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          Silicone Breast Implants and Your Body: What's the Real Deal?

          You have probably heard a lot of back and forth about the safety of silicone-filled breast implants. The good news is that these implants have been largely exonerated from concerns that they increase your risk of breast cancer and autoimmune/connective tissue diseases such as lupus and arthritis. Silicone-filled breast implants are now an option for women who wish to undergo breast augmentation.

          The best way to make an informed decision about what type of implant to choose for your breast augmentation is to carefully weigh, and understand, the advantages and disadvantages of the available implant options.

          What Is Silicone? A Brief Chemistry Lesson

          Silicon is the second most abundant element on the planet. In nature, silicon combines with oxygen to produce the many types of silicas that are part of the environment, including sand, quartz, and minerals. In fact, silicon and oxygen together comprise three-quarters of the Earth's crust. Silicone was used in prehistoric times to create tools and weapons.

          Silicone became a staple ingredient in commercial products in the early 1940s. Scientists and chemists ultimately found ways to use it in a host of products in just about every industry known to man — including the food processing, textile, aerospace and medical industries.

          While people often think "breast implants" when they hear the word "silicone," this ubiquitous polymer is also used to augment or reconstruct cheeks, chins, brow bones, calves, pectoral muscles and joints. Silicone products, in their solid form, have been safely used within the body for years.

          Silicone Controversy

          So how did all the controversy regarding silicone breast implants take shape?

          Breast implant manufacturers first came up with the idea of silicone-filled implants with thin shells in the 1970s and 1980s. Their earlier incarnation had thicker shells, so the breasts did not look natural. The new thinner shell solved this problem. Unfortunately, it also made them more likely to rupture — and leak.

          This is when all the trouble started.

          It was in the 1980s that reports of silicone gel leaking out of the implant shells first surfaced. The gel migrated into the pocket containing the implant and, occasionally, into other areas of the body. A disproportionate number of women with these implants seemed to develop autoimmune diseases and connective tissue diseases such as lupus and arthritis. What followed was a host of class action lawsuits and several million-dollar judgments against implant manufacturers. The controversy surrounding silicone gel implants went on for years. (For more detailed information, see our timeline of the key events in the history of breast augmentation).

          In 1991, the Food and Drug Administration (FDA) asked implant manufacturers to submit evidence that silicone-gel-filled breast implants were safe and effective. At that time, the manufacturers could not provide the required information. In January 1992, the FDA called for a voluntary moratorium on the use of silicone breast implants. Later that year, the agency lifted this ban, stating that silicone-gel-filled breast implants should be available only for women seeking breast reconstruction after breast cancer treatment or revision of an existing breast surgery. Implant makers were told to conduct rigorous studies on women in these categories who received the implants.

          The Institute of Medicine stepped in soon thereafter. This well-respected organization concluded that silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, but they do not cause systemic diseases.

          In November 2006, the FDA approved the sale of two brands of silicone-filled breast implants. Allergan received approval to market its Inamed® Silicone-Filled Breast Implants and Mentor Corporation received approval to market its Mentor MemoryGel™ Silicone Gel-filled Breast Implants.

          Silicone-gel-filled breast implants are now considered a safe and natural option for the hundreds of thousands women seeking cosmetic breast augmentation. In 2011, the FDA stated that silicone gel-filled breast implants are relatively safe, but may need to be removed or replaced within a 10-year span. The FDA is requiring that manufacturers continue to study their implants.

          In a further testament to the safety of silicone gel-filled breast implants, the FDA approved two highly cohesive, form-stable "gummy bear" breast implants including Allergan’s Natrelle 410 implant and Sientra’s line of breast implants. These aptly named implants have the consistency of a gummy bear, meaning that if they were to rupture, the gel wouldn't migrate.

          There has been some concern that errant gel could cause some local problems such as granulomas (small areas of inflammation within the tissue), and it is hoped that the gummies will alleviate these concerns, possibly providing a safety edge.

          Your Silicone Breast Implants: Be Vigilant

          Women may also choose saline breast implants. If a saline-filled implant ruptures, it is immediately apparent, as the implant will deflate. But the salt water will be harmlessly absorbed by the body. It is not always evident if a silicone gel implant ruptures, because it leaks out gradually. Women with silicone-gel-filled implants need a magnetic resonance imaging (MRI) exam of their breasts three years after their surgery, and then every two years, to check for these silent ruptures.

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            Joseph A. Mele, MD, FACS

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            A.J. Khalil, MD

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