The current recommendations for silicone implants are to undergo routine screening tests for rupture. The FDA has established guidelines that include a first MRI at three years post-implantation followed by every two years. Recommendations also include a preventive implant exchange every 10 years. It is not yet clear if this will prove to be the best way to screen for leaks or prevent problems related to ruptured implants.

Saline implants are different from silicone when it comes to rupture. If they leak, the body quickly and safely reabsorbs the saltwater, and deflation becomes obvious. An implant may appear softer and less full, or it may deflate fully and flatten. In these cases, patients should undergo surgery to replace the implant as soon as it is convenient, although there are no health-related concerns.

Both types of implants normally develop a capsule of scar tissue around them. When this scar tissue becomes thickened and squeezes on an implant, a condition called capsular contracture develops. In and of itself, this condition is not dangerous, though it may cause an implant to change shape and appearance and become hard. In severe cases capsular contracture may cause discomfort and would result in an additional surgery to repair or replace the implant.

Women who get implants tend to be very pleased with the results, but they should be aware that implants in general are not lifetime devices. After implantation it is likely that at some point they will need additional surgery. In one large study, 15 percent of women who underwent a first-time breast augmentation had additional surgery within three years. The main reason for this additional procedure was to repair scarring around the implant. The second most common reason patients had additional surgery was to change the size or shape of the implant. For women who had implants for reconstruction after breast cancer surgery, 27 percent underwent a second procedure within three years. Among these women the main reason for the second procedure was to address asymmetry.

Rely on Safe Medicine and Sound Data

The saga of silicone implants highlights the importance of medical decision-making and health policy that is based on fact and scientific data and not swayed by sensationalism, speculation, and widespread litigation. It also highlights the importance of safe utilization of medical innovations. Women considering implants should be sure that they are seeing a reputable surgeon, trained in plastic surgery, with whom they can work for immediate care as well as for long-term follow-up.

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